[Federal Register Volume 89, Number 92 (Friday, May 10, 2024)]
[Rules and Regulations]
[Pages 40876-41000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08273]



[[Page 40875]]

Vol. 89

Friday,

No. 92

May 10, 2024

Part III





 Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 438, 442, and 483





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

  Federal Register / Vol. 89, No. 92 / Friday, May 10, 2024 / Rules and 
Regulations  

[[Page 40876]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 438, 442, and 483

[CMS-3442-F]
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: Final rule.

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SUMMARY: This final rule establishes minimum staffing standards for 
long-term care facilities, as part of the Biden-Harris Administration's 
nursing home reform initiative to ensure safe and quality care in long-
term care facilities. In addition, this rule requires States to report 
the percent of Medicaid payments for certain Medicaid-covered 
institutional services that are spent on compensation for direct care 
workers and support staff.

DATES: 
    Effective date: These regulations are effective on June 21, 2024.
    Implementation date: Except as set forth in this section, these 
regulations must be implemented upon the effective date.
     The regulations at Sec.  483.71 must be implemented by 
August 8, 2024, for all facilities.
     The regulations at Sec.  483.35(b)(1) and (c)(1) must be 
implemented by May 11, 2026, for non-rural facilities and May 10, 2027, 
for rural facilities as defined by the Office of Management and Budget.
     The regulations at Sec.  483.35(b)(1)(i) and (ii) must be 
implemented by May 10, 2027, for non-rural facilities and May 10, 2029, 
for rural facilities as defined by the Office of Management and Budget.
     The regulations at Sec. Sec.  438.72(a) and 442.43 must be 
implemented by all States and territories with Medicaid-certified 
nursing facilities and intermediate care facilities for individuals 
with intellectual disabilities beginning May 10, 2028.

FOR FURTHER INFORMATION CONTACT: The Clinical Standard Group's Long 
Term Care Team at [email protected] for information 
related to the minimum staffing standards.
    Anne Blackfield, (410) 786-8518, for information related to 
Medicaid institutional payment transparency reporting.

SUPPLEMENTARY INFORMATION: 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 Provisions
    C. Summary of Cost and Benefits
II. Minimum Staffing Standards for Long-Term Care Facilities in 
Response to the Presidential Initiative
    A. Background
    B. Provisions of the Proposed Regulations and Analysis of and 
Response to Public Comments
    1. General Comments
    2. Definitions
    3. Minimum Staffing Standards
    4. Registered Nurse 24 Hours per Day, 7 Days a Week
    5. Hardship Exemption
    6. Facility Assessment
    7. Implementation Timeframe
    8. Severability Clause
    C. Consultation With State Agencies and Other Organizations
III. Medicaid Institutional Payment Transparency Reporting Provision
IV. Provisions of the Final Regulations
V. Collection of Information Requirements
VI. Response to Comments
VII. Regulatory Impact Analysis

I. Executive Summary

A. Purpose

    This final rule establishes minimum staffing standards to address 
ongoing safety and quality concerns for the 1.2 million \1\ residents 
receiving services in Medicare and Medicaid certified Long-Term Care 
(LTC) facilities each day. As we have heard from residents, staff, and 
advocates across the country in response to the proposed rule, ensuring 
adequate staffing levels is essential to the safety and quality of 
long-term care facilities. On February 28, 2022, President Biden 
announced that CMS would establish minimum staffing standards that 
nursing homes must meet, based in part on evidence from a new research 
study that would focus on the level and type of staffing needed to 
ensure safe and quality care.\2\ This announcement was part of an 
overall reform plan to improve the quality and safety of nursing homes. 
In addition, on April 18, 2023, President Biden issued Executive Order 
14095, ``Increasing Access to High-Quality Care and Supporting 
Caregivers,'' \3\ which directs the Secretary of HHS to consider 
actions to reduce nursing staff turnover, which is associated with 
negative impacts on safety and quality of care.4 5 On 
September 6, 2023, we published the ``Medicare and Medicaid programs; 
Minimum Staffing Standards for Long-Term Care Facilities and Medicaid 
Institutional Payment Transparency Reporting'' \6\ proposed rule 
(referred to as the ``proposed rule'').
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    \1\ https://data.cms.gov/provider-data/dataset/4pq5-n9py.
    \2\ 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/.
    \3\ E.O. 14095, 88 FR 24669 (Apr. 21, 2023).
    \4\ 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.
    \5\ 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.
    \6\ 88 FR 61352 through 61429.
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    The safety and quality concerns identified by the President stem, 
at least in part, from chronic understaffing in LTC facilities, and are 
particularly associated with insufficient numbers of registered nurses 
(RNs) and nurse aides (NAs), as evidenced from, among other things, a 
review of data collected since 2016 and lessons learned during the 
COVID-19 Public Health Emergency (PHE). Numerous studies, including a 
new research study commissioned by CMS as well as existing literature, 
have shown that staffing levels are closely correlated with the quality 
of care that LTC facility residents receive as well as with improved 
health outcomes. Higher staffing levels also provide staff in LTC 
facilities the support they need to safely care for residents. Minimum 
staffing standards can thus help prevent staff burnout, thereby 
reducing staff turnover, which can lead to more consistent care and 
improved safety and quality for residents and staff. This final rule 
also promotes public transparency related to the percent of Medicaid 
payments for certain institutional services that are spent on 
compensation to direct care workers and support staff.

B. Summary of Provisions

    We are updating the Federal ``Requirements for Medicare and 
Medicaid Long Term Care Facilities'' minimum staffing standards (``LTC 
requirements''). We will survey facilities for compliance with the 
updated LTC requirements in the rule and enforce them as part of CMS's 
existing survey, certification, and enforcement process for LTC 
facilities. In addition, consistent with the President's reform plan, 
we will display our determinations of

[[Page 40877]]

facility compliance with the minimum staffing standards on Care Compare 
\7\ and require facilities to post a public notice within the facility 
if they are out of compliance with the standards so it is easily 
visible for staff and residents.
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    \7\ https://www.medicare.gov/care-compare/?redirect=true&providerType=NursingHome.
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    We are establishing Federal minimum nurse staffing standards for a 
number of reasons, including the growing body of evidence demonstrating 
the importance of staffing to resident health and safety, continued 
insufficient staffing, non-compliance by a subset of facilities, the 
need to create a consistent floor to reduce variability in the minimum 
floor for nurse-to-resident ratios across States, the need to support 
nursing home staff, and, most importantly, to reduce the risk of 
residents receiving unsafe and low-quality care.
    The regulatory updates are based on evidence we collected using a 
multifaceted approach, informed by multiple sources of information, 
including the 2022 Nursing Home Staffing Study; more than 3,000 public 
comment submissions from the Fiscal Year 2023 Skilled Nursing Facility 
Prospective Payment System proposed rule (FY2023 SNF PPS) request for 
information (RFI); academic and other literature; Payroll Based Journal 
(PBJ) System data; detailed listening sessions with residents and their 
families, workers, health care providers, and advocacy groups; and 
analyzing the 46,520 comments received on the proposed rule.
    Specifically, in the final rule, we are revising Sec.  483.35(b) to 
require an RN to be on site 24 hours per day and 7 days per week (24/7 
RN) to provide skilled nursing care to all residents in accordance with 
resident care plans, with an exemption from 8 hours per day of the 
onsite RN requirement under certain circumstances. Requirements for 
this exemption are consistent with the requirements for other waivers 
and exemptions set forth in the LTC requirements. We are also adopting 
total nurse staffing and individual minimum nurse staffing 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). We are specifying that facilities must provide, at a minimum, 
3.48 total nurse staffing hours per resident day (HPRD) of nursing 
care, with 0.55 RN HPRD and 2.45 NA HPRD. We are defining ``hours per 
resident day'' 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 CMS. We note that while the 3.48 
total nurse staffing, 0.55 RN, and 2.45 NA 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 minimum 3.48 total 
nurse staffing, 0.55 RN, and 2.45 NA HPRD standards regardless of the 
individual facility's resident case-mix, as they are the minimum 
standard of staffing. If the acuity needs of residents in a facility 
require a higher level of care, as the acuity needs in many facilities 
will, a higher total, RN, and NA staffing level will likely be 
required. As further described below, the minimum staffing standard is 
supported by literature evidence, analysis of staffing data and health 
outcomes, discussions with residents, staff, and industry \8\ and other 
factors.
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    \8\ 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.
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    Each of the minimum staffing requirements independently supports 
resident health and safety and is evaluated separately. Therefore, 
compliance with the 24/7 RN requirement does not simultaneously 
constitute compliance with the minimum 3.48 HPRD total nurse staffing 
standard, the 0.55 RN HPRD, or the 2.45 NA HPRD requirements or vice 
versa. Similarly, but separately, a minimum number of total nurse 
staffing including RN and NA hours per resident per day improves 
overall quality of care. Both independently and collaboratively, these 
requirements and the totality of the LTC requirements for 
participation, will 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.
    The resulting, evidence-based final rule appropriately prioritizes 
quality and safety of care gains from establishing minimum standards 
for nurse staffing, including RNs and NAs, with a particular emphasis 
on the direct care delivered at the bedside, and effective 
implementation of these new requirements. These new required minimum 
staffing requirements will increase staffing in more than 79 percent of 
nursing facilities nationwide,\9\ and the specific RN and NA HPRD 
requirements exceed the existing minimum staffing requirements in 
nearly all States.\10\ We remain committed to continued examination of 
staffing thresholds, including careful work to review quality and 
safety data resulting from initial implementation of the final rule and 
robust public engagement. Should subsequent data indicate that 
additional increases to staffing minimums are warranted and feasible, 
we anticipate that we will revisit the minimum staffing standards to 
shift them toward the higher ranges supported by the evidence, with 
continued consideration of all relevant factors.
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    \9\ PBJ data from the October 2021 Nursing Home Care Compare 
data set.
    \10\ Based on information in the staffing study report appendix 
E2 all States with the exception of 2 have a total staffing HPRD 
greater than 3.48 or for RN greater than .55HPRD (source: PBJ data 
Average 2022 Q1 nursing staffing levels by State).
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    We are also revising the existing Facility Assessment requirements 
at Sec.  483.70(e). We are redesignating the provisions at Sec.  
483.70(e) to a standalone section at Sec.  483.71. We are further 
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.
    As we indicated in the proposed rule, we are finalizing a staggered 
implementation of these requirements over a period of up to 5 years for 
rural facilities and 3 years for non-rural facilities to allow all 
facilities the time needed to prepare and comply with the new 
requirements.
    Exemption from the minimum standards of 0.55 HPRD for RNs, 2.45 
HPRD for NAs and 3.48 HPRD for total nurse staffing, and the 8-hours 
per day of the 24/7 RN onsite requirement would be available only in 
limited circumstances. In order to qualify for an exemption, a facility 
must meet the following criteria: (1) the workforce is unavailable as 
measured by having a nursing workforce per labor category that is a 
minimum of 20 percent below the national average for the applicable 
nurse staffing type, as calculated by CMS, by using the Bureau of Labor 
Statistics and Census Bureau data; \11\ (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; (4) the facility 
posts a notice of its exemption status in a prominent and publicly 
viewable location in each resident facility; and (5) the facility 
provides individual notice of its exemption status and the degree to

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which it is not in compliance with the HPRD requirements to each 
current and prospective resident and sends a copy of the notice to a 
representative of the Office of the State Long-Term Care Ombudsman. If 
the exemption is granted, CMS will post on Care Compare a notice of its 
exemption status and the degree to which it is not in compliance with 
the requirements.
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    \11\ For example, Hospital Review at https://www.beckershospitalreview.com/workforce/nurses-per-capita-ranked-by-state.html.
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    A facility will be excluded from being eligible to receive an 
exemption if it: (1) has failed to submit PBJ data in accordance with 
re-designated Sec.  483.70(p); (2) is a Special Focus Facility (SFF); 
(3) has 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; or (4) has 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. We note that the 
existing statutory waiver for all RN hours over 40 hours per week will 
still be available as required by sections 1819(b)(4)(C)(ii) and 
1919(b)(4)(C)(ii) of the Act, as this rule does not purport to 
eliminate or modify the existing statutory waiver.
    As with other LTC requirements for participation, enforcement 
actions, also called remedies, may be taken against facilities that are 
not in substantial compliance with these Federal participation 
requirements under 42 CFR part 488, subpart F. The remedies that may be 
imposed include, but are not limited to, the termination of the 
provider agreement, denial of payment for new admissions, and/or civil 
money penalties.
    We also proposed, and are finalizing, new regulations at 42 CFR 
442.43 (with a cross-reference at 42 CFR 438.72) to 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 (ICFs/IID) that are 
spent on compensation for direct care workers and support staff. This 
requirement 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. In addition, the 
requirements being finalized in this final rule are consistent with 
efforts to address the sufficiency of payments for home and community-
based services (HCBS) to direct care workers and access to and the 
quality of services received by beneficiaries of HCBS finalized in the 
Ensuring Access to Medicaid Services final rule published elsewhere in 
this Federal Register. As finalized, States will have to comply with 
these requirements beginning 4 years from the effective date of this 
final rule.

C. Summary of Cost and Benefits
[GRAPHIC] [TIFF OMITTED] TR10MY24.081


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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 permits 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 \12\ 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.
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    \12\ 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.
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    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. In order to be 
certified to participate in Medicare and Medicaid programs, prospective 
and existing providers of services must meet and continue to meet all 
applicable Federal participation requirements. These Federal 
participation requirements are the basis for survey activities in LTC 
facilities for ensuring that residents' minimum health and safety 
requirements are met and maintained, as well as for facilities 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 
(SNF/NF) 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 that 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.
    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.\13\
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    \13\ https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-483#483.70.
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    The participation requirements for LTC facilities (Federal 
requirements) are set forth at Sec. Sec.  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 (Sec.  
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 (Sec.  
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 (Sec.  
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''.
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. As part of this 2016 final rule, we 
revised the LTC 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. Prior to issuing 
this final rule, in August 2015 we mandated the requirement for LTC 
facilities to submit direct care staffing information based on payroll 
data to CMS as part of the ``Medicare Program; Prospective Payment 
System and Consolidated Billing for Skilled Nursing Facilities for FY 
2016, SNF Value-Based Purchasing Program, SNF Quality Reporting 
Program, and Staffing Data Collection final rule'' (80 FR 46390).\14\ 
In the 2015 Reform of Requirements for Long-Term Care Facilities 
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). Since

[[Page 40880]]

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, which was unavailable at the 
time, and new evidence from the literature.
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    \14\ Medicare Program; SNF PPS FY 2016 Final Rule. https://www.federalregister.gov/documents/2015/08/04/2015-18950/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities.
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    Additionally, as a part of the FY 2023 Skilled Nursing Facility 
Prospective Payment System Proposed Rule Request for Information (FY 
2023 SNF PPS RFI) commenters provided examples of ongoing quality and 
safety concerns within LTC facilities.\15\ These included, but were not 
limited to, residents going entire shifts without receiving toileting 
or multiple 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 \16\ corroborated these comments and identified that 
basic care tasks, such as bathing, toileting, and mobility assistance, 
are often delayed when LTC facilities are understaffed, which is not 
sufficient to meet the nursing needs of residents. 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. We refer readers to the proposed rule for a 
detailed discussion of the concerns highlighted in interviews as part 
of the 2022 Staffing Study (88 FR 61359).\17\
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    \15\ 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. 87 FR 22720, April 15, 2022 (https://www.federalregister.gov/documents/2022/04/15/2022-07906/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities).
    \16\ 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.
    \17\ https://www.federalregister.gov/documents/2023/09/06/2023-18781/medicare-and-medicaid-programs-minimum-staffing-standards-for-long-term-care-facilities-and-medicaid.
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    The academic literature also suggests the importance of adequate 
staffing in LTC facilities. In a 2021 study, where interview data were 
examined, and multivariate analyses of resident outcomes were 
conducted, the 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 a decreased number of outpatient emergency department 
visits.\18\ 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.\19\
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    \18\ 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.
    \19\ 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.
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    The COVID-19 Public Health Emergency (PHE) further highlighted and 
exacerbated long-standing concerns about inadequate staffing in LTC 
facilities. The COVID-19 PHE also yielded evidence that appropriate 
staffing made a difference as a part of the overall response in LTC 
facilities. 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 more stars for nurse staffing in the Five Star Quality 
Rating System than in counterpart facilities with a rating of one to 
three stars for staffing.\20\ 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 
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.\21\ These 
findings suggest that there is a positive relationship between the 
hours of direct care that RNs provide and infection transmission in LTC 
facilities.
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    \20\ 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.
    \21\ https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.16689.
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    Workforce challenges have also contributed to understaffing, nurse 
burnout, and position turnover.\22\ 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. 
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 for a variety of reasons including the 
difficulty of the work and comparatively lower pay, although it has 
steadily increased over the past year and a half.23 24 There 
is also evidence that facilities have additional funding that they 
could be devoting to staffing. For example, one paper found that 
nursing homes in Illinois were much more profitable than claimed but 
that 63 percent of those profits were hidden and directed to related 
parties of the owner. If those hidden profits were instead put toward 
staffing, the study found, RN staffing could be substantially increased 
and the share of facilities in compliance with the registered nurse 
requirements of the proposed rule would rise by twenty percentage 
points from 55.2 percent to 75.6 percent and compliance with the nurse 
aide HRPD requirement would rise from 15.3 percent to 36.1 percent in 
Illinois.\25\
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    \22\ 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.
    \23\ Refer, for example, to a report from the Kaiser Family 
Foundation indicating that as of March 20, 2022, 28 percent 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.
    \24\ https://data.bls.gov/timeseries/CES6562300001?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true.
    \25\ Ashvin Gandhi and Andrew Olenski, Tunneling and Hidden 
Profits in Health Care, NBER Working Paper (March 2024), Tunneling 
and Hidden Profits in Health Care (nber.org).
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    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) 
highlight the need for national minimum staffing standards for direct 
care in LTC facilities.

[[Page 40881]]

    Chronic understaffing nonetheless continues in LTC facilities, and 
evidence demonstrates the benefits of increased nurse staffing in these 
facilities. For example, a report by the HHS 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.\26\ The literature also 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. 
In particular, there has been evidence of new for-profit owners 
reducing levels of registered nurse staffing in order to reduce 
costs.\27\
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    \26\ Office of Inspector General (OIG), Some Nursing Homes' 
Reported Staffing Levels in 2018 Raise Concerns; Consumer 
Transparency Could Be Increased, OEI-04-18-00450, August 2020. 
https://oig.hhs.gov/oei/reports/oei-04-18-00450.asp.
    \27\ https://www.nber.org/system/files/working_papers/w28474/w28474.pdf.
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    Finally, multiple studies have shown that nursing home quality is 
generally lower in LTC facilities that serve high proportions of 
minority residents.28 29 30 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.31 32 Furthermore, disparities in 
safety and quality of care exist between LTC facilities with a high 
number of Medicaid residents and LTC facilities that have a high number 
of Medicare residents, with facilities with a high number of Medicaid 
residents tending to have worse outcomes.\33\ These disparities can 
contribute to differences in quality across facilities' sites.\34\ 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, will help to advance equitable, safe, and 
quality care sufficient to meet the nursing needs for all residents and 
greater consistency across facilities.
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    \28\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3805666/.
    \29\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4108174/.
    \30\ https://onlinelibrary.wiley.com/doi/epdf/10.1111/1475-6773.12079.
    \31\ https://www.jamda.com/article/S1525-8610(21)00243-7/
fulltext.
    \32\ https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094.
    \33\ 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.
    \34\ https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094.
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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 was to establish a minimum nursing home 
staffing requirement for LTC facilities participating in Medicare and 
Medicaid.\35\ 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 FY 2023 SNF PPS RFI,\36\ 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 would affect other CMS programs and/or 
initiatives as well as the enforceability of such standards.
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    \35\ 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/.
    \36\ 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. https://www.federalregister.gov/documents/2022/04/15/2022-07906/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities.
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    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, providers and provider 
industry associations, labor unions and organizations, nursing home 
residents, staff and administrators, industry experts, researchers, 
family members, and caregivers of residents in LTC facilities.
    In the proposed rule we discussed the 2022 nursing home staffing 
study \37\ that CMS commissioned (see 88 FR 61359-61364). In brief, the 
key takeaways were:
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    \37\ 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.
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     There is no clear, consistent, and universal methodology 
for setting specific minimum staffing standards, as evidenced by the 
varying current standards across the 38 States and the District of 
Columbia that have adopted their own staffing standards.
     The relationship between staffing and quality of care and 
safety, varies by staff type and level as follows:
    ++ Total Nurse Staffing hours per resident day of 3.30 or more have 
a strong association with safety and quality care.
    ++ 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 appear to 
have any consistent association with safety and quality of care.
    However, we recognize that LPN/LVN professionals undoubtedly 
provide important services to LTC facility residents despite the 
findings that LPN/LVN staffing levels do not appear to have a 
consistent association with safety and quality of care, unlike RN and 
NA staffing levels.
     Increasing nursing staffing levels are associated with 
benefits including enhanced safety and quality, as well as costs, 
namely financial costs to LTC facilities.
    In addition to commissioning the 2022 Nursing Home Staffing Study 
and issuing the FY 2023 SNF PPS RFI, CMS 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. We described the 
general content of these listening sessions in the 2023 proposed rule 
(see 88 FR 61352).
4. Ongoing CMS Initiatives and Programs Impacting LTC Facilities
    In establishing the proposed and final minimum staffing standards, 
we also considered ongoing CMS policies, programs, and operations, 
including the SNF Prospective Payment System (SNF PPS), 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.

[[Page 40882]]

a. Medicare Skilled Nursing Facility Prospective Payment System
    The Medicare SNF PPS 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) that is statutorily 
required to be updated annually. The FY 2025 SNF PPS proposed rule 
published on April 3, 2024, and proposed to update the Medicare payment 
policies and rates for SNFs for FY 2025. For the proposed FY 2025 
update, CMS estimated that the aggregate impact of the payment policies 
in the proposed rule would result in a net increase of 4.1 percent, or 
approximately $1.3 billion, in Medicare Part A payments to SNFs in FY 
2025, if finalized. 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 prices. Specifics 
regarding the process to update SNF PPS payment rates are discussed in 
the rule.\38\
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    \38\ 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 2025. https://www.cms.gov/newsroom/fact-sheets/fy-25-skilled-nursing-facility-prospective-payment-system-proposed-rule-cms-1802-p.
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b. 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 to improve quality of care 
provided to residents.\39\ Performance on the Total Nurse Staffing 
measure in FY 2024 will be used to make payment adjustments 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 minimum staffing standards are not duplicative of this existing 
measure; rather, they are complementary by establishing a consistent 
and broadly applicable national floor (baseline) 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.
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    \39\ https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2023-skilled-nursing-facility-prospective-payment-system-final-rule-cms-1765-f.
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c. Nursing Home Survey and Enforcement
    The LTC minimum staffing standards in this regulation are part of 
the Federal participation requirements for LTC facilities which 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 processes under 42 CFR part 488.\40\ 
Section 1864(a) of the Act authorizes the Secretary to enter into 
agreements with the State survey agencies to determine whether SNFs 
meet the Federal participation requirements for Medicare. Section 
1902(a)(33)(b) of the Act provides for the State survey agencies to 
perform the same survey tasks for NFs in Medicaid. The results of these 
surveys are used by CMS and the State Medicaid Agency, respectively, as 
a basis for a decision to enter into, deny, or terminate a provider 
agreement with the facility. They are also used to determine whether 
one or more enforcement remedies should be imposed against LTC 
facilities that are not in substantial compliance with these Federal 
participation requirements. 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 substantial compliance with the Federal 
participation requirements. Specifically, enforcement remedies that may 
be imposed include the following:
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    \40\ https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationenforcement/nursing-home-enforcement.
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     Termination of the provider agreement;
     Temporary management;
     Denial of payment for all Medicare and/or Medicaid 
individuals by CMS to a facility, for Medicare, or to a State, for 
Medicaid;
     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 
seriousness, that is, 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 Medicare and Medicaid LTC facilities on the CMS 
public-facing Care Compare website, including the number of certified 
beds and a facility's overall Five Star quality rating, including three 
individual star ratings in the categories of inspections, staffing, and 
quality measurement.\41\ In addition, individual performance quality 
measures are included on Care Compare. With respect to nursing home 
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 (health inspection data), reporting through the PBJ System, 
and resident assessment data reported by LTC facilities to us.
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    \41\ 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.
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    Over the last several years, CMS has taken a number of actions to 
strengthen our oversight and enforcement of compliance. For example, in 
2022, CMS began integrating PBJ data into the survey process to help 
target surveyors' investigations of a facility's compliance; in 2023, 
CMS announced it would undertake new analyses of State inspection 
findings to ensure cited deficiencies receive the appropriate 
consequence, particularly involving resident harm.\42\ Additionally, we 
began posting levels of weekend staffing and rates of staff turnover, 
and using these metrics in the Five Star Quality Rating System to help 
provide more useful information to consumers. Furthermore, CMS revised 
the policies in the Special Focus Facility (SFF) program to ensure 
these facilities make sustainable improvements to protect residents' 
health and safety.\43\ In January 2023, CMS began conducting audits of

[[Page 40883]]

facilities' medical records to identify if residents were 
inappropriately given a diagnosis of schizophrenia, and administered 
antipsychotics drugs, which are very dangerous for residents. Lastly, 
in November 2023, CMS released a final rule that implemented portions 
of section 6101 of the Affordable Care Act, requiring the disclosure of 
certain ownership, managerial, and other information regarding LTC 
facilities.\44\
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    \42\ https://www.whitehouse.gov/briefing-room/statements-releases/2023/09/01/fact-sheet-biden-harris-administration-takes-steps-to-crack-down-on-nursing-homes-that-endanger-resident-safety/.
    \43\ https://www.cms.gov/newsroom/press-releases/biden-harris-administration-strengthens-oversight-nations-poorest-performing-nursing-homes.
    \44\ https://www.cms.gov/newsroom/fact-sheets/disclosures-ownership-and-additional-disclosable-parties-information-skilled-nursing-facilities-and-0.
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    As noted previously in this section, we have been moving towards 
more data-driven enforcement, including use of the PBJ System data to 
guide monitoring, surveys and enforcement of existing staffing 
requirements. Additionally, starting in late 2023, CMS expanded audits 
of these data. We continue to recognize, however, 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. Often, that will 
require higher staffing than the minimum requirements. The additional 
requirements 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 (baseline).
    In summary, the benefits and success of minimum staffing standards 
are heavily dependent on our utilization of the survey and enforcement 
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.
d. 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 
Ensuring Access to Medicaid Services final rule published elsewhere in 
this Federal Register and Medicaid and CHIP Managed Care Access, 
Finance, and Quality final rule published elsewhere in this Federal 
Register, we finalized several policies that will work alongside those 
included in this rule. These finalized 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 certain Medicaid HCBS providers' 
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.\45\
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    \45\ Money Follows the Person [verbar] Medicaid, https://www.medicaid.gov/medicaid/long-term-services-supports/money-follows-person/index.html.
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    Notably, similar to the findings in the 2022 Nursing Home Staffing 
Study, we believe that the minimum staffing standards finalized in this 
rule will improve quality of care which includes facilitating the 
transition of care to community-based care services and potential 
Medicare savings.

B. Provisions of the Proposed Regulations and Analysis and Response to 
Public Comments

    In response to the proposed rule, we received 46,520 total 
comments. Commenters included long term care consumers, advocacy groups 
for long-term care consumers, organizations representing providers of 
long-term care and senior service, long-term care ombudsmen, State 
survey agencies, various health care associations, legal organizations, 
labor unions, residents, families, and many individual health care 
professionals (such as nursing organizations) and administrative staff. 
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. Most commenters supported the proposed 
rule's goals to ensure safe and quality care in LTC facilities.
    In this final rule, we provide a summary of each proposed 
provision, a summary of the public comments received and our responses 
to them, and an explanation for changes in the policies that we are 
finalizing.
1. General Comments
    Comment: Many commenters shared their personal stories of care 
provided and received in nursing homes. While a majority of these 
commenters shared observations of the compassion shown by well-meaning 
staff, they also shared observations of missed care and avoidable harm 
that occurred due to insufficient staffing. A resident stated:
     ``I was in a nursing home for rehab on discharge from 
hospital the day after I broke my shoulder in a fall down a staircase. 
When a fire alarm sounded I was on the toilet. I heard the automatic 
fire doors close. I stayed as calm as I could, reminding myself someone 
would come to get me off the toilet and out to safety. Half an hour 
later activity resumed nearby and a CNA did help me off the toilet. She 
said `Oh I wasn't worried about you, I knew you'd get yourself out 
through the window if you needed to.' ''
    Many family members and friends shared personal stories, urging CMS 
to adopt minimum staffing standards to prevent future incidences like 
the ones that their loved ones experienced. Families and friends wrote:
     ``She was a successful Real-estate broker her whole adult 
life, who suffered a tragic fall that left her with multiple breaks in 
her leg and landed her in a nursing home for rehab. What she lost in 
the nursing home was far greater than the break, she lost her dignity 
and self-worth as she was forced to lay in her own urine on a regular 
basis and on several occasion her own feces. The staff were caring and 
capable but there was never enough of them.''
     ``The major concern was the stage 4 bed sores that Jerry 
developed after 6 weeks at BNR while Jerry was under their care. Jerry 
was continually left sitting in his own feces as he was both urinary 
and bowel incontinent. He was unable to get help or attention on 
numerous occasions by pressing the call button, to the point of 
purchasing a bull

[[Page 40884]]

horn with a siren to summon help, of course this didn't improve 
matters. Several times his roommate would be unconscious and hanging 
out of his bed a hairs breadth away from falling with no belts or 
restraints, which I personally witnessed and alerted an aide who 
replied `he likes it that way' ''.
     ``I had a loved one recently fall in a Memory Care 
Facility. She was on the floor for quite some time before she was 
discovered. She had a broken hip and no ability to become ambulatory. 
All she had done was attempt to go to the bathroom in the middle of the 
night. My recommendation is that a patient should not be left to get 
themself to the bathroom alone in the night. Why can't they have enough 
staff on hand that they can provide someone to help each patient to the 
bathroom and safely return to bed?''
     ``This past year my partner spent several months in a 
nursing home/rehab facility and I personally saw how shorthanded they 
were. The lack of adequate staff, number of part-time and substitute 
staffing, poor pay, was obvious. The nights were the worse time. A 
patient could ring for help and wait and wait an hour for a response. 
They could ask for a glass of water and wait hours for it to come. They 
could lay in their own waste or urine-soaked bedding for way too long, 
day or night. Those who needed help being fed would often just have the 
food delivered and if a family member wasn't there to help them eat 
they would go hungry.''
     ``They were supposed to check in on him every hour and to 
help him turn from side to side at least every two hours. Later, when 
he got better, they were supposed to check on him every four hours, but 
they didn't. They were supposed to change his clothing and bedsheets 
regularly. They did none of that often enough, so he developed 
bedsores/open wounds as big as your hand on his backside because of a 
lack of care. How would you like your dad to go through that experience 
in the last 24 months of his life, after all he'd been through in 90 
years?''
     ``In June 2021 while the day shift nurse was making 
morning rounds she found my family member aspirating on vomit, having 
seizures, with a 106 degree temperature which turned in to a case of 
sepsis. The nurse said she had no idea how long my family member was 
lying there in that condition as there was only 1 nurse and 1 aide for 
over 100 residents on the overnight shift. Since that incident my 
family member has lost the ability to speak and/or respond to questions 
and or commands. As a result I have personally spent 10 to 12 hours a 
day, every day, with my family member at the LTC to ensure they are 
getting the care they need.''
     ``My loved one was basically starved to death--all 
dementia patients in that specific ward were, due to not enough staff 
helping them eat. Two people were on staff to help 20 patients, so only 
the three catatonic people got help. Other patients would be 
distracted, which is natural, at meals, but then weren't encouraged to 
eat, due to lack of sufficient staff. The patients would therefore lose 
weight weekly and be dizzy, malnourished weak, leading to frequent 
falls and more and more bedridden patients. These patients would then 
get pneumonia and die. There were never enough staff to clean up spills 
and urine fast enough- I visited frequently and witnessed fall after 
fall constantly around me due to this problem. There were never enough 
staff to do ANYthing.''
    Likewise, many nursing home staff wrote of their own experiences 
and observations while trying to safely deliver care to residents. 
Staff wrote:
     ``Personal observations from my nursing home consulting 
work as a Registered Dietitian: Nurses so short staffed they declare a 
`med holiday' and throw away all the meds for one shift because they 
don't have time to pass them out. Nursing so understaffed that bedtime 
snacks, though made and delivered to the nursing station, are not 
passed out. Resulting in one insulin dependent diabetic resident's 
blood sugar zeroing out in the wee hours of the night. Patient died.''
     ``Recently a resident got skin ulcers after no one was 
able to see him for the entire 8-hour shift, and who knows how long 
before that? When you have 14 or 18 or 20 residents to care for, 
there's simply not enough time for everyone. Feeding them all takes so 
much time, several hours combined right there. Thats how other basic 
needs fall by the wayside. When you're doing the job of two CNAs, it 
really means that half of your residents are going to have to go 
without.''
     ``Last week, after two aides did not show up for their 
shift, it led to several residents missing their breakfast. Thats just 
one example unfortunately, residents regularly miss meals or have to 
eat them late. The problem is that whenever staff is needed for one 
urgent task, were usually in the middle of another urgent task that 
cannot be interrupted.''
     ``Residents in our facility are recovering from surgery or 
things like strokes and they need a lot of help. With how many 
residents I am caring for, I don't have time to give them the best 
care. I feel like I'm always rushing to the next person, and they get 
upset, and this is not good for their recovery. If they have to go to 
the bathroom and can't wait, they try to go by themselves and they end 
up falling.''
    Response: We thank commenters for sharing their personal stories. 
The compelling narratives shared by commenters demonstrate the dangers 
of inadequate staffing in nursing homes, not as an impersonal set of 
numbers and percentages, but as the lived experiences of the more than 
1 million people receiving nursing home services each year. As 
evidenced by the thousands of personal stories told in the comments, 
there is a persistent, pervasive problem in the safety of nursing home 
care across the country that must be addressed. This final rule 
includes policies that will advance resident safety, and we are 
committed to using all available CMS authorities to continue protecting 
residents now and in the future.
    Comment: Comments on the proposed rule varied in level of support 
and opposition. Many commenters expressed overall support for the 
proposed revisions to the regulations and concern about the health and 
safety of nursing home residents. Numerous commenters encouraged CMS to 
further strengthen the requirements and not finalize the version of the 
rule as proposed. A large number of commenters applauded CMS for taking 
a first step toward improvements for staff and residents in LTC 
facilities and noted additional opportunities to address workforce 
challenges. Many NAs and family representatives described the negative 
impact of low staffing levels on meeting residents' needs, writing of 
situations that ranged from residents that needed assistance with meals 
not getting that assistance and losing weight, to accounts of residents 
that had to stay in bed all weekend because the facility was short 
staffed. Many comments centered on unnecessary falls that occur because 
no one is around to assist residents to and from the bathroom. For 
example, one commenter who described themselves as a family member of 
many residents shared a personal description of their experience with a 
nursing facility, noting that their loved ones often share that ``they 
have been waiting for hours just to go to the bathroom.'' Commenters 
noted that most LTC direct staff are doing the best they can and that 
increasing staff will decrease burnout, make their jobs safer, and 
lessen the potential for resident's safety events such as falls and 
pressure ulcers. For example, one NA with over 22 years of

[[Page 40885]]

experience highlighted that while they love their jobs, it has been one 
the hardest they ever held and having ``Federal guidelines in place 
could help the elderly and their families feel more confident in the 
facilities.'' This commenter also indicated that having Federal 
guidelines in place will provide individuals ``more of an incentive to 
work in a long-term care facility.''
    In contrast, other commenters expressed a desire to rescind the 
proposed rule, citing overall concerns about the financial burden and 
workforce shortages, training challenges, administrative burden, and 
limited housing options in sparsely populated areas for new staff.
    Response: The large volume of comments that we received 
demonstrates the interest in resident health and safety issues. 
Numerous comments from residents, families, staff, and ombudsmen make 
it clear that there is a widespread lack of sufficient care by nursing 
staff in our nation's LTC facilities. These comments provide further 
evidence of and support for our view that we will significantly improve 
resident safety through the establishment of minimum staffing 
requirements. The changes that we discuss in this final rule are 
intended to promote resident health, safety, and access to care.
    We acknowledge the workforce challenges in LTC facilities. 
According to the Bureau of Labor Statistics (BLS), in March 2020, there 
were 3,372,000 staff working in nursing homes and other LTC facilities 
and an average of 1,319,318 residents per day in nursing homes. Total 
staffing dropped to a low of 2,961,200 for staff working in nursing 
homes and other LTC facilities in January 2022, a decrease of 
approximately 410,000 staff from March 2020. The daily census of 
residents averaged 1,152,842 per day in nursing homes in January 2022. 
Workforce challenges may have contributed to the drop in staff, but it 
appears to have been caused by multiple factors, such as the drop in 
the number of nursing home residents. The number of staff is improving, 
as of November 2023 there are 3,216,700 staff working in nursing homes 
and other LTC facilities, still 155,300 less than March 2020. 
Facilities averaged 1,201,585 residents per day in November 2023. 
Please note, this data is for all employees in these facilities, not 
just healthcare staff.\46\ As stated in the proposed rule, it is the 
policy of the Biden-Harris Administration to ensure that the LTC 
workforce is supported, valued, and well-paid.\47\
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    \46\ Bureau of Labor Statistics. https://data.bls.gov/timeseries/CES6562300001?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true. Accessed 02/28/24.
    \47\ 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 
March 19, 2023.
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    We note the efforts that many commenters described regarding their 
recruitment, hiring and training of employees along with retention 
efforts for existing employees. We support the concept of implementing 
workforce development programs, as they benefit not only the employees 
but ultimately the residents. CMS is launching a comprehensive 
workforce development initiative \48\ and is also exploring the 
potential to provide technical assistance to LTC facilities through the 
existing Quality Improvement Organizations. While the requirements of 
this rule are intended to improve resident safety and care, they may 
also improve the working environment in LTC facilities. Establishing 
staffing minimums will assure that NAs, for example, have enough 
nursing staff present in the facility for a safe 2-person resident 
transfer using a mechanical lift, reducing resident and staff injuries, 
as well as staff burnout. The new requirement that facilities must 
involve their direct care workers and their representatives in the 
facility assessment allows the staff to provide meaningful input 
regarding the facility's operations, which has the potential to lead to 
a better working environment that complements retention and hiring 
efforts. In addition, having a 24/7 RN presence can improve resident 
safety \49\ with the added benefit of providing more professional 
support to all facility workers.
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    \48\ FACT SHEET: Biden-Harris Administration Takes Steps to 
Crack Down on Nursing Homes that Endanger Resident Safety [verbar] 
The White House: https://www.whitehouse.gov/briefing-room/statements-releases/2023/09/01/fact-sheet-biden-harris-administration-takes-steps-to-crack-down-on-nursing-homes-that-endanger-resident-safety/.
    \49\ 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.
---------------------------------------------------------------------------

    Comment: Some commenters stated that the pool of former nursing 
home workers who left the sector is more than sufficient to cover the 
demand for new workers, while numerous commenters voiced questions 
about the availability of workforce and whether this is the right time 
to implement staffing minimums. A few commenters denied the existence 
of a staffing shortage. One commenter stated it was a pay shortage and 
that challenges with a lack of qualified staff would be readily 
resolved by higher pay and better working conditions. Some commenters 
explained that the LTC workforce has not recovered from the impact of 
the COVID PHE. Some commenters noted that LTC facilities were already 
having issues hiring sufficient staff due to the lack of qualified, 
available staff in their area. For example, one commenter pointed out 
that in the State of Missouri, less than 4 percent of RNs were looking 
for work and that more than a quarter of RNs were 54 or older, 
suggesting that not only were there few RNs looking for work but also a 
significant number would likely be retiring in the next several 
years.\50\ The commenter noted that compliance with these minimum 
staffing requirements would require hundreds of new RNs. Some 
commenters asked where these additional RNs would come from to staff 
LTC facilities. Some commenters shared concern about shortages of RNs 
overall and specifically the scarcity of RNs who chose to work in LTC 
facilities. They stated this needs to be recognized as an impediment to 
some facilities being able to meet staffing minimums. A commenter 
expressed concerns that due to the minimum staffing requirements, 
providers will likely encounter heightened levels of competition in 
each labor market for RNs and NAs. Moreover, the commenter stated that 
it would be even more challenging to recruit and retain staff for 
``smaller LTC facilities and those located in rural areas than larger, 
better-funded facilities in nearby urban areas''. Some recommended that 
this minimum staffing standards regulation be suspended until there 
were enough RNs to staff LTC facilities to comply with the 24/7 RN and 
0.55 RN HPRD requirements. Other commenters stated that their 
facilities have been trying to hire nursing staff without success and 
that they rely on staffing agencies, a process which offers its own set 
of unique challenges for facilities.
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    \50\ Missouri State Board of Nursing. (2022). 2022 Missouri 
Nursing Workforce Report. Jefferson City, MO: Missouri State Board 
of Nursing. https://pr.mo.gov/boards/nursing/2022%20Missouri%20Nursing%20Workforce%20Report.pdf.
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    Response: We acknowledge that there are workforce challenges in 
various areas of the country. CMS is committing over $75 million to 
launch an initiative to help increase the long-term care workforce.\51\ 
We expect that these funds

[[Page 40886]]

will be allocated for such purposes as for tuition reimbursement, we 
are also exploring the potential to provide additional technical 
assistance to LTC facilities through the Quality Improvement 
Organizations. The Department of Labor and other parts of the Biden-
Harris Administration are also investing in building a strong nursing 
workforce and expanding the pipeline of new staff. In response to 
comments, and in addition to the $75 million workforce development 
investment and potential technical assistance, we have made some 
changes to the proposed minimum staffing standards requirements to 
provide additional flexibility and time for facilities to implement 
these changes while maintaining safety and quality. The final 
requirements have staggered implementation dates over a period of up to 
five years. A total nurse staffing standard has been added and there 
are exemptions from the minimum staffing standards. We will continue to 
examine resident safety issues and potential changes going forward. The 
minimum staffing standards will provide staff in LTC facilities the 
support they need to safely care for residents, and help prevent staff 
burnout, thereby reducing staff turnover, which can lead to improved 
safety.
---------------------------------------------------------------------------

    \51\ FACT SHEET: Biden-Harris Administration Takes Steps to 
Crack Down on Nursing Homes that Endanger Resident Safety [verbar] 
The White House: https://www.whitehouse.gov/briefing-room/statements-releases/2023/09/01/fact-sheet-biden-harris-administration-takes-steps-to-crack-down-on-nursing-homes-that-endanger-resident-safety/.
---------------------------------------------------------------------------

    Comment: Numerous commenters voiced support for the proposed 
regulations but asked for funding, indicating that the financial 
implication of hiring staff to meet the standards was a roadblock. 
Commenters stated that the implementation of the minimum nursing 
staffing requirement will bring increased costs, and in the absence of 
reimbursement for these costs, the LTC facilities will have to absorb 
those increased costs, causing financial strain. One commenter 
recommended increasing payment rates using wage pass through rules. 
Some commenters stated that nursing homes cannot compete with hospitals 
for RN salaries. Other commenters expressed concern that unintended 
consequences of hiring more staff would result in higher fees for 
residents and their families. In contrast, other commenters suggested 
that nursing homes have the financial means to provide quality 
staffing, without additional funding. Some of these commenters 
highlighted the profits earned by nursing homes, which make them a 
desirable investment opportunity, as well as diversion of funds to 
related-party expenses or excess administrative costs.\52\
---------------------------------------------------------------------------

    \52\ Comments of the Long Term Care Community Coalition at 10-
11.
---------------------------------------------------------------------------

    Response: While funding, salaries paid by other healthcare 
providers, and fees that residents are charged are outside the scope of 
this rulemaking, we crafted the rule with careful consideration that 
the majority of LTC facilities will need to recruit, hire, and train 
new staff. In the proposed rule we noted that non-profit nursing homes 
were three times more likely to already be in compliance with the 
proposed minimum staffing requirements suggesting a relationship 
between profit model and staffing.\53\ Through phased-in implementation 
facilities may not have to hire all the necessary nursing staff at one 
time. There are also waivers and hardship exemptions available to LTC 
facilities on a case-by-case basis. Please see sections II B.4, 
``Registered Nurse 24 hours per day 7 days per week,'' and II B.5, 
``Hardship Exemption from Minimum Hours per Resident Day and RN onsite 
24 hours per day 7 days per week,'' of this rule for more details. In 
addition, please see section VI, ``Regulatory Impact Analysis,'' for 
estimates of expenditures related to this final rule.
---------------------------------------------------------------------------

    \53\ 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.
---------------------------------------------------------------------------

    Comment: A commenter noted that LTC facilities must meet State and 
Federal requirements for health and safety. Some commenters were 
concerned about the burden of meeting both their State requirements and 
Federal requirements. A commenter expressed concern about conflicts 
between State and Federal staffing requirements. The commenter 
suggested rewards for facilities located in States that have higher 
staffing standards and reimbursement cuts for facilities located in 
States that have reduced or eliminated staffing standards compared to 
Federal minimum staffing standards.
    Response: Complying with State and Federal requirements is not new 
to LTC facilities. Generally, healthcare facilities in the United 
States function under State and Federal regulations. With regard to the 
updates to the requirements for Medicare and Medicaid participation for 
LTC facilities, the provisions in this final rule are not intended to 
and would not preempt the applicability of any State or local law 
providing a higher standard. In States where there is a higher HPRD 
requirement for RNs or NAs, or an RN coverage requirement in excess of 
at least one RN on site 24-hours per day, 7 days a week, or a total 
nurse staffing minimum above 3.48 HPRD that is required by this final 
rule, or any other specific requirement such as for LPNs/LVNs, the 
facility would be expected by its State or local government to meet the 
higher standard. To the extent Federal standards exceed State and local 
law minimum staffing standards, no Federal pre-emption is implicated 
because facilities complying with Federal law would also be in 
compliance with State or local law. Facilities in states that have 
eliminated their staffing standards are required to comply with Federal 
law. We are not aware of any State or local law providing for a maximum 
staffing level. This final rule, however, is intended to and would 
preempt the applicability of any State or local law providing for a 
maximum staffing level, to the extent that such a State or local 
maximum staffing level would prohibit a Medicare, Medicaid, or dually 
certified LTC facility from meeting the minimum HPRD requirements and 
RN coverage levels finalized in this rule or from meeting higher 
staffing levels required based on the facility assessment provisions 
finalized in this rule. Financial adjustments related to State staffing 
requirements are outside the scope of this rule.
    Comment: Numerous commenters described various issues involving 
nursing education and the volume of new nurse graduates. Some 
commenters suggested investing in nursing school infrastructure. 
Another commenter recommended a policy that includes educational 
opportunities for individuals to enter nursing and other health care 
fields, increasing the number of nursing educators, and subsidies for 
NA training programs. One commenter asked that CMS offer student loan 
forgiveness, or no-interest student loans for those entering the 
nursing profession. Some commenters stated that the proposed $75 
million workforce campaign that will be coordinated by CMS and was 
announced in tandem with the proposed rule, is not sufficient to train 
the additional nursing staff that are needed. Other commenters asked 
that CMS work to ensure funding for training and recruiting qualified 
staff that includes home health and hospice providers. Another 
commenter asked CMS to work on recruitment and retention of LTC 
facility nursing staff. Other commenters expressed concern that the $75 
million workforce campaign funds should not be used to train surveyors 
who will eventually

[[Page 40887]]

assess enforcement actions against nursing homes.
    Response: We agree that educating and training new nursing staff is 
important for the nursing home workforce. On September 1, 2023, the 
White House published a fact sheet detailing various initiatives that 
promote safety in LTC facilities.\54\ One of the initiatives is focused 
on growing the nursing workforce. CMS is launching a new nursing home 
staffing campaign to help workers pursue careers in nursing homes. This 
campaign will support the recruitment, training, and retention of 
nursing home workers, including the CMS investment of over $75 million 
in financial incentives for nurses to work in nursing homes, through 
the Civil Money Penalty (CMP) Reinvestment Program. Other parts of the 
Federal Government are also investing in the nursing workforce. The 
Substance Abuse and Mental Health Services Administration (SAMHSA) 
provides training and technical assistance to nursing facility staff 
serving individuals with serious mental illness and/or substance use 
disorders through its Center of Excellence for Building Capacity in 
Nursing Facilities to Care for Residents with Behavioral Health 
Conditions. The Department of Labor also provided $80 million in grants 
last year as part of its Nursing Expansion Grant program to increase 
clinical and vocational nursing instructors and educators in the U.S., 
and train healthcare professionals, including direct care workers. The 
Health Resources and Services Administration (HRSA) has also 
administered other programs to increase the number of nurse preceptors, 
an example of a HRSA program that supports the training of clinical 
nurse preceptors is the Nurse Education, Practice, Quality and 
Retention-Clinical Faculty and Preceptor Academies (NEPQR-CFPA) 
Program.\55\ Another nurse education program administered by HRSA is 
the FY 2023 Nurse Education, Practice, Quality and Retention (NEPQR)-
Pathway to Registered Nurse Program (PRNP) Awards, this program creates 
a pathway for LPNs and LVNs to become RNs.\56\
---------------------------------------------------------------------------

    \54\ FACT SHEET: Biden-Harris Administration Takes Steps to 
Crack Down on Nursing Homes that Endanger Resident Safety [verbar] 
The White House:_https://www.whitehouse.gov/briefing-room/statements-releases/2023/09/01/fact-sheet-biden-harris-administration-takes-steps-to-crack-down-on-nursing-homes-that-endanger-resident-safety/.
    \55\ Nurse Education, Practice, Quality and Retention-Clinical 
Faculty and Preceptor Academies (NEPQR-CFPA) Program [verbar] HRSA.
    \56\ FY 2023 Nurse Education, Practice, Quality and Retention 
(NEPQR)-Pathway to Registered Nurse Program (PRNP) Awards [verbar] 
Bureau of Health Workforce (hrsa.gov).
---------------------------------------------------------------------------

    While the comments received on the specific details of the CMS 
nursing home staffing campaign are outside the scope of this rule, we 
acknowledge that workforce development is a shared responsibility, and 
encourage LTC facilities to partner with education and training sources 
to meet their staffing needs. We are also exploring the potential to 
provide additional technical assistance to LTC facilities through the 
Quality Improvement Organizations. We appreciate the information 
regarding nursing education, the number of new graduates and the 
suggestion to invest in nursing school infrastructure; however, these 
issues are not within the scope of CMS authority and this final rule. 
Likewise, the request for training and recruiting home health and 
hospice providers is also outside the scope of this rule. The request 
for student loan considerations is also outside the scope of this rule.
    Comment: Several commenters suggested that CMS should work to 
promote an immigration policy that supports nursing staff to enter the 
United States and the nursing home workforce. Another commenter 
suggested building a domestic and international pipeline for potential 
nursing home workers to be recruited and trained.
    Response: We appreciate these comments regarding the relationship 
between staffing and immigration policy. However, immigration policy is 
not within the scope of CMS authority.
    Comment: One commenter stated that CMS should revisit the 
standards, at minimum, within one to two years of full implementation 
to determine if the agency's approach is yielding its intended outcomes 
and assess their impact on quality, safety, and access, followed by 
periodic reevaluations and redeterminations.
    Response: We agree that it is important to review the impact that 
this final rule has on the delivery of care and services in LTC 
facilities. We also intend to monitor emerging research in this area to 
further inform our policy decisions. CMS continually reviews existing 
regulations to assess their appropriateness, effectiveness, and 
continued necessity. We intend to monitor LTC facility services, as 
well as the safety and quality of resident care, through the survey 
process, quality measure performance, and PBJ data to assess the impact 
of these new requirements and determine what, if any, future actions 
should be taken to assure that all residents receive safe care at all 
times and that their needs are met. We realize that standards of care 
are constantly evolving and staffing standards may need to be raised to 
meet the health and safety needs of facilities over time. The 
requirements in this rule are minimum baseline standards for safety and 
quality without accounting for resident acuity. We will continue to 
engage stakeholders as the requirements are implemented.
    Comment: Many commenters expressed concern about potential 
systemwide impacts of the proposed changes, ranging from the potential 
for reductions in LTC facility admissions and census, facility 
closures, and the impact of those closures on residents and their 
families. Commenters gave scenarios of residents or individuals that 
may need admission to a LTC facility and not be able to find the care 
they need if fewer beds were available. Commenters suggested that 
residents in LTC facilities might face forced discharge or transfer if 
sufficient RNs and other staff were not available at the facility, 
resulting in inappropriate discharges to home or other inappropriate 
settings for residents. Some commenters expressed concern about 
readmission protections for residents when facilities say they can't 
readmit due to low staffing.
    In addition, commenters stated that various issues may occur in 
other provider settings as the current state of nurse staffing at LTC 
facilities evolves. Some commenters noted that fewer LTC facility beds 
could result in hospitals having a harder time discharging patients in 
need of LTC. The commenters stated that without the ability to transfer 
patients in need of LTC to an appropriate facility, people in need of 
admission to a hospital might have to wait longer for an available bed. 
This could also result in a backup in the emergency department 
resulting in longer waits for care. A commenter stated that patients 
discharged from hospitals to LTC facilities have more acute clinical 
needs than patients discharged to home.
    Response: While increased staffing needs in one provider setting 
can impact other provider settings, LTC facilities must be able to 
demonstrate that the care and services they provide meet the resident's 
needs. LTC facilities are responsible for compliance with requirements 
for participation, including but not limited to Sec.  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

[[Page 40888]]

resident's comprehensive assessment and plan of care. This rule 
provides flexibilities through phased implementation timeframes and 
hardship exemptions, which can provide temporary relief to facilities 
that are having workforce issues. We have built in these flexibilities 
for facilities while still prioritizing resident safety and quality of 
care. The minimum staffing standards support existing regulations and 
help to ensure the staff needed to meet the care needs and improve the 
LTC facilities' ability to care for patients discharged from the 
hospital and prevent hospital readmissions. Although the practices of 
other healthcare settings are not within the scope of this rule, we 
intend to monitor its impact for unintended system-wide changes that 
may hinder or harm patient and resident care. We encourage LTC 
facilities to work with local hospitals to ensure safe care patient 
transitions. The requirements for participation at Sec.  483.15(e)(1) 
are in place to ensure that facilities develop and implement policies 
that help facilitate the return of residents to the facility after a 
hospitalization. Facilities must have a sufficient number of qualified 
staff to meet each resident's needs, to protect resident health and 
safety while supporting access to care. We will use available data for 
monitoring residents' health, and safety and any unintended 
consequences during the multi-year implementation of this final rule.
    Comment: Commenters expressed concerns that the proposed rule would 
draw funding and staff away from home and community-based services 
(HCBS) to facility-based settings. Moreover, this would lead to an 
increased unmet need for HCBS, poorer health outcomes for individuals, 
and reduced access to training and support for caregivers. Furthermore, 
the commenter thought that it would lead to reduced access to 
culturally and linguistically appropriate HCBS which will negatively 
impact communities of color.
    Response: The HCBS workforce comprises a diverse array of worker 
categories including workers who provide nursing services, assist with 
activities of daily living (such as mobility, personal hygiene, eating) 
or instrumental activities of daily living (such as cooking, grocery 
shopping, managing finances), and provide behavioral supports, 
employment supports, or other services to promote community 
integration. While these workers do include nurses (RNs and licensed 
practical nurses) and NAs, the HCBS workforce comprises many other 
workers (both with and without professional degrees) that are not 
included in the minimum staffing requirement. Although there may be 
some overlap in demand for staff in LTC facilities and HCBS programs, 
we do not have reason to believe the overlap will be significant. We 
appreciate the comments, and CMS will continue to monitor these trends. 
Over time, additional, useful information will be supplied through 
finalized policies in the Medicaid access rule and this rulemaking 
concerning Medicaid funds dedicated to the direct care workforce in 
HCBS, LTC, and other institutional settings.
    Comment: Some commenters included requests for staffing minimums 
for other categories of nursing home employees, including full time 
social workers and infection prevention control specialists. Other 
commenters suggested that CMS conduct research to determine why nurses 
are leaving the nursing workforce, noting that, since the COVID-19 PHE, 
many staff are going back to school for degrees not related to nursing.
    Response: We agree that other LTC facility staff provide important 
services for resident well-being. However, suggestions related to 
establishing minimum standards for other types of employees are outside 
the scope of this final rule. We also agree that it is critical to 
understand the drivers of changes in the national nursing workforce and 
encourage interested parties to conduct research into these issues that 
can inform future policy decisions.
    Comment: A commenter urged CMS to conduct research and rulemaking 
to enhance social work in nursing homes.
    Response: We support the use of social work services in LTC 
facilities and encourage interested parties to conduct research into 
the care and services provided by social workers and the impacts to 
residents' highest practicable physical, mental, and psychosocial well-
being, consistent with the resident's comprehensive assessment and plan 
of care. However, suggestions related to establishing minimum standards 
for other types of employees are outside the scope of this rule.
    Comment: A commenter asked CMS to support and protect union rights 
through implementation of a labor relations quality measure.
    Response: The protection of union rights through the development of 
quality measures or any other means is outside the scope of this rule. 
This rule, however, is intended to support all workers in nursing 
facilities by ensuring there is sufficient staff to care for residents 
safely and thus reducing the burden on existing workers.
    Comment: A commenter expressed concern that the proposed rule would 
undermine payments for LTC pharmacy services. For example, a facility 
census may decline resulting in a decrease in the use of pharmacy 
services causing various economic challenges for LTC pharmacies.
    Response: We disagree with the commenter's assumption that 
implementation of this rule will result in an overall decline in 
resident census that undermines reimbursement and affects LTC pharmacy 
services. This final rule includes multiple flexibilities for eligible 
facilities located in areas affected by pronounced workforce shortages 
and provides staggered implementation periods to allow time for 
additional workforce development to comply with the requirements of 
this rule.
    Comment: A commenter made suggestions to add additional items 
related to revenue and costs to the Federal cost reports that LTC 
facilities must complete and recommended that CMS publicly release that 
additional data after it is collected.
    Response: Federal cost reporting changes are not within the scope 
of this final rule. We note that information collections require 
statutory authority. We will take the request under advisement.
    Comment: Several commenters asked if every nursing home survey 
would assess compliance with the staffing requirements and staffing 
adequacy, while other commenters asked if we would bolster the survey 
process, to accommodate enforcement of the staffing standard. 
Commenters voiced concern about the additional time that would be 
required by surveyors to determine compliance with the minimum staffing 
requirements, and other commenters questioned whether States would get 
more funds for training and technical support to conduct surveys. Some 
commenters suggest increasing the State survey budget and the survey 
workforce so that enforcement of staffing requirements will be timely 
and successful.
    Response: We appreciate the comments received on the survey 
process. We envision using a combination of PBJ data and onsite surveys 
to assess compliance with various aspects of these requirements.
    We will publish more details on how compliance will be assessed 
after the publication of this final rule in advance of each 
implementation date for the different components of the rule. We intend 
to use the traditional process of

[[Page 40889]]

communication of information to providers and surveyors via CMS's 
Quality, Safety and Oversight Group (QSO) memoranda and publication of 
information in the CMS State Operations Manual (internet Only 
Publication, 100-07). The links to these resources are listed below.
     Policy & Memos to States and CMS Locations [verbar] CMS: 
https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/policy-memos-states-and-cms-locations.
     Quality Safety & Oversight- Guidance to Laws & Regulations 
[verbar] CMS: https://www.cms.gov/medicare/health-safety-standards/guidance-for-laws-regulations.
    We are also committed to robustly funding the survey, 
certification, and enforcement programs to the extent possible. The 
President's FY 2025 Budget calls for an increase in funding for these 
important programs and for the survey and certification funding to be 
shifted to mandatory spending starting in the FY 2026 budget to better 
align the continued need for surveys with the type of funding.
    Comment: Several commenters asked for an evidence-based template 
and updated surveyor guidance for monitoring and enforcing staffing 
levels. In addition, commenters questioned whether surveyors will be 
taught principles of evidence-based staffing research so that their 
determinations of compliance with staffing minimums are neither 
subjective nor the opinion of the surveyor.
    Response: We thank the commenters for their feedback. We will 
publish more details on how compliance will be assessed after the 
publication of this final rule in advance of each implementation date 
for the different components of the rule. We envision using a 
combination of PBJ data and onsite surveys to assess compliance with 
various aspects of the requirements. We note that since the 
requirements specify specific staffing minimum thresholds, the 
determination of compliance with these thresholds will be objective, 
and not subjective. However, our decisions to grant exceptions are 
based on criteria that will require the agency to use its best judgment 
(for instance, in determining whether a facility has made a good-faith 
effort to hire additional staff).
    Comment: Many commenters expressed concerns related to the 
importance of identifying noncompliance and taking appropriate 
enforcement actions so that residents' health and safety are protected. 
Commenters asked about the timeframe between the determination that a 
provider is found out of substantial compliance with the new staffing 
standards and any resultant enforcement actions, citing concerns about 
potential significant time lags. Many commenters suggested CMS consider 
survey results and PBJ data for compliance determinations and 
enforcement actions. Other commenters noted that PBJ data is available 
on a quarterly basis and could be used for more frequent compliance 
reviews. A commenter asked if day to day fluctuations in staffing will 
result in citations. Some commenters suggested rulemaking to adopt 
specific enforcement rules for the HPRD numerical minimums. Some 
commenters stated that when enforcement actions are taken, they are too 
severe. Several commenters urged CMS to establish detailed guidelines 
on when a surveyor should assess appropriate penalties at the harm or 
immediate jeopardy level whenever there is serious harm, injury, 
impairment or death of a resident. Others recognized that enforcement 
is critical to ensure successful implementation of the minimum staffing 
standards and that nursing homes should know that they face 
consequences for substantial non-compliance.
    Response: We appreciate and will consider the comments as we move 
forward and recognize that rigorous data-driven enforcement will be 
critical to the successful implementation of this rule. We will publish 
more details on how compliance will be assessed and how enforcement 
remedies will be imposed after the publication of this final rule in 
advance of each implementation date for the different components of the 
rule. We envision using a combination of PBJ data and onsite surveys to 
assess compliance with various aspects of the requirements. 
Additionally, if finalized, the proposal for revisions to CMPs in the 
forthcoming FY 25 SNF payment rule will give CMS more flexibility to 
assess fines associated with the severity of the citation.
    Comment: The PBJ allows staffing data to be collected from LTC 
facilities on a regular basis. Several commenters suggested that CMS 
improve PBJ implementation so that it allows facilities to report all 
hours worked by staff including nurses and nurse aides and offers 
facilities a reasonable opportunity to appeal/correct PBJ data. A 
commenter suggested that CMS should send letters to facilities that 
submit PBJ data showing staffing levels that do not comply with 
requirements and ask for an explanation. Many commenters recommended 
monitoring PBJ staffing data and wanted automatic citations issued for 
failure to comply with the standards. One commenter suggested that 
Federal surveyors use the PBJ data as the basis for citations for 
deficiencies and to conduct more frequent reviews of facility 
compliance with HPRD minimums than what is currently required.
    Response: Per Federal law, staffing data submitted by a facility to 
the PBJ system must be auditable back to payrolls and other verifiable 
information. Therefore, CMS does not agree that all hours worked by 
staff (such as hours that cannot be verified) should be reported and 
credited, but auditable back to verifiable information should be 
reported and credited to the HPRD calculations (unless they meet the 
reporting requirements). Furthermore, facilities have up to 45 days 
after the end of each quarter to review and make any corrections needed 
to the data prior to submission. Therefore, facilities already have the 
opportunity to correct their PBJ data. We note that providers will 
retain their ability to exercise existing regulatory provisions to 
dispute or appeal citations for noncompliance, such as informal dispute 
resolution. Additionally, CMS does inform providers of their staffing 
levels prior to public posting. However, we disagree that CMS should 
give facilities an opportunity for an explanation, as compliance with 
the requirements is based on whether the facility meets the specific 
required staffing thresholds, regardless of justification. A facility 
that in good faith believes that it cannot consistently meet the HPRD 
standards may request an exemption, pursuant to Sec.  483.35(g) as set 
out in this final rule. For comments related to automatic citations, we 
appreciate the suggestion and note that surveys of compliance and 
enforcement actions are conducted pursuant to 42 CFR part 488, subparts 
E and F, respectively. We will publish more details on how compliance 
will be assessed after the publication of the final rule in advance of 
each implementation date for the different components of the rule.
    Comment: Several commenters requested that CMS publicly identify 
nursing homes that fail to adjust staffing levels for resident acuity. 
Other commenters suggest that CMS should include easy to understand 
information about whether a nursing home meets the minimum staffing 
standards on Care Compare.
    Response: As part of CMS' survey and enforcement activities, we 
currently publish data for all LTC facilities on the

[[Page 40890]]

Care Compare website. We appreciate the suggestions and are committed 
to providing consumers, families, and caregivers with useful 
information to help support their healthcare decisions. Care Compare 
will be updated to show whether a facility has an exemption and will 
note the extent to which a facility falls short of the minimum staffing 
standards.
    Comment: A commenter suggested that PBJ and Minimum Data Set (MDS) 
be improved to ensure compliance with minimum staffing standards.
    Response: We appreciate this suggestion, and welcome suggestions 
for improvement. However, the commenter did not provide details on how 
PBJ and the MDS could be improved.
    Comment: A commenter requested that CMS issue guidance prior to the 
final rule on additional staffing standards based on resident acuity 
and activities of daily living (ADL) needs.
    Response: We appreciate the suggestion. CMS will issue 
subregulatory guidance to surveyors for specific requirements after the 
publication of this final rule in advance of each implementation date 
for the different components of the rule. However, we note the existing 
regulations require facilities to consider residents' conditions and 
acuity when developing their facility assessment to determine the 
personnel needed to meet residents' needs. Subregulatory guidance for 
this requirement can be found in the State Operations Manual, appendix 
PP, sec. 483.70(e) (https://www.cms.gov/medicare/provider-enrollment-and-certification/guidanceforlawsandregulations/downloads/appendix-pp-state-operations-manual.pdf).
    Comment: Some commenters suggested that CMS consider ways to 
enhance compliance among LTC facilities with automated data collection 
techniques or other forms of information technology.
    Response: We appreciate the suggestion. CMS remains open to 
exploring ways that technology can be leveraged to streamline data 
collection and improve compliance and enforcement.
    Comment: One commenter expressed concern that PBJ reporting 
guidelines are technical and the data submitted do not always reflect 
the actual staffing levels. The concern centered around rural providers 
with small census using one nurse per shift, the nurse stays onsite for 
the entire shift, including the lunch break. However, the PBJ reporting 
guidelines always exclude a 30-minute rest period, regardless of 
whether the nurse took a 30-minute uninterrupted break.
    Response: We appreciate the concern raised by the commenter. It is 
very important that PBJ data is auditable. Facilities need to deduct a 
30-minute meal-break from each eight-hour shift. As the staffing data 
must be auditable back to payrolls, there is no way to audit and verify 
the portion of their meal break that was spent working versus eating. 
Also, some facilities pay for meal breaks, and some do not. Allowing 
some facilities to report hours for paid meal breaks would result in 
reporting higher levels of staffing based on whether or not a facility 
pays for meal breaks, instead of actual differences in the amount of 
direct resident care their staff provide. Therefore, to measure all 
facilities equally, we require all facilities to deduct 30 minutes per 
shift. Information on this and other policies related to PBJ can be 
found on the CMS website for Staffing Data Submission Payroll-Based 
Journal: https://www.cms.gov/medicare/quality/nursing-home-improvement/staffing-data-submission.
    Comment: One commenter suggested better coordination between State 
surveyors and the CMS designated Quality Innovation Network Quality 
Improvement Organizations (QIN-QIOs).
    Response: We thank the commenter for their feedback. CMS is 
committed to ensuring coordination between State surveyors and QIN-QIOs 
as they conduct their individual and unique responsibilities.
    Comment: We received many recommendations for alternative policies 
or strategies for supplementing or enhancing the LTC facility 
workforce. Commenters suggested various ways of substituting staff when 
determining compliance with HPRD minimums set out in this rule: one 
commenter suggested allowing LPNs to substitute for NAs, another 
suggested facilities will substitute NAs for LPNs, yet another 
commenter related that LPNs and RNs can substitute for NAs in addition 
to their own job requirements. A commenter proposed the creation of a 
transportation aide role so that residents could move around the 
facility, and this would in turn improve quality of life. One commenter 
stated that expansion of training for paid feeding assistants would be 
beneficial to the residents. The same commenter suggested flexibility 
within the regulations to allow technology to supplement the workforce 
such as robots, that can deliver food to residents at their tables.
    Response: We thank commenters for these recommendations. Under the 
current regulations, facilities can already use many of these 
suggestions, such as using feeding assistants, transportation aides, 
and technology to supplement the nursing workforce in LTC facilities, 
paying nurse aides while they are in training, and using LPNs/LVNs to 
deliver some NA care. Facilities may continue to implement these 
strategies as needed to ensure that all residents receive high-quality 
care in accordance with their plan of care and consistent with the 
requirements for participation.
    Comment: A small number of commenters addressed the relationship 
between the proposed requirements and CMS' statutory authority. A 
commenter noted that CMS is taking these minimum staffing requirement 
actions based on the statutory authority 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. 
This commenter urged CMS to establish higher minimum staffing levels in 
a way that fulfills this statutory mandate. One commenter suggested 
that CMS did not have authority to establish RN staffing standards for 
24 hours per day, 7 days per week, and suggested that CMS should 
augment the current 8 hours per day, 7 days a week RN services 
requirement with a higher minimum RN HPRD to achieve our policy goal. 
Finally, one commenter contended that CMS lacks the authority to 
finalize the minimum staffing standards, suggesting that CMS cannot 
require HPRD standards or increase the current 8 consecutive hours of 
registered nurse hours a day 7 days a week minimum standard to 24 hours 
a day standard.
    Response: We appreciate the comments received on whether or not CMS 
has the authority to enact these regulations. As discussed in section 
II.A.1. of this final rule, various provisions in sections 1819 and 
1919 of the Act provide CMS with the statutory authority for the 
requirements of this rule. The Secretary has concluded that these HPRD 
levels and RN onsite 24/7 requirements are necessary for resident 
health, safety, and well-being, under sections 1819(d)(4)(B) and 
1919(d)(4)(B) of the Act, which instruct the Secretary to issue such 
regulations relating to the health, safety, and well-being of residents 
as the Secretary may find necessary. We agree with the commenter that 
section 1819(b)(2) and 1919(b)(2) of the Act, which require facilities 
to provide services to attain or maintain the highest practicable 
physical, mental, and psychosocial well-being of each resident, also

[[Page 40891]]

supports CMS authority to establish these requirements. Also, 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. While sections 1819(b)(4)(C) and 1919(b)(4)(C) 
of the Act state that a facility must provide 24-hour licensed nursing 
services which are sufficient to meet the nursing needs of its 
residents, and must use the services of a registered professional nurse 
for at least 8 consecutive hours a day, 7 days a week, CMS is using 
separate authority as described above to establish these new 
requirements rather than the authorities found at sections 
1819(b)(4)(C) and 1919(b)(4)(C) of the Act. Our goal is to protect 
resident health and safety, and the persistent and pervasive safety 
issues described in the proposed rule and in this final rule make it 
clear that it is necessary to establish new minimum requirements to 
fulfill the Secretary's responsibility to establish other requirements 
related to resident health and safety.
2. Definitions (Sec.  483.5)
    We proposed to revise Sec.  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.\57\ We 
also proposed to add the definition of ``representative of direct care 
employees'' who is an employee of the facility or a third party 
authorized by direct care employees at the facility to provide 
expertise and input on behalf of the employees for the purposes of 
informing a facility assessment. We received no comments on how we 
define hours per resident per day (HPRD). We received no comments on 
how we define representative of direct care employees. As such, we are 
finalizing the definition of ``hours per resident day'' (HPRD) and 
``representative of direct care employees'' as proposed.
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    \57\ https://data.cms.gov/provider-data/dataset/4pq5-n9py.
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    Final Rule Action: We are finalizing the definition of ``hours per 
resident day'' as the total number of hours worked by each type of 
staff divided by the total number of residents as calculated by CMS. We 
are finalizing the definition of ``representative of direct care 
employees'' as an employee of the facility or a third party authorized 
by direct care employees at the facility to provide expertise and input 
on behalf of the employees for the purposes of informing a facility 
assessment.
3. Minimum Staffing Standards (Sec.  483.35(a))
    In the proposed rule, we discussed revisions to the Nursing 
Services regulations at Sec.  483.35(a)(1)(i) and (ii) to require 
facilities to meet minimum staffing standards--0.55 HPRD of RNs and 
2.45 HPRD of NAs (see 88 FR 61366 through 61370, 61428). Specifically, 
at Sec.  483.35(a)(1)(i) we proposed individual nurse staffing type 
standards for RNs and NAs. We proposed to require facilities to meet 
minimum staffing standards--0.55 HPRD of RNs and 2.45 HPRD of NAs--as 
well as to maintain sufficient additional 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 new Sec.  483.71. We also solicited comments on 
establishing an alternative total nurse staffing standard, such as 3.48 
HPRD, in place of a requirement only for RNs and NAs, or in addition to 
a requirement for RNs and NAs that could also encompass other nursing 
staff types. We considered an alternative standard of 3.48 HPRD for 
total nurse staffing--inclusive of the 0.55 HPRD of RNs and 2.45 HPRD 
of NAs minimum standards--based on the literature evidence (see 88 FR 
61259 through 61366 for more details). CMS solicited comments on a 
minimum total nurse staffing standard of 3.48 HPRD, the necessity of a 
total staffing standard, and whether a total staffing standard should 
be adopted in place of a requirement only for RNs and NAs, or in 
addition to a requirement for RNs and NAs. We also emphasized that 
comments on the recommended policy or an alternative, must support and 
promote acceptable quality and safety in LTC facilities, which is the 
intended goal. We also requested that commenters submit evidence and 
data to support their recommendations to the extent possible.
    Comment: We received many comments on the numerical HPRD minimum 
staffing standards. Commenters offered numerous reasons for supporting 
CMS efforts to establish minimum staffing standards, including 
increased accountability for facilities regarding the treatment of 
staff and residents, and the care provided. Commenters that supported 
establishing numerical HPRD standards also noted that such requirements 
would assure that safety is not compromised for both staff and 
residents. Commenters also stated that the proposed staffing 
requirements should be considered as the start of improvements to be 
built upon over time, rather than as the singular end goal for 
addressing LTC facility safety and quality challenges. Others commended 
the Administration for proposing minimum nurse staffing standards, 
stating that ``the NPRM [notice of proposed rulemaking] represents a 
paradigm shift in nursing home oversight to promote quality of care''. 
Another commenter stated, ``we strongly encourage CMS to adopt the 
proposed standards. These standards will set a floor (baseline) that 
prevents overall resident harm and jeopardy and ensure all residents, 
regardless of race or geography, and allows for nursing home to staff 
above those standards based on resident acuity.'' Another commenter 
noted that CMS must clarify that, ``the minimum staffing levels are 
considered to be only for residents with the lowest acuity needs.''
    Response: We thank commenters for their support in improving 
resident care and safety. We agree that establishing minimum staffing 
requirements will promote quality in LTC facilities and ensure safety 
is not compromised for both staff and all residents. Facilities must 
meet, at a minimum, the 3.48 total nurse staffing, .55 RN, and 2.45 NA 
HPRD (as finalized in this rule and discussed in detail later in this 
section) regardless of the individual facility's resident case-mix, as 
these requirements establish the minimum floor (baseline) for staffing 
requirements. We expect that many facilities will need to staff above 
the minimum standards to meet the acuity needs of their residents 
depending on case-mix and as mandated by the facility assessment 
required at Sec.  483.71.
    Comment: We received several comments on establishing individual 
minimum standards for RNs and NAs. Some commenters supported 
establishing individual standards, noting that setting individual 
minimum staffing standards will ``avoid aggregating HPRD across job 
classifications.'' For example, commenters noted that mandating a 
specific number of minimum hours for care provided by NAs would 
increase facility accountability and reduce discretion regarding the 
type of staff facilities may use to comply with the requirement. In 
addition, one commenter noted the specific individual standards for RNs 
and NAs would improve some residents' health and quality of life.
    Commenters also questioned our use of the acronyms ``NA'' (nurse 
aide) versus ``CNA'' (certified nurse aide) and requested clarification 
regarding the

[[Page 40892]]

type of staff that would count towards the minimum requirement. Some 
commenters supported having a minimum staffing standard for NAs. 
However other commenters suggested that CMS require the use of CNAs 
since this is a Federal requirement and strongly opposed the use of 
``uncertified and untrained staff''. For example, one commenter noted 
that nursing assistants are required to meet certification standards 
within a specified period and indicated that nursing homes are not 
allowed to rely on NAs to provide basic care unless they meet the 
training requirements as required.
    Response: We appreciate the commenters' support for the minimum 
HPRD staffing standard. Current regulations at Sec.  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.\58\ Nurse aides include 
certified nurse aides (CNAs), aides in training and medication aides/
technicians, which all require training. Specifically, at Sec.  483.5 
existing regulations define ``nurse aide'' as any individual providing 
nursing or nursing-related services to residents in a facility. This 
term may also include an individual who provides these services through 
an agency or under a contract with the facility but is not a licensed 
health professional, a registered dietitian, or someone who volunteers 
to provide such services without pay. Nurse aides do not include those 
individuals who furnish services to residents only as paid feeding 
assistants as defined in 42 CFR 488.301. As such, we disagree with 
having a staffing standard for CNAs only. In addition, in some 
facilities there is an overlap in responsibilities between CNAs, 
medication aides/technicians, and aides in training. We agree with 
commenters that having a separate, specific minimum staffing level 
requirement for RNs and NAs is important to improving resident health 
and safety and are finalizing this proposed requirement at Sec.  
483.35.
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    \58\ 42 CFR 483.35, 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/.
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    Comment: Many commenters who supported establishing numerical 
staffing standards recommended ways to strengthen the proposed minimum 
HPRD staffing requirements. The commenters stated that the proposed 
0.55 RN and 2.45 NA HPRD requirements were ``not sufficient to protect 
the health and safety of residents'' and ``risk normalizing staffing 
levels associated with poor quality of care. . . .'' Commenters also 
noted that facilities in both urban and rural areas already meet far 
higher nurse staffing standards than what CMS proposed and as such CMS 
should consider strengthening the proposed minimum nurse staffing 
standard. Commenters offered varying modifications to strengthen the 
proposed minimum nurse staffing standard, which included establishing a 
range of minimum staffing standards based on resident acuity and need 
for assistance with activities of daily living (ADLs) or establishing a 
higher HPRD as the minimum standard. For example, one commenter 
suggested that CMS revise the proposal to require facilities to meet a 
minimum 0.75 HPRD for RNs and 2.8 HPRD for NAs, noting that many 
nursing homes currently staff at an average of 3.63 HPRD which is above 
the proposed minimum standard. While some commenters supported 
establishing specific minimum requirements for RNs and NAs, several 
commenters strongly supported the creation of a minimum total direct 
care nurse staffing standard that would include minimum HPRD 
requirements for RNs and nurse aides and incorporate LPNs/LVNs either 
as part of a minimum licensed nursing standard that includes a minimum 
RN HPRD or as a separate minimum LPN/LVN HPRD standard. For example, 
one commentator indicated that ``a minimum standard for LPNs would 
reinforce a minimum standard of 1.4 HPRD for licensed nurses''. Others 
suggested ``LPNs need to count toward either RN or CNA mandated ratios. 
One commentator noted that ``LPNs should also be counted in the 0.55 RN 
HPRD requirement.'' Commenters who supported the inclusion of LPNs 
emphasized the unique role that LPNs play in providing quality care and 
the importance of capturing their contributions in a minimum nurse 
staffing standard. Commenters indicated that LPNs provide essential 
skilled care and critical services that are not within a CNA's scope of 
practice. Furthermore, some commenters shared concerns about the 
unintended consequences that establishing a minimum nurse staffing 
standard that lacks LPNs may have on staff retention and career 
advancement. These commenters suggested that our proposal, and the lack 
of incorporating LPNs into the requirement, marginalized the 
contributions of LPNs in the LTC facility workforce. However, 
commentators were not consistent in their suggestions for HPRD ratios 
of LPN/LVNs.'' Lastly, many commenters strongly supported a minimum 
threshold of 3.48 HPRD for total nurse staffing and suggested 
finalizing an even higher numerical standard than the 3.48 total HPRD, 
ranging up to 4.2 HPRD.
    Response: We appreciate the thoughtful and nuanced comments 
received on the proposed minimum HPRD staffing standard and the 
suggestions for revision to further strengthen the requirement. 
Ensuring that nursing home residents receive safe, reliable, and 
quality care is a critical function of the Medicare and Medicaid 
programs and a top priority for CMS. As such, requiring Federal minimum 
nurse staffing standards will create a consistent minimum floor 
specific to nurse staffing levels and reduce the variability in nurse 
staffing across States. In addition, while establishing minimum nurse 
staffing standards will create broadly applicable standards at which 
all residents across all facilities will be at significantly lower risk 
of receiving unsafe and low-quality care. We emphasized in the proposed 
rule and reiterate here that facilities are also required to staff 
above the minimum standard, as appropriate, to address the specific 
needs of their resident population (88 FR 61369). We expect that most 
facilities will do so in line with strengthened facility assessment 
requirements at Sec.  483.71 (88 FR 61368). As stated in the proposed 
rule, we will also revisit the Federal minimum staffing standard over 
time, as the rule is implemented, to determine whether upward revisions 
in staffing levels are needed.
    We appreciate the comments received requesting that we incorporate 
a total nursing standard that includes a minimum HPRD specifically for 
LPN/LVNs. In the proposed rule, we indicated minimum individual 
standards for RNs and NAs based on evidence demonstrating that RNs and 
NAs have a consistently greater demonstrable effect on quality. While 
we believe LPNs, in addition to all staff, are vitally important to 
resident care, we detailed in the proposed rule the research evidence 
that suggest that a greater RN presence has been associated with higher 
quality of care and fewer deficiencies. We also noted literature in 
support of having adequate staffing levels, specifically NAs, to 
prevent a high rate of unusual patient safety events such as resident 
falls.
    We recognize the importance of the role of LPN/LVNs staffing in LTC 
facilities and acknowledge their increasing responsibilities for 
providing resident care. However, we found

[[Page 40893]]

insufficient research evidence that supports a particular minimum 
standard for LPN/LVNs nor did we receive supporting evidence for 
particular minimum standards for LPN/LVNs from commenters. We also 
noted that facilities must maintain sufficient additional 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 Sec.  483.71 (88 FR 61368). 
Additionally, hours worked by LPN/LVNs may be counted toward the 3.48 
total nurse staffing HPRD requirement being finalized as part of this 
rule.
    We agree that a higher HPRD of nursing staff such as 0.75 HPRD of 
RNs, 2.8 HPRD of NAs, and 4.1 HPRD of total nurse staffing could 
produce increased improvements in safety and quality of resident care 
and that the alternative approach to establish a minimum total nursing 
standard is one effective way to create improvements while also 
providing flexibility. We also recognize that there is evidence that 
suggests that a lower HPRD of nursing staff--0.45 HPRD of RNs, 2.15 
HPRD of NAs, and 3.30 HPRD of total nurse staffing could lead to a 3.3 
percent of care delayed, whereas having no minimum staffing 
requirements could result in a higher i.e. a. 5.6 percent of care 
delayed. However, we maintain that establishing individual minimum 
staffing standards for RNs and NAs specifically is the best approach to 
increasing quality and safety given the evidence suggesting that RNs 
and higher numbers of NAs significantly improve quality.
    We also recognize that establishing a total nurse staffing standard 
could produce increased improvements in safety and quality of resident 
care. We agree with commenters' assertions that the proposed staffing 
standards could be strengthened, and we believe that the addition of a 
total nurse staffing standard will promote resident safety and high-
quality care. We have chosen 3.48 HPRD as the minimum total staffing 
standard, which is inclusive of individual staff-specific standards, in 
light of comments on the proposed rule indicating the value of this 
addition and evidence from the 2022 Nursing Home Staffing Study, in 
addition to other factors discussed in the proposed rule. Finally, we 
share the concern raised by commenters about the potential for 
unintended consequences resulting from the absence of an LPN/LVN 
standard, noting facilities may be incentivized to terminate LPN/LVNs 
and replace them with either nurse aides, RNs or a lower paid 
unlicensed staff. A total nurse staffing standard guards against these 
unintended consequences. Therefore, we are finalizing a minimum 
standard for total nurse staffing and requiring minimum individual 
standards for RNs and NAs. Specifically, we are finalizing a 
requirement for facilities to provide the minimum 3.48 HPRD of total 
nurse staffing, which must include at least 0.55 HPRD of RNs and 2.45 
HPRD of NAs. We note that facilities may use any combination of nurse 
staffing (RN, LPN/LVN, or NA) to account for the additional 0.48 HPRD 
to comply with the total nurse staffing standard. 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 revisions to the staffing minimums are 
warranted, we will revisit the minimum staffing standards with 
continued consideration of all relevant factors.
    Comment: Many commenters did not support the proposed rule and 
establishing minimum staffing standards, whether at the individual or 
total nurse staffing levels. Commenters cited several concerns, 
including workforce shortages, costs of implementing the proposed 
changes, Medicaid underfunding, the diversity of nursing homes and 
their resident needs, and potential unintended consequences. For 
example, one commenter stated that ``the proposed rule fails to 
consider in a serious way where nursing homes will find the estimated 
12,639 additional registered nurses (RNs) and 76,376 additional nurse 
aides (NAs) needed to comply with its requirements.'' Other commenters 
suggested that compliance with the HPRD minimums will be difficult or 
impossible to achieve with staffing shortages and major challenges with 
workforce training and development. Many commenters focused on the 
challenges faced by rural facilities, noting that they may face greater 
challenges recruiting staff.
    Several commenters shared concerns regarding the costs and burden 
imposed by the proposed rule and opposed a minimum staffing standard 
without dedicated funding to support its implementation. These 
commenters suggested that the cost of compliance would create 
unsustainable financial burdens for facilities and negatively impact 
residents by forcing facilities to limit admissions or close. For 
example, we received many comments from certain categories of 
facilities that expressed concerns about the potential impact of the 
minimum HPRD requirements on the operations of their individual 
facilities and unique resident populations, such as tribally-owned 
facilities. However, several commenters also asserted that existing 
facility resources may be allocated to support staffing improvements 
and a minimum staffing standard, but indicated that facilities may be 
allocating such resources elsewhere. Moreover, commenters opposed to 
establishing a minimum staffing standard described the proposal as a 
``one-size-fits-all'' numeric standard and strongly encouraged CMS not 
to proceed with finalizing the proposed rule, especially as the LTC 
workforce continues to rebound from the COVID-19 PHE. These commenters 
preferred that staffing standards be regulated at the State level and 
shared concerns about conflict between our proposal and States that 
already have staffing standards. Some commenters also suggested that 
there are currently facilities that demonstrate a high quality of care 
delivery, despite not currently meeting the proposed staffing levels. 
They also noted that there are facilities with some of the poorest 
quality outcomes based on CMS data who currently meet the proposed 
staffing levels.
    Response: We appreciate the concerns raised by commenters regarding 
the challenges that a minimum staffing requirement will impose on LTC 
facilities. We also acknowledge the impact of the COVID-19 PHE on the 
health care industry, as discussed in the proposed rule, and recognize 
the challenges that nursing homes are facing as they relate to 
staffing. However, the COVID-19 PHE also highlighted the long-standing 
concerns with inadequate staffing in LTC facilities and we reiterate 
that evidence has shown that appropriate staffing made a crucial 
difference in quality of care as part of the overall response to the 
COVID-19 PHE in LTC facilities (see 88 FR 61356).
    In the proposed rule, we outlined the need for a minimum nurse 
staffing standard noting the consequences of inadequate staffing, such 
as poor resident outcomes, adverse events, and delayed or omitted basic 
care tasks (88 FR 61355). We also included in the proposed rule an 
impact analysis for public comment and responses to comments received 
can be found in section VI., ``Regulatory Impact Analysis,'' of this 
final rule. We maintain that chronic understaffing continues in LTC 
facilities and evidence demonstrates the benefits of increased nurse 
staffing in these facilities. Indeed, a number of the comments we 
received on the proposed rule further highlighted the danger from a 
lack of sufficient

[[Page 40894]]

staffing for residents as well as the negative effects that chronic 
understaffing has on the nursing workforce. As such, we believe that 
requiring a Federal minimum nurse staffing standard will create a 
consistent floor (baseline) across all facilities and reduce the 
variability in the nurse staffing HPRD across States. In tandem, we 
believe policies finalized and discussed in this rule will help to 
advance equitable, safe, and quality care for all residents by reducing 
the risk of residents receiving unsafe and low-quality care. Therefore, 
we are finalizing our proposal to establish minimum nurse staffing 
standards for LTC facilities as discussed in this final rule.
    We recognize the concerns raised by commenters regarding the cost 
of this rule, requests for additional funding, and workforce 
challenges. In light of these concerns, CMS announced a national 
campaign to support staffing in nursing homes.\59\ As previously 
discussed, CMS will work to develop programs that make it easier for 
individuals to enter careers in nursing homes, investing over $75 
million in financial incentives such as tuition reimbursement. In 
addition, the implementation of the requirements in this final rule are 
phased-in to allow all facilities the time needed to prepare and comply 
with the new requirements specifically to recruit, retain, and hire 
nurse staff as needed. Finally, the rule also finalizes requirements 
that will allow for a hardship exemption in limited circumstances. 
While we fully expect that LTC facilities will be able to meet our 
requirements, we recognize that external circumstances may temporarily 
prevent a facility from achieving compliance despite a facility's 
demonstrated best efforts. Details regarding the finalized 
implementation timeframe and exemption framework are discussed in 
sections II.B.5 and II.B.7 of this rule, respectively (that is, a 
phased implementation up to 5 years for rural facilities and up to 3 
years for non-rural facilities).
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    \59\ https://www.cms.gov/newsroom/fact-sheets/medicare-and-medicaid-programs-minimum-staffing-standards-long-term-care-facilities-and-medicaid.
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    Comment: Some commenters suggested that the timeframe used to 
determine compliance with the minimum HPRD should be set for at least 
one year from the date of the survey for which the compliance is being 
determined. Specifically, commenters suggested that the lookback period 
should cover a full annual certification period and emphasized that 
facilities should be held accountable for staffing decisions through an 
entire certification period. Comments also suggested that compliance 
should be determined by reviewing the facility's quarterly average HPRD 
and the lookback period should be no longer than 1 year. For example, 
one commenter stated that a quarterly average of a facility's HPRD for 
nurse staffing would align more closely to what consumers see on CMS 
Care Compare and what is used in the CMS Five-Star Quality System. They 
note that this type of consistency helps consumers and providers 
understand the requirements and monitor performance.
    Response: We agree that creating consistency between what is 
publicly reported can better inform consumers and help facilities' 
understanding of the compliance requirements. As such, we are not 
finalizing our proposal to limit determinations of compliance with 
hours per resident day requirements to the most recent available 
quarter of PBJ System data submitted in accordance with Sec.  
483.70(p). We envision compliance will be assessed by using a 
combination of PBJ data and surveyor review and observations. We note 
that CMS already uses PBJ in the existing survey process, and we 
instruct surveyors to review a report of each facility's most recent 
quarter of PBJ data (or additional quarters if warranted), to help 
target their investigations of compliance. CMS intends to calculate 
each facility's staffing hours per resident per day based on data 
required to be submitted to CMS, such as existing data required at 
Sec.  483.70(p) (as redesignated in this final rule) for electronic 
submission of staffing information (which is submitted through the PBJ 
system). As with all regulations, CMS publishes information on how 
compliance will be assessed in the State Operations Manual, appendix 
PP, and in the survey procedure documents found on the CMS web page for 
nursing home surveys.\60\ Similarly, we will publish more details on 
how compliance will be assessed after the publication of this final 
rule in advance of each implementation date for the different 
components of the rule.
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    \60\ https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes.
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    Comment: In addition to the proposed requirements, we also 
solicited comments on the following issues:
     The benefits and trade-offs associated with different 
staffing standards;
     Use of case-mix adjusted staffing HPRD for each facility 
(rather than solely the facility's self-reported staffing information) 
to assess compliance with the minimum staffing standards, steps CMS can 
take to support LTC facilities in predicting what their case-mix 
adjusted staff might be and hire in expectation of that adjusted 
staffing level, and any resources facilities will need to proactively 
calculate their existing HPRD for nursing staff;
     Alternative policies or strategies we should consider to 
ensure that we enhance compliance, safeguard resident access to care, 
and minimize provider burden.
    We received few comments related to the specific benefits and 
trade-offs associated with different staffing standards. Commenters 
stated that a requirement with individual staffing levels for specific 
nurse types reduces flexibility, which may result in non-compliance 
with the staffing requirements. In contrast, a total nurse staffing 
standard or combined total standard with individual thresholds for 
specific nurse types offers the facility the flexibility to adjust as 
needed to day-to-day shifts in staffing. Moreover, commenters noted 
concerns about complying with minimum staffing standards that differ 
significantly from State staffing requirements. We also received very 
few comments related to adopting a case-mix adjusted staffing HPRD for 
each facility to assess compliance with the minimum staffing standards. 
However, commenters who provided feedback shared concerns with adopting 
case-mix adjustments to staffing HPRD standards, noting that the 
adjusted HPRD is derived from MDS data that offers a snapshot of the 
past and does not predict future staffing needs. Another commenter also 
shared concerns that the data currently used to determine case-mix 
adjustments is flawed and should not be used to create acuity-adjusted 
staffing requirements.
    Response: We thank commenters for their thoughtful feedback in 
response to our comment solicitations. We agree that there are varying 
approaches to establishing a minimum staffing standard that would 
create greater flexibility, such as a implementing a total nurse 
staffing standard with individual staffing levels for specific nurse 
staff. As discussed, we are modifying our proposal to finalize a higher 
total standard that will increase improvements in quality and safety 
while providing flexibility for providers in meeting the minimum 
standard. We agree with commenters who indicated that there are several 
factors to consider when making case-mix adjustments to assess 
compliance with the minimum HPRD staffing standards, including the

[[Page 40895]]

need to ensure that facilities are able to proactively predict and 
calculate what their case-mix adjusted HPRD for staff might be. We 
believe that additional consideration is needed to analyze the use of 
case-mix adjusted staffing HPRD for each facility to assess compliance 
with the minimum staffing standard and will keep this suggested 
approach in mind for future rulemaking.
    Comment: We solicited comments on evidence that States relied on 
when they adopted their specific minimum nurse staffing standards and 
the rate of compliance with the State's staffing standards. We did not 
receive comments that provide the evidence that States relied on when 
they adopted specific minimum nurse staffing standards, however we did 
receive very few comments on the impact of the minimum nurse staffing 
standards that States adopted. One commenter stated that overall number 
of nursing staff in nursing homes influences quality in nursing homes. 
Another commenter noted that ``Washington State already has established 
staffing minimums. They are effective, they are enforced, and there is 
an established process for waivers.''
    We also received very few comments on rates of compliance with 
State staffing mandates. For example, one commenter stated that nearly 
30 percent of their State's nursing homes have difficultly complying 
with their minimum staffing requirement. Another commenter noted that 
their State successfully improved compliance with minimum staffing 
requirements as a result of the implementation of administrative 
penalties for facilities that failed to comply with the State's minimum 
HPRD staffing requirement, citing public health data following the 
implementation of State's requirements.\61\
---------------------------------------------------------------------------

    \61\ California Department of Public Health, 3.2 Nursing Hours 
Per Patient Day data as of November 6, 2019.
---------------------------------------------------------------------------

    Response: We appreciate the comments received on compliance with 
State minimum staffing requirements, which appears to vary. We believe 
that establishing a national floor (baseline) for nurse staffing in 
nursing homes will lead to improvements in quality across all States 
and reduce disparities in care. However, as mentioned previously, the 
provisions of this rule are not intended to, and do not preempt the 
applicability of any State or local law providing a higher standard (in 
this case, a higher HPRD requirement for total nurse staffing, RNs and/
or NAs, an RN coverage requirement in excess of at least one RN on site 
24 hours per day, 7 days a week) than required by this final rule.
    Final Rule Action: We are modifying our proposal and finalizing a 
requirement for facilities to provide a minimum total nurse staffing 
standard of 3.48 HPRD that must include at least 0.55 HPRD of RNs and 
2.45 HPRD of NAs. We are not finalizing our proposal to limit 
determinations of compliance with hours per resident day requirements 
to the most recent available quarter of PBJ System data submitted in 
accordance with Sec.  483.70(p).
4. Registered Nurse 24 Hours per Day, 7 Days a Week (Sec.  
483.35(b)(1))
    The existing LTC facility staffing regulations require an RN to be 
onsite 8 consecutive hours a day, 7 days a week (Sec.  
483.35(b)(1)).\62\ 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. To address health and quality of care concerns and to 
avoid placing LTC facility residents at risk of preventable safety 
events due to the absence of an RN, we proposed to revise Sec.  
483.35(b)(1) to require LTC facilities to have an RN onsite 24 hours a 
day, 7 days a week.
---------------------------------------------------------------------------

    \62\ 42 CFR 483.35, 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/.
---------------------------------------------------------------------------

    An existing statutory waiver for Medicare SNFs, set out at section 
1819(b)(4)(C)(ii) of the Act and implemented at Sec.  483.35(f), 
permits the Secretary to waive the requirements of Sec.  483.35(b) to 
provide the services of a RN for more than 40 hours a week, including 
the director of nursing. We proposed that facilities would use this 
process to pursue a waiver of the 24 hours a day, 7 days a week 
requirement.
    In addition to proposing the 24-hour, 7 days a week requirement for 
an RN, we noted that the separate existing requirement for the director 
of nursing (DON) at Sec.  483.35(b)(2) would remain. Specifically, all 
LTC facilities are required to designate an RN to serve as the DON on a 
full-time basis (Sec.  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 (Sec.  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 likely 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 in the proposed rule, in which the 
NASEM recommended that the DON not be counted in the requirement for an 
RN 24 hours, 7 days a week.\63\ Hence, in the 2023 proposed rule we 
also solicited comments on the following specific questions:
---------------------------------------------------------------------------

    \63\ 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.
---------------------------------------------------------------------------

     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?
     Are there alternative policy strategies that we should 
consider to address staffing supply issues such as nursing shortages?
    We received numerous comments regarding this proposal. Upon 
reviewing and analyzing these comments, we are finalizing a revision of 
the proposal as described in the responses below:
    Comment: Many commenters, including some professional provider 
organizations, advocacy groups, and labor organizations supported the 
proposed requirement for an RN to be onsite 24 hours a day, 7 days a 
week that is available for direct resident care. Some of these 
commenters also noted that other experts and organizations have for 
many years been supporting a requirement for at least one RN on site at 
a LTC facility 24 hours a day, 7 days

[[Page 40896]]

a week. One commenter noted that it was the RN that put the ``skilled'' 
into ``skilled nursing care'' that residents require for a stay in a 
LTC facility. Some of these commenters stated that the current 
requirement was not only insufficient but put residents at risk of 
preventable safety events. Some commenters also supported the proposal 
for a 24/7 RN due to the increased acuity of residents and their 
complex medical, physical, and behavioral health care needs. As 
commenters noted, LTC facilities are caring for residents with complex 
medical and behavioral health needs. They are also caring for a growing 
population of short-term residents recovering from serious health care 
issues, surgery, or other injuries. Other commenters pointed out the 
improved outcomes to residents that result from greater RN staffing. 
Commenters also pointed out that greater RN staffing levels are 
associated with positive quality measures and fewer quality of care 
deficiencies, such as, fewer pressure ulcers; lower restraint use; 
decreased infections, including urinary tract infections (UTIs); less 
pain and the need for pain medication; improved activities of daily 
living (ADLs); less weight loss and dehydration, less use of 
antipsychotic medication; more morning care; and lower mortality rates.
    Many other commenters, including some industry and provider 
organizations, supported the 24/7 RN requirement but were very 
concerned about some LTC facilities' ability to comply with this 
requirement. Other commenters, for the same reasons, opposed the 24/7 
RN requirement. Some commenters contended that the requirement was too 
expensive and was an unfunded mandate. While others contended that the 
requirement was not feasible due to a lack of available staff. As noted 
previously, however, some commenters denied there was a staffing 
shortage noting that the ``shortage'' could be resolved by higher pay 
and better working conditions.
    Response: As demonstrated by the comment summary, we received an 
abundance of comments expressing diverse views on the 24/7 RN 
requirement. We appreciate the support for the proposal. We agree that 
an RN's education, training, and scope of practice is necessary to 
provide the skilled care that LTC facility residents require for safe 
and quality care. The increased acuity of residents, both short and 
long-term, with their correspondingly complex medical, physical, and 
behavioral health care needs requires an RN's expertise. In addition, 
the literature clearly demonstrates improvement in resident outcomes 
when there is an increase in RN staffing. While we acknowledge the 
assertions by the commenters who were either concerned about the 
feasibility of the proposal or opposed to the proposal, we believe that 
the benefits of improving resident health and limiting preventable 
safety events by a stronger RN presence are vital. Therefore, we are 
finalizing the 24/7 RN proposal with revisions as detailed below.
    Comment: Some commenters stated that a 24/7 RN was unnecessary for 
resident care. They pointed out that the residents are sleeping during 
the night and do not require an RN's services. They also asserted that 
the care staff at most SNFs can provide quality care by following care 
plans and initiating the protocols established by the RN during the day 
without the RN being on site 24 hours a day. They contended that the 
only facility where RNs are needed around the clock are hospitals, 
especially in the areas of critical care. One organization noted that 
according to its members the majority of LTC facilities do not have an 
RN on site 24/7.
    Response: We agree with the commenters that LPN/LVNs and NAs can 
provide quality care by following the care plans and protocols 
established by an RN. However, it is the RN's education, training, and 
scope of practice, especially in nursing assessment, that is missing 
from resident care when an RN is not readily available. Residents can 
have changes in their physical and behavioral health at any time of the 
day. These changes could possibly require that the nursing staff assess 
the resident to determine whether there needs to be a change to a 
resident's care, such as the administration of some pro re nata or PRN 
\64\ medications; whether consultation with another health care 
provider, such as a physician is required; or whether the resident 
requires care beyond what the LTC facility could provide, requiring a 
transfer to another facility such as an acute care hospital. It is an 
RN whose education, training, and scope of practice includes the 
nursing assessment skills needed to make these determinations and the 
training and expertise to provide the quality of nursing care residents 
require in such circumstances.
---------------------------------------------------------------------------

    \64\ PRN medications are medications that are given as needed 
when certain circumstance occur. Those circumstances would be 
indicated in the medication order. For example, a PRN medication 
could be given when a resident has a temperature over a certain 
degree or for agitation. In a LTC facility, it would generally be a 
licensed nurse who makes the determination to give a PRN medication.
---------------------------------------------------------------------------

    Comment: Some commenters not only supported the proposal for an RN 
24/7 but also recommended that the requirement be strengthened. Many 
commenters were concerned about LTC facilities only being required to 
have the RN ``available'' to provide direct resident care and not 
requiring the RN to be ``providing'' direct resident care. These 
commenters recommended that the requirement be strengthened to require 
that the RN be providing direct resident care as that is the level of 
care that should be provided in a LTC facility. These commenters agreed 
with the 2022 Nursing Home Study that more RN staff should result in 
fewer deficiencies in care; however, they also insist that the RN 
cannot be simply ``present'' in the LTC facility. They contend that 
while having an RN onsite 24/7 in LTC facilities is important for 
resident care quality and safety, it is the active contributions and 
clinical expertise of RNs that ensures the delivery of skilled quality 
care for residents. Other commenters recommended that there be more 
than one RN onsite. For example, some commenters recommended one RN for 
every 100 residents.
    Response: We appreciate the commenters support for the 24/7 RN 
proposal. Regarding the commenters that recommended strengthening the 
requirement by requiring one RN for every 100 residents, we do not 
agree with those comments. We believe that having a RN onsite 24/7 to 
help with preventable issues and creating a specific standard to ensure 
residents receive on average at least 0.55 hours of RN care per day is 
a stronger approach to improve resident health and safety than 
requiring one RN for every 100 residents. We are thus finalizing a 
total nurse staffing requirement of 3.48 HPRD that must include RN 
direct care levels of at least 0.55 HPRD. Although this does not go as 
far as requiring direct care from a 24/7 RN would, it will still 
provide for greater required RN direct care than current standards do. 
These requirements are set forth at Sec.  483.35(b)(1) as finalized in 
this rule. Thus, the RN direct care staff requirement will be adjusted 
according to the number of residents in the facility. Regarding the 
commenters who recommended changing the proposed requirement that an RN 
be ``available to provide direct care,'' to require the RN ``providing 
direct resident care'', we are not modifying the proposed requirements 
to incorporate that comment. The total nurse staffing requirement 
finalized in this rule

[[Page 40897]]

contains an RN direct care level of at least 0.55 HPRD. This 
requirement along with the requirement for a 24/7 RN available to 
provide direct resident care should provide the high-quality, safe care 
that residents need.
    Comment: In the proposed rule, we specifically solicited comments 
on whether the DON should be counted towards the 24/7 RN requirement or 
should the DON only count under specific circumstances. Commenters were 
divided on this question. Many commenters opposed the DON being counted 
towards the 24/7 RN requirement, as well as any other RN that is 
assigned to administrative duties. They contended that only RNs 
providing direct resident care should be counted towards the 
requirement. Still other commenters thought the DON should be included 
since they would be onsite at the LTC facility and could provide direct 
resident care, if needed. However, other commenters did not oppose 
including the DON in the requirement, especially if the resident census 
was below 30 residents.
    Response: As discussed in the previous comment, we are finalizing 
the 24/7 RN requirement to require that the RN is available to provide 
direct resident care as proposed. Therefore, if the DON is a RN and is 
available to provide direct resident care, then the DON will count 
towards this requirement. We are not establishing a specific resident 
census for this requirement because we have no reliable evidence upon 
which to base a specific number of residents for this requirement.
    Comment: Many commenters were concerned about the statutory waivers 
cited in the proposed rule and CMS's assertion that the statutory 
waiver would apply to the proposed 24/7 RN requirement. They contended 
that these waivers diminished the requirement for a 24/7 RN and would 
result in a reduced quality of care for residents. Other commenters 
also noted that these statutory waivers were difficult to 
operationalize and were rarely granted. Specifically, commenters noted 
that the requirements for the statutory waiver were difficult for many 
LTC facilities to meet, such as the requirement for SNFs to be in a 
rural area. Some commenters thought these waivers could actually 
undermine the 24/7 RN requirement by enabling too many LTC facilities 
to avoid the requirement. At least one commenter recommended that LTC 
facilities use the same exemption criteria proposed as Sec.  483.35(g) 
(finalized at Sec.  483.35(h) as discussed in this rule), which would 
be applied to hardship exemptions for the minimum nurse HPRD standards 
set forth at proposed Sec.  483.35(b)(1) (finalized at Sec.  
483.35(c)(1) as discussed in this rule).
    However, other commenters contended that it was unnecessary for the 
RN to even be on site at the LTC facility 24/7. These commenters stated 
that part of the 24 hours could be satisfied through some type of 
``virtual'' presence by an RN. Commenters suggested that an RN could be 
available by phone, internet, or be able to get to the LTC facility 
within a certain amount of time, such as 30 minutes. Commenters stated 
that a one-size-fits-all approach was unnecessary, and requirements 
should be based on resident acuity. Commenters insisted that by 
allowing for a part of the 24/7 RN coverage to be virtual, each LTC 
facility could determine if their resident population needs an RN on 
site 24/7 or whether the RN could be virtually present during a part of 
the day. Some commenters specifically recommended that an RN could 
virtually support LPNs on the evening and night shifts. There were also 
commenters who noted that while there was a process for obtaining a 
hardship exemption to the minimum nurse staffing requirement, there was 
no waiver or exemption process for the 24/7 RN requirement.
    Response: The current requirement is that the LTC facility provide 
24 hours of licensed nursing services (RN or LPN/LVN) and RN services 7 
days a week for 8 consecutive hours per day as set forth at existing 
sections Sec.  483.35(a) and (b). There are two waivers discussed in 
Sec.  483.35 of the LTC participation requirements that are set forth 
in paragraphs (e) and (f) (redesignated in this final rule as 
paragraphs (f) and (g), respectively). The requirements for these 
waivers come directly from the statute, specifically section 
1819(b)(4)(C)(ii) and 1919(b)(4)(C)(ii) of the Act, respectively. Since 
these two waivers are statutory, the waivers can only be removed or 
modified in detail by legislation. Thus, the waivers in existing Sec.  
435.35(e) and (f) (redesignated as paragraphs (f) and (g) in this final 
rule) will not be changed except for conforming changes, which we will 
discuss further, to ensure that the statutory waivers do not conflict 
with the regulatory flexibilities finalized in this final rule at Sec.  
483.35(h). To assist readers and provide clarity, table 2 provides an 
overview of the differing requirements for the statutory waiver at 
Sec.  483.35(e) and (f) (finalized as paragraphs (f) and (g) in this 
rule).
BILLING CODE 4120-01-P

[[Page 40898]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.082

BILLING CODE 4120-01-C
    While the details of the statutory waivers, described in table 2, 
can only be modified by legislation, we agree with the commenters that 
LTC facilities

[[Page 40899]]

need to have some flexibility with the 24/7 RN requirements. We are 
especially concerned about those LTC facilities that meet the 
requirements for hardship exemptions. If a LTC facility is unable to 
meet the minimum staffing requirements as set forth at Sec.  483.35(b) 
(as finalized in this rule), it also might not be able to comply with 
the 24/7 RN requirement because this could be an indication of the LTC 
facility's difficulty in obtaining staff in general. Conversely, if a 
LTC facility does not meet the requirements for a hardship waiver, it 
should be able to comply with the 24/7 RN requirement by the required 
implementation deadlines. Thus, we are finalizing an additional 
exemption for facilities that experience a hardship complying with the 
24/7 RN requirement. This exemption will be in addition to the existing 
statutory waiver process set forth at Sec.  483.35(e) and (f) 
(finalized in this rule as paragraphs (f) and (g)). Specifically, we 
are revising the requirements at proposed Sec.  483.35(b) (finalized at 
Sec.  483.35(c)(1) as discussed in this rule) to indicate that 
facilities must have a RN onsite 24 hours per day, 7 days a week that 
is available to provide direct resident care, except when this 
requirement is waived in accordance with the existing statutory waivers 
at Sec.  483.35(e) and (f) (redesignated as paragraphs (f) and (g) as 
discussed in this rule) or exempted in accordance with the criteria for 
regulatory flexibilities at Sec.  483.35(h). Section 483.35(h) 
specifies that a facility may qualify for a hardship exemption of 8 
hours a day from the 24/7 RN requirement if the facility is located in 
an area where the RN to population ratio is a minimum of 20 percent 
below the national average, as calculated by CMS, by using data from 
the Bureau of Labor Statistics and Census Bureau. The finalized 
regulatory flexibilities and criteria for eligibility at Sec.  
483.35(h), including the basis for why such eligibilities have been set 
at current thresholds, are discussed in detail in the next section, 
section II.B.5. of this rule. We expect that those facilities currently 
meeting the 24/7 RN staffing requirement will continue meeting the 
requirement.
    Furthermore, we are adding a requirement to specify that for any 
periods when the onsite RN requirements are exempted in accordance with 
the exemption criteria at Sec.  483.35(h), facilities must have a 
registered nurse, nurse practitioner, physician assistant, or physician 
available to respond immediately to telephone calls from the facility. 
At existing Sec.  483.35(e) (finalized at Sec.  483.35(f)) we are 
modifying the heading of the paragraph to read ``Nursing facilities: 
Waiver of requirement to provide licensed nurses and a registered nurse 
on a 24-hour basis''. This paragraph applies to NFs only and the 
modified heading helps to clarify those requirements that are 
applicable to the waiver set out at section 1919(b)(4)(C)(ii) of the 
Act. In addition, we are modifying the language at existing Sec.  
483.35(f) (finalized at Sec.  483.35(g)) to revise the heading of the 
paragraph to read ``SNFs: Waiver of the requirement to provide services 
of a registered nurse for at least 112 hours a week''. This paragraph 
would be applicable to facilities that meet the statutory 
qualifications for the waiver set out at section 1819(b)(4)(C)(ii) of 
the Act.
    Given that this rule finalizes an additional regulatory flexibility 
for facilities to receive an exemption of 8 hours per day of the 24/7 
RN requirement, we want to clarify that facilities who may also meet 
the requirements for the statutory waivers as detailed at existing 
sections Sec.  483.35(e) and (f) (finalized as paragraphs (f) and (g) 
in this rule) will still have the ability to choose which process they 
want to pursue to achieve regulatory flexibility from the 24/7 RN 
requirement. For example, a SNF may be exempted from 8 hours per day of 
the 24/7 RN requirement if they meet the criteria specified in Sec.  
483.35(h). If this SNF is rurally located, then in accordance with 
existing Sec.  483.35(f) (finalized in this rule at paragraph (g)) this 
facility may choose to instead pursue the statutory waiver for SNFs to 
achieve greater flexibility from the 24/7 RN requirement based on their 
specific situation and ability to meet the criteria outlined by the 
statute for the waiver rather than pursue the 8 hours per day exemption 
provided under new Sec.  483.35(h).
    Final Rule Action: We are finalizing with revisions the proposed 
requirement for an RN to be onsite 24 hours a day, 7 days a week and 
available to provide direct resident care. The RN can be the DON; 
however, they must be available to provide direct resident care. Also, 
LTC facilities that qualify for a hardship exemption to the minimum 
nurse staffing requirement set forth at Sec.  483.35(b)(1)(i) in 
accordance with the criteria outlined at Sec.  483.35(h) (as finalized 
in the rule) may also request an exemption of 8 hours per day of the 
24/7 RN requirement. We have added this as we believe that additional 
flexibility is needed for facilities as they adopt the 24/7 RN 
requirement. We have added a requirement at Sec.  483.35(c)(2) to 
specify that for any periods when the onsite RN requirements in are 
exempted in accordance with Sec.  483.35(h), facilities must have a 
registered nurse, nurse practitioner, physician assistant, or physician 
available to respond immediately to telephone calls from the facility. 
In addition, we are modifying the language at existing Sec.  483.35(e) 
(finalized at Sec.  483.35(f)) to revise the heading of the paragraph 
to read ``Nursing facilities: Waiver of requirement to provide licensed 
nurses and a registered nurse on a 24-hour basis''. We are also, 
modifying the language at existing Sec.  483.35(f) (finalized at Sec.  
483.35(g)) to revise the heading of the paragraph to read ``SNFs: 
Waiver of the requirement to provide services of a registered nurse for 
at least 112 hours a week''.
5. Hardship Exemptions From the Minimum Hours per Resident Day 
Requirements (Sec.  483.35(g))
    We proposed at new Sec.  483.35(g), that facilities could be 
exempted from the 0.55 HPRD of RNs and/or 2.45 HPRD of NAs requirements 
if they were found non-compliant with the HPRD requirements and met 
four eligibility criteria, based on location, good faith efforts to 
hire, disclosure of financial information, and were not excluded based 
on the prior year's citations, failure to submit data to the PBJ, or 
having been designated as a Special Focus Facility. We stated that 
determinations regarding exemptions would be made during a survey. We 
also proposed that facilities could only receive an exemption from the 
proposed minimum HPRD requirements and not the proposed 24/7 RN 
requirements. We noted that a waiver of the proposed 24/7 RN 
requirements must be granted in accordance with the existing statutory 
waivers at Sec.  483.35(e) and (f). We further proposed that the 
Secretary, through CMS or the applicable State Agency, would make the 
determination about exemption from the HPRD requirements and that such 
exemptions would be in effect for one year and renewable annually if 
facilities continued to meet the exemption requirements. We received a 
large number of comments that addressed exemptions. Comments ranged 
from robust objection to any exemptions, to support for exemptions as 
proposed or in concept, with both opposing and supporting commenters 
recommending a wide variety of specific changes to revise and improve 
our proposal. These comments reflected disparate and often opposing 
views on the provision of exemptions. In addition to proposing specific 
exemption criteria,

[[Page 40900]]

we also solicited comment on several specific questions related to 
exemptions.
    We discuss and respond to these comments and responses to our 
questions in detail below.
    Comment: Many commenters objected to allowing any exemption from 
the HRPD requirements. Some commenters stated that understaffing 
results in falls, injuries, and even death. Some commenters stated that 
the proposed exemptions would normalize inadequate staffing, depress 
wages, and would be dangerous and undermine or jeopardize the health 
and safety of residents. Other commenters stated that every nursing 
home resident deserved high quality care, regardless of their 
geographic location or other factors. One commenter stated that CMS 
must stop putting the financial priorities of the nursing home industry 
above the basic needs and dignity of nursing home residents. Some 
commenters suggested that certain facilities, including rural 
facilities, should be given special consideration, while others 
suggested that no facility should be given special consideration. 
Several commenters stated that they believed there should be 
progressive enforcement of the requirement, with reduced penalties in 
clear instances of a good faith effort to meet the staffing standards.
    Response: We appreciate all of the commenters' concerns and 
suggestions. Our goal is to promote safe, high-quality care for all 
residents. We also recognize the need to strike an appropriate balance 
that considers the current challenges some LTC facilities are 
experiencing, particularly in rural areas. We have decided to retain 
the availability of exemptions under certain circumstances for select 
facilities, which would include some that are rural, after 
consideration of the comments, recognition of both quality of care and 
access to care concerns. We note the continued availability of recourse 
when there is a quality of care concern, including those that may be 
related to safety and staffing availability, such as complaints to 
survey agencies, QIOs, and State long-term care ombudsman programs. 
Exemptions may remain in place only until the next standard survey, and 
we expect any LTC facility receiving an exemption to work toward full 
compliance with the staffing standards.
    Comment: Some commenters stated that any exemptions should be 
limited in number and frequency and must be paired with specific 
elements of heightened scrutiny and transparency. Furthermore, the 
commenters asserted that the need for such an exemption must be 
compelling. One commenter stated that only if facilities, at their 
current staffing ratios, are performing well on outcomes such as 
hospital readmission rates, nurse turnover, facility acquired injuries, 
anti-psychotic medication use, would there be a logical justification 
to give them a waiver. Commenters also recommended concrete standards 
and clear, measurable, and rigorous criteria for receiving an 
exemption. One commenter recommended that CMS narrowly tailor the 
workforce shortage exemption. Other commenters suggested many specific 
changes, such as:
     Capping the number of exemptions a facility can receive, 
to avoid facilities that are perpetually exempted;
     Prohibiting any facility that does not meet the staffing 
requirements from admitting new residents;
     Disqualifying facilities operating under an exemption from 
any type of value-based purchasing initiatives within either the 
Medicare or Medicaid programs;
     Requiring facilities with an exemption to demonstrate 
progress on reducing turnover and increasing wages;
     Appointing an independent entity to monitor performance of 
any facility with an exemption;
     Ensuring transparency around exemptions through such tools 
as prominent display of exemption status on Nursing Home Compare with a 
warning about the possible consequences of nursing understaffing, 
posted notice within the facility, and specific notice to any 
individual/family residing in or seeking admission, as well as the 
Long-Term Care Ombudsman Program;
     Requiring that the facility's staffing plans demonstrate 
consideration of nationally recognized best practices, such as PHI's 5 
Pillars of Direct Care Job Quality; and that the facility provide 
evidence related to best practices beyond offering prevailing wages, 
such as enhanced benefits, expanded training programs, worker surveys 
to inform workplace improvements, improved scheduling policies, 
participation in job fairs, and partnerships with schools;
     Requiring ``good faith efforts to hire and retain staff'' 
to include documentation of recruiting efforts, a specific method for 
calculating and reporting staff turnover, and an explicit target and 
plan for reducing turnover, including regular reporting to CMS;
     Requiring ``documentation of financial commitment to 
staffing'' that includes investments in recruiting and retention, and 
evidence of increased wages;
     Requiring an alternate viable plan for meeting the needs 
of the residents in their care, not solely on financial difficulties;
     Establishing a sunset date for hardship exemptions; and
     Placing nursing homes granted an exemption on a `do not 
refer' list that is distributed to area hospitals and other providers.
    Response: We thank the commenters for their suggestions. The 
exemption framework provides qualifying LTC facilities with the 
opportunity to receive time-limited flexibility upon completion of 
several essential documentation and transparency requirements. We 
considered each option suggested. While we are not implementing all of 
them at this time, we have included some, including around transparency 
and we may consider them in future rulemaking. In response to the 
concerns raised, we have made some revisions. Specifically, we have 
removed the distance criterion and narrowed the availability of 
exemptions to those facilities in staff shortage areas where the supply 
of applicable healthcare staff (RN, NA, or combined licensed nurse, 
which includes both RNs and LVN/LPNs, and nurse aide) is not sufficient 
to meet area needs as evidenced by the applicable provider-population 
ratio for nursing workforce that is a minimum of 20 percent below the 
national average for the applicable exemption (RN, NA, or combined 
licensed nurse and nurse aide), as calculated by CMS, by using the 
Bureau of Labor Statistics and Census Bureau data. The area is the 
geographical area defined as the metropolitan statistical area (MSA) or 
nonmetropolitan statistical area (non-MSA) where the LTC facility is 
located using data from the U.S. Bureau of Labor Statistics (available 
at https://www.bls.gov/oes/current/msa_def.htm). Furthermore, we agree 
that transparency to current and potential residents, as well as the 
State Long Term Care Ombudsman Program is a necessary element. We are 
therefore adding transparency requirements in order to receive an 
exemption. First, a facility must post in a prominent, publicly 
viewable location in the facility a notice of the facility's exemption 
status, the extent to which the facility does not meet the minimum 
staffing requirements, and the timeframe during which the exemption 
applies. Second, a facility must provide a similar notice to each 
resident or resident representative, and to each prospective resident 
or prospective resident representative, that includes a statement 
reminding residents of their rights to contact advocacy and oversight 
entities, as

[[Page 40901]]

provided in the notice provided to them under Sec.  483.10(g)(4). 
Finally, the facility must send a copy of the notice to a 
representative of the Office of the State Long-Term Care Ombudsman. 
Exemption information will also be publicly available on Care Compare. 
We considered capping the number of exemptions or establishing 
escalating requirements for subsequent exemptions, but at this time, 
find that the underlying requirements to obtain an exemption are 
sufficient to encourage ongoing good faith efforts to meet the new 
requirements, to evaluate facilities quality of care prior to granting 
each exemption, and to ensure that residents and their representatives 
are aware of the exemption status of the facility.
    Comment: Many commenters stated that the proposed exemption process 
was unfair and unworkable. Others described it as not meaningful or too 
burdensome and limited to be useful. Other commenters supported the 
proposed process. One commenter noted that the proposed staggered 
implementation dates and exemption criteria reflect a nuanced 
understanding of the challenges faced by LTC facilities and called the 
exemption criteria reasonable. Another stated that the exemption 
process would only postpone the challenges of meeting the minimum 
staffing standards. Some stated that small, rural facilities most in 
need of an exemption would not be able to meet the criteria to qualify 
while others suggested that few facilities at all would be able to 
qualify, stating that the criteria will be difficult if not impossible 
for most nursing homes to meet in all but the extreme circumstances. 
Some commenters urged CMS to streamline the exemption requirements to 
offer greater flexibility. Some commenters stated that the process 
should not be punitive, but should help facilities comply with the rule 
or that the process should protect facilities from monetary penalties 
and have checks and balances to ensure facilities are not punished for 
not meeting unattainable goals. One commenter recommended that CMS 
create a waiver process that is available to all facilities without 
exclusions; does not entail citation; is attainable by any facility 
that is in need and that is making good faith efforts (reasonable 
process); and includes support from a QIO or another party to assist 
facilities in securing support resources to meet applicable needs. Some 
commenters stated that disparities between criteria for exemptions or 
waivers should be minimized and should be ``somewhat uniform'' since 
they relate to the issue of insufficient workforce. One commenter 
stated that any exemption should be based on the availability of 
workers, compensation offered, and working conditions. Other commenters 
recommended adding an exemption for unforeseen circumstances, temporary 
weather-related staffing reductions, or exigent circumstances. One 
commenter noted that their State considers extraordinary circumstances 
such as natural disaster, catastrophic event or a national or State-
declared emergency; location in a region that the health commissioner 
has declared is experiencing an acute labor shortage; and a verifiable 
union dispute as mitigating factors for understaffing. Another 
recommended that CMS create a protocol for State agencies to implement 
to ensure consistency and provided details of how their State 
implemented exemptions to State requirements. Finally, one commenter 
stated that they were pleased that compliance with the 24/7 RN 
requirement did not imply compliance with the minimum staffing HPRD 
standard and that the hardship exemption process cannot be used to 
circumvent that [24/7 RN] requirement. Another stated that adding 
additional requirements that already have a foundation in regulations 
is illogical and risks further erosion of an already fragile system.
    Response: We appreciate the comments in support of the exemption 
process and have considered the concerns raised about it. We have 
determined, in the interest of resident health and safety, that it is 
not acceptable to significantly expand the exemption process. However, 
based on the feedback from commenters and concerns raised regarding 
access to care, as discussed previously we have modified our proposal 
to allow facilities that can demonstrate a limited supply of RNs (based 
on a provider-to-population ratio 20 percent below the national 
average) and meet the exemption criteria to receive an exemption from 8 
hours per day of the 24/7 RN requirement. In keeping with the comments 
regarding uniformity and exemptions based on worker availability, we 
are also finalizing, as part of the exemption process, a comparable 
exemption criterion for determining the workforce unavailability 
criterion for the total nurse staffing 3.48 HPRD standard that we are 
finalizing. Specifically, we will incorporate a provider to population 
ratio for combined licensed nurse and nurse aide workforce into the 
exemption requirements where such a ratio must be at least a minimum of 
20 percent below the national average. As explained in the proposed 
rule (88 FR 61378), to calculate whether a LTC facility is in an area 
with a shortage of RNs or NAs, we first use the Care Compare data to 
identify the State and county where each LTC facility is located. We 
then combine these data with information from the U.S. Bureau of Labor 
Statistics (available at https://www.bls.gov/oes/ on the counties in 
each MSA and non-MSA to identify the MSA or non-MSA where each LTC 
facility is located. Next, we identify the total number of RNs and NAs 
in each MSA and non-MSA using the Bureau of Labor Statistic's 
Occupational Employment and Wage Statistics Query System (available at 
https://data.bls.gov/oes/#/home). Afterwards, we calculate the 
population for each MSA or non-MSA using population estimates from the 
United States Census Bureau by summing the population for all counties 
in the MSA or non-MSA (available at https://www.census.gov/data/tables/time-series/demo/popest/2020s-counties-total.html#v2022). Finally, we 
calculate whether the LTC facility is located in an MSA or a non-MSA 
with a medium or low provider-to-population ratio by comparing the 
area's provider-to-population ratio to the average provider-to-
population ratio for the United States. We note that facilities that do 
not receive an exemption will have the opportunities afforded by the 
enforcement process to address any noncompliance deficiency citations, 
such as informal dispute resolution processes and administrative and 
judicial appeals. We have determined that this is the appropriate set 
of criteria to use for exemptions from both the 24/7 RN requirement and 
the 3.48 total staffing standard as it is appropriate to apply the same 
criteria for workforce insufficiency (20 percent below the national 
average for the applicable staff category) across all exemptions.
    Comment: Many commenters suggested that facilities that receive an 
exemption should have to demonstrate progress on staffing related 
issues. For example, one commenter recommended we add a provision to 
require the facility to increase retention to 75 percent or higher if 
the facility will utilize an exemption, as there are many methods that 
can be utilized to increase staff retention, including flexible work 
schedules, bonuses, well-trained managers/supervisors, incentive 
programs and much more. This commenter stated that reducing turnover 
rates will significantly increase resident care/safety as well as 
reduce

[[Page 40902]]

the recruitment burden on managers. Several commenters mentioned 
turnover rates in the context of retention and recruiting, and one 
suggested that, for RNs and/or CNAs and other nursing staff, if the 
turnover rate is higher than 35 percent, a facility should not meet the 
good faith effort requirement for an exemption. Another commenter 
suggested adding a provision that would bar nursing homes with a 
turnover rate higher than the State median from receiving hardship 
exemptions.
    Response: We thank commenters for these suggestions. At this time, 
we are not adding additional requirements related to turnover to 
qualify for an exemption. The facility's staffing plan in accordance 
with Sec.  483.71(b)(4), however, requires the facility to develop and 
maintain a staffing plan to maximize recruitment and retention of 
direct care staff, and is considered part of a demonstration of a good 
faith effort to hire. Retention and turnover may thus be considered in 
evaluating whether a facility is complying with its staffing plan in 
seeking exemption. We also note that information on turnover is 
publicly available on Care Compare. In 2022, CMS began posting levels 
of weekend staffing and rates of staff turnover and using these metrics 
in the Five Star Quality Rating System to help provide more useful 
information to consumers. In addition, CMS is adopting the Nursing 
Staff Turnover Measure for the SNF VBP program beginning with the FY 
2026 program year. This is a structural measure that has been collected 
and publicly reported on Care Compare and assesses the stability of the 
staffing within an SNF using nursing staff turnover. This is part of 
the Administration's focus to ensure adequate staffing in long-term 
care settings and delivers on a commitment included in the President's 
Executive Order 14070, Increasing Access to High-Quality Care and 
Supporting Caregivers. Facilities would begin reporting for this 
measure in FY 2024, with payment effects beginning in FY 2026. While we 
are not adopting these suggestions at this time, we may consider them 
for future rulemaking.
    Comment: Several commenters objected to the demonstration of 
financial commitment as an exemption criterion. Some commenters felt 
that this criterion was duplicative of the information that would be 
provided in the good faith effort to hire criterion. One noted that the 
framework for exemptions was likely to encourage the use of temporary 
staffing and that, given the cost of temporary labor, this may create a 
wrong impression while accelerating predatory temporary labor pricing. 
Another comment recommended requiring facilities that intend to utilize 
a staffing exemption provide full disclosure of all financial 
documents, including ownership, related parties, profits, tax and 
corporate filings, audits, and financial statements and requiring that 
these documents be made available within 10 days of the request to 
residents, resident responsible parties, executors/trustees of resident 
estates, advocates, and regulatory agencies. One commenter suggested 
that in order to qualify for an exemption, a facility must demonstrate 
that its owners and management are not profiting from the nursing home 
or any company that is paid by the facility. Another stated that any 
exemption related to claimed financial constraints must be considered 
with far more robust transparency requirements. One commenter stated 
that the requirement is vague. In response to our question regarding a 
spending threshold, several commenters recommended that CMS establish 
that facilities must spend 80 percent of revenue on direct care 
services, similar to the proposed CMS requirements for HCBS services 
\65\ and requirements in four States (New Jersey, New York, 
Massachusetts, and Pennsylvania). Another commenter recommended 75 
percent as a threshold, with independent confirmation. One commenter 
stated that CMS must either conduct or direct the State survey agency 
to conduct an audit of the nursing home's finances.
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    \65\ https://www.cms.gov/newsroom/fact-sheets/ensuring-access-medicaid-services-cms-2442-p-notice-proposed-rulemaking.
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    Response: We thank commenters for these suggestions. We have 
considered both the comments supporting and the comments objecting to 
the financial commitment criterion. We recognize that the requirement 
we are finalizing only requires the facility to document and provide 
information when needed to receive an exemption. We believe that the 
financial commitment criterion will lead facilities to evaluate their 
financial commitment to staffing while leading CMS to better understand 
facility investment in staffing and the implications of expanding the 
requirement by establishing a threshold, requiring additional 
documentation, or other modifications. While we are not adopting these 
suggestions at this time, we will consider them for future rulemaking.
    Comment: Some commenters specifically objected to the exemption 
determination being made after a facility is surveyed and determined to 
be out of compliance with the HRPD staffing requirement. Several 
commenters indicated that being cited and fined before getting an 
exemption was unreasonable. One suggested that extensions of the 
exemption period should be automatic ``if conditions persist.'' Many 
commenters felt that facilities should proactively be able to apply for 
an exemption through the submission of documentation. One commenter was 
concerned that the process requires facilities to open themselves up to 
additional scrutiny to qualify and that this could mean a provider 
opens themselves up to exclusion if a surveyor determines their 
insufficient staffing has resulted in harm or inaccurately cites the 
PBJ tag. Another commenter stated that facilities are already heavily 
penalized for not submitting PBJ data, and this exclusion should be 
limited to allow for a temporary lapse, especially when it results from 
emergent reasons, such as a disaster that the facility didn't report or 
when a facility is unable to submit data, despite trying, due to 
technical portal issues. One commenter noted that this would increase 
the workload on already over-burdened and underfunded State survey 
agencies. Others noted that States already have significant backlogs of 
surveys and facilities should not be penalized for that. One commenter 
recommended that CMS develop a streamlined process to apply for an 
exemption without requiring an onsite survey and noted that the 
exemption request process must be simple and not burdensome.
    Response: We thank commenters for their feedback. We believe that 
the exemption criteria recognizes that some facilities may have 
difficulty meeting the new requirements and therefore may obtain an 
exemption if they meet the qualifications. However, this is balanced by 
the need to ensure residents' health and safety. With respect to a 
survey preceding the granting of an exemption, we note that facilities 
cannot request, and a State would not conduct, a survey specifically 
for the purpose of granting an exemption, but rather that facilities 
would be evaluated during a survey, such as the standard 
recertification survey, to determine if they were eligible for an 
exemption. A survey preceding any determination regarding an exemption 
would identify any other deficiencies of the facility, including those 
that could disqualify a facility from receiving an exemption and help 
ensure that safety and quality of care is maintained. As mentioned 
previously, we will publish more details on how compliance will be 
assessed after publication of this final rule in advance

[[Page 40903]]

of each implementation date for the different components of the rule. 
We intend to use the traditional process of communication of 
information via CMS QSO memoranda and publication of information in the 
State Operations Manual.
    Comment: Some commenters recommended that specific types of LTC 
facilities be exempt from the HRPD requirements. One commenter 
recommended that Life Plan Communities (similar to Continuing Care 
Retirement Communities) be exempt. Some commenters suggested that all 
Tribal facilities be exempt from the HRPD requirements. Other 
commenters suggested that some specialized facilities (subacute units, 
hospital-based SNFs, and distinct part units of hospitals, any facility 
in an auto-HPSA) also be exempt from the HRPD requirements. One 
commenter recommended exempting nursing homes in States that have 
existing staffing ratio requirements for licensure. Others suggested 
that facilities with high quality measures at their current staffing 
levels be automatically exempted or be qualified to request an 
exemption. Some commenters said that they found the lack of 
flexibility, waiver, or leniency for communities taking good faith 
efforts to comply unfair. Finally, one commenter suggested that all 
rural facilities should be exempt.
    Response: We thank commenters for these suggestions. As noted 
earlier, our goal is to promote safe, high-quality care for all 
residents. We also recognize the need to strike an appropriate balance 
that considers the current challenges some LTC facilities are 
experiencing, particularly in rural areas. We considered establishing 
categories for blanket exemptions, but are not adopting any at this 
time. Blanket exemptions for an entire category of facilities lacks the 
facility-specific assessment required under our proposal. In 
particular, we are finalizing a process under which any facility 
granted an exemption must have a preceding survey to determine its 
compliance with the requirements. However, such compliance 
determinations would not be conducted if we were to establish blanket 
exemptions. At this time, we want to ensure we are aware of any quality 
of care concerns at the individual facility level prior to granting an 
exemption. As we gain insight into facility compliance with the 
staffing minimums and in the application of the exemption process, we 
can consider suggestions to tighten the exemption process in future 
rulemaking. We note that hospital providers of long-term care services 
(swing-beds) are not subject to the Nursing Services requirements under 
Sec.  483.35, but instead are subject to the hospital conditions of 
participation, including staffing (Sec.  482.23), as well as specific 
provisions of 42 CFR part 483 identified in Sec.  482.58.
    Comment: Some commenters objected to using location as an exemption 
criterion, while others supported a location criterion. Many responded 
to our question regarding the ``right distance'' from another facility 
to warrant a hardship exemption, often suggesting an alternative or 
stating that mileage is not an indicator of hardship and objecting to 
any mileage-based criterion. One commenter stated that the mileage-
based criterion was arbitrarily set and did not account for multiple 
facilities in the same area needing to apply for an exemption. 
Commenters noted a variety of BLS limitations, geographic features, and 
transit system considerations that made the location criteria 
problematic. Several commenters suggested that a provider to population 
ratio does not reflect the true availability of the workforce, and that 
this must be considered when determining eligibility for waivers and 
exemptions. One commenter supported the location criterion as proposed 
but wanted it to also be applied to the statutory waiver for RNs/
licensed nurses; other commenters voiced similar concerns about the 
existing RN/licensed nurse waiver. Some commenters suggested removing 
the provider to population ratio, and reducing the mileage criteria to 
10 or 15 miles. One commenter noted that the presence of a CAH near an 
LTC facility also impacted staff availability, even in the face of 
collaborative efforts. One commenter also suggested the mileage-based 
criterion be clarified for Tribal facilities to state that for Tribal 
facilities, it must be another Tribal facility within 20 miles. A 
different commenter suggested the mileage criterion should be 50 miles, 
stating that the average daily commute in the United States is 37 miles 
one-way (per U.S. Department of Transportation) and that it is not 
appropriate to jeopardize the health and welfare of a nursing facility 
resident with a staffing exemption for 20 miles when that is 17 miles 
less than the average commute of the staff who work at care facilities. 
Fifty miles was also suggested by another commenter who also felt the 
provider to population ratio should be changed to a more stringent 50 
percent below the national average. Another supported 40 percent below 
the national average as the requirement. Other commenters stated HPSA 
data is not a good criterion to determine exemption status, as the data 
only shows how many licensed nurses are in an area and does not 
consider how many of those nurses are willing to work in an LTC 
facility and that availability should take into consideration 
competition from other types of providers. One commenter pointed out 
problems with urban/rural definitions and further encouraged including 
urban facilities in eligibility for exemptions. Another commenter 
stated that the proposed method to determine a workforce shortage area 
is unworkable and inaccurate, because it is based on an already 
depressed national average. One commenter who objected to any 
exemptions stated that every nursing home resident deserved high-
quality care, regardless of their geographic location or other factors. 
Many commenters who supported the need for staffing requirements also 
objected to exemptions, noting that all residents, regardless of zip 
code, are entitled to appropriate professional nursing care. One 
commenter recommended re-evaluating these criteria every six months and 
one year after implementation and annually.
    Response: We thank commenters for these suggestions. We have 
considered the many perspectives and potential alternatives presented. 
Given that there was not a public consensus on the appropriate distance 
and considering the general opposition received in establishing this 
specific criterion, we have revised our proposal. We are only 
finalizing the applicable provider-population ratio for nursing 
workforce (RN, NA, or combined licensed nurse and nurse aide) in the 
facility area as a location criterion, removing the additional mileage-
based criterion. As a threshold for determining a workforce shortage, 
given concerns raised about workforce unavailability, and in light of 
eliminating the distance criterion, we concluded that finalizing the 
moderate standard is appropriate. Therefore, we are finalizing that the 
provider-population ratio must be a minimum of 20 percent below the 
national average, as calculated by CMS, by using the Bureau of Labor 
Statistics and Census Bureau data.
    Comment: One commenter objected to the use of the term ``good faith 
effort'' as too subjective and recommended that any term used must be 
objectively measurable. Several commenters were concerned with the term 
`prevailing wage' and one suggested CMS should define the term 
``prevailing wage'' in a manner that is more consistent with its use 
elsewhere in Federal law and

[[Page 40904]]

regulations. This commenter recommended looking to collectively 
bargained wage rates as a source of data on competitive wage levels, 
counting benefits as well as wages in the determination, and taking 
into account wage levels for jobs in other industries with similar 
entry requirements and for nursing positions in hospitals, staffing 
agencies, and other settings in determining the prevailing wage.
    Response: We appreciate these comments and concerns. After 
considering all of the information and suggestions presented, we are 
finalizing the proposal regarding ``good faith efforts'' and 
``prevailing wages'' as published. The language about prevailing wages 
is consistent with the statutory language in section 1919(b)(4)(C)(ii) 
of the Act in establishing requirements for facility waivers, which 
states that `the facility demonstrates to the satisfaction of the State 
that the facility has been unable, despite diligent efforts (including 
offering wages at the community prevailing rate for nursing 
facilities), to recruit appropriate personnel,' Therefore, we believe 
that the language used is appropriate. However, while we are not 
adopting these suggestions at this time, we may consider them for 
future rulemaking.
    Comment: In response to CMS's question about additional hardships 
that CMS should consider in providing exemptions, some commenters 
supported adding financial difficulties/constraints. Commenters noted 
that many facilities receive most of their revenue from Medicaid, which 
commenters characterized as inadequate in many States to cover the 
daily costs of care for the resident. According to commenters, these 
facilities would not be able to afford the increased staffing 
requirements and would most likely reduce the number of beds, lower the 
number of Medicaid residents they admit, or close, leaving many 
residents without housing because hospitals and other high-quality 
facilities may not admit residents who pose a high risk for negative 
outcomes. A commenter suggested that CMS provide exemptions based on 
financial hardship such as changes in financial performance as it 
relates to provision of care and services to residents, including 
financial exemptions based on customary accounting measurements such as 
changes in operating income, variances versus annual budget or prior 
year performance, and changes in cash flow. Others objected to a 
hardship exemption based on the financial condition of the provider. 
One commenter stated that we do not allow car manufacturers in 
financial distress to produce vehicles without seatbelts or with less 
effective crumple zones in front-end bumpers; we do not allow airlines 
in financial distress to fly without stewards or qualified pilots and 
that adequate staffing should be a core element of any nursing home's 
financial plans rather than an extra for those facilities that can 
afford it.
    Response: We thank commenters for their concerns and suggestions. 
We have considered all of the information submitted and, given the 
competing nature of those comments and information, it would be 
challenging to define exactly what constitutes a financial challenge. 
Therefore, we are not at this time including an exemption criterion 
based on financial need but are maintaining a criterion based on a 
provider to population ratio. We note that facilities will be required 
to demonstrate through documentation the amount of financial resources 
that the facility expends on nurse staffing relative to revenue prior 
to being granted an exemption. While we are not adopting these 
suggestions at this time, we may consider them for future rulemaking.
    Comment: Some commenters objected to the exclusion criterion for 
exemptions, either suggesting less restrictive or more restrictive 
exclusion criteria. A commenter stated that CMS should remove all the 
proposed exclusion criteria because all facilities should be afforded 
an opportunity for an exemption. Another commenter stated that 
facilities should not be required to be cited for staffing 
noncompliance before being eligible for an exemption and that 
facilities should be eligible to apply for an exemption based on the 
workforce supply and the facility's good-faith efforts to hire and 
retain staff--no exceptions. Some commenters supported the exclusion 
criteria and one commended CMS for not considering HPRD exemptions for 
providers with a history of staffing concerns, poor care delivery, or 
harm or abuse to residents to whom they are entrusted to provide care. 
In response to our question about additional exclusions, some 
commenters felt CMS should expand exclusions to include Special Focus 
Facility Candidates (not just SFFs) and perennial 1-star rated 
facilities. Another suggested expanding the criteria that makes a 
facility ineligible for an exemption to include facilities that have 
recently been cited for failing to meet staffing standards and/or abuse 
or neglect of residents. A commenter suggested that CMS give States the 
option to tailor the exemption process to align with their existing 
frameworks if those States have existing staffing standards and 
exemption. Another asked CMS to clearly indicate that the final rule 
will not preempt any higher State standards or State consumer 
protection and Medicaid Fraud Control Unit's (``MFCUs'') efforts 
related to staffing or quality of nursing care in LTC facilities.
    Response: CMS has considered these suggestions, balanced these 
noted concerns, and determined that, at this time, we will finalize our 
proposed exclusion criteria without modification. We note that it is a 
long-standing requirement that all facilities must comply with both 
State and Federal standards, and therefore, would be held to any higher 
standards imposed by a State.
    Comment: One commenter specifically supported the 1-year time frame 
for exemptions. Many commenters noted that there are not enough 
surveyors or that surveys do not occur exactly 1 year apart.
    Response: We thank commenters for their support and for voicing 
their concerns about the timing of surveys. In response, we are 
revising the timeframe for exemptions under Sec.  483.35(h) from 1 
year, to the next standard recertification survey. Thus, no matter when 
the exemption is initially approved following a survey, it is in effect 
until the next standard survey, unless it is removed as a result of a 
facility falling into the exclusion category. The exemption can be 
removed any time a facility develops any one of the exclusions. Waivers 
under Sec. Sec.  483.35(f) (Medicaid nursing facilities) and 483.35(g) 
(Medicare skilled nursing facilities) are subject to annual review or 
renewal, respectively, pursuant to the waiver language set out in the 
Social Security Act.
    Final Rule Action: After consideration of the comments, we received 
on the proposed rule, we are finalizing our proposal for hardship 
exemptions to the HRPD requirements with the following modifications:
     We have redesignated the proposed hardship exemption from 
the minimum hours per day requirements at Sec.  483.35(g) as new 
paragraph (h) in this final rule and revised the heading to also 
include a hardship exemption from the ``registered nurse onsite 24 
hours per day, for 7 days a week requirements''.
     We have revised the location criteria at newly 
redesignated Sec.  483.35(h)(1) (proposed Sec.  483.35 (g)(1)) to 
eliminate the 20 mile criterion and remove all references to a 40 
percent below national average provider-to-population ratio. We are 
finalizing at

[[Page 40905]]

newly redesignated Sec.  483.35 (h)(1) (proposed Sec.  483.35 (g)(1)) 
the requirement that the facility be located in an area where the 
supply of applicable healthcare staff (RN, or NA, or total nurse 
staffing) is not sufficient to meet area needs as evidenced by the 
applicable provider-to-population ratio for nursing workforce(RN, NA, 
or combined licensed nurse and nurse aide) that is a minimum of 20 
percent below the national average, as calculated by CMS, by using the 
Bureau of Labor Statistics and Census Bureau data.
     We have modified the requirements at Sec.  483.35(h)(1) to 
specify that a facility can receive an exemption from one, two, or all 
three of the following requirements, as follows:
    (1) The facility may receive an exemption from the total nurse 
staffing requirement of 3.48 hours per resident day at Sec.  
483.35(b)(1) if the combined licensed nurse, which includes both RNs 
and LVN/LPNs, and nurse aide to population ratio in the area is a 
minimum of 20 percent below the national average.
    (2) The facility may receive an exemption from the RN 0.55 hours 
per resident day requirement (Sec.  483.35(b)(1)(i)) and an exemption 
of 8 hours a day from the RN on site 24 hours per day, for 7 days a 
week requirement (Sec.  483.35(c)(1)) if the RN to population ratio in 
the area is a minimum of 20 percent below the national average.
    (3) The facility may receive an exemption from the NA 2.45 hours 
per resident day requirement at Sec.  483.35(b)(1)(ii) if the NA to 
population ratio in the area is a minimum of 20 percent below the 
national average.
     We have added new requirements at Sec.  483.35(h)(4), 
Disclosure of exemption status, to require that the facility:
    (1) Posts, in a prominent location in the facility, and in a form 
and manner accessible and understandable to residents, and resident 
representatives, a notice of the facility's exemption status, the 
extent to which the facility does not meet the minimum staffing 
requirements, and the timeframe during which the exemption applies; and
    (2) Provides to each resident or resident representative, and to 
each prospective resident or resident representative, a notice of the 
facility's exemption status, including the extent to which the facility 
does not meet the staffing requirements, the timeframe during which the 
exemption applies, and a statement reminding residents of their rights 
to contact advocacy and oversight entities, as provided in the notice 
provided to them at Sec.  483.10(g)(4); and
    (3) Sends a copy of the notice to a representative of the Office of 
the State Long-Term Care Ombudsman.
     We are not finalizing paragraph (g)(5)(iv) due to changes 
made to exemptions for the 24/7 RN requirement.
     We are finalizing, as proposed, requirements for good 
faith efforts to hire (Sec.  483.35(h)(2)) and demonstrated financial 
commitment (Sec.  483.35(h)(3)).
     We renumbered proposed paragraphs (g)(4) through (6) as 
paragraphs (h)(5) through (7) in the section accordingly.
     We have revised paragraph (h)(7) to provide that the term 
for a hardship exemption under Sec.  483.35(h) is from grant of 
exemption until the next standard recertification survey, unless the 
facility becomes an Special Focus Facility, or is cited for widespread 
insufficient staffing with resultant resident actual harm or a pattern 
of insufficient staffing with resultant resident actual harm, is or 
cited at the immediate jeopardy level of severity with respect to 
insufficient staffing as determined by CMS, or fails to submit Payroll 
Based Journal data in accordance with Sec.  483.70(p). A hardship 
exemption may be extended on each standard recertification survey, 
after the initial period, if the facility continues to meet the 
exemption criteria in Sec.  483.35(h)(1) through (5), as determined by 
the Secretary.
6. Facility Assessment (Proposed Sec.  483.71)
    Facility assessments play an important role in ensuring that LTC 
facilities develop thoughtful, informed staffing plans to meet the 
needs of their specific residents based on case mix and other factors. 
The current requirements for the facility assessment are set forth at 
Sec.  483.70(e) and require each LTC facility to conduct and document a 
facility-wide assessment to determine what resources are necessary to 
care for its resident population competently during both day-to-day 
operations and emergencies. It must be reviewed and updated annually, 
as necessary, and whenever the facility plans for or has any change in 
its facility or population that would require a substantial change to 
any part of the assessment. The assessment must address or include 
evaluation of the resident population, the facility's resources, and a 
facility-based and community-based risk assessment that utilizes the 
all-hazards approach. For the reasons set forth in the proposed rule, 
we proposed to redesignate (that is, relocate or move) the existing 
requirements for the facility assessment to its own standalone section 
from Sec.  483.70(e) to proposed Sec.  483.71. We also proposed 
technical changes throughout the CFR to replace references to Sec.  
483.70(e) with Sec.  483.71 based on this proposed change. We also 
proposed technical changes throughout the CFR to replace references to 
Sec.  483.70(e) with Sec.  483.71 based on this proposed change. For 
organizational purposes, we proposed to redesignate the stem statement 
for current Sec.  483.70(e) to the stem statement for proposed Sec.  
483.71 and existing Sec.  483.70(e)(1) through (3). We proposed to 
redesignate Sec.  483.70(e)(1) through (3) as proposed Sec.  
483.71(a)(1) through (3), respectively.
    At new Sec.  483.71(a)(1)(ii), we proposed to clarify that 
facilities would have to address in the facility assessment details of 
its resident population, including the care required by the resident 
population, using evidence-based, data driven methods that consider the 
types of diseases, conditions, physical and behavioral health issues, 
cognitive disabilities, overall acuity, and other pertinent facts that 
are present within that population, consistent with and informed by 
individual resident assessments as required under existing Sec.  
483.20, ``Resident Assessment.'' Specifically, we proposed to revise 
this paragraph by specifying the ``use of evidence-based, data driven 
methods'' and create a link to the requirements for the resident 
assessment. Facilities are expected to update their facility assessment 
as needed, no less than annually, using evidence-based, data-driven 
methods, that consider the needs of their residents and the 
competencies of their staff.
    We also proposed to revise this paragraph to add ``behavioral 
health issues'' to clarify that LTC facilities must consider their 
residents' physical and behavioral health issues. At new Sec.  
483.71(a)(1)(iii), we proposed to add ``and skill sets'' so the 
requirement reads: ``The staff competencies and skill sets that are 
necessary to provide the level and types of care needed for the 
resident population.'' At new Sec.  483.71(a)(3), we proposed to add a 
cross-reference to the existing requirements for facilities to conduct 
a facility and community-based risk assessment as part of their 
emergency planning resources.
    At new Sec.  483.71(a)(4), we proposed to require facilities to 
include the input of facility staff, including but not limited to 
categories such as nursing home leadership, management, direct care 
staff and their representatives, and staff providing other services.

[[Page 40906]]

    We proposed at new Sec.  483.71(b)(1) to require facilities to use 
the facility assessment to inform staffing decisions to ensure 
appropriate staff are available with the necessary competencies and 
skill sets necessary to care for its residents' needs as identified 
through resident assessments and plans of care as required in Sec.  
483.35(a)(3).
    In addition, we proposed a new Sec.  483.71(b)(2) to require 
facilities to use the facility assessment to assess the specific needs 
for each resident unit in the facility, and to adjust as necessary 
based on any significant changes in the resident population. Facilities 
would also be required, at proposed Sec.  483.71(b)(3), to consider the 
specific staffing needs for each shift, such as day, evening, night, 
weekends, and to adjust as necessary based on any significant changes 
to the resident population.
    We proposed at new Sec.  483.71(b)(4) that LTC facilities would 
have to use their facility assessment to develop and maintain a 
staffing plan to maximize recruitment and retention of nursing staff. 
We did not propose to specify how the staffing plan should be developed 
or what it must contain. We solicited comments on the operational 
challenges or burdens of this proposed provision, as well as how CMS 
could best provide oversight of this proposed requirement.
    We proposed at Sec.  483.71(b)(5), to require facilities to use the 
facility assessment to inform contingency planning for events that do 
not necessarily require the activation of the facility's emergency plan 
but do have the potential to impact resident care.
    Based upon our review and analysis of the comments, we are 
finalizing the proposed requirements as proposed with some revisions. 
The language we are finalizing and the reasons for those changes are 
detailed in the comments and responses below.
    Comment: A few commenters supported the move to relocate the 
current requirements at Sec.  483.70(c) (Facility assessment to a 
standalone) to Sec.  483.71 (Facility assessment). However, other 
commenters opposed any changes to the current facility assessment 
requirements as unnecessary.
    Response: We acknowledge that relocating the facility assessment 
requirements might not appear to be a substantial change. However, the 
facility assessment requirements are the foundation for any LTC 
facility's planning for the staffing and other resources that are 
necessary to provide the appropriate care required for its resident 
population. This merits a separate requirement and also emphasizes the 
importance of the facility assessment. Hence, we are finalizing this 
redesignation as proposed.
    Comment: Some commenters were supportive of the proposed changes to 
the facility assessment requirements. Several commenters were 
particularly supportive of the insertion of ``behavioral health 
issues'' in Sec.  483.35(a)(1)(ii) in describing the factors the LTC 
facility's assessment must address regarding its resident population. 
One commenter even stated that the proposed changes to the facility 
assessment requirement were one of the most important changes that were 
proposed. However, there were also many commenters that opposed the 
proposed changes. Some commenters thought that the requirement was 
formulaic and many LTC facilities just ``sleepwalked'' through the 
process. Some opposed the proposed changes contending that they would 
only result in more paperwork and take direct care staff away from 
resident care. They contended that there was little, if any, evidence 
that the current requirements in any way benefitted residents, 
especially regarding nurse staffing. Other commenters noted that the 
facility assessment requirement has been essentially ignored by both 
LTC facilities and surveyors. They noted that from FY 2021 to FY 2023, 
there had only been 592 deficiencies cited regarding the facility 
assessment requirement and in only 10 of these cases was it even likely 
a financial penalty would be imposed. However, other commenters 
indicated that the proposed changes were not necessary because the vast 
majority of LTC facilities were already in substantial compliance with 
the current requirements.
    Response: The comments received regarding facility assessment 
demonstrated a diversity of opinions on the proposed changes. We agree 
that the proposed changes will strengthen the overall facility 
assessment, which we have long viewed as a foundational element to care 
and resource planning in LTC facilities. The facility assessment is an 
important complement to the minimum staffing requirements finalized as 
part of this rule as it sets standards that must be met for staffing 
based on actual resident case-mix, not just the floor (baseline) 
created by the minimum staffing requirements. We agree with the 
commenters that the addition of ``behavioral health issues'' is an 
important change and emphasizes the need to consider these issues in 
the facility assessment. Thus, we are finalizing the addition of ``and 
behavioral health'' at Sec.  483.35(a)(1)(ii) as proposed.
    However, we disagree with commenters about the meaning of the 
number of deficiencies cited by surveyors. While the number of 
deficiencies is relatively low, this is not an indication that the 
requirement is being ignored or dismissed by the LTC facilities or 
surveyors. As some commenters indicated, the vast majority of LTC 
facilities are complying with the facility assessment requirement. 
Also, some surveyors might choose to cite a deficiency based on a 
requirement set out elsewhere in the LTC participation requirements 
instead of the facility assessment requirement. For example, a surveyor 
might cite a noncompliance deficiency for the sufficient nurse staffing 
requirement set forth at Sec.  483.35(a)(1) rather than the facility 
assessment requirement. Regarding the commenters who opined that LTC 
facilities were only ``sleepwalking'' through the process, the 
governing body is responsible for the quality of care provided to 
residents and how the LTC facility's policies are established and 
implemented (Sec.  483.70(d)(a)). The medical director is responsible 
for the implementation of resident care policies; and the coordination 
of medical care in the facility (Sec.  483.70(h)). Hence, it is the 
responsibility of both the governing body and the medical director to 
ensure that requirements, including the facility assessment 
requirement, are complied with at their facility to ensure that 
residents receive quality, safe care. To address this concern, we are 
finalizing at Sec.  483.71(b) a requirement that the LTC facility must 
ensure the active participation of a member of the governing body and 
the medical director in the facility assessment process. This is 
discussed in more detail below.
    Comment: Many commenters supported the proposed facility assessment 
changes and recommended the requirement be strengthened. Some 
recommended that a tool be developed for LTC facilities to follow in 
conducting their facility assessments. Others recommended that LTC 
facilities could be required to follow a prescribed method or specific 
methodologies to provide some uniformity in the facility assessments 
and focus the assessments on resident acuity. They also suggested that 
the facility assessments should be reviewed and updated more often, 
such as quarterly. A few commenters recommended that the facility 
assessment either be included in or structured similarly to the quality 
assessment and program improvement (QAPI) program. Some others wanted 
to

[[Page 40907]]

require an evaluation of all of the training programs in the facility 
assessment process.
    Response: CMS thanks the commenters for their recommendations. 
However, we will not finalize any of these recommendations as 
requirements in this rule. We will continue to evaluate these 
suggestions and consider these comments if there is future rulemaking 
regarding the facility assessment requirement. Regarding an evaluation 
of training programs in the facility assessment, at Sec.  483.95 we 
require LTC facilities to develop, implement, and maintain an effective 
training program for all new and existing staff; individuals providing 
services under a contractual arrangement; and volunteers, consistent 
with their expected roles. LTC facilities are required to determine the 
amount and type of training necessary based on their facility 
assessment as now set forth at new Sec.  483.71. Hence, part of 
developing or reviewing and updating the facility assessment would 
include determining the amount of and type of training each individual 
providing services to residents should receive.
    Comment: Several commenters were concerned about the proposed staff 
required to be involved in the facility assessment process, although 
many other commenters supported the idea that direct care staff should 
be closely involved in creating the facility assessments. Some 
commenters wanted to specifically name RNs and all other levels of 
nursing staff to ensure their input on staffing was included in the 
facility assessment. They contended that RNs were in the best position 
to determine staffing levels for the various units in the LTC facility. 
Other commenters contended that Nas should be specifically named since 
they provide most of the direct resident care. Some commenters were 
very supportive of our proposal because they believed the LTC 
facility's Medical Director should be actively involved in the facility 
assessment process. A few also suggested that the governing board be 
included in the process. However, other commenters opposed expanding 
the requirements for who should be involved in this process, especially 
in requiring non-staff or other third parties in the facility 
assessment process. Commenters contended that this would be 
inappropriate since it is an operational document for the facility. 
They suggested that the inclusion of third parties, especially union 
representatives, could be disruptive, divisive, and render the facility 
assessment ineffective. In addition, there are concerns that third 
parties, especially union representatives, would not be primarily 
concerned about the residents' care and well-being but the workers they 
represent. Specifically, they raised their concerns that union 
representatives would be concerned with their members' compensation, 
benefits, and working conditions and not the care provided to 
residents. To address this concern, a few commenters recommended that 
any representatives of direct care workers also be an employee of the 
LTC facility. These commenters contended that only another employee 
would have the knowledge of the facility and its operations to provide 
beneficial input into the facility assessment. Other commenters noted 
that the guidance contained in the State Operation Manual that is used 
for surveys already indicates that LTC facilities should seek input 
from residents, resident representatives, resident families, and family 
councils.\66\
---------------------------------------------------------------------------

    \66\ State Operations Manual, appendix PP Guidance to Surveyors 
for Long Term Care Facilities (Rev. 211, 02-03-23), Tag F838, 
Guidance sec. 483.70(e) (Rev.: 173, Issued: 11-22-17, Effective 11-
28-17, Implementation: 11-28-17).
---------------------------------------------------------------------------

    Response: The staff involved in the facility assessment are 
essential to the quality and comprehensiveness of the assessment. We 
agree with the commenters that all levels of the nursing staff need to 
be included in the facility assessment process so that the final 
product is comprehensive and provides the maximum benefit to the 
residents and the LTC facility. As discussed above, it is the governing 
body that is responsible for establishing and implementing the policies 
(Sec.  483.70(d)(a)) and the medical director is responsible for the 
implementation of that these individuals would also be essential to the 
facility assessment process. The most contentious comments generally 
regarded the proposal for representatives of direct care staff. We 
thank commenters for their suggestions. We agree the purpose of the 
facility assessment is to identify the resources and supports needed to 
safely care for residents. However, we also believe that individuals 
other than facility staff could offer beneficial input for the process. 
Input from the representatives of direct care staff, for example, 
third-party elected local union representatives, business agents, 
safety and health specialists, or a non-union worker's designated 
representatives from a worker advocacy group, community organization, 
local safety organization, or labor union, could be especially 
important. Direct care staff may be hesitant to criticize staffing 
decisions of management or fear retaliation. Their representatives 
would generally be able to speak more freely and can reflect concerns 
that they have heard across a number of staff members. We agree that 
representatives who are not themselves employees may not have the 
knowledge of the facility or its operations as an employee would; 
however, it is the representatives' ability to provide input that 
employees might be hesitant to provide themselves that could be 
valuable input.
    We want to clarify that the requirement for ``direct care staff'' 
means more than RNs, LPNs/LVNs, and Nas alone. We encourage LTC 
facilities to solicit input or even active participation from other 
direct care staff, especially physicians, nurse practitioners, 
physician assistants, social workers, activity directors, dieticians/
nutritionists, and other therapists. Also, if the LTC facility has 
specialized units, such as, memory care, behavioral health, sub-acute, 
or ventilator/trach dependent, we encourage the inclusion or input of 
staff from those units. Due to the care provided by these specialized 
units, their staff could provide valuable input into the staffing and 
other resource requirements needed for the residents care for in units.
    We also want to clarify our expectations regarding ``active 
participation'' for the staff identified in this requirement. LTC 
facilities need flexibility in how they conduct, develop, and implement 
their facility assessments. Hence, ``active participation'' does not 
require that all identified staff or their representatives are at every 
meeting or discussion or must approve the final facility assessment. 
However, at a minimum, all identified staff should have the opportunity 
to present their views and have those views considered by the other 
staff that are actively participating in the process. LTC facilities 
should determine the level of active participation for each individual 
thereafter. For example, if some meetings would focus on nurse 
staffing, the LTC facility would not necessarily have to require a 
physical therapist or a member of the food and nutrition staff to 
attend. Also, the LTC facility could limit the staff who would be 
responsible for the final approval of the facility assessment. In 
addition, individuals could participate in-person or virtually. For 
example, the medical director or member of the governing body could 
participate by phone in meetings or provide their input and comments on 
drafts in written form. Regarding those individuals whose input should 
be

[[Page 40908]]

solicited and considered if received, the LTC facility should actively 
solicit input from identified participants. The LTC facility should 
determine the best way to contact these individuals to solicit their 
input. The input should then be shared with all of the individuals who 
are actively participating in the facility assessment process in time 
for there to be a discussion of the received input. The time period for 
providing input should be reasonable. The individuals from whom input 
is being sought would likely need more than a few days or a week to 
contemplate what input they want to provide.
    Hence, we are revising Sec.  483.71(b)(1) to require that the LTC 
facility require the active participation of the nursing home 
leadership and management including but not limited to, a member of the 
governing body, the medical director, an administrator, and the 
director of nursing; and, direct care staff, including but not limited 
to, RNs, LPNs/LVNs, Nas, and representatives of direct care staff, if 
applicable. The LTC facility must also solicit and consider input 
received from residents, resident representatives, family members.
    Comment: Some commenters contended that the proposed requirements 
conflicted with each other, especially the minimum nurse staffing and 
24/7 RN requirements. They also noted concerns about how the facility 
assessment requirement worked with these requirements.
    Response: All of the requirements in this finalized rule are 
designed to both function independently and work together to ensure 
that LTC facility residents receive the quality care required for their 
health and safety needs. The minimum nurse staffing requirement as set 
forth in Sec.  483.35(a)(1) requires LTC facilities to have a minimum 
total nurse staffing of 3.48 HPRD with a minimum 0.55 HPRD for RNs, and 
a minimum total of 2.45 HPRD for Nas. Unless a LTC facility is exempted 
as described in Sec.  483.35(h), each LTC facility must comply with the 
requirement. The 24/7 RN requirement is in addition to the minimum 
nurse staffing requirement; however, each RN that is on duty and 
providing direct resident care also counts towards both requirements. 
Hence, there is no conflict between these requirements. The facility 
assessment requirement as set forth at Sec.  483.71 is a separate 
requirement that is designed to ensure that each LTC facility has 
assessed its resident population to determine the resources, including 
direct care staff, their competencies, and skill sets, the facility 
needs to provide the required resident care. If the facility assessment 
indicates that a higher HPRD for either total nursing staff or an 
individual nursing category is necessary for ``sufficient staffing'', 
the facility must comply with that determination to satisfy the 
requirement for sufficient staffing as set forth at Sec.  483.35(a)(1). 
The facility assessment requirement ensures that each LTC facility 
assesses the needs of its resident population to determine the 
resources it needs to provide the care its residents require. However, 
if the facility assessment indicates that a lower HPRD or that a 24/7 
RN is not required to care for their resident population, the LTC 
facility must still comply with those minimum staffing requirements. 
Hence, these requirements do not conflict with each other. Each 
requirement works independently to achieve the separate goals of a 
minimum nurse staffing requirement and an assessment of the resources 
that are required to care for the LTC facility's resident population. 
They also work together to ensure that each LTC facility is providing 
the quality, safe care required for their resident population.
    Comment: Some commenters questioned the usefulness of the facility 
assessment regarding determinations of daily staffing needs. They 
contended that the facility assessment is more global rather than 
granular, that is, it cannot assist with the daily changes in resident 
acuity.
    Response: We acknowledge that resident acuity and daily staffing 
needs can vary. LTC facilities must already contend with and adjust for 
these changes daily. However, if the facility assessment was conducted 
according to the requirements finalized in this rule, LTC facilities 
should know the number of staff, the competencies, skills sets they 
need, and the other resources needed to care for residents in their 
facilities. This should enable LTC facilities to adjust their staffing 
and other resources to compensate for resident acuity and changes 
needed in daily staffing.
    Comment: In the proposed rule, we discussed some of the reasons 
input from representatives of direct care representatives could be 
important for the facility assessment process. One statement was, 
``[a]longside direct care employees, their representatives may also 
help ensure facility assessments are up-to-date and used to inform 
facility staffing'' (emphasis added) (88 FR 61375). Several commenters 
disagreed with the part of the statement emphasized in italics above. 
These commenters contended the enforcement role belongs exclusively to 
State and Federal surveyors and is never the domain of a third-party 
representatives.
    Response: We agree with the commenters that the enforcement of the 
LTC participation requirements is not within the scope of participation 
of third-party representatives. However, the referenced statement in 
the proposed rule located at 88 FR 61375 is not referring to any 
enforcement role. As stated in the proposed rule, the input from 
representatives of direct care workers could be beneficial, especially 
when the direct care workers are hesitant to raise concerns with their 
employers about the current staffing in the facility. In such 
instances, representatives can provide the LTC facility with 
assessments and recommendations anonymously from direct care workers 
free from the fear of retaliation, which could assist LTC facilities in 
ensuring their facility assessments are up to date and accurately 
inform facility staffing without retaliation. Ultimately, we believe 
that this type of input can positively impact staff leading to better 
and safer care for residents. Hence, we are finalizing a requirement 
that LTC facilities ensure the active participation of direct care 
staff, including but not limited to, RNs, LPNs/LVNs, NAs, and 
representatives of direct care staff, if applicable.
    Comment: Some commenters contended that the proposed changes 
constitute a one-size-fits-all approach that is inconsistent with the 
goals of the facility assessment. They contend that the individual 
needs of the residents and LTC facilities are not being considered or 
acknowledged in the proposed rule.
    Response: We do not agree that these requirements utilize a ``one-
size-fits-all'' approach. The minimum nurse staffing requirement as set 
forth in Sec.  483.35(b)(1) requires LTC facilities to have a minimum 
total nurse staffing of 3.48 HPRD with a minimum 0.55 HPRD for RNs, and 
a minimum total of 2.45 HPRD for NAs. Because HPRD involves an 
assessment of the total number of hours worked by each type of staff 
compared to the actual number of residents in the facility, it is 
automatically adjusted for size of facility. With the facility 
assessment requirement, each individual LTC facility assesses its own 
resident population and the resources needed to care for them, which 
will often result in facilities needing to staff higher than the 
minimum staffing requirements. Thus, neither of these requirements is 
``one-size-fits-all'' because they are tailored to each LTC facility. 
The only requirement that is the same regardless of the LTC facility or 
its

[[Page 40909]]

resident population is the 24/7 RN requirement. However, this 
requirement is designed to reduce the occurrence of preventable safety 
events for residents, as well as address health and quality concerns, 
which requires at least one RN providing direct resident care 
throughout the day. LTC facilities are expected to increase RN coverage 
as needed to comply with the minimum nurse staffing requirements and 
their facility assessment. The minimum nurse staffing and 24/7 RN 
requirements are not justifications for any LTC facility to fail to 
provide the direct care staff with the appropriate competencies and 
skill sets and other resources required to appropriately care for its 
resident population.
    Comment: Some commenters were supportive of the requirement for 
certain individuals to be involved in the facility assessment process 
but recommended more time to comply with the requirement. These 
commenters noted that it would be difficult to assemble the staff 
required, develop the facility assessment, and a staffing plan in the 
usual time allotted after a final rule is published. One commenter 
recommended 120 days after the final rule was published, and another 
recommended two years.
    Response: All LTC facilities should already have a facility 
assessment. While it should not take an extended period of time to do 
so, CMS is concerned that some LTC facilities might need more time to 
comply with the requirements finalized in this rule. For example, some 
LTC facilities might need additional time due to staffing issues or a 
lack of previous documentation. Hence, we are finalizing a longer 
implementation date for the facility assessment requirements in this 
rule to allow more time for LTC facilities to come into compliance. We 
proposed a 60-day implementation date for the facility assessment 
requirements, however, we are modifying our proposal to require 
implementation of the facility assessment requirements 90 days after 
publication of this final rule. LTC facilities should be using the 
facility assessment to determine appropriate staffing needs based on 
their resident population's care needs and meet these requirements in 
an accelerated manner.
    Comment: Commenters were divided on the proposed requirement that 
set forth how LTC facilities were to use their facility assessments. 
Many commenters opined that additional requirements were unnecessary, 
burdensome, and would also be taking direct care staff away from 
resident care. There were also many commenters that were supportive, 
especially regarding the requirement that the LTC facility use their 
facility assessment in making staffing decisions and in developing and 
implementing the staffing plan. One commenter was grateful that this 
section was clarifying how the facility assessment should be used and 
indicated that this made it more meaningful. Other commenters 
recommended that the requirement be strengthened to increase its 
effectiveness. Some commenters recommended a requirement for an 
assessment committee. Other commenters recommended a requirement on 
specific items that should be considered or included in the staffing 
plan, such as compensation and training for direct care staff.
    Response: The new requirement at Sec.  483.71(c) is intended to 
provide clarification on how LTC facilities are to use their facility 
assessments. While some commenters might argue that it is unnecessary, 
we disagree. The facility assessment is the foundation for LTC 
facilities to assess their resident population and determine the direct 
care staffing and other resources, to provide the required care to 
their residents. The facility assessment must be conducted and 
developed with the intent of using it to inform decision making, 
especially about staffing decisions. The facility assessment must be 
used to develop and maintain the staffing plan or the plan to maximize 
recruitment and retention of direct care staff. The facility assessment 
should identify the numbers of staff, types of staff, the required 
competencies and skill sets that staff require to care for the resident 
population. Thus, the facility assessment would inform the staffing 
plan the LTC facility requires. The facility assessment must also be 
used to inform contingency planning. LTC facilities will likely 
encounter different events that have the potential to affect resident 
care. These events, however, do not necessarily require activation of 
the facility's emergency plan. The facility assessment should be used 
to inform contingency planning to address these types of events. For 
example, direct care staff will call in sick some days. LTC facility 
must have contingency plans for when direct care staff cannot come into 
work. Hence, we are finalizing Sec.  483.71(c) as proposed.
    Comment: Some commenters opposed facility assessment requirements 
being used to cite for deficiencies during a survey. Commenters 
asserted that surveyors could not determine the quality of the facility 
assessment or the staffing plan. Also, they noted that even if the 
staffing plan was well developed, its effectiveness depended on so many 
factors that LTC facility should not be responsible for any results.
    Response: We agree with the commenters that surveyors cannot 
determine the quality of the facility assessment. Surveyors determine 
whether or not the LTC facility has complied with the facility 
assessment requirements as set forth at new Sec.  483.71. Therefore, an 
LTC facility could be cited for non-compliance if its facility 
assessment failed to contain all the requirements set forth in new 
Sec.  483.71 and failed to determine a direct care staffing plan 
consistent with facility resident acuity levels.''
    Comment: Some commenters were concerned about the potential of 
direct care staff, especially nurses, encountering retaliation as a 
result of participation in the facility assessment process. These staff 
might hesitate to criticize the LTC facility's staffing policies or 
make recommendations about staffing that they know will not be endorsed 
by the management. Some commenters recommended that nurses have some 
protections, such as whistleblower protections.
    Response: RNs, LPNs/LVNs, and NAs are critical to a comprehensive 
and effective facility assessment. We encourage all direct care staff 
involved in the facility assessment process to provide thoughtful and 
honest feedback when participating in the facility review and 
development process for the assessment. Similarly, management should 
not punish or retaliate against direct care staff for providing honest 
input. In this rule, we are finalizing a requirement for facilities to 
ensure active participation from representatives of direct care staff, 
if applicable, as such we encourage staff, especially those who may be 
concerned about potential retaliation, to communicate with and utilize 
their representatives as a resource for sharing input. In addition, the 
Occupational Safety and Health Administration (OSHA) has resources to 
help employers learn about recommended practices to keep their 
workplaces free of illegal retaliation.\67\
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    \67\ https://www.osha.gov/sites/default/files/publications/OSHA3905.pdf.
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    Final Rule Action: We are finalizing as proposed the relocation of 
Sec.  483.70(e) to a standalone section, Sec.  483.71. We are 
finalizing as proposed the addition of ``behavioral health issues'' to 
Sec.  483.71(a)(1)(ii); the addition of ``and skill sets'' to Sec.  
483.71(a)(1)(iii); and the addition of ``as required'' in Sec.  
483.73(a)(1) through (3). We are also finalizing our proposal to 
redesignate the stem statement for current Sec.  483.70(e) to the stem 
statement for

[[Page 40910]]

proposed Sec.  483.71 and existing Sec.  483.70(e)(1) through (3) as 
proposed Sec.  483.71(a)(1) through (3), respectively. We are 
finalizing as revised Sec.  483.71(b) to require that the LTC facility 
actively require the participation of the nursing home leadership and 
management, including but not limited to, a member of the governing 
body, the medical director, an administrator, and the director of 
nursing; and, direct care staff, including but not limited to, RNs, 
LPNs/LVNs, NAs, and representatives of direct care staff, if 
applicable. The LTC facility must also solicit and consider input 
received from residents, resident representatives, family members, and 
representatives of direct care staff. We are also finalizing as 
proposed Sec.  483.71(c) that sets out the activities for which the LTC 
facility must use the facility assessment, including making staffing 
decisions, developing and maintaining a plan to maximize recruitment 
and retention of direct care staff, to inform contingency planning for 
events that do not necessarily require activation of the facility's 
emergency plan.
7. Implementation Timeframe
    We proposed to implement the 0.55 RN and 2.45 NA HPRD, the RN 
onsite 24 hours a day, 7 days a week, and facility assessment 
requirements in three phases, to avoid any unintended consequences or 
unanticipated risks to resident care when a facility is developing new 
policies and procedures necessary to comply with these requirements. 
This would give facilities significant time to recruit additional staff 
needed to meet the requirements.
    In addition, we anticipate that additional time would be needed to 
develop revised interpretive guidance and survey processes, conduct 
surveyor training on the changes, and implement the changes in the 
Long-Term Care Survey Process system.
    For facilities located in urban areas, we proposed that 
implementation of the final requirements be achieved in three phases, 
over a 3-year period. Specifically, we proposed that--
     Phase 1 would require facilities to comply with the 
facility assessment requirements (Sec.  483.71) 60-days after the 
publication date of the final rule.
     Phase 2 would require facilities to comply with the 
requirement for a RN onsite 24 hours a day, 7 days a week (Sec.  
483.35(b)(1)) 2 years after the publication date of the final rule.
     Phase 3 would require facilities to comply with the 
minimum staffing requirement of 0.55 and 2.45 HPRD for RNs and NAs 
respectively (Sec.  483.35(a)(1)(i) and (ii)) 3 years after the 
publication date of the final rule.
    For facilities located in rural areas, we proposed the 
implementation of the final requirements be achieved in three phases, 
over a 5-year period. Specifically, we proposed that--
     Phase 1 would require facilities to comply with the 
facility assessment requirements (Sec.  483.71) 60-days after the 
publication date of the final rule.
     Phase 2 would require facilities to comply with the 
requirement for a RN onsite 24 hours a day, 7 days a week (Sec.  
483.35(b)(1)) 3 years after the publication date of the final rule.
     Phase 3 would require facilities to comply with the 
minimum staffing requirement of 0.55 and 2.45 HPRD for RNs and NAs 
respectively (Sec.  483.35(a)(1)(i) and (ii)) 5 years after the 
publication date of the final rule.
    For purposes of the implementation timeframe, we proposed to define 
``rural'' in accordance with the Census Bureau definition. ``Rural'' 
encompasses all population, housing, and territory not included within 
an urban area \68\ We also solicited public comments on whether a 
different definition should be used. We noted that the final 
regulations would be effective 60 days following the publication of the 
final rule in the Federal Register and solicited public comments.
---------------------------------------------------------------------------

    \68\ https://www.census.gov/programs-surveys/geography/guidance/
geo-areas/urban-
rural.html#:~:text=Rural%20encompasses%20all%20population%2C%20housin
g,and%2For%20population%20density%20requirements.
---------------------------------------------------------------------------

    We received the following comments in response to this 
solicitation.
    Comment: Many commenters supported a single implementation 
timeframe for both rural and urban LTC facilities. They expressed 
concerns that workforce shortages existed in both urban and rural areas 
regardless of facility location. One commenter stated that the separate 
phase-in timeframes would foster competition between urban and rural 
facilities, that nursing staff would be recruited away from rural areas 
to fulfill the needs of urban areas first, and when it became time for 
rural areas to recruit, they would find themselves competing to bring 
staff back. Many commenters noted that an extended implementation 
timeframe for rural areas would exacerbate existing disparities in the 
quality of care for rural residents. Moreover, commenters emphasized 
that residents in rural LTC facilities were entitled to the same 
quality of care as those in urban and underserved areas. Some 
commenters expressed concerns that the proposed implementation 
timeframe favored rural areas as they would have not only an extended 
phase-in timeframe but also would be able to utilize the exemptions.
    Response: We agree that residents in both urban and rural LTC 
facilities deserve access to safe and high-quality care and are 
finalizing for all LTC facilities, regardless of location, minimum 
nurse staffing standards along with a 24 hour per day, 7 day per week 
requirement for an RN to be onsite and available to provide resident 
care. We also agree with commenters that workforce shortages exist 
regardless of facility location, which is why we are finalizing 
exemption criteria that focus on the provider-to population ratio 
rather than on a facility's rural status alone. Equal access to 
exemptions from the requirements of this rule based on a pronounced 
unavailability of registered nurses and nurse aides will address this 
concern. We do not agree that a staggered implementation will result in 
potential employees being recruited away by facilities in urban areas, 
as there is no regulation that would prohibit any rural LTC facility 
from recruiting and retaining all nursing staff at any time, including 
those times when non-rural facilities are actively increasing their own 
staffing levels to comply with the requirements of this final rule. 
However, we recognize that there is a possibility that potential 
employees may opt to relocate if employers offer a more competitive 
salary. Additionally, all LTC facilities are required to comply with 
the facility assessment requirements at Sec.  483.71 within the same 
timeframe, regardless of their location, effective 90 days after 
publication of this final rule. As part of the facility assessment, LTC 
facilities must develop and maintain a plan to maximize recruitment and 
retention of direct care staff.
    We continue to recognize that rural areas face myriad challenges 
ranging from worker housing shortages to severe transportation 
challenges for remote facilities that are unique to their location. We 
are thus finalizing, in addition to an exemption framework, a staggered 
implementation timeline that allows additional time for rural 
facilities to comply with the requirements of this rule.
    Comment: Many commenters expressed concerns that the proposed U.S. 
Census Bureau definition of ``rural'', for purposes of the proposed 
implementation timeframe, does not accurately represent rural areas. In 
2022, the U.S. Census Bureau published updated criteria on how it will 
define

[[Page 40911]]

urban areas.\69\ An urban area is comprised of a densely settled core 
of census blocks that meet minimum housing unit density and/or 
population density requirements. To qualify as an urban area, the 
territory identified according to criteria must encompass at least 
2,000 housing units or have a population of at least 5,000 and rural 
consists of all territory, population, and housing units located 
outside urban areas.\70\ Commenters expressed concern that the revised 
definition is too narrow, would exclude many areas that historically 
have qualified as rural or areas that fall under other Federal or State 
definitions of ``rural'' and that as a result, many LTC facilities in 
such areas would not qualify for the proposed extended implementation 
timeframe for rural areas. Numerous commenters suggested a wide variety 
of sources for alternative definitions of ``rural'' that CMS should 
consider using. A few commenters suggested aligning the definition of 
``rural'' with other Medicare programs in order to promote consistency 
and assure access to services in rural communities that depend on LTC 
facilities for care delivery.
---------------------------------------------------------------------------

    \69\ 87 FR 16706, March 24, 2022 (https://www.federalregister.gov/documents/2022/03/24/2022-06180/urban-area-criteria-for-the-2020-census-final-criteria).
    \70\ https://www.census.gov/programs-surveys/geography/guidance/
geo-areas/urban-
rural.html#:~:text=Rural%20encompasses%20all%20population%2C%20housin
gand%2For%20population%20density%20requirements.
---------------------------------------------------------------------------

    Specifically, these commenters suggested using the ``rural'' 
definitions from the Medicare Rural Hospital Flexibility Program, or 
the CMS-SNF-IRF wage index. Numerous other commenters suggested that 
CMS use an alternative definition that is used by other Federal 
programs and agencies. Commenters suggested these alternative 
definitions to address concerns that the current definition is not 
sufficiently accurate. Commenters suggested using definitions from the 
Office of Management and Budget (OMB),\71\ or the Federal Office of 
Rural Health Policy (FORHP.) \72\
---------------------------------------------------------------------------

    \71\ https://www.ruralhealthinfo.org/topics/what-is-rural.
    \72\ https://www.hhs.gov/guidance/document/defining-rural-population.
---------------------------------------------------------------------------

    Response: We appreciate the varied comments received on the 
proposed ``rural'' definition. While most commenters did not support 
the use of the Census Bureau's definition of ``rural'' and suggested 
using alternative definitions, there was not a consensus about which 
definition of ``rural'' would be most appropriate to use for the rule. 
However, we do acknowledge that using the Census Bureau definition of 
``rural'' for this rule could mean that counties that were considered 
rural prior to the Census Bureau updates in 2022 or under alternative 
Federal definitions such as the Office of Management and Budget (OMB), 
would now be considered urban. For example, if we were to use the 
Census Bureau's definition of ``urban'', 2,645 counties would be 
classified as urban,\73\ while if we were to use OMB's definition of 
``urban'', 1,252 counties would be considered ``urban.'' \74\ 
Furthermore, the 2022 urban area delineations issued by U.S. Census 
Bureau removed the subcategories of urbanized areas (encompasses a 
population of 50,000 or more people) and urban clusters (encompasses a 
population of at least 2,500 and less than 50,000 people).\75\ This 
means that towns as small as 5,000 people are delineated as urban areas 
with no differentiation between small towns and large cities.
---------------------------------------------------------------------------

    \73\ A list of all 2020 Census Urban Areas from the U.S., Puerto 
Rico, and Island Areas sorted by Urban Areas Census (UACE): https://www.census.gov/programs-surveys/geography/guidance/geo-areas/urban-rural.html.
    \74\ Core Based Statistical Areas (CBSAs), Metropolitan 
Divisions, and Combined Statistical Areas (CSAs): https://www.census.gov/geographies/reference-files/time-series/demo/metro-micro/delineation-files.html.
    \75\ https://www.ruralhealthinfo.org/topics/what-is-rural.
---------------------------------------------------------------------------

    We agree that the definition used in the rule should be consistent 
with the definition used in other Medicare programs and note that the 
definition of ``rural'' from OMB has been used by the critical access 
hospital requirements (see 42 CFR 485.610 \76\), and rural emergency 
hospital requirements (see section 1886(d)(2)(D) of the Act \77\ and 42 
CFR 485.506 \78\).
---------------------------------------------------------------------------

    \76\ https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-485/subpart-F/section-485.610.
    \77\ https://www.ssa.gov/OP_Home/ssact/title18/1886.htm.
    \78\ https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-485/subpart-E.
---------------------------------------------------------------------------

    Based on the considerations of the comments and suggested 
alternatives, we are finalizing to define ``rural'' in accordance with 
the OMB definition. OMB designates counties as Metropolitan (metro), 
Micropolitan (micro), or neither. ``A Metro area contains a core urban 
area of 50,000 or more population, and a Micro area contains an urban 
core of at least 10,000 (but less than 50,000) population. All counties 
that are not part of a Metropolitan Statistical Area (MSA) are 
considered rural.'' \79\
---------------------------------------------------------------------------

    \79\ https://www.hhs.gov/guidance/document/defining-rural-population.
---------------------------------------------------------------------------

    Comment: Many commenters stated that the adoption of a final rule 
establishing minimum staffing in LTC facilities was essential. However, 
the commenters suggested various implementation timeframes. Many 
commenters recommended that CMS shorten the implementation timeframe to 
less than five years, with some suggesting that a shorter 
implementation timeframe would motivate facilities to begin recruiting 
and retaining staff to meet the finalized requirements as soon as 
possible. A commenter suggested that the LTC facilities would be able 
to meet the standards in a shorter phase-in because the proposed 
minimum nursing standards were relatively low and that the nursing 
staff needed would not need more than two hours of training.
    Conversely, numerous other commenters suggested that CMS implement 
a phase-in timeframe of more than five years for all LTC facilities. 
One commenter expressed that the proposed phase-in timeframes did not 
allow sufficient time to recruit, train and graduate enough RNs due to 
the shortage of available seats in nursing schools. The commenter 
suggested that an unintended consequence of the proposed rule would be 
to force LTC facilities to hire nurses that might not be qualified and 
the LTC facilities would not have the time to train new staff ``to 
ensure competency'' and as a result, the LTC facilities would meet the 
minimum nursing requirement, but the residents would still be at risk 
due to the untrained staff. A commenter expressed that the additional 
time would allow facilities the time and financial support needed to 
``build out the necessary education and workforce infrastructure, so 
that hiring of the additional staff can happen.'' Moreover, one 
commenter suggested that CMS delay the implementation timeframe of all 
LTC facilities ``to at least 5 years after the date of the final rule, 
with an additional at least 36-month allowance period for facilities to 
hire staff once the workforce is available''.
    Response: We agree with the commenters that the minimum staffing 
requirements are essential and are finalizing them with the revisions 
described in this rule. In determining the question of the appropriate 
timeline for implementing these changes, we sought to strike a balance 
between ensuring a higher level of resident safety through earlier 
implementation and assuring that the implementation of these changes is 
not so aggressive as to result in unintended facility closures or 
resident census reductions, both of which could negatively impact the

[[Page 40912]]

ability of residents to receive care in a location that is close to 
their loved ones. In addition to considering comments regarding the 
exact implementation timeframe, we also considered the totality of the 
many flexibilities that are included in this final rule, including 
finalization of the proposed exemptions to the NA and RN HPRD 
requirements, and the addition of exemptions for the total nurse 3.48 
HPRD requirement and for the 24 hours per day, 7 days per week RN 
requirement. As such, we are finalizing the implementation timeframe as 
proposed for all non-rural LTC facilities to complete implementation 3 
years after the publication date of this final rule and all rural 
facilities will complete implementation 5 years after the publication 
date of this final rule. We believe that this is the most appropriate 
approach to implementation in light of the conflicting public comments 
on the subject of the implementation timeframes, the many revisions 
that we have made to the policies within this rule, and our policy goal 
of improving the care of all LTC facility residents while avoiding 
unintended consequences. We strongly encourage all LTC facilities to 
begin working towards full compliance as quickly as possible.
    Comment: Numerous commenters suggested that CMS outline interim 
milestones gradually increasing each year until LTC facilities meet the 
final RN and NA HPRD requirements. They stated that this approach would 
allow for LTC facilities to slowly adapt to the new minimum staffing 
requirements while continuing to provide safe and quality care. In 
addition, this approach would discourage last-minute hiring practices 
by LTC facilities.
    Response: Taking into consideration conflicting comments, we have 
structured the implementation of the final policy discussed in this 
rule to occur in three phases; Phase 1 requires facilities to comply 
with the facility assessment requirements; Phase 2 requires facilities 
to comply with the requirement for a facility to provide 3.48 HPRD of 
nursing care and to have a RN onsite 24 hours a day, 7 days a week; and 
Phase 3 requires facilities to comply with the minimum staffing 
requirements of 0.55 and 2.45 HPRD for RNs and NAs respectively. We are 
phasing in the 3.48 HPRD total staffing requirements during Phase 2 as 
we expect LTC facilities will be able to comply quickly with this 
requirement since facilities may use any combination of nursing 
staffing types (RN, LPN/LVN, or NA), rather than using specific nursing 
staffing types to meet this requirement. However, we expect LTC 
facilities that are currently staffing in excess of 3.48 HPRD of total 
nursing care will not reduce their total nurse staffing HPRD when the 
3.48 HPRD for total nurse staffing requirement is implemented. LTC 
facilities should continue using the facility assessment to determine 
staffing needs above the finalized minimum standards to provide safe 
and quality care based on resident acuity.
    Beyond these phases, we do not agree that it is appropriate to 
specify additional interim milestones. We believe that milestones 
should be specific to the needs of each facility and as part of the 
facility assessment, a LTC facility must have a facility-wide 
assessment to determine what resources are necessary to care for its 
residents. That assessment should consider, among other things, the 
facility's resident population, staff competencies and necessary skill 
set, its resources, and other factors that may affect the care it 
provides. The facility must use this facility assessment to inform 
staffing decisions to ensure that there are a sufficient number of 
staff with the appropriate competencies and skill sets necessary to 
care for residents' needs and to develop and maintain a plan to 
maximize recruitment and retention of direct care staff. The facility 
assessment will drive the interim steps that need to occur at each 
facility in preparation for complying with the requirements of this 
final rule.
    Comment: A commenter suggested that we delay the implementation of 
the requirements until CMS has completed a pilot program first.
    Response: We appreciate this suggestion. However, we believe that 
the minimum staffing requirements need to be implemented as soon as 
possibly feasible to ensure residents receive safe and quality care in 
LTC facilities. Therefore, CMS will not proceed with a pilot program.
    Comment: Commenters expressed that there is not a need for a longer 
implementation timeframe for other underserved communities, as there is 
no evidence available to show that LTC residents in underserved 
communities have lesser needs than LTC residents in other areas. They 
stated that it would only perpetuate poor quality care for underserved 
communities, especially among racial and ethnic minorities.
    Response: We agree with the commenters. Residents in LTC facilities 
should have access to safe and quality care, regardless of location. 
Therefore, we are not extending the implementation timeline for 
medically underserved communities.
    Comment: A commenter recommended that we consider ways to 
incentivize nursing homes to meet the minimum nursing requirements on 
an accelerated timeline.
    Response: In the FY 2023 SNF Prospective Payment System (PPS) Rule 
final rule (87 FR 47570 through 47576), we adopted the Total Nursing 
Hours per Resident Day Staffing (Total Nursing Staffing) measure for 
the Skilled Nursing Facility Value-Based Purchasing (SNF VBP) Program-
beginning with the FY 2026 program year. LTC facilities that have SNF 
beds participate in the SNF VBP Program and are subject to payment 
incentives under the program. Therefore, these LTC facilities will be 
incentivized to comply with the minimum staffing requirements because 
as their performance on the Total Nursing Staffing measure for the SNF 
VBP Program improves, those facilities may receive more favorable 
payment adjustments. Specifically, the LTC facilities that increase 
their staffing levels in FY 2025 and FY 2026 may receive either 
increased improvement or achievement scores under the SNF VBP Program. 
CMS awards achievement points to facilities that perform higher than 
the 25th percentile of national SNF performance on program measures and 
awards improvement points to facilities that have shown improvements in 
the measure performances from the baseline period to the performance 
period. Performance on the Total Nurse Staffing measure in the FY 2025 
and FY 2026 performance year will affect payment adjustments in FY 2027 
and FY 2028 program years respectively. LTC facilities that focus early 
on increasing their nurse staffing levels and otherwise improving 
performance on quality measures, such as the Total Nurse Staffing 
measure would have the opportunity to identify areas for further 
improvements and to take the necessary steps to address them. This 
could result in higher scores for the Total Nurse Staffing measure and 
subsequent increases in payment adjustments.
    Regardless of these incentives, LTC facilities should use the 
facility assessment to determine appropriate staffing needs based on 
their resident population and their needs and meet these requirements 
in an accelerated manner to ensure timely and quality care to 
residents.
    Comment: Some commenters recommended that we provide technical 
assistance to help LTC facilities meet the minimum staffing 
requirements within the proposed timeframe.
    Response: As noted previously, CMS is launching an initiative to 
help increase the LTC workforce by committing over $75 million in 
financial incentives, such as tuition

[[Page 40913]]

reimbursement, to support the recruitment, training, and retention of 
nursing staff.\80\ CMS is also exploring the potential to provide 
technical assistance to LTC facilities through the Quality Improvement 
Organizations and additional opportunities to provide technical 
assistance to those facilities impacted by this final rule. CMS will 
release interpretative guidance following the publication of the rule 
ahead of each implementation phase.
---------------------------------------------------------------------------

    \80\ FACT SHEET: Biden-Harris Administration Takes Steps to 
Crack Down on Nursing Homes that Endanger Resident Safety [verbar] 
The White House: https://www.whitehouse.gov/briefing-room/statements-releases/2023/09/01/fact-sheet-biden-harris-administration-takes-steps-to-crack-down-on-nursing-homes-that-endanger-resident-safety/.
---------------------------------------------------------------------------

    Comment: A few commenters expressed that State governments must 
plan for and readjust funds in order to meet the increased expense that 
hiring staff will require. According to the commenters, currently most 
State Medicaid rates do not cover the daily cost of care for residents 
and will not be able to cover the increased cost of labor this minimum 
staffing requirement will incur. Commenters suggested working with 
State Medicaid officials and managed care plans to ensure appropriate 
reimbursement rates while a commenter recommended that we establish 
advance funding for State governments.
    Response: While the actions of State governments, including 
Medicaid rates, are not within the scope of this rule, we note that the 
policies in this rule will be phased in over a period of up to 5 years.
    Final Rule Action: After consideration of the comments, we received 
on the proposed rule, we are finalizing the following implementation 
timeframe as follows:
     Rural facilities (as defined by OMB):
    ++ The requirement related to the Facility assessment at Sec.  
483.71 must be completed 90-days after the publication date of this 
final rule.
    ++ The requirement related to providing 3.48 HPRD for total nurse 
staffing at Sec.  483.35(b)(1) and the requirement related to 24/7 
onsite RN at Sec.  483.35(c)(1) must be implemented 3 years after the 
publication date of this final rule.
    ++ The requirements related to providing 0.55 RN and 2.45 NA HPRD 
at Sec.  483.35(b)(1)(i) and (ii) must be implemented 5 years after the 
publication date of this final rule.
     Non-rural facilities:
    ++ The requirement related to the Facility assessment at Sec.  
483.71 must be completed 90 days after the publication date of this 
final rule.
    ++ The requirement related to providing 3.48 HPRD for total nurse 
staffing at Sec.  483.35(b)(1) and the requirement related to 24/7 
onsite RN at Sec.  483.35(c)(1) must be implemented 2 years after the 
publication date of this final rule.
    ++ The requirements related to providing 0.55 RN and 2.45 NA HPRD 
at Sec.  483.35(b)(1)(i) and (ii) must be implemented 3 years after the 
publication date of this final rule.
    These regulations are effective 60-days following the publication 
of the final rule in the Federal Register. The implementation date for 
the specific requirements are listed in detail in tables 3 and 4.
[GRAPHIC] [TIFF OMITTED] TR10MY24.084

[GRAPHIC] [TIFF OMITTED] TR10MY24.085

C. Severability Clause

    Finally, we stated and continue to affirm that, to the extent a 
court may enjoin any part of the rule, the Department of Health and 
Human Services intends that other provisions or parts of provisions 
should remain in effect. Any provision of this final rule held to be 
invalid or unenforceable by its terms, or as applied to any person or 
circumstance, shall be construed so as to continue to give maximum 
effect to the provision permitted by law, unless such holding shall be 
one of utter invalidity or unenforceability, in which event the 
provision shall be severable from this final rule and shall not affect 
the remainder thereof or the application of the provision to persons 
not similarly situated or to dissimilar circumstances. For instance, 
the specific HPRD and 24 hour, 7 day a week RN staffing requirements 
finalized at Sec.  483.35(b)(1) and (c)(1) could independently make 
improvements in the number of staff present at a LTC facility--the 
continuity of any one of the numeric standards would be helpful, and 
they do not require enforcement of the others to improve conditions at 
LTC facilities. We also note that the Medicaid reporting provisions of 
this final rule regarding the percent of payments spent on compensation 
for direct care and support staff workforce operate independently of 
mandated levels of nurse staffing--this is a reporting requirement, and 
the information about Medicaid expenditures on compensation for direct 
care and support staff workforce is important for CMS and the public in 
helping determine whether Medicaid service payments are economic and 
efficient, as well as adequate to support sufficient access for 
beneficiaries to high quality care.

[[Page 40914]]

D. Consultation With State Agencies and Other Organizations

    Section 1863 of the Act (42 U.S.C. 1395z), requires the Secretary 
to consult with appropriate State agencies and recognized national 
listing or accrediting bodies, and appropriate local agencies, in 
relation to the determination of conditions of participation for 
providers of services. We held two listening sessions on June 27, 2022, 
and August 29, 2022, to allow all stakeholders, including State 
agencies and other organizations, to voice their concerns about the 
impact of a staffing standard, and took into consideration comments 
provided by State agencies.
    Pursuant to section 1863 of the Act, in addition to publishing the 
proposed rule in order to solicit the views of States, we received 
comments from 11 State and local government organizations.

III. Medicaid Institutional Payment Transparency Reporting Provision 
(Sec. Sec.  438.72 and 442.43)

A. General

    In response to concerns about transparency in the use of Medicaid 
payments and chronic understaffing in Medicaid institutional services 
(discussed in detail in our proposed rule at 88 FR 61381 through 
61384), we proposed new Federal requirements to promote public 
transparency around States' statutory obligation under section 
1902(a)(30)(A) of the Social Security Act (the Act) and around the 
quality requirements in section 1932(c) of the Act for services 
furnished through managed care organizations (MCOs) and prepaid 
inpatient health plans (PIHPs) under our authority under section 
1902(a)(4) of the Act.\81\ Specifically, we proposed to add new Federal 
requirements to promote better understanding and transparency related 
to the percentages of Medicaid payments for nursing facility and 
Intermediate Care Facilities for Individuals with Intellectual 
Disabilities (ICF/IID) services that are spent on compensation to 
direct care workers and support staff. As noted in 88 FR 61382, this 
proposal was specific to nursing facility and ICF/IID services, which 
we at times may refer to collectively in this preamble as 
``institutional services.'' We also noted in 88 FR 61382 that unlike in 
sections I. and II. of this rule, we will not be referring to LTC 
facilities, as this section (section III. of the final rule) focuses on 
Medicaid-certified nursing facilities and ICFs/IID, which are not 
referred to as LTC facilities. As discussed in the proposed rule at 88 
FR 61383, we relied on several sections of the Act for our authority to 
propose these reporting requirements. Section 1902(a)(30)(A) of the Act 
requires State Medicaid programs to ensure that payments to providers 
are consistent with efficiency, economy, and quality of care and are 
sufficient to enlist enough providers so that care and services are 
available to beneficiaries at least to the extent as to the general 
population in the same geographic area. Section 1902(a)(6) of the Act 
requires State Medicaid agencies to make such reports, in such form and 
containing such information, as the Secretary may from time to time 
require, and to comply with such provisions as the Secretary may find 
necessary to assure the correctness and verification of such reports.
---------------------------------------------------------------------------

    \81\ Throughout this section, section III. of the final rule, 
the use of the term ``managed care plan'' means managed care 
organization (MCOs) and prepaid inpatient health plans (PIHPs).
---------------------------------------------------------------------------

    Under our authority at section 1902(a)(6) of the Act, and 
consistent with section 1902(a)(30)(A) of the Act, we proposed at Sec.  
442.43 to newly require that State Medicaid agencies report, at the 
facility level, on the percent of payments for nursing facility and 
ICF/IID services that are spent on compensation for the direct care and 
support staff workforce. While some States have voluntarily established 
similar transparency policies or initiatives, we noted our belief that 
a Federal requirement is necessary and would be more effective to 
generate more meaningful and comparable data and support transparency 
nationwide.
    As discussed in our proposed rule at 88 FR 63184, we proposed that 
the reporting requirement at Sec.  442.43 would apply not only to 
services provided under a fee for service (FFS) delivery system, but 
also when long-term services and supports (LTSS) systems are covered 
through managed care. For States that contract with MCOs and PIHPs to 
cover services delivered by nursing facilities and ICFs/IID, we 
proposed that States report annually on the percent of payments made to 
nursing facilities and ICFs/IID that is spent for compensation to 
direct care workers and support staff. Section 1932(c) of the Act lays 
out quality assurance standards with which States must comply when 
delivering Medicaid services through MCOs. This includes services 
delivered by MCOs authorized under section 1932(c), which requires the 
Secretary to both monitor States and consult with States on strategies 
to ensure quality of care. Additionally, based on our authority under 
section 1902(a)(4) of the Act to specify methods of administration that 
are necessary for proper and efficient administration of the State 
plan, we also proposed to apply the requirement to services delivered 
by PIHPs.
    In addition, while we noted in the proposed rule at 88 FR 61383 
that our proposal focused on institutional services, this proposal 
(which is being finalized in this rule) is consistent with efforts to 
address the sufficiency of payments for HCBS to direct care workers and 
access to and the quality of services received by beneficiaries of HCBS 
finalized in the Ensuring Access to Medicaid Services final rule 
published elsewhere in this Federal Register.
    We received comments on our proposal. The following is a summary of 
these comments and our responses.
    Comment: A number of commenters expressed broad support for the 
proposal to require States to report on the percent of Medicaid 
payments that nursing facilities and ICFs/IID are spending on 
compensation to direct care workers and support staff, and to make this 
information publicly available. Many of these commenters expressed 
concerns about low worker wages and chronic understaffing; a few 
commenters noted that low wages to institutional direct care workers 
and support staff have a disproportionate impact on women and people of 
color who make up a large proportion of this workforce. Many supportive 
commenters noted that collecting these data will help demonstrate the 
links between Medicaid payment rates, worker compensation, staffing 
levels, and quality of care. Commenters noted that more transparency 
and accountability in the use of Medicaid funds may address public 
mistrust of how facilities are spending Medicaid payments, empower 
beneficiaries to advocate for more investment in quality care, and 
ensure public resources are being allocated for adequate staffing 
levels, wages, and benefits.
    A few commenters provided anecdotal examples of when facilities 
have received temporary or long-term rate increases, but the increases 
were not passed along to staff. A few commenters noted that while 
interested parties might cite low Medicaid payment rates as a barrier 
to fair compensation, there is inadequate evidence to support this 
statement due to the lack of transparent and uniform reporting on 
Medicaid payment rates; these commenters indicated that a reporting 
requirement could help clarify concerns regarding the sufficiency of 
Medicaid payment rates.
    A few commenters noted that this information could be useful to

[[Page 40915]]

researchers and policymakers. One commenter noted this proposal would 
create a better understanding around compensation differences across 
States, which will help to inform future policy improvements and help 
policymakers better understand where to target interventions for 
facilities that are outliers in terms of workforce compensation that 
may affect the quality and quantity of care provided to residents.
    Response: We thank commenters for their support.
    Comment: A number of commenters did not support finalizing the 
proposed reporting requirement, although many expressed general support 
for the principle of payment transparency. Many of these commenters 
indicated that the reporting requirement would pose an unreasonable 
burden on State Medicaid agencies and nursing facilities and ICFs/IDD. 
One commenter noted that the requirements might have a disproportionate 
negative impact on smaller facilities that have fewer streamlined 
administrative processes.
    A number of commenters representing both nursing facilities and 
ICFs/IID raised concerns that the proposal did not directly address 
Medicaid payment rates, which commenters believed are insufficient to 
support high-quality care or increases in direct care worker and 
support staff compensation; some of these commenters asked that we not 
finalize this proposal and instead propose requirements that States 
must regularly review Medicaid payment rates. Some of these commenters 
also suggested that without an increase in Medicaid payment rates to 
help offset the additional administrative burdens associated with 
reporting, facilities may have to redirect resources away from training 
and supervision, or some facilities may close.
    A few commenters noted that the requirements as proposed, 
particularly the definition of direct care worker and reporting 
timeframes, do not align with current reporting requirements in the 
commenters' respective States. The commenters asked that we either not 
finalize the proposed provision or that we analyze existing State 
reporting requirements to ensure that any new Federal reporting 
requirements are not duplicative or misaligned with State reporting.
    A few commenters representing ICFs/IID suggested finalization of 
the proposed requirements be delayed until we take into consideration 
differences between ICFs/IID and nursing facilities. These commenters 
stated that differences include variations in size, location, and 
physical layout; staff responsibilities; and services offered to 
residents, including active treatment and community engagement. A few 
commenters suggested that ICFs/IID should be exempted from the 
requirements if they are finalized.
    Response: We acknowledge that complying with this reporting 
requirement will necessitate the use of resources and time on the part 
of providers and States. We believe that the value of the data 
collected through their efforts makes this use of resources and time 
worthwhile. As discussed further in this section, we are finalizing our 
definitions of compensation and direct care workers at Sec.  442.43(a) 
with modifications to better account for the costs of clinical 
supervision, training, and other expenses that are essential to high-
quality care. Additionally, as discussed further in this section, we 
are finalizing our proposal at Sec.  442.43(b) to require only 
aggregated data reported at the facility level and by worker category 
(direct care worker or support staff), which we believe will limit 
burden on both providers and States.
    We believe that, generally speaking, States and providers should 
already have information about the amount of Medicaid payments 
providers receive for specific services, and that providers likely 
already track expenditures for wages and benefits for their workers. We 
also believe that the aggregated reporting will be easier for States to 
validate and incorporate into their existing auditing processes.
    While section 1902(a)(30)(A) of the Act does not provide us with 
authority to require specific payment rates or rate methodologies, 
section 1902(a)(30)(A) of the Act does provide us with authority to 
oversee that States assure that payments are consistent with 
efficiency, economy, and quality of care and are sufficient to enlist 
enough providers so that care and services are available under the 
plan, at least to the extent that such care and services are available 
to the general population in the geographic area.
    For managed care, section 1932(c)(1)(A)(ii) of the Act similarly 
does not speak explicitly to Medicaid provider payment rates but 
requires that States' quality strategies include an examination of 
other aspects of care and service directly related to the improvement 
of quality of care. Further, section 1932(c)(1)(A)(iii) of the Act 
authorizes the proposals being finalized in this section of this final 
rule, which enable States to compare payment data among managed care 
plans in their program; this could provide useful data to fulfill their 
statutory obligations for monitoring and evaluating quality and 
appropriateness of care. This authority under section 1932(c)(1)(A)(ii) 
and (iii) of the Act is extended to PIHPs through our authority under 
section 1902(a)(4) of the Act.
    We will be making the reporting methodology and reporting template 
for the requirements finalized at Sec.  442.43 available for public 
comment through the Paperwork Reduction Act notice and comment process, 
which will give the public the opportunity to provide specific feedback 
and help us align the methodology and reporting process with existing 
State practices to the greatest extent possible. However, we 
acknowledge that because State processes, timelines, and definitions 
vary, it may not be possible to align all details of the reporting 
process with existing practices in multiple States. We therefore plan 
to provide technical assistance, as needed, to facilitate further 
alignment with States' current reporting practices, to the greatest 
extent possible.
    We decline to exclude ICFs/IID from the reporting requirement, as 
we do not believe such an exclusion would be warranted. We note that 
specific concerns related to ICF/IID reporting are addressed throughout 
section III. of this final rule.
    Comment: One commenter stated that we already collect multiple data 
sets that could be used to approximate the information that would be 
subject to the proposed reporting requirement, including: direct care 
salary, benefits, and hours for freestanding nursing facilities using 
the Medicare Cost Report; Medicaid fee-for-service per diems in upper 
payment limit reporting; and quarterly supplemental payment information 
through the Medicaid Budget and Expenditure Systems (MBES) and in CMS-
64 reports. This commenter stated that we should use existing Federal 
data to approximate the proposed metrics, which the commenter believed 
would reduce administrative burden and ensure consistent calculations 
across Medicaid programs. A few commenters noted that facilities 
already complete cost reports and suggested that researchers and 
regulators interested in Medicaid expenditures could obtain spending 
information from these cost reports.
    One commenter stated that Medicaid wage and benefit data are 
available in some States while Medicaid financial data are not 
available in other States; the commenter stated that while it would be 
ideal to have more detailed information on wages and benefits, the 
commenter did not believe that most State Medicaid programs would have 
this information available without developing a more

[[Page 40916]]

comprehensive financial reporting system.
    Response: We disagree that these data are readily available from 
existing data sources currently collected by CMS. The data sources that 
the commenter listed would not provide information about Medicaid 
revenues at the facility level. We note, for instance, that the 
Medicare Cost Reports do not break out Medicaid revenues, nor are they 
completed by providers who do not bill Medicare. Other data sources 
cited by the commenters, such as the upper payment limit (UPL) 
reporting and quarterly supplemental payment information are data 
collection efforts related to provider payments that are intended for a 
different purpose and do not provide the information we intend to 
capture with the reporting requirement at Sec.  442.43. We also note 
the supplemental payment reporting data does not capture the whole 
provider payment (that is, base plus supplemental payments). 
Additionally, the UPL reporting provides estimates of Medicaid payments 
to facilities; States have flexibility in how they calculate their UPL, 
using the best and most recent data available to the State either 
through Medicare cost reports or State-specific cost reports.
    We also disagree that nationally comparable data could be 
extrapolated from current cost reports, given the variations among cost 
reporting forms, practices, and delivery systems. A number of States do 
not make cost reporting data readily available to the public in a way 
that facilitates easy analysis.
    We agree with the commenter who observed that data are not 
consistently available from all States. As discussed throughout this 
section (section III. of the final rule), we have designed the 
requirement to promote greater consistency and transparency while also 
attempting to minimize burden for States, particularly those States 
with less experience collecting and tracking wage data, as well as for 
providers.
    Comment: A few commenters did not believe that the reporting 
requirement as proposed would yield consistent or fully transparent 
data, given the differences among facilities, their payment models, 
current reporting practices, case mixes, size, geographical location, 
staffing requirements, and staff roles. A few commenters also noted 
that States have different wage laws that could impact the percent of 
Medicaid payments that facilities allocate to direct care worker and 
support staff compensation.
    Response: We believe the diversity among facilities and State 
reporting practices and employment laws is why a broad, national 
reporting requirement is necessary to help establish baseline data 
measuring investment in the direct care and support workforce. We note 
that the requirement is constructed so that States will report an 
aggregate percentage that will allow for national comparisons, as well 
as facility-level data that will allow for more granular differences 
among facilities to be identified.
    Comment: A few commenters expressed concern that the reporting 
requirement would result in the generation of misleading data and 
perpetuate the idea that facilities' expenditures on any expenses other 
than direct care worker compensation are invalid or go only to profit. 
A few of these commenters suggested that facilities use Medicaid 
payments for a variety of expenses such as providing residents with 
private rooms, improving facility ventilation, evaluating and testing 
emergency preparedness plans, and other non-compensation activities 
that improve residents' care and safety. These commenters expressed 
concerns that reporting on the percent of Medicaid payments going only 
to compensation for direct care workers or support staff would lead 
policymakers to draw erroneous conclusions about facilities' 
expenditures and discourage increased investment in long-term care or 
the raising of Medicaid rates. One commenter expressed opposition to 
what they regarded as an underlying assumption that facilities are not 
allowed to be profitable.
    Response: The purpose of this requirement is not to suggest that 
all non-compensation facility expenditures (including profits that may 
incentivize the operation of a facility) are invalid, or that any 
particular such expenditure is not worthwhile. Specifically, we are not 
suggesting that by designating certain activities as administrative and 
by not considering certain expenditures as compensation under this 
rule, they are inessential. Rather, we believe, as has been discussed 
at length in the proposed rule at 88 FR 61381 through 61382, that 
understaffing in facilities is well-documented and chronic and poses a 
risk to the quality of care. As a result, we have made addressing 
compensation for institutional direct care workers and support staff a 
particular focus of this requirement. We also remind commenters that 
the purpose of this rule is to create a reporting requirement, not to 
require that a certain amount of the Medicaid payment be allocated to 
compensation. We believe that gathering data on what percent of 
Medicaid payments facilities are spending on compensation will help us 
understand what percent of Medicaid payments is also needed for non-
compensation costs, which we understand includes many essential 
activities.
    Comment: A few commenters expressed concerns that residents would 
not find the data helpful in making decisions about their long-term 
care and that beneficiaries and residents can already get valuable 
information about nursing facilities from Nursing Home Compare.
    Response: We disagree that beneficiaries would not find the data 
helpful and note that some commenters expressed the contrary view that 
these data can help beneficiaries advocate for high-quality care. While 
we agree that Nursing Home Compare provides beneficiaries with useful 
information about nursing facilities, Nursing Home Compare does not 
include data on how much facilities spend on compensation to direct 
care workers and support staff.\82\ We believe that facility-level data 
on the percent of Medicaid payments spent on direct care worker and 
support staff compensation will be a useful complement to the facility-
level quality data in Nursing Home Compare and help make available more 
comprehensive information on nursing facilities for beneficiaries and 
other members of the public.
---------------------------------------------------------------------------

    \82\ To view what information is available on Nursing Home 
Compare, visit the Nursing Home Compare website at: https://www.medicare.gov/care-compare/?redirect=true&providerType=NursingHome.
---------------------------------------------------------------------------

    Comment: One commenter requested that this requirement be made a 
Condition of Participation for nursing facilities to encourage 
compliance and to allow the information to be included in Nursing Home 
Compare.
    Response: We decline to make the reporting requirement a Condition 
of Participation at this time. We note that the provision being 
finalized at Sec.  442.43 is a requirement that must be followed by 
States and does not directly impose requirements on providers. We 
believe it is important to first develop the reporting process and 
acclimate States and providers to this requirement before considering 
making it a Condition of Participation for providers, although we may 
consider proposing to do so at a later time.
    Comment: A few commenters noted that the proposed requirement could 
help assess the extent to which facilities with a large Medicaid 
population have challenges achieving compliance with the minimum 
staffing standards finalized in section II. of this final rule.
    Response: We agree that facility-level data reported by States 
could help

[[Page 40917]]

identify facilities that are outliers in terms of allocating Medicaid 
payments for compensation for direct care workers and support staff, 
which could be relevant when examining understaffing or staff turnover 
at certain facilities. We also note that our intention with the 
reporting requirement at Sec.  442.43 is to align with a similar 
reporting requirement focused on the percent of Medicaid payments for 
certain home and community-based services (HCBS) spent on compensation 
for direct care workers finalized in the Ensuring Access to Medicaid 
Services final rule published elsewhere in this Federal Register. These 
aligned requirements will provide a more consistent picture of 
compensation to the direct care workforce providing services to 
individuals receiving Medicaid-covered LTSS across settings.
    Comment: One commenter asked that ICFs/IID be exempted from the 
minimum staffing standards.
    Response: We clarify that while the provision at Sec.  442.43 being 
finalized in this section (section III. of this final rule) applies to 
ICFs/IID, the minimum staffing standards being finalized in section II. 
of this final rule do not apply to ICFs/IID.

B. Definition of Compensation

    At Sec.  442.43(a)(1), we proposed to define compensation to 
include salary, wages, and other remuneration, as those terms are 
defined by the Fair Labor Standards Act (FLSA) and implementing 
regulations (29 U.S.C. 201 et seq., 29 CFR parts 531 and 778), and 
benefits (such as health and dental benefits, sick leave, and tuition 
reimbursement). In addition, we proposed to define compensation to 
include the employer share of payroll taxes for direct care workers and 
support staff delivering Medicaid-covered nursing facility and ICF/IID 
services (which, while not necessarily paid directly to the workers, is 
paid on their behalf). We considered whether to include training or 
other costs in our proposed definition of compensation. However, we 
believed that a definition that more directly addresses the financial 
benefits to workers would better measure the portion of the payment for 
services that went to direct care workers and support staff, as it is 
unclear that the cost of training and other workforce activities is an 
appropriate way to quantify the benefit of those activities for 
workers. We were also concerned that requesting providers to quantify 
and include costs of non-financial benefits in their reporting would 
prove burdensome and could introduce a lack of uniformity in 
determining and reporting related costs. We requested comment on our 
proposed definition of compensation, particularly whether the 
definition of compensation should include other specific financial and 
non-financial forms of compensation for the workers included in the 
proposed provisions.
    We received comments on our proposal. The following is a summary of 
these comments and our responses.
    Comment: Several commenters supported our definition of 
compensation.
    Response: We thank the commenters for their support.
    Comment: One commenter suggested that we align the definition with 
items normally reported on Internal Revenue Service (IRS) form W-2.
    Response: We decline to make modifications to the proposed 
definition of compensation based on this comment. We believe the 
proposed definition encompasses the relevant compensation items that 
would be captured on a W-2 form, including the employee's salary, 
wages, other remuneration, benefits, and information about payroll 
taxes.
    Comment: One commenter suggested we add differential pay and 
incentives to the definition of compensation.
    Response: We are not certain what type of ``incentives'' the 
commenter was referring to. Our definition of compensation as proposed 
at Sec.  442.43(a)(1) includes salary, wages, and other remuneration as 
defined by the FLSA and its regulations. The Department of Labor has 
advised that shift differential pay and nondiscretionary bonuses in 
health care settings are included within the definition of salary, 
wages, and other remuneration under the FLSA.\83\ Non-discretionary 
bonuses \84\ include those that are announced to employees to encourage 
them to work more steadily, rapidly or efficiently, and bonuses 
designed to encourage employees to remain with a facility.\85\ 
Generally, we intended for the definition at Sec.  442.43(a)(1) to 
include most types of payments made directly to direct care workers or 
support staff as salary, wages, and remuneration; we will provide 
technical assistance as needed for questions regarding specific types 
of payments.
---------------------------------------------------------------------------

    \83\ Refer to U.S. Department of Labor, Fact Sheet #54--The 
Health Care Industry and Calculating Overtime Pay. https://www.dol.gov/agencies/whd/fact-sheets/54-healthcare-overtime.
    \84\ The Department of Labor has advised that few bonuses are 
discretionary under the FLSA. Id.
    \85\ See regulations 29 CFR 778.200 and 778.208 for more 
information.
---------------------------------------------------------------------------

    Comment: One commenter, while expressing support for the proposed 
definition of compensation, noted the importance of including medical, 
dental, and vision benefits, and retirement plans. A few commenters 
suggested we add paid leave and vacation time to the definition of 
compensation.
    Response: We believe that all the items identified by these 
commenters--medical, dental and vision benefits, retirement, and paid 
time off--are either explicitly included in the proposed definition or 
would be reasonably considered part of benefits for the purpose of 
compensation.
    In its glossary, the Bureau of Labor Statistics (BLS) defines 
compensation as ``employer costs for wages, salaries, and employee 
benefits,'' and notes that the National Compensation Survey includes 
the following categories in employee benefits: insurance (life 
insurance, health benefits, short-term disability, and long-term 
disability insurance); paid leave (vacations, holidays, and sick 
leave); and retirement (defined benefit and defined contribution 
plans).\86\ We believe the items suggested by the commenters align with 
our intent and are reflected by a common understanding of ``benefits'' 
as exemplified in the BLS glossary.
---------------------------------------------------------------------------

    \86\ See BLS ``Glossary'' at https://www.bls.gov/bls/glossary.htm.
---------------------------------------------------------------------------

    We are finalizing the definition of ``benefits'' at Sec.  
442.43(a)(1)(ii) with several modifications that we believe will help 
clarify what is included in the definition, will better align the 
definition with what is referenced in the BLS glossary, and will align 
this definition with a definition of compensation in a similar 
compensation reporting requirement finalized at Sec.  441.311(e) as 
part of the Ensuring Access to Medicaid Services final rule published 
elsewhere in this Federal Register. The purpose of aligning these 
requirements is to provide a more consistent picture of investment in 
the direct care workforce providing Medicaid-covered LTSS across 
settings.
    We are retaining ``health and dental benefits'' but also adding to 
the list ``life and disability insurance'' to reflect the examples of 
insurance included in the BLS glossary. (We are using ``disability 
insurance'' to refer to short- or long-term disability insurance.) We 
note that the proposed definition at Sec.  441.43(a)(1)(ii) already 
included health insurance, which we believe can be regarded as the same 
as medical benefits. The proposed definition also already included 
dental benefits. While we decline to specify vision benefits in this 
definition, which

[[Page 40918]]

were not included in the proposal and is not part of the BLS glossary 
definition as a separate item from ``health benefits,'' we note that 
the list of benefits provided in Sec.  442.43(a)(1)(ii) is not 
exhaustive, and that vision benefits, when offered by an employer, 
would reasonably be considered as part of compensation.
    We are also changing ``sick leave'' to the broader term ``paid 
leave,'' as this should be understood to cover any time for which the 
employee is paid, whether it be for sick leave, holidays, vacations, 
and so forth. We are also adding retirement, which we believe is also a 
useful blanket term for different types of retirement plans or 
contributions on the employee's behalf.
    Thus, Sec.  442.43(a)(1)(ii) as finalized in this final rule 
specifies that compensation includes benefits, such as health and 
dental benefits, life and disability insurance, paid leave, retirement, 
and tuition reimbursement.
    Comment: A few commenters, while not clearly requesting that these 
benefits be added to the definition of compensation, noted a number of 
benefits that employers may offer that may be difficult to quantify if 
they were to be included in reporting. These benefits included: 
recruitment and retention activities, gym fees, pet insurance, employee 
wellness programs, childcare support, nutrition programs, and 
assistance for staff experiencing financial shortfalls.
    One commenter believed that including additional benefits in the 
definition of compensation would undermine the purpose of the 
requirement, which the commenter believed should focus on direct 
payments to workers.
    Response: We are not making additional modifications to the 
benefits definition listed at Sec.  442.43(a)(1)(ii) beyond what we 
described in the prior response. When proposing that benefits be 
included in the definition of compensation, we intentionally included 
the phrase ``such as'' when describing benefits to indicate that the 
example of benefits provided in the definition is not exhaustive. We 
did not attempt to list all possible benefits in the regulatory 
definition, as we run the risk of creating a definition that is too 
narrow.
    However, we note that some of the items listed previously, such as 
employee wellness programs, which make available non-financial 
assistance to all employees (rather than being a specific financial 
benefit for the employee) would qualify as administrative expenses.\87\ 
We plan to provide technical assistance to States to help ensure that 
States understand what are considered administrative expenses versus 
compensation expenses.
---------------------------------------------------------------------------

    \87\ See 29 CFR 778.224(b) (describing various workplace perks 
which are not considered employee compensation when calculating 
overtime pay under the FLSA, such as the cost to an employer that 
provides gym memberships, wellness programs, or nutrition programs).
---------------------------------------------------------------------------

    Comment: A few commenters noted specific support for including the 
employer share of payroll taxes in the compensation definition, as this 
is also an important component of the full compensation cost. One 
commenter suggested that the definition should include worker's 
compensation taxes.
    Response: It is our intention to include employers' payroll tax 
contributions for worker's compensation (as well as other payments 
required by the Federal Insurance Compensation Act) under Sec.  
442.43(a)(1)(iii) (and thus as part of the definition of compensation). 
While not necessarily paid directly to the workers, these expenses are 
paid on their behalf. We also note, for instance, that per the BLS, the 
National Compensation Survey calls payroll taxes for worker's 
compensation ``legally mandated employee benefits'' and includes them 
as part of the definition of ``employee benefits'' for the purposes of 
determining compensation.\88\ We decline to make changes in this final 
rule based on these comments, but we plan to provide technical 
assistance to States on how to help ensure that providers are including 
payroll tax contributions for worker's compensation, as well as 
contributions for other payroll taxes such as unemployment insurance, 
when reporting on compensation to workers.
---------------------------------------------------------------------------

    \88\ See BLS ``Glossary'' at https://www.bls.gov/bls/glossary.htm.
---------------------------------------------------------------------------

    Comment: A few commenters suggested that we add training costs to 
the definition of compensation, and a few commenters expressed specific 
concerns that the cost of specialized training for ICF/IID staff was 
not included in the definition of compensation. Commenters noted that 
training is a critical element of providing care.
    In contrast, a commenter noted that attempting to disclose and 
quantify non-financial compensation forms would make reporting 
confusing and cumbersome and could lead to variations in reporting 
among States that would undermine the goal of uniform reporting. 
Another commenter agreed that we should not include training costs in 
the definition of compensation; the commenter noted that nursing 
facilities are generally required to pay the costs for training 
required for certification of nurse aides but may then be reimbursed 
for the costs through a variety of payment methods or State grants. The 
commenter also noted that some facilities may choose to offer 
additional training as part of a collective bargaining agreement or to 
help reduce worker turnover, but did not believe the related costs 
should be considered part of the compensation package for workers.
    A commenter asked that we add mileage reimbursement to cover the 
costs to deliver services in various locations.
    Response: We clarify that the time direct care workers spend in 
training would already be accounted for in the definition of 
compensation. We agree with commenters that training is critical to the 
quality of services, and that some facilities, due to the needs of the 
residents, may require specialized training. We do not want to 
encourage providers to reduce training to cut administrative costs. We 
also agree that training costs may be difficult to standardize and are 
further complicated by the fact that some facilities may receive 
funding for training of some staff from sources other than their 
Medicaid payments.
    We remain reluctant, upon considering comments, to treat all 
training costs as ``compensation'' to the direct care worker or support 
staff. Trainings are often required as part of the job and may vary 
depending on the services or the needs of the beneficiaries they serve. 
We are concerned that including training costs in the definition of 
compensation could mean that direct care workers with higher training 
requirements would see more of their ``compensation'' going to training 
expenses, which could cause them to be regarded as more highly 
compensated while receiving lower take-home pay than colleagues with 
fewer training requirements.
    Rather than include training costs in the definition of 
``compensation,'' we are creating a new Sec.  442.43(a)(4) for the 
purposes of the reporting requirement in Sec.  442.43 to define 
``excluded costs.'' Excluded costs are those that are not included in 
the calculation of the percentage of Medicaid payments that is spent on 
compensation for direct care workers and support staff. We are 
specifying at Sec.  442.43(a)(4)(i) that required training costs (such 
as costs for qualified trainers and training materials) reasonably 
associated with Medicaid-covered nursing facility or ICF/IID services 
are excluded from the calculation of the percent of Medicaid

[[Page 40919]]

payments to providers that is spent on compensation for direct care 
workers and support staff. This means that, unless providers receive 
payment for trainings from sources other than their Medicaid payments 
for nursing facility or ICF/IID services, providers could deduct the 
total eligible training expenses for direct care workers and support 
staff reasonably associated with delivering Medicaid-covered nursing 
facility or ICF/IID services from the provider's total Medicaid 
payments before the compensation percentage is determined. We note that 
in facilities that also serve residents whose services are covered by 
non-Medicaid payment sources, we expect that the facility would 
calculate the excluded costs by estimating the percent of total 
eligible training expenses reasonably associated with providing 
Medicaid-covered nursing facility or ICF/IID services, based on the 
percent of the facility's residents whose care is primarily paid for by 
Medicaid.
    Similarly, we do not agree that mileage reimbursement or travel 
should be considered compensation to direct care workers and support 
staff. Since the reporting provision at Sec.  442.43 pertains to 
facility-based services, we do not believe that travel expenses for 
direct care workers and support staff are necessarily high for a 
significant portion of facilities. However, we also acknowledge that 
there are reasons why facilities may need to require staff to travel as 
part of their duties, particularly in rural or smaller facilities or 
some ICFs/IID, which might require staff to transport beneficiaries to 
activities and appointments, assist beneficiaries in the community, or 
travel between facilities that are operated by the same provider. In 
these cases, the travel would not be for the direct care worker or 
support staff's personal benefit.\89\ We also agree that travel costs 
will vary significantly by facility, depending on the facility size, 
staff makeup, nature of the services provided, and the beneficiaries 
served. We are concerned that including travel in the definition of 
compensation could mean that direct care workers or support staff with 
higher travel demands would see more of their compensation going to 
travel, which could cause them to be regarded as more highly 
compensated while receiving lower take-home pay than colleagues with 
lower travel demands.
---------------------------------------------------------------------------

    \89\ See 29 U.S.C. 207(e)(2) (permitting employers to exclude 
``reasonable payments for traveling expenses'' when determining an 
employee's regular rate of pay under the FLSA); see also 29 CFR 
778.217 (same).
---------------------------------------------------------------------------

    To preserve beneficiary access to services (and access to the 
community for facility residents) and avoid burden or disparate impact 
on beneficiaries, direct care workers, support staff, and providers in 
rural or underserved areas, we are excluding travel costs reasonably 
associated with providing Medicaid-covered nursing facility or ICF/IID 
services in this final rule from the calculation of the percent of 
Medicaid payments for nursing facility or ICF/IID services going to 
compensation for direct care workers and support staff. This means that 
providers could deduct the total eligible travel costs for direct care 
workers and support staff reasonably associated with delivering 
Medicaid-covered nursing facility or ICF/IID services from the 
provider's total Medicaid payments before the compensation percentage 
is determined. We note that in facilities that also serve residents 
whose services are covered by non-Medicaid payment sources, we expect 
that the facility would calculate the excluded costs by estimating the 
percent of total eligible travel expenses reasonably associated with 
providing Medicaid-covered nursing facility or ICF/IID services, based 
on the percent of the facility's residents whose care is primarily paid 
for by Medicaid.
    To reflect the exclusion of travel costs from the payment 
calculation, we are adding a new Sec.  442.43(a)(4)(ii) that specifies 
that travel costs for direct care workers and support staff (such as 
mileage reimbursements and public transportation subsidies) are 
considered an excluded cost for the purposes of the calculation at 
Sec.  442.43(c).
    We note that the finalization of excluded costs for training and 
travel at Sec.  442.43(a)(4) aligns with the definition of excluded 
costs finalized at Sec.  441.311(e)(1)(iii) as part of the Ensuring 
Access to Medicaid Services published elsewhere in this Federal 
Register. This definition also excludes training and travel costs from 
the calculation of the percentage of Medicaid payments for certain HCBS 
being spent on compensation for direct care workers. We reiterate that 
we believe alignment between these reporting provisions in Sec. Sec.  
442.311(e) and 442.43 is important to provide a more consistent picture 
of investment in the direct care workforce providing Medicaid-covered 
LTSS across settings.
    Comment: While not necessarily asking that we account for personal 
protective equipment (PPE) in the reporting requirement, many 
commenters wrote about the importance of PPE in facility-based 
settings. Many of these commenters were self-identified direct care 
workers or other staff working in facilities and shared frustrations 
with not having sufficient PPE during (and even after) the COVID-19 
Public Health Emergency (PHE). A few of these commenters also noted 
specific concerns regarding administrative staff's access to PPE; one 
commenter, who self-identified as a receptionist in a nursing facility, 
shared an experience of being asked to interact with residents during 
the COVID-19 PHE without being provided PPE.
    Response: We believe that these comments serve as an important 
reminder, especially given the recent experience with the COVID-19 PHE, 
that PPE should be treated as essential to supporting direct care 
workers and support staff's ability to perform their duties on par with 
training and travel. Providing direct care workers and support staff 
with adequate PPE is critical for the health and safety of both the 
workers and the beneficiaries they serve. We also do not believe that 
direct care workers or support staff should have to pay for PPE out-of-
pocket or that it should be considered part of their compensation. We 
also note that due to the enclosed environment of many facilities, 
providing PPE to all staff is critical for maintaining health and 
safety for all staff and beneficiaries.
    Similar to our approach with travel and training, we are also 
finalizing a new Sec.  442.43(a)(4)(iii) to exclude costs for PPE 
reasonably associated with providing Medicaid-covered nursing facility 
or ICF/IID services. We note that this is consistent with an exclusion 
of PPE costs finalized at Sec.  441.311(e)(1)(iii) in the Ensuring 
Access to Medicaid Services final rule published elsewhere in this 
Federal Register.
    We are excluding PPE costs for facility staff reasonably associated 
with providing Medicaid-covered nursing facility or ICF/IID services in 
this final rule from the calculation of the percent of Medicaid 
payments for nursing facility or ICF/IID services going to compensation 
for direct care workers and support staff. This would mean that 
providers could deduct the total eligible PPE expenses for their 
facilities reasonably associated with delivering Medicaid-covered 
nursing facility or ICF/IID services from the provider's total Medicaid 
payments before the compensation percentage is determined. We note that 
in facilities that also serve residents whose services are covered by 
non-Medicaid payment sources, we expect that the facility would 
calculate the excluded costs by estimating the percent of total 
eligible PPE expenses reasonably associated with providing Medicaid-
covered nursing facility or ICF/IID services, based on the percent of 
the facility's residents whose care is primarily paid for by Medicaid.

[[Page 40920]]

    To reflect the exclusion of PPE costs from the payment calculation, 
we are adding a new Sec.  442.43(a)(4)(iii) that specifies that a 
provider's PPE costs reasonably associated with providing Medicaid-
covered nursing facility and ICF/IID services may be considered 
excluded costs for the purposes of the calculation at Sec.  442.43(c).
    After consideration of the comments, we are finalizing Sec.  
442.43(a)(1)(i) and (iii) as proposed. We are finalizing Sec.  
442.43(a)(1)(ii) with modifications to specify that compensation 
includes benefits, such as health and dental benefits, life and 
disability insurance, paid leave, retirement, and tuition 
reimbursement.
    We are also finalizing a new definition at Sec.  442.43(a)(4) to 
define excluded costs, which are costs reasonably associated with 
delivering Medicaid-covered nursing facility or ICF/IID services that 
are not included in the calculation of the percentage of Medicaid 
payments that is spent on compensation for direct care workers and 
support staff. Such costs are limited to: costs of required trainings 
for direct care workers and support staff (such as costs for qualified 
trainers and training materials); travel costs for direct care workers 
and support staff (such as mileage reimbursement or public 
transportation subsidies); and costs of personal protective equipment 
for facility staff.

C. Definitions of Direct Care Workers and Support Staff

    At Sec.  442.43(a)(2), for the purposes of the proposed reporting 
provision at Sec.  442.43(b), we proposed to define direct care workers 
to include: nurses (registered nurses, licensed practical nurses, nurse 
practitioners, or clinical nurse specialists) who provide nursing 
services to Medicaid-eligible individuals receiving nursing facility 
and ICF/IID services; certified nurse aides who provide such services 
under the supervision of one of the foregoing nurse provider types; 
licensed physical therapists, occupational therapists, speech-language 
pathologists, and respiratory therapists; certified physical therapy 
assistants, occupational therapy assistants, speech-language therapy 
assistants, and respiratory therapy assistants or technicians; social 
workers; personal care aides; medication assistants, aides, and 
technicians; feeding assistants; activities staff; and other 
individuals who are paid to provide clinical services, behavioral 
supports, active treatment (as defined at Sec.  483.440), or address 
activities of daily living (such as those described in Sec.  483.24(b), 
which includes activities related to mobility, personal hygiene, 
eating, elimination, and communication), for individuals receiving 
Medicaid-covered nursing facility and ICF/IID services. Our proposed 
definition of direct care worker was intended to broadly define such 
workers to ensure that the definition appropriately captured the 
diversity of roles and titles that direct care workers may have. For 
the reasons discussed in the proposed rule (88 FR 61385), our proposed 
definition of direct care worker differs from the definition of direct 
care staff in LTC facilities at Sec.  483.70(q)(1), which was 
established for the PBJ reporting program at Sec.  483.70(q). We 
requested comment on whether we should adopt the definition of direct 
care staff at Sec.  483.70(q)(1), instead of our proposed definition of 
direct care worker.
    We requested feedback on our proposed definition of direct care 
worker at Sec.  442.43(a)(2). We specifically requested whether there 
are categories of staff we should add to, or remove from, our proposed 
definition. We requested feedback from the public as to whether our 
proposed definition appropriately included workers who are instrumental 
in helping residents achieve the level of health or develop skills 
needed to transition from facility settings back into the community, 
assess residents for readiness for transition, and support in discharge 
planning, or if these workers should be included as a separate 
category.
    At Sec.  442.43(a)(3), for the purposes of the proposed reporting 
requirement at Sec.  442.43(b), we proposed to define support staff to 
include individuals who are not direct care workers and who maintain 
the physical environment of the care facility or support other services 
(such as cooking or housekeeping) for residents. Similar to our 
proposed definition of direct care worker, our proposed definition of 
support staff was intended to broadly define such workers to ensure 
that the definition appropriately captures the diversity of roles and 
titles that such workers may have. Specifically, we proposed to define 
support staff to include: housekeepers; janitors and environmental 
services workers; groundskeepers; food service and dietary workers; 
drivers responsible for transporting residents; and any other 
individuals who are not direct care workers and who maintain the 
physical environment of the care facility or support other services for 
individuals receiving Medicaid-covered nursing facility and ICF/IID 
services. We requested comment on whether there are other specific 
types of workers, such as security guards, who should be included in 
the definition. We also solicited comment on whether any of the types 
of workers listed in this proposal should be excluded from the 
definition of support staff. We also requested comment, generally, on 
our proposal to include support staff in this proposed reporting 
requirement.
    We also proposed in both Sec.  442.43(a)(2) and (3) to define 
direct care workers and support staff, respectively, to include 
individuals employed by or contracted or subcontracted with a Medicaid 
provider or State or local government agency. This proposal was in 
recognition of the varied ownership and employment relationships that 
can exist in Medicaid institutional services. For instance, differences 
may include: institutions that are privately owned and operated or 
facilities owned and operated by a local or State government; 
facilities that are partially or wholly staffed through a third-party 
staffing organization through a contractual arrangement; or staff who 
are employed directly or as independent contractors. Additionally, a 
facility may contract with, for example, a third-party transportation 
company to provide transportation services to residents. We solicited 
comment on whether this component of our proposed definition adequately 
captures the universe of potential employment or contractual 
relationships between institutional facilities and relevant direct care 
workers and support staff.
    We received comments on our proposal. The following is a summary of 
these comments and our responses.
    Comment: A few commenters expressed support for the definition of 
direct care worker. A commenter noted that the definition appears to 
capture most, if not all, positions that provide direct care to 
residents. Another commenter supported the definition because they 
believed it includes only the staff who provide direct care services to 
residents.
    A commenter responded to our comment solicitation on using the 
definition of direct care staff at Sec.  483.70(q)(1); this commenter 
did not support using the definition of direct care staff at Sec.  
483.70(q)(1) because it did not align with the duties and 
responsibilities of staff in ICFs/IID.
    Response: We thank commenters for their support. With the exception 
of a few modifications noted later in this section, we are finalizing 
the definition of direct care worker that we proposed at Sec.  
442.43(a)(2).
    Comment: A commenter noted that the examples of workers included in 
the direct care worker definition include

[[Page 40921]]

many workers who complement or supplement shortfalls in registered 
nurses and other long-term care staffing and contribute to the quality 
of care. This commenter supported the broad definition of direct care 
worker proposed at Sec.  442.43(a)(2), and believed that for 
consistency throughout this final rule, these staff should count 
towards any minimum staffing requirement (which is discussed in section 
II. of this final rule). Another commenter requested that we clarify 
that the direct care worker definition at Sec.  443.42(a)(2) is broader 
than that used in the proposed minimum staffing standard and therefore 
is for the purposes of this section only. A commenter expressed concern 
that this definition will lead some facilities to treat the workers 
included in this direct care worker definition interchangeably, such as 
asking skilled clinicians to perform unskilled services such as meal 
delivery or personal hygiene services. The commenter also raised a 
concern that some facilities might inappropriately substitute one type 
of clinical specialty for another if a broad direct care worker 
definition fails to recognize the unique clinical skills of each member 
of the multidisciplinary care team.
    Response: We clarify that the definition proposed at Sec.  
442.43(a)(2) is only for the purposes of the reporting requirement 
being finalized in Sec.  442.43 and is not to be used for the purposes 
of the minimum staffing requirements being finalized in section II. of 
this final rule. We also note that the intent of this requirement is to 
list the different staff whose compensation must be included in the 
numerator of the reported percent of Medicaid payments being spent on 
compensation. The intent is not to define a single category of 
interchangeable workers.
    Comment: A commenter requested that we clarify that the definition 
excludes nurses who perform primarily administrative tasks. A commenter 
supported excluding administrative staff who are primarily in a 
supervisory position (such as a director of nursing) or primarily 
completing paperwork (such as nurses assigned to complete Minimum Data 
Set paperwork) and stated that the definition should include only the 
services of hands[hyphen]on, direct care workers.
    A commenter suggested we include physicians and physician 
assistants in the definition of direct care workers, given the 
importance of these staff to nursing facilities' patient care. A 
commenter stated that while they are not recommending we add physicians 
and physician assistants to the definition, they would like to know the 
purpose of the data to understand why these roles were excluded. A few 
commenters also suggested we add pharmacists.
    Response: Consistent with the proposed rule, our definition is 
intended to exclude staff who perform administrative tasks (such as 
overseeing business operations) and whose primary duty is to provide 
non-clinical supervision to other staff.
    Upon further consideration, we are modifying our definition of 
direct care worker at Sec.  442.43(a)(2) to clarify that the definition 
includes nurses or other staff providing clinical supervision. This 
modification is in recognition of the importance of clinical 
supervision in facility settings and to align with a similar 
modification made to the direct care worker definition finalized at 
Sec.  441.311(e) in the Ensuring Access to Medicaid Services final rule 
published elsewhere in this Federal Register. (As noted in our proposed 
rule at 88 FR 61385, we believe it is important to keep the definitions 
of direct care workers in this rule and the Ensuring Access to Medicaid 
services rule as closely aligned as possible.) We clarify that nurses 
or other staff who provide clinical oversight and training for direct 
care staff (as allowed by their professional license), participate in 
activities directly related to provision of beneficiary care (such as 
completing or reviewing documentation of care), are qualified to 
provide services directly to beneficiaries, and periodically interact 
with beneficiaries should be included in the definition of direct care 
worker. In some instances, this may also pertain to physicians, 
physician assistants, or pharmacists that meet the elements of this 
description of nurses or other staff who provide clinical supervision. 
We decline to add physicians, physician assistants, or pharmacists as 
additional categories in the definition of direct care worker because 
we want to keep the definition focused on the staff that commonly 
provide most of the direct care in facilities.
    We reiterate that our intention is to align the reporting 
requirement at Sec.  442.43 with similar reporting requirements 
finalized in the Ensuring Access to Medicaid Services final rule 
published elsewhere in this Federal Register, which focuses on 
compensation rates for direct care workers providing Medicaid HCBS. The 
purpose of these aligned requirements is to provide a more consistent 
picture of the investment in the direct care workforce providing 
Medicaid-covered LTSS across settings.
    Comment: One commenter requested clarification on whether Certified 
Medication Aides were included in the definition of direct care worker, 
and suggested we add this job duty if it was not included.
    Response: We believe that a Certified Medication Aide would likely 
fall under the definition of direct care worker as proposed at Sec.  
442.43(a)(2)(vii), which specifies a medication assistant, aide, or 
technician. We note that job titles at facilities may vary, and States 
should apply their best judgment when determining if certain titles fit 
within the definition of direct care worker at Sec.  442.43(a)(2). We 
will also supply technical assistance as needed.
    Comment: A number of commenters representing ICFs/IID were 
concerned that Qualified Intellectual Disability Professionals (QIDPs) 
were not included in the definition. Commenters noted that, in addition 
to being a required position in ICFs/IID, QIDPs have specialized 
training and are responsible for care coordination and assessing, 
monitoring, documenting, and ensuring the provision of quality care to 
ICF/IID residents.
    Response: We acknowledge that ICFs/IID are required at Sec.  
483.430(a) to be staffed by a QIDP, who may be doctors, nurses, or 
other professionals described at Sec.  483.430 with specialized 
training in care for people with intellectual and developmental 
disabilities. It is our understanding that QIDPs' roles may vary in 
different States or even among different facilities within a State. For 
instance, some QIDPs may actively participate in direct care while 
others may take on more of an administrative or care coordination role. 
We note that the proposed definition of direct care worker included a 
broad category proposed at Sec.  442.43(a)(2)(x) (but being finalized 
at Sec.  442.43(a)(2)(xi), as discussed below), which specifies any 
other individual who is paid to provide clinical services, behavioral 
supports, active treatment (as defined at Sec.  483.440), or address 
activities of daily living (such as those described in Sec.  483.24(b)) 
for Medicaid-eligible individuals receiving Medicaid services under 
this part. We defer to States to determine if the QIDPs working in 
their ICFs/IID meet this definition or other elements of the definition 
of direct care worker at Sec.  442.43(a)(2), and we have not added this 
position explicitly to the definition.
    Comment: A number of commenters representing ICFs/IID expressed 
concern that Direct Support Professionals (DSPs) were not included in 
the definition of direct care worker. Commenters noted that in many 
States, ``Direct Support

[[Page 40922]]

Professional'' is a typical professional designation and a critical 
position in ICFs/IID; DSPs are often the staff that provide direct, 
daily support to ICF/IID residents. Commenters asked that we add DSPs 
to the definition of direct care worker at Sec.  442.43(a)(2).
    A few commenters noted that it may cause confusion to exclude DSPs 
from the definition of direct care worker in Sec.  442.43(a)(2) when 
DSPs were included in the definition of direct care worker in the 
Ensuring Access to Medicaid Services rule (as the definition was 
proposed at 88 FR 27984). One commenter recommended we include DSPs in 
the definition at Sec.  442.43(a)(2) to align the definitions in the 
two rules and acknowledge the role that DSPs play in providing LTSS 
care across settings.
    Response: We are persuaded both by the characterization of DSPs as 
direct care workers and the concern that omitting DSPs in the 
definition of direct care worker at Sec.  442.43(a)(2) would misalign 
the definition with the definition of direct care worker finalized in 
the Ensuring Access to Medicaid Services final rule published elsewhere 
in this Federal Register. We reiterate, as noted in prior responses, 
that our intention is to align the reporting requirement at Sec.  
442.43 with similar reporting requirements finalized in the Ensuring 
Access to Medicaid Services final rule published elsewhere in this 
Federal Register, which focuses on compensation rates for direct care 
workers providing HCBS. The purpose of these aligned requirements is to 
provide a more consistent picture of the direct care workforce for 
individuals receiving Medicaid-covered LTSS across settings.
    After consideration of the commenters received, we are modifying 
the definition of direct care worker at Sec.  442.43(a)(2) to include 
DSPs.
    Comment: A few commenters responded to our comment solicitation 
regarding whether we should add to the definition staff who can be 
instrumental in helping residents achieve the level of health or 
develop skills needed to transition from nursing facilities back into 
the community, assess residents for readiness for transition, and 
support in discharge planning. A commenter agreed that these staff 
duties should be added to the definition. Another commenter, however, 
stated that these staff should only be added to the definition if they 
are in a separate category from direct care workers. The commenter 
noted that these workers are providing important services to improve 
the residents' health, safety, and autonomy, but the job duties vary 
much more broadly than in the case of the direct care workers 
identified in Sec.  442.43(a)(2).
    Response: Based on the comments received, we are not modifying the 
definition of direct care staff at Sec.  442.43(a)(2) to include a 
specific category of staff who provide transition supports. Although a 
few commenters were supportive of their inclusion as a separate 
category, we were not persuaded by the balance of the comments that 
staff who provide these supports are not already reflected in the 
different categories of workers contained in the definition. We also 
want to ensure that the definition focuses on workers who provide 
direct care, rather than what in some cases could be primarily 
administrative support.
    We note that the proposed definition of direct care worker included 
a broad category at Sec.  442.43(a)(2)(x) (being finalized at Sec.  
442.43(a)(2)(xi)), which specifies any other individual who is paid to 
provide clinical services, behavioral supports, active treatment (as 
defined at Sec.  483.440), or address activities of daily living (such 
as those described in Sec.  483.24(b)) for Medicaid-eligible 
individuals receiving Medicaid services under this part. We defer to 
States to determine if staff who provide discharge planning or other 
transition supports in facilities meet this definition or other 
elements of the definition of direct care worker at Sec.  442.43(a)(2).
    Comment: A number of commenters requested that we divide the 
definition of direct care worker into two categories: a direct care 
worker category and a category referred to as either ``ancillary 
staff'' or ``licensed staff.''
    One group of commenters advocated restricting the definition of 
direct care workers to nursing staff and recommended defining direct 
care workers as registered nurses, licensed practical nurses, and 
certified nursing assistants--a list they believed would align with the 
staff addressed by the minimum staffing requirements proposed in 
section II. of this final rule. Some of these commenters suggested this 
alignment would aid in interested parties' ability to draw inferences 
from the data regarding the impact of the minimum staffing requirements 
proposed in section II. of this final rule. A few commenters suggested 
retaining nurse practitioners and clinical nurse specialists, in 
addition to registered nurses, licensed practical nurses, and certified 
nursing assistants. A commenter suggested that restricting the 
definition of direct care workers to nursing staff would aid in data 
consistency among States because, while every facility employs nursing 
staff, there may be more variation among States and facilities in the 
types of the other workers; the commenter provided the example that 
some States recognize feeding and medication assistants, and others do 
not. Commenters who recommended limiting the definition of direct care 
worker to nursing staff suggested that a second category, ``ancillary 
staff,'' should be defined to include the other staff listed in Sec.  
442.43(a)(2) such as physical therapists, occupational therapists, 
speech-language pathologists, and therapy aides; some of these 
commenters also suggested adding physicians, physician assistants, and 
pharmacists to this category.
    Other commenters advocated for limiting the definition of direct 
care workers to certified nursing assistants and, where relevant, 
personal care aides and home health aides. One of these commenters also 
suggested retaining feeding assistants in the definition. These 
commenters suggested that these roles are responsible for providing 
most of the direct care to nursing facility and ICF/IID residents, 
particularly in regard to activities of daily living. A few of these 
commenters suggested that these roles would align more closely with the 
definition of direct care worker in the Ensuring Access to Medicaid 
Services rule (as the definition was proposed at 88 FR 27984) and the 
way that the term direct care worker has been used by other Federal 
agencies such as the Administration for Community Living. Commenters 
also believed this would allow for the transparent reporting of 
compensation paid to workers who typically receive lower pay. 
Commenters expressed concerns that if compensation to these workers 
were reported together with the compensation paid to typically higher-
paid workers, this would obscure the ``unique contributions and 
challenges of these roles.'' A few commenters suggested other staff 
listed in Sec.  442.43(a)(2) should be included in an ``ancillary 
staff'' category. A commenter suggested that, rather than an ancillary 
staff category, we create a ``licensed staff'' category that includes 
all of the staff that typically require licensure.
    Response: We decline to create a new category of ancillary or 
licensed staff apart from the direct care worker category. We note that 
there was not consensus among commenters that the definition of direct 
care workers should be limited to staff with nursing duties, staff 
without professional licenses, or staff who typically receive lower 
pay. We believe the category of direct care

[[Page 40923]]

workers as proposed at Sec.  442.43(a)(2) is appropriately broad to 
capture a spectrum of workers who provide direct care to residents.
    Limiting the definition of direct care workers to nursing staff 
does not align with our intention to examine expenditures for all staff 
who provide direct care to residents receiving Medicaid institutional 
LTSS. We also note that the reporting requirement we proposed (and are 
finalizing in this final rule) includes ICFs/IID, which do not 
necessarily focus on nursing services to the same extent as nursing 
facilities do. We agree with the commenter who noted that there might 
be variation in the types of non-nursing staff in nursing facilities, 
but we note that there is variety in the roles of all staff across 
facilities. Attempting to parse the direct care workforce into 
additional categories for reporting purposes not only adds 
administrative burden, it also could undermine our goal of creating 
simple, nationally comparable baseline data.
    We continue to believe it is appropriate to include licensed 
professionals in the definition of direct care worker. There is a 
shortage of nurses and other clinicians delivering LTSS, and we believe 
it is important to support these members of the LTSS workforce 
especially, as they also work directly with residents. We disagree with 
commenters who stated that restricting the definition of direct care 
workers to certified nursing assistants, personal care aides, and 
feeding assistants would align the definition with the definition of 
direct care workers in the Ensuring Access to Medicaid Services final 
rule published elsewhere in this Federal Register. We note that the 
definition finalized at Sec.  441.311(e), like the definition at Sec.  
442.43(a)(2), includes both licensed clinicians and other unlicensed 
direct care workers.
    We also decline to add home health aides to the definition of 
direct care worker at Sec.  442.43(a)(2). We agree with commenters that 
home health aides are part of the definition of direct care workers 
finalized in the reporting requirement at Sec.  441.311(e) in the 
Ensuring Access to Medicaid Service final rule published elsewhere in 
this Federal Register. However, while we intend to align these 
definitions as much as possible to provide a complete picture of 
compensation for all direct care workers providing Medicaid LTSS, we 
also believe it is important to adapt each definition to their 
respective settings. We do not believe home health aides typically 
provide services in institutional facilities. In a situation where care 
might be provided by someone described as a home health aide, we 
believe this role would be addressed by the category proposed at Sec.  
442.43(a)(2)(ix) (being finalized at Sec.  442.43(a)(2)(xi)), which 
specifies inclusion of any other individual who is paid to provide 
clinical services, behavioral supports, active treatment (as defined at 
Sec.  483.440), or address activities of daily living (such as those 
described in Sec.  483.24(b)) for Medicaid-eligible individuals 
receiving Medicaid services under this part.
    Comment: A number of commenters supported our definition of support 
staff and agreed that the definition was broad enough to include the 
workers responsible for supporting residents' health, safety, quality 
of care, and, in ICFs/IID, active treatment. A few commenters expressed 
specific support for including compensation for support staff in the 
reporting requirement.
    Response: We thank commenters for their support.
    Comment: A few commenters responded positively to our comment 
solicitation regarding the inclusion of security guards in the list of 
support staff, agreeing that these workers should be added to the list 
in Sec.  442.43(a)(3). One commenter noted that some ICFs/IID that 
serve residents with aggressive behavior may be required to have 
security guards as part of their licensure.
    Commenters suggested that we include the following workers in the 
definition of support staff: administrative staff (including billing 
staff); receptionists; information technology (IT) staff; central 
supply staff who purchase and distribute food, supplies, and materials 
for providers who maintain multiple facilities; staff who provide 
laundry or linen service; and transportation drivers.
    A commenter noted that every employee who works in a facility 
contributes, in some way, to the care of those residents. The commenter 
stated that all persons contributing to the care of the residents, 
whether directly employed by the facility or through contract with an 
outside entity, should be included as either direct care or support 
staff.
    Response: Based on feedback from commenters, we will modify the 
definition of support staff at Sec.  442.43(a)(3) to include security 
guards. We believe that security guards provide important services that 
support the safety of staff and beneficiaries in facilities, but that 
these services may not intuitively fall under any of the other 
categories already included in the definition of support staff. Thus, 
we believe it is important to explicitly include security guards as a 
category of worker included in the definition finalized at Sec.  
442.43(a)(3).
    We decline to make other modifications to the definition based on 
comments. We believe laundry services are already included in the 
definition of support staff at Sec.  442.43(a)(3)(i) as part of 
housekeeping duties, and thus, we decline to add that as a separate 
category in the definition. Transportation drivers are addressed in the 
proposed definition (and the definition we are finalizing) at Sec.  
442.43(a)(3)(v).
    We believe the other specific positions described by commenters are 
administrative roles and would not be included in our definition of 
support staff at Sec.  442.43(a)(3). We agree that all staff, including 
those who provide administrative support, are critical to the 
functioning of a facility. We also believe, as has been discussed at 
length in the proposed rule at 88 FR 61381 through 61383, that direct 
care worker understaffing in facilities is well-documented and chronic 
and poses a risk to the quality of care. As a result, we have made 
addressing compensation for institutional direct care workers and 
support staff a particular focus of this requirement.
    Comment: A number of commenters, particularly those representing 
ICFs/IID, expressed concern that some staff may have duties that 
encompass components of both the direct care worker definition in Sec.  
442.43(a)(2) and the support staff definition in Sec.  442.43(a)(3), 
such as DSPs who also provide services such as cooking, housekeeping, 
or maintaining the physical environment of an ICF/IID. Commenters 
expressed concern that this overlap in duties would create inconsistent 
reporting, confusion, or additional administrative burden if facilities 
had to report portions of the same staff's compensation in two 
categories. A commenter suggested we resolve this overlap by allowing 
the full compensation for these DSPs to be included in the direct care 
worker cost category.
    One commenter also noted that the definitions of direct care worker 
and support staff do not address universal care workers who provide 
both nursing services and support services.
    Response: We believe that for reporting purposes, compensation for 
staff that act as direct care workers and support staff should be 
reported according to the staff's primary job duties. We do not expect 
the calculations of the percent of payments for nursing facility and 
ICF/IID services that are spent on compensation for the

[[Page 40924]]

direct care and support staff workforce to allocate compensation across 
direct care and support staff categories based on the proportion of 
time an individual worker performs specific tasks.
    Comment: A few commenters specifically noted support for the 
inclusion of third-party contracted and subcontracted staff in the 
definitions of direct care workers and support staff at Sec.  
442.43(a)(2) and (3). A commenter noted that if we were to exclude 
contracted staff from the reporting requirement, we would be missing 
critical information on staff compensation expenditures and create an 
incentive for facilities to rely even more heavily on contracted staff 
to avoid having to report on payments to these staff.
    A few commenters suggested that we expand the definitions of direct 
care workers and support staff as they relate to the inclusion of 
third-party contracted staff. These commenters noted that nursing 
facility ownership structures have become extremely complicated and 
that organizations can engage with facilities in a variety of ways 
including complicated related-party transactions. These commenters 
recommended we expand the direct care worker and support staff 
definitions to include all individuals or entities providing services 
under contract, subcontract, or other related agreement, in whole or in 
part, with an organization or provider that provides goods or services 
to the facility through contract, subcontract, or other related 
agreement, in-whole or in-part. This includes direct care workers, 
ancillary services staff, and support staff providing goods or services 
to the facility under a contract, subcontract, or other related 
agreement, in-whole or in-part, and regardless of whether the 
individual receives a W-2 from either the contracted organization or 
the facility.
    A few commenters observed that many facilities use contract labor 
(in which the contract price includes wages, benefits, and 
administrative costs) and all-inclusive contracts (in which a facility 
pays a monthly rate for labor, supplies, and other items). A commenter 
suggested that we modify the definition of compensation or benefits to 
clarify that the definition excludes any payment that is not directly 
received by the worker or excludes any payment that is retained by a 
related party or contracted agency. A commenter requested we issue 
guidance requiring facilities to report only the portion of contracted 
costs that are actually related to compensation; this commenter 
suggested that if it is not possible for facilities to report only the 
portion of contracts related to compensation, that we require States to 
discount costs for payments to agencies and contractors by an amount 
that represents the average percentage of these payments that is not 
related to actual worker compensation, based on a State examination of 
a sample of such payments.
    A number of commenters representing ICFs/IID noted that ICFs/IID 
often contract for many services. These commenters stated that 
obtaining compensation information from third-party organizations may 
be burdensome, might require obtaining confidential or proprietary 
information, discourage third party entities from contracting with 
ICFs/IID, create administrative burden and complexity, and open ICFs/
IID to penalties if they are unable to track down this information. 
Some of these commenters specified concern about the impact of the 
requirement on ICFs/IID that contract with HCBS providers to allow the 
ICF/IID residents to attend community day programs. Relatedly, a few 
commenters noted that ICFs/IID may contract with other community 
organizations to provide ICF/IID residents access to, for example, YMCA 
programs, bowling alleys, or other recreational activities. These 
commenters were concerned that these community providers or 
organizations would not accept the ICF/IID residents if they were 
required to report on compensation to their staff. A few commenters 
expressed concern that States would reduce ICF/IID services or that 
ICFs/IID would stop offering community engagement activities or feel 
penalized for offering community engagement if presented with increased 
reporting burden.
    To address the potential complexity of reporting on third-party 
contracted staff, a commenter suggested we allow the full cost of 
contracts to be reported separately, based on the general type of 
service being delivered, which the commenter believed aligns with most 
States' current ICF/IID cost reporting. Similarly, another commenter 
noted that in the commenter's State, Medicaid cost reports separate 
agency (contract) spending from compensation paid to employed workers 
and suggested that we adopt the same approach.
    Response: We decline to modify the definitions of direct care 
worker or support staff in response to these comments. We agree that it 
is important to report on the compensation paid to contracted staff, 
not the value of the entire contract to a third-party. As noted by 
commenters, the value of the entire contract may include administrative 
or other costs that would fall outside the definition of compensation 
and inflate the reported percentage of compensation. We also agree with 
commenters that excluding contracted staff would not provide accurate 
insight into allocation of Medicaid payments to the workers providing 
direct care and support to residents. We believe that the language in 
the definitions of direct care worker and support staff at Sec.  
442.43(a)(2) and (3) already indicates that it is compensation to 
workers employed as part of a contract, not the value of an entire 
contract for services, that should be included in the reporting.
    We are concerned that some of the alternate language proposed by 
commenters might alter the definition in ways beyond what we intended 
for the definitions of direct care worker and support staff. For 
instance, we are uncertain what commenters meant in their proposed 
alternative definition by individuals who provide services ``in-whole 
or in-part.'' If this is a reference to workers who provide services on 
less than a full-time basis, then we believe these individuals are 
already included in our definitions of direct care worker and support 
staff at Sec.  442.43(a)(2) and (3), as these definitions do not 
specify whether a worker is employed on a part- or full-time basis. We 
are concerned that the language suggested by commenters could be 
interpreted as including compensation to individuals who, while 
supporting an organization that provides contracted services to 
residents, do not themselves provide services specifically for the 
residents.
    We also note that the definitions of direct care workers and 
support staff that we proposed (and are finalizing, with modifications, 
in this final rule) are meant to capture employees and contracted staff 
who provide services, not goods, to facility residents. We would not, 
for instance, expect the compensation of staff working for a wholesale 
grocer that supplies food to a facility to be included in the reported 
compensation.
    We acknowledge that some facilities may rely on a number of 
contracts to provide services for residents (including contracts with 
HCBS providers or other entities in the community). We do not believe 
the compensation of all workers employed by a contractor or 
subcontractor will be relevant to the reporting requirement. Given the 
variety of contracting models we will provide subregulatory guidance to 
States on how to approach reporting on compensation to contracted and 
subcontracted staff.
    Comment: One commenter noted that HCBS providers providing 
contracted services for ICF/IID residents may face additional, 
duplicative, or conflicting

[[Page 40925]]

reporting requirements, due to finalization of compensation-related 
reporting requirements in the Ensuring Access to Medicaid Services 
rule.
    Response: As finalized at Sec.  441.311(e) in the Ensuring Access 
to Medicaid Services rule published elsewhere in this Federal Register, 
HCBS providers that provide homemaker, home health aide, personal care, 
or habilitation services will be required to report on the percent of 
Medicaid payments going to direct care worker compensation. We will 
provide subregulatory guidance on how States should approach reporting 
by HCBS providers who fall within the reporting requirement at Sec.  
441.311(e) and who also provide contracted services to nursing facility 
or ICF/IID residents to minimize reporting burden on these providers.
    After consideration of the comments received, we are finalizing the 
definition of direct care worker at Sec.  442.43(a)(2) with a 
modification to add DSPs and to include nurses or other staff who 
provide clinical supervision. We are finalizing the definition of 
support staff at Sec.  442.43(a)(3) with a modification to add security 
guards.

D. Reporting Requirement

    Based on our authority at sections 1902(a)(6) and 1902(a)(30)(A) of 
the Act with respect to FFS, and sections 1902(a)(4) and 1932(c) of the 
Act with respect to managed care plans (that is, MCOs and PIHPs), we 
proposed new reporting requirements at Sec.  442.43(b) to require 
States to report annually, by delivery system (if applicable) and by 
facility, on the percent of Medicaid payments for nursing facility and 
ICF/IID services that is spent on compensation for direct care workers 
and on compensation for support staff, at the time and in the form and 
manner specified by CMS. As noted in our responses previously, and as 
discussed in the proposed rule at 88 FR 61386, we believe that this 
information will help identify national trends and also help States 
identify facilities that appear to be outliers in terms of the amount 
of Medicaid payment going to direct care worker and support staff 
compensation. We believe that contextualizing direct care worker and 
support staff compensation information in this manner will help States 
understand whether current payment rates for nursing facility and ICF/
IID services are consistent with economy, efficiency, and quality, and 
sufficient to ensure meaningful beneficiary access.
    We proposed that the reporting to CMS would be for all Medicaid 
payments made to nursing facility and ICF/IID providers receiving 
payment under FFS or managed care delivery systems. As discussed in 88 
FR 61387, for FFS payments, this would include base payments and 
supplemental payments for nursing facility and ICF/IID services. For 
FFS base and supplemental payments, we are relying on the definition of 
supplemental payments provided in section 1903(bb)(2) of the Act, which 
defines supplemental payments as Medicaid payments to a provider that 
are in addition to any base payment made to providers under the State 
plan or under demonstration authority. As discussed in guidance 
released in 2021, we interpret base payment (as used in the definition 
of supplemental payment in section 1903(bb)(2)(A) of the Act) to refer 
to a standard payment to the provider on a per-claim basis for services 
rendered to a Medicaid beneficiary in an FFS environment. The base 
payment can include: (1) any payment adjustments; (2) any add-ons; and/
or (3) any other additional payments received by the provider that can 
be attributed to services identifiable as having been provided to an 
individual beneficiary, including those that are made to account for a 
higher level of care, complexity, or intensity of services provided to 
an individual beneficiary.\90\ We solicited comment on whether, for FFS 
payments, we should instead require reporting on only the percent of 
base payments spent on such compensation, or separate reporting on the 
percent of base payments and on the percent of aggregated payments 
(base plus supplemental payments) spent on such compensation.
---------------------------------------------------------------------------

    \90\ Centers for Medicare & Medicaid Services, State Medicaid 
Directors Letter # 21-006, New Supplemental Payment Reporting and 
Medicaid Disproportionate Share Hospital Requirements under the 
Consolidated Appropriations Act, 2021, December 10, 2021. https://www.medicaid.gov/federal-policy-guidance/downloads/smd21006.pdf.
---------------------------------------------------------------------------

    We also proposed at Sec.  442.43(b) that, for States that contract 
with MCOs and/or PIHPs to cover services delivered by nursing 
facilities and/or ICFs/IID, States report on the percent of payments 
made by the MCO or PIHP to nursing facilities and ICFs/IID that is 
spent for compensation to direct care workers and support staff. For 
these managed care plans, payments would include the managed care 
plan's contractually negotiated rate, State directed payments defined 
in Sec.  438.6(a), pass-through payments defined in Sec.  438.6(a) for 
nursing facilities, and any other payments from the MCO or PIHP to the 
nursing facility or ICF/IID.
    We also proposed to require that, if States deliver the relevant 
services through both FFS and managed care, the States report 
separately for each delivery system.
    We proposed that the reporting be performed annually. We solicited 
comment on this timeframe. We requested comment on whether annual 
reporting is reasonable, or if we should reduce the frequency of 
reporting to every other year or every 3 years.
    We received comments on our proposal. The following is a summary of 
these comments and our responses.
    Comment: A number of commenters recommended that instead of, or in 
addition to, our proposed reporting requirements we implement the 
Medicaid transparency recommendations of the March 2023 Medicaid and 
CHIP Payment and Access Commission (MACPAC).\91\ The MACPAC 
recommendations call for State Medicaid programs to make nursing 
facility payment and cost data publicly available for each nursing 
facility in a standard format that includes: (1) FFS base Medicaid 
payments, FFS supplemental payments, managed care State directed 
payments, and beneficiary contributions to their share of costs; (2) 
the amount of provider contributions to the non-Federal share of 
Medicaid payments to calculate net payments to providers; (3) expenses 
for wages and benefits separately for nursing, ancillary, and support 
services as well as administrative staff and other employees; (4) 
expenses for direct care including staffing costs for nursing, 
ancillary, and support services; (5) expenses for administration, 
property, and profits; and (6) detailed expenses for related-party 
transactions, real estate ownership, and disallowed costs. These 
commenters believed that unless Medicaid programs are required to 
provide more comprehensive data on rates and payments as well as 
expenses, we will not be able to draw any useful conclusions from the 
proposed transparency requirement.
---------------------------------------------------------------------------

    \91\ Medicaid and CHIP Advisory Committee, March 2023 Report to 
Congress on Medicaid and CHIP. See specifically ``Chapter 2: 
Principles for Assessing Medicaid Nursing Facility Payment Policy.'' 
Available at: https://www.macpac.gov/publication/principles-for-assessing-medicaid-nursing-facility-payment-policies/.
---------------------------------------------------------------------------

    Response: We defer to States as to whether they wish to make this 
information available to the public. While we agree that this level of 
granular detail would generate a great deal of potentially useful 
information, we strongly disagree with commenters that reporting on 
higher-level aggregated data would not yield useful information. We 
note that the reporting requirement at Sec.  442.43 will provide data 
on the

[[Page 40926]]

percent of Medicaid payments (including FFS base payments, FFS 
supplemental payments, managed care State directed payments, and 
beneficiary contributions) that is being spent on compensation for 
direct care and support staff as well as other payments that may not 
all be captured in the MACPAC recommendations, such as other payments 
in managed care delivery systems, including contractually negotiated 
rates, pass-through payments, and any other payments from the MCO or 
PIHP in managed care delivery systems. As noted in a prior response, we 
decline to subdivide direct care workers into nursing and ancillary 
staff categories. We believe that this reporting requirement will 
result in nationally comparable baseline data that will allow for 
inferences regarding investment in the direct care and support staff 
workforce. While we will take the other recommendations under 
consideration, at this time we do not intend to increase administrative 
burden on States and providers by requiring Federal reporting on 
additional categories that fall outside of our focus on the direct care 
and support staff workforce.
    We also point commenters to the Disclosures of Ownership and 
Additional Disclosable Parties Information for Skilled Nursing 
Facilities and Nursing Facilities final rule (88 FR 80141) published on 
November 17, 2023, which implements portions of section 6101 of the 
Patient Protection and Affordable Care Act requiring the disclosure of 
certain ownership, managerial, and other information regarding Medicare 
skilled nursing facilities (SNFs) and Medicaid nursing facilities. Some 
of the commenters' additional concerns regarding facility ownership 
structures may be addressed by the requirements in that rule.
    Comment: A few commenters noted support for requiring reporting of 
both FFS base and supplemental payments, pointing out that supplemental 
payments contribute to total revenue in the same way that base rates do 
and should not be treated differently or excluded.
    One commenter noted that in the commenter's State, facilities do 
not receive FFS supplemental payments but rather receive varying FFS 
base payments depending on the acuity of the residents. This commenter 
stated that requiring reporting on total payments would result in 
better comparisons across States. A few commenters stated that FFS 
payment base rates do not fluctuate drastically year-to-year without 
changes to the State plan, and thus believed that including both FFS 
base and supplemental payments would not be burdensome and would 
provide a comprehensive picture of nursing facilities' expenditures on 
compensation. A few commenters also noted support for requiring 
reporting on all payments from an MCO or PIHP, including State directed 
payments made by these managed care plans.
    One commenter, on the other hand, supported reporting on FFS base 
and supplemental payments separately. The commenter stated that 
separate reporting would illustrate the separate roles of the FFS base 
payment and supplemental payments, which in turn would be important to 
understanding how Medicaid payments support nursing facility staffing 
and ensure supplemental payments were also being used to support worker 
compensation.
    Response: We are finalizing the substantive language at Sec.  
442.43(b) specifically requiring reporting on Medicaid FFS base and 
supplemental payments as proposed. (We note that we are finalizing 
Sec.  442.43(b) with some non-substantive technical modifications to 
improve the overall clarity of the requirement.) We agree with 
commenters that requiring reporting on both Medicaid FFS base and 
supplemental payments (added together) strikes the right balance of 
providing a complete picture of Medicaid FFS payments while minimizing 
administrative burden to the greatest extent possible.
    Upon further consideration, we are finalizing Sec.  442.43(b) with 
a modification to remove the specification that reporting is ``by 
delivery system.'' We continue to expect that services delivered under 
a managed care delivery system will be part of the reporting 
requirement. We do not, however, intend to require that States report 
data to us separately by delivery system. We note that commenters did 
not express specific support for this separate reporting, and we are 
concerned that this separate reporting may increase administrative 
burden in States that provide services through both FFS and managed 
care delivery systems. We also note that the compensation reporting 
requirement (reporting on the percent of Medicaid payments made to 
direct care workers providing Medicaid HCBS) finalized at Sec.  
441.311(e) in the Ensuring Access to Medicaid Services final rule 
published elsewhere in this Federal Register does not require separate 
reporting by delivery system. We intend to align these reporting 
requirements to the greatest extent possible.
    Comment: A commenter requested that CMS clarify what payments are 
required to be reported in accordance with Sec.  442.43(b) for 
providers that are network providers for an MCO or PIHP.
    Response: We point readers to the language being finalized at Sec.  
442.43(b), which states that the Medicaid payments that must be 
included in the State reporting include the contractually negotiated 
rate, State directed payments, pass-through payments, and any other 
payments from the MCO or PIHP for nursing facility and ICF/IID 
providers.
    Comment: Several commenters supported requiring reporting at least 
annually for both FFS and managed care delivery systems, which 
commenters believed would aid in tracking trends in worker compensation 
across facilities and States. One commenter noted that an annual 
frequency appropriately balances the need for actionable information 
with administrative burden. One commenter noted that timely data on 
Medicaid is critical as rates can be too low and not updated 
frequently, which can have a negative impact on providers and on 
beneficiaries' access to care. One commenter noted that frequent public 
reporting can be a critical element to promoting policy change and 
improving health care quality.
    A few commenters, however, while stating that they found the annual 
reporting frequency to be reasonable, noted that States have many 
reporting burdens and asked that we remain receptive to alternative 
frequencies proposed by States. One of these commenters noted that some 
States may need more time than others to come into compliance with the 
requirement and suggested that we allow for some flexibility to 
accommodate different States' circumstances or allow States to 
determine their own timeframe.
    A few commenters, citing concerns about the burden associated with 
collecting and analyzing reimbursement streams and worker compensation 
data, as well as competing reporting priorities and limited staff 
resources, suggested we require reporting every 3 years. One of these 
commenters noted that some of the wage and benefit information that 
would be required is not readily available to some Medicaid agencies, 
not all cost reports have this information, and providers do not 
typically report this type of information to their State Medicaid 
agencies.
    Response: We are finalizing the annual reporting frequency as 
proposed. We agree with commenters that receiving timely reporting data 
is critical, and we are concerned that if too much time elapses between 
each

[[Page 40927]]

reporting period, the reports, when released, will become quickly out 
of date. Additionally, as discussed further in this section, we are 
finalizing at Sec.  442.43(f) an applicability date that will give 
States 4 years to comply with this reporting requirement. Once States 
that do not currently collect these data update their systems 
appropriately, we believe the reporting will become routine and the 
initial administrative burden will lessen. We will provide technical 
assistance to States as needed as they develop their reporting 
capacity.
    After consideration of the comments received, we are finalizing a 
modification to Sec.  442.43(b) to strike ``by delivery system'' from 
the reporting requirement.
    We are also finalizing Sec.  442.43(b) with minor modifications to 
clarify that the Medicaid payments used in the calculation required at 
Sec.  442.43(b) do not include excluded costs (which are being 
finalized at Sec.  442.43(a)(4), as discussed in section III.B. of this 
final rule.) Additionally, we are finalizing the regulatory text at 
Sec.  442.43(b) with technical modifications to aid with clarity and 
correct minor grammatical errors.

E. Exclusion of Certain Payments

    We proposed at Sec.  442.43(b)(1) to require reporting for 
payments, including FFS base and FFS supplemental payments, and 
payments from managed care plans, to nursing facilities and ICFs/IID 
for Medicaid-covered services, with the exception of services offered 
in swing bed hospitals (as described in Sec.  440.40(a)(1)(ii)(B)). We 
proposed to exclude swing bed hospitals, as we do not want to pose a 
burden on rural hospitals that provide LTSS to a comparatively small 
number of beneficiaries. We solicited comment on this proposal.
    For reasons described in the proposed rule at 88 FR 61387, at Sec.  
442.43(b)(2), we proposed that States exclude from the reporting 
payments for which Medicaid is not the primary payer, meaning that 
States would exclude payments for services for residents who are dually 
eligible for Medicare and Medicaid and whose skilled nursing care 
services are paid for by Medicare. We solicited feedback from the 
public on whether including cost-sharing payments for services that 
were primarily paid for by Medicare would provide a more accurate 
picture of the relationship between Medicaid payments and worker 
compensation. We also requested comment on whether excluding cost-
sharing payments would increase or decrease burden on States and 
providers.
    For reasons discussed at 88 FR 61387, we did not propose to exclude 
beneficiary contributions to their care when Medicaid is the primary 
payer of the services.
    We considered whether to allow States, at their option, to exclude, 
from their reporting, payments to providers that have low Medicaid 
revenues or serve a small number of Medicaid beneficiaries, based on 
Medicaid revenues for the service, the number of Medicaid beneficiaries 
receiving the service, or other Medicaid utilization data including but 
not limited to Medicaid bed days. We considered this option as a way to 
reduce State, managed care plan, and provider data collection and 
reporting burden based on the experience of States that have 
implemented similar reporting requirements. However, we were concerned 
that such an option could discourage providers from serving Medicaid 
beneficiaries or increasing the number of Medicaid beneficiaries 
served. We requested comment on whether we should allow States the 
option to exclude, from their reporting to us, payments to providers 
that have low Medicaid revenues or serve a small number of Medicaid 
beneficiaries, based on Medicaid revenues for the service, the number 
of Medicaid beneficiaries receiving the service, or other Medicaid 
utilization data including but not limited to Medicaid bed days. We 
also requested comment on whether we should establish a specific limit 
on such an exclusion and, if so, the specific limit we should 
establish, such as to limit the exclusion to providers in the lowest 
5th, 10th, 15th, or 20th percentile of providers in terms of Medicaid 
revenues for the service, number of Medicaid beneficiaries served, or 
other Medicaid utilization data (including but not limited to Medicaid 
bed days).
    We received comments on our proposal. The following is a summary of 
these comments and our responses.
    Comment: A few commenters supported our decision to exclude 
payments to swing beds from the reporting in the proposed rule. These 
commenters noted that swing bed hospitals utilize different accounting 
systems for their expenditures and thus should not be included in 
nursing facility reporting. One commenter agreed that swing bed 
hospitals should be excluded to avoid placing a burden on rural 
facilities that serve a relatively low number of nursing facility 
residents.
    Response: We thank commenters for their support. We are finalizing 
the exclusion of payments to swing bed hospitals at Sec.  442.43(b)(1) 
as proposed.
    Comment: A few commenters agreed with excluding payments for 
services in which Medicaid is not the primary payor. One commenter 
specifically agreed that this exclusion would reduce burden on States 
and providers and that payments from other payors would not provide 
meaningful insight into the allocation of Medicaid payments for 
compensation of workers. However, a number of commenters recommended we 
require that reporting be for the percent of all revenue spent on 
compensation (and not limited just to the percent of Medicaid 
payments). Commenters believed this would further aid in transparency 
and oversight of how facilities allocate their revenue. A few 
commenters also stated that requiring only reporting on payments for 
which Medicaid is the primary payer actually increases burden and 
recommended that reporting be on the percentage of all revenues that 
are spent on compensation. Commenters noted that nursing facilities 
receive revenue from many sources apart from Medicaid payments and pay 
direct care workers and support staff compensation from a pool 
comprised of all revenue sources.
    A number of commenters recommended we expand this requirement to 
include Medicare as well as Medicaid payments. A few of these 
commenters disagreed with our statement that including Medicare 
payments was out of scope. These commenters stated that not only is 
including Medicare payments within our authority, not doing so ignores 
our legal obligations under the Nursing Home Reform Act (specifically, 
42 U.S.C. 1396r(f)(1)) to protect residents and make sure that public 
funding is effectively and efficiently used, as well as our obligations 
under section 6104 of the Affordable Care Act (requiring that skilled 
nursing facilities receiving Medicare payments disclose wages paid to 
direct care staff on their cost reports).
    Response: We decline to modify the requirements to require 
reporting for all revenue or for Medicare revenue, as this would be out 
of scope for the proposal. We believe that States and facilities are 
aware of the amount of Medicaid payments received by each facility. We 
understand that all revenue received by a facility ultimately gets 
pooled together for the purposes of paying worker compensation and that 
facilities often serve a mix of residents with different payers and 
different needs. As discussed further in this section, we will provide 
a methodology that will allow States to make a reasonable calculation 
of what percent of a facility's direct care and support staff

[[Page 40928]]

workforce was paid from Medicaid revenues.
    As discussed in the proposed rule at 88 FR 61383, we proposed these 
reporting requirements in part using our authority under section 
1902(a)(30)(A) of the Act, which requires State Medicaid programs to 
ensure that payments to providers are consistent with efficiency, 
economy, and quality of care and are sufficient to enlist enough 
providers so that care and services are available to beneficiaries at 
least to the extent as to the general population in the same geographic 
area. We believe section 1902(a)(30)(A) of the Act speaks specifically 
to Medicaid payments, not to all payments received by providers. We 
will take under advisement commenters' recommendations regarding 
reporting on all revenue but cannot pursue such a requirement in this 
rule.
    We also reiterate that our intention is to align the reporting 
requirement at Sec.  442.43 with similar reporting requirements 
finalized in the Ensuring Access to Medicaid Services final rule 
published elsewhere in this Federal Register, which focuses on the 
percent of Medicaid payments for certain HCBS going to compensation for 
the direct care workforce. The purpose of these aligned requirements is 
to provide a consistent picture of the percent of Medicaid payments 
going to compensation for the direct care workforce for Medicaid-
covered LTSS across settings. Not only would adding reporting on 
Medicare payments be out of scope for this reporting requirement, we 
believe that doing so would obscure data on the allocation of Medicaid 
payments. We thank commenters for their feedback and will consider a 
reporting requirement for Medicare payments for future rulemaking.
    Comment: A few commenters agreed that beneficiary contributions, 
such as co-pays (to the extent they exist) should also be included in 
the revenue side of the calculation. A few commenters noted that 
because beneficiary contributions can fluctuate, they can have an 
impact on the resources available for compensation to staff and thus 
should be included in the reporting.
    One commenter asked for clarification on which beneficiary 
contributions should be included. The commenter noted that in the 
proposed rule we mentioned deductibles and coinsurance but did not 
mention resident contributions to the cost of their care as a result of 
Medicaid rules for post-eligibility treatment of income (PETI). The 
commenter expressed concern that we had not listed all types of 
beneficiary contributions in the regulatory text.
    Response: We thank commenters for their support. We clarify that 
beneficiary contributions, including contributions to the cost of their 
care as a result of Medicaid rules for PETI, are part of Medicaid total 
payments for the purposes of this reporting requirement. We decline to 
specify beneficiary contributions in the regulatory text because we 
believe these are already understood to be part of total Medicaid 
payments. As noted in the proposed rule at 88 FR 61387, Sec.  447.15 
defines payment-in-full as ``the amounts paid by the agency plus any 
deductible, coinsurance or copayment required by the [State] plan to be 
paid by the individual.'' For managed care delivery systems, although 
the term ``payment-in-full'' as defined at Sec.  447.15 is not 
applicable, for consistency between FFS and managed care delivery 
systems, any deductible, coinsurance, or copayment required to be paid 
by the individual would similarly be included in the total amount used 
to determine the percent of Medicaid payments for nursing facility and 
ICF/IID services under managed care delivery systems that is spent on 
compensation for direct care workers and support staff.
    Comment: Most commenters who responded to our comment solicitation 
on small provider exemptions did not support exempting small providers 
from the reporting requirement because a complete picture of Medicaid 
spending on compensation in all nursing facilities and ICFs/IID is 
critically needed. A few commenters agreed with the reasons we cited in 
the proposed rule, that excluding certain providers would create the 
potential for disincentivizing providers to accept Medicaid patients. A 
commenter noted that ICFs/IID in particular tend to be small, so 
excluding small providers could mean a significant number (if not all) 
of some States' ICF/IID providers might be exempted.
    One commenter did support excluding certain providers, noting that 
providers with a low number of nursing beds or extremely high or 
extremely low Medicaid utilization will typically not have operating 
costs that reflect the average for the industry and as such may change 
the State reported averages. The commenter proposed that providers 
should be excluded from reporting information required by this rule if 
they have any of the following characteristics during the reporting 
period: (1) Medicaid utilization based on census of 30 percent or less; 
(2) Medicaid utilization based on census of 80 percent or more; or (3) 
40 or fewer Medicaid-certified beds. One commenter recommended 
excluding payments for out-of-State single-case agreements, due to the 
difficulties collecting data from out-of-State facilities.
    Response: We thank commenters for their feedback regarding concerns 
related to offering exemptions from the reporting requirement. We agree 
that offering exemptions would create disincentives to serve Medicaid 
beneficiaries and would not provide a comprehensive picture of 
compensation for the direct care and support staff workforce. We also 
note that we are especially interested in the expenditures of 
facilities serving a high percentage of Medicaid beneficiaries and, 
thus, would not wish to exclude them from this reporting. We will not 
modify this reporting requirement to add exemptions for providers. We 
will provide technical assistance as needed to address payments for 
Medicaid beneficiaries in out-of-State facilities.
    Comment: One commenter expressed concern about the impact of dually 
eligible individuals on cost calculations, as Medicaid does not bear 
the cost of therapy provision or prescription drugs for dually eligible 
nursing facility residents.
    Response: As discussed in the proposed rule at 88 FR 61386, States 
would exclude Medicaid payments to cover only cost-sharing payments on 
behalf of residents who are dually eligible for Medicare and Medicaid 
and whose skilled nursing care services are paid for by Medicare. We 
will provide technical assistance on how to calculate costs for dually 
eligible residents whose nursing facility care is being covered by 
Medicaid, but some aspects of their care are paid for by Medicare.
    After consideration of the comments received, we are finalizing the 
requirements at Sec.  442.43(b)(1) and (2) as proposed.
    We are also finalizing at new Sec.  442.43(b)(3) an exemption of 
data from Indian Health Service (IHS) and Tribal health programs 
subject to 25 U.S.C. 1641. During our finalization of the Ensuring 
Access to Medicaid Services final rule published elsewhere in this 
Federal Register, it came to our attention that requirements 
potentially affecting IHS or Tribal provider expenditures would 
conflict with 25 U.S.C. 1641, governing how IHS and Tribal health 
programs may use Medicare and Medicaid funds, and other applicable laws 
providing for Tribal self-governance and self-determination. Although 
we are not finalizing a requirement in this final rule to require that 
providers spend a

[[Page 40929]]

minimum percentage of their Medicaid payments for nursing facility or 
ICF/IID services on direct care worker and support staff compensation, 
we have left open the possibility that the data collected under Sec.  
442.43 could help inform a minimum performance proposal in future 
rulemaking. Given the conflict between such a minimum performance 
requirement and the statutory requirements at 25 U.S.C. 1641, we will 
be unable to use data from IHS and Tribal health programs to inform 
future policy making related to direct care worker and support staff 
compensation. We believe that requiring States to report on data from 
IHS and Tribal programs would create unnecessary burden and (given 
their current allocation requirements) might skew the other data States 
would collect and report to CMS. Further, we note that finalizing an 
exemption for IHS and Tribal programs at Sec.  442.43(b)(3) aligns with 
an exemption in the compensation reporting requirement finalized at 
Sec.  442.311(e)(2) in the Ensuring Access to Medicaid Services final 
rule published elsewhere in this Federal Register.

F. Report Contents and Methodology

    At Sec.  442.43(c)(1), we proposed that the reporting must provide 
information necessary to identify, at the facility level, the percent 
of Medicaid payments spent on compensation to: direct care workers at 
each nursing facility, support staff at each nursing facility, direct 
care workers at each ICF/IID, and support staff at each ICF/IID. We 
anticipate that States and providers would be able to obtain the 
information needed to calculate the percent of Medicaid payments made 
to direct care workers and support staff using data used in rate 
setting, internal wage information, cost reports, and resident census 
numbers (which would indicate the number of days residents had 
Medicaid-covered stays during the year). However, we solicited comment 
on our proposal that information be reported at the facility level, 
particularly on any concerns about potential burden on providers and 
States.
    We proposed to include in the reporting requirement the percentages 
of Medicaid payments to each nursing facility or ICF/IID that are going 
towards compensation to direct care workers and support staff at those 
facilities. However, we stated in the proposed rule at 88 FR 61387 that 
we would consider adding to the proposed reporting requirements 
additional elements for States to report on median hourly compensation 
for direct care workers and median hourly compensation for support 
staff, in addition to the percent of Medicaid payments going to overall 
compensation for these workers. We requested that commenters also 
provide feedback on whether the reporting should be on salary/wages or 
on total compensation (salary/wages and other remuneration, including 
employer expenditures for benefits and payroll taxes) and whether the 
information should be calculated for all direct care workers and for 
all support staff or further broken down by the staff categories 
specified in our proposal at Sec.  442.43(a)(2) and (3).
    At Sec.  442.43(c)(2), we proposed that States must report the 
information required at Sec.  442.43(c)(1) (the percent of Medicaid 
payment going to compensation for direct care workers and support staff 
and, if added to the provision, median hourly wages) according to a 
methodology that we provide. For reasons discussed in the proposed rule 
at 88 FR 61387 through 61388, we did not propose to codify a specific 
reporting methodology. In the proposed rule at 88 FR 61387, we stated 
that if this proposal is finalized, we would specify a reporting 
methodology as part of the reporting instrument, which would be 
submitted separately for formal public comment under the processes set 
forth by the Paperwork Reduction Act. We solicited initial suggestions 
for an appropriate methodology for identifying the percentage of 
Medicaid payment that has gone to direct care worker and support staff 
compensation. We also solicited initial suggestions about whether 
separate methodologies would be appropriate for FFS base payments and 
supplemental payments and if so, suggestions for each. Commenters who 
supported adding a requirement to report median hourly wages were also 
asked to provide suggestions for a methodology for those calculations.
    To support our goal of transparency, we considered adding a 
provision requiring that States make publicly available information 
about the underlying FFS payment rates themselves for nursing facility 
and ICF/IID services. For the reasons discussed in 88 FR 61388, we 
considered adding to the proposed reporting provisions a requirement 
that, as applicable, States report a single average Statewide FFS per 
diem rate (one reported rate for nursing facility services and one 
reported rate for ICF/IID services). We also requested comment on 
whether the reported average should be the average of only the per diem 
FFS base payment rates or the average of the per diem FFS base payment 
rates plus FFS supplemental payments.
    Finally, as discussed in 88 FR 61388, in consideration of potential 
future rulemaking, we requested comment on whether we should require 
that a minimum percentage of the payments for Medicaid-covered nursing 
facility services and ICF/IID services be spent on compensation for 
direct care workers and support staff. We also requested comment on 
whether such a requirement would be necessary to ensure that payment 
rates and methodologies are economic and efficient and consistent with 
meaningful beneficiary access to safe, high-quality care, or otherwise 
necessary for the proper and efficient operation of the State plan. 
Additionally, we requested suggestions on the specific minimum 
percentage of payments for Medicaid-covered nursing facility services 
and ICF/IID services that should be required to be spent on 
compensation to direct care workers and support staff. If a minimum 
percentage was recommended, we requested that commenters provide 
separate recommendations for nursing facility services and ICF/IID 
services and the rationale for each such minimum percentage that is 
recommended. We requested that commenters provide data or evidence to 
support such recommendations, which we will review as part of our 
consideration of policy and rulemaking options.
    We received comments on our proposal. The following is a summary of 
these comments and our responses.
    Comment: A few commenters expressed support for the requirement 
that States collect data at the facility level. A commenter noted 
specific support for including both privately- and publicly owned 
facilities.
    A few commenters noted that facility-level reporting may be 
burdensome. One of these commenters asked for clarification as to 
whether the reporting will be by provider or by facility; the commenter 
noted that some providers operate multiple individual facilities and 
that requiring reporting at the facility level rather than the provider 
level will increase burden.
    Response: As stated in our proposed requirement at Sec.  442.43(c), 
the reporting gathered by the State should be at the facility level 
(but reported to CMS, for each nursing facility, as a single aggregated 
percentage for direct care worker compensation and, separately, a 
single aggregated percentage for support staff compensation and, for 
each ICF/IID, a single aggregated percentage for direct care worker 
compensation and, separately, a single aggregated percentage support 
staff compensation). We will provide technical assistance to

[[Page 40930]]

States on how to collect data from providers that operate multiple 
facilities to minimize administrative burden.
    Comment: Many commenters supported disaggregating the reporting 
requirements by job duty or title, rather than reporting a percentage 
for direct care workers and a percentage for support staff. Several 
commenters also supported requiring reporting on median hourly wages 
(again, disaggregated by job duty). These commenters noted that wages 
for different types of direct care workers and support staff are wide 
ranging, and commenters were concerned that posting broad categorical 
percentages or median hourly wages for a range of job classifications 
would not provide transparency regarding how the facility is staffed 
and how each type of worker is compensated.
    Other commenters did not support reporting on median hourly wages. 
A commenter, representing a number of State Medicaid agencies, stated 
that while some Medicaid agencies agreed that this data would help 
evaluate the impact of rate increases on staff wages, others were 
strongly opposed to additional reporting due to the increased 
administrative burden on States and providers. A commenter noted that 
the cost reports in the commenter's State do not currently include 
median hourly wages and that having to obtain that information from 
facilities would significantly increase burden.
    A few commenters believed that if median hourly wage was reported, 
it should be reported for total compensation. One of these commenters 
observed that facilities might have to make changes to their facility's 
human resources or accounting software to accommodate further 
disaggregation of wage reporting. The commenter also noted that the 
wide variety of salary or wage types and pay systems would make data 
disaggregated beyond total compensation difficult to compare among 
States and across providers.
    A few commenters suggested that this reporting be disaggregated by 
the subcategories of compensation listed in the definition of 
compensation at Sec.  442.43(a)(1). A few commenters suggested that the 
subcategories should be further disaggregated, such as requiring 
reporting separately on overtime payments, the cost of paid time off, 
and the cost of health benefits.
    A few commenters suggested we require disaggregation beyond 
compensation subcategory or job duty. A commenter suggested we require 
disaggregating median wage by part- and full-time status, as well as by 
contracted and employee status, which the commenter believed would 
allow policymakers to better understand the relationships between 
Medicaid payment, provider employment practices, and quality of care. A 
commenter, making a similar suggestion to require separate reporting of 
contracted staff, also suggested we require that facilities report 
whether they have an ownership interest in the third-party entity 
providing the contracted services. A few commenters suggested we 
require separate reporting on wages paid to new staff, to ensure 
facilities were appropriately investing in increasing staffing levels. 
A commenter suggested reporting on whether a facility offers health and 
retirement benefits and the percent of workers enrolling in those 
benefits. A few commenters also recommended we encourage States to 
collect data that would demonstrate racial, gender, and career 
advancement disparities.
    A few commenters suggested that reporting be disaggregated by rate 
component. A commenter explained that due to the large variations 
between the Medicaid reimbursement systems used in the States and 
territories, reporting by rate component would allow for a variety of 
percentage of payment calculations by individual rate component and in 
total.
    Response: We are finalizing the Federal reporting requirement as 
proposed (to require aggregated reporting of direct care worker 
compensation and support staff compensation) and without requiring 
reporting on median hourly wages.
    In previous comment summaries and responses, we discussed concerns 
about variations in job titles and duties and are concerned that 
requiring payment broken down by job title may make national 
comparisons difficult, and significantly increase the reporting burden. 
For similar reasons, we decline at this time to require reporting on 
median hourly wage. As noted by commenters, there are variations among 
State and local wage laws and cost of living that would make meaningful 
comparisons of median hourly wages difficult at a national level. We 
believe it is important to first establish competency with collecting 
and reporting broad baseline data before requiring more granular 
reporting, although we recognize there could be value to collecting 
more granular data, including on median wages, in the future.
    Additionally, upon consideration of the comments, we have 
identified no compelling reason to implement a Federal requirement for 
disaggregating the data by compensation category. We believe that 
employee benefits, in addition to wages, are also integral to the 
compensation of direct care workers and support staff. The third 
component of compensation--employers' share of payroll taxes--is a 
fixed percentage of the employee's wages set by law.
    We thank commenters for their thoughtful feedback and suggestions 
for additional reporting components or metrics. We note that States 
may, at their discretion, require additional disaggregated data that 
they feel would be helpful in tracking local trends in workforce 
compensation and providing oversight and transparency.
    Comment: Many commenters recommended that nursing homes should be 
required to detail other expenses, including any payments to related 
parties. These commenters believed that this would support greater 
financial transparency. One commenter recommended that both Medicare 
and Medicaid cost reports be made publicly available to disclose the 
total amount of spending on nursing, ancillary, and support services 
compared with spending on administration, property, profits, related 
party transactions, and disallowances.
    One commenter recommended that additional data be collected on 
other outcome measures, including staffing levels for direct care 
workers and workers who provide indirect care (such as housekeeping or 
food services); the number of short- and long-stay residents; payer 
distribution of residents; quality measures constructed from the 
Minimum Data Set; safety measures constructed from health inspection 
data collected from nursing homes during on-site inspection surveys; 
medical outcomes from Medicare data, including hospital admissions, 
emergency department visits, mortality, hospital readmissions, and 
successful community discharge (short stay); and results from surveys 
of residents, family, and staff.
    Response: We thank commenters for their suggestions but note that 
recommendations regarding reporting on expenditures other than 
compensation are out of scope for this rule, as are requests that we 
create and finalize requirements regarding cost reports. As stated in 
prior responses, the purpose of this requirement is not the granular 
tracking of all facility expenditures. As discussed at length in the 
proposed rule at 88 FR 61831 through 61833, understaffing in facilities 
is well-documented and chronic and poses a risk to the quality of care, 
and thus we have made addressing compensation for

[[Page 40931]]

institutional direct care workers and support staff a particular focus 
of this requirement. We recognize the role of related-party and other 
transactions in affecting the overall costs and profits of nursing 
facilities, and in turn the amount of funding available for direct care 
and administrative staffing; we will examine this issue and its impacts 
on quality in the future.
    We also note that Nursing Home Compare contains a great deal of 
information regarding quality measures for nursing facilities.
    Comment: Although they did not necessarily provide recommendations 
for a methodology, some commenters expressed concerns about how the 
required information will be calculated. These concerns include:
     For facilities that accept payments from multiple payers, 
identifying the amount of compensation for services provided to 
residents with stays covered by Medicaid;
     Accounting for variations in beneficiary acuity, which can 
impact both the amount of Medicaid payments and the facility resources 
allocated to the beneficiaries;
     Accounting for third party contracts in which (1) the 
contract price includes wages, benefits, and administrative costs, or 
(2) all-inclusive contracts (in which a facility pays a monthly rate 
for labor, supplies, and other items);
     Calculating the percent of Medicaid payments going to 
compensation if the Medicaid payment is less than the facility's 
standard rate; and
     Determining a reporting period (such as provider fiscal 
year, State fiscal year, or calendar year) that promotes consistency 
without creating administrative burden or confusion for providers.
    A few commenters made specific suggestions regarding methodology 
and the reporting period. A commenter recommended the percentage be 
calculated by determining (a) a per diem salary cost amount 
(compensation costs divided by total patient days) and (b) a per diem 
revenue amount (Medicaid payments divided by Medicaid days), and 
dividing amount (a) by amount (b). The commenter cautioned, however, 
that this method will not provide information about whether revenues 
are being diverted away from patient care.
    A commenter noted that a potential challenge could arise when 
accounting for payment adjustments that occur in one year that are paid 
in a different year, which could either under-report or over-report the 
payments to providers. To address this, the commenter suggested that 
States be required to report payments based on actual dates of service, 
not the dates payments are made to providers.
    A commenter recommended that the reporting period should be the 
facility's fiscal year or cost report year, but that changes in the 
reporting period should be allowed if the facility changes ownership. A 
commenter suggested we allow States to determine the reporting period.
    A few commenters suggested we develop a reporting methodology based 
on a review of current nursing facility and ICF/IID cost reports or 
other State-level reporting practices.
    Response: We thank commenters for their feedback, which we will 
take into consideration when developing the reporting methodology and 
reporting template (including reporting period), that we will be making 
available for public comment through the Paperwork Reduction Act notice 
and comment process. This will give the public the opportunity to 
provide specific feedback and help us align the methodology and 
reporting process with existing State practices to the greatest extent 
possible.
    We received public comment on our solicitation regarding whether we 
should require State reporting on per diem Medicaid FFS payment rates 
for nursing facilities and ICFs/IID. A few commenters wrote in support 
of adding this requirement to the reporting requirement at Sec.  
442.43(c). However, we have finalized a requirement at Sec.  
447.203(b)(1) in the Ensuring Access to Medicaid Services final rule 
published elsewhere in this Federal Register requiring State agencies 
to publish all Medicaid FFS fee schedule payment rates on a website 
that is accessible to the general public. We are not finalizing a 
reporting requirement at Sec.  442.43(c) that would largely duplicate 
the reporting requirement at Sec.  447.203(b)(1).
    We received responses to our request for comment on whether, as 
part of future rulemaking, we should require that a minimum percentage 
of the payments for Medicaid-covered nursing facility services and ICF/
IID services be spent on compensation for direct care workers and 
support staff. We received comments both in support of and in 
opposition to the idea of requiring a minimum threshold. We did not 
receive comments providing data supporting a specific minimum 
threshold. We thank commenters for their feedback and will take these 
comments into consideration in pursuing any future rulemaking on this 
issue.
    After consideration of the comments received, we are finalizing 
Sec.  442.43(c)(1) and (2) as proposed.

G. Website Posting

    Based on our authority in sections 1902(a)(6) and 1902(a)(30)(A) of 
the Act with respect to FFS and sections 1902(a)(4) and 1932(c) of the 
Act with respect to managed care plans, we proposed new requirements to 
promote public transparency related to the administration of Medicaid-
covered institutional services. For the reasons discussed in 88 FR 
613888 and 61389 we proposed at Sec.  442.43(d) to require States to 
operate a website that meets the availability and accessibility 
requirements at Sec.  435.905(b) and that provides the results of the 
newly proposed reporting requirements in Sec.  442.43(b). We requested 
comment on whether the proposed requirements at Sec.  435.905(b) are 
adequate to ensure the availability and the accessibility of the 
information for people receiving LTSS and other interested parties. We 
noted that the accessibility and availability requirements set forth in 
Sec.  435.905(b) focus on whether the language used on a website is 
accessible to computer users with disabilities or limited English 
proficiency.
    At Sec.  442.43(d)(1), we proposed to require that the data and 
information that States are required to report in Sec.  442.43(b) be 
provided on one website, either directly or by linking to relevant 
information on the websites of the managed care plan(s) that is 
contracted to cover nursing facility or ICF/IID services. We explained 
our intent for the States to be ultimately responsible for ensuring 
compliance with the proposal, including to ensure through contractual 
arrangements with managed care plans, as applicable, that the proposed 
requirements are satisfied when required information is provided on 
websites maintained by these plans. Proposed Sec.  442.43(d) 
contemplates that some States that provide nursing facility or ICF/IID 
services through a managed care delivery system may decide to work with 
their managed care plans to make the reporting information available on 
the managed care plans' websites, rather than replicating the 
information directly on the State's website. We requested comment on 
whether States should be permitted to link to websites of these managed 
care plans and, if so, whether we should limit the number of separate 
websites that a State could link to in place of directly reporting the 
information on its own website; or whether we should require that all 
the required information be posted directly on a website maintained by 
the State.
    At Sec.  442.43(d)(2), we proposed to require that the website 
include clear

[[Page 40932]]

and easy to understand labels on documents and links. At Sec.  
442.43(d)(3), we proposed to require that States verify the accurate 
function of the website and the timeliness of the information and links 
at least quarterly. The intent of Sec.  442.43(d)(3) is to require that 
States ensure that the reporting information on their own website is up 
to date. We would also expect, if the State is linking to a managed 
care plan's website, that the State ensure on at least a quarterly 
basis that the links are operational and continue to link to the 
information States are required to report in Sec.  442.43(b). We did 
not propose to direct that managed care plans must also review their 
websites quarterly, but rather we expect that States would develop a 
process with their managed care plans to ensure that any reporting 
information contained on a managed care plan website is timely and 
accurate. If a State obtains information that a managed care plan 
website to which the State links as a means of publishing the required 
reporting information is not being maintained with timely updates for 
ongoing accuracy, we expect that the State would work with the relevant 
managed care plan to correct the situation and, if unsuccessful, cease 
linking to that managed care plan's website and begin posting the 
required reporting information on a State-maintained website. We 
requested comment on this proposal, including whether this timeframe 
for website review is sufficient or if we should require a shorter 
timeframe (monthly) or a longer timeframe (semi-annually or annually).
    At Sec.  442.43(d)(4), we proposed to require that States include 
prominent language on the website explaining that assistance in 
accessing the required information on the website is available at no 
cost to the public. We also proposed to require that States include 
information on the availability of oral interpretation in all languages 
and written translation available in each non-English language, how to 
request auxiliary aids and services, and a toll-free and TTY/TDY 
telephone number. We requested comment on whether these requirements 
would be sufficient to ensure the accessibility of the information for 
people receiving nursing facility or ICF/IID services and other 
interested parties.
    We also proposed at Sec.  442.43(e) that we must report on our 
website (Medicaid.gov or a successor website) the information reported 
by States to us under Sec.  442.43(b). Specifically, we envision that 
we would update our website to provide information reported by each 
State on the percent of payments for Medicaid-covered services 
delivered by nursing facilities and ICFs/IID that is spent on 
compensation to direct care workers and support staff (and, if added to 
the provision, information on median hourly wages) which would allow 
the information to be compared across States and providers. We also 
envisioned using data from State reporting in future iterations of the 
CMS Medicaid and CHIP Scorecard.\92\ In the proposed rule at 88 FR 
61389, we noted that if, based on public comment, we add a requirement 
that States provide information about their payment rates for nursing 
facility and ICF/IID services, we would provide this information on our 
website as a way of providing easy-to-find context for the other 
payment information reported by States. We currently do not intend to 
include the information on payment rates in the CMS Medicaid and CHIP 
Scorecard.
---------------------------------------------------------------------------

    \92\ CMS's Medicaid and CHIP Scorecard. Accessed at https://www.medicaid.gov/state-overviews/scorecard/index.html.
---------------------------------------------------------------------------

    We received public comment on these proposals. The following is a 
summary of these comments and our responses.
    Comment: A few commenters stated that they supported requiring 
States to have only one website with all the data and information 
related to reporting requirements. A commenter noted that this makes 
accessing data much easier and more accurate than external links to 
managed care plans' websites. A commenter requested we also require 
that data be in a downloadable format that supports use of the data, to 
support analysis by the public, researchers, and other interested 
parties.
    Response: We decline to make modifications to this requirement. We 
agree with commenters that having one website on which the public may 
access data is a good practice. However, we have finalized a 
requirement at Sec.  441.313(a)(1) in the Ensuring Access to Medicaid 
Services final rule published elsewhere in this Federal Register that 
gives States flexibility to maintain either a single website or link to 
managed care plan websites. To provide parity for both HCBS and 
institutional Medicaid services, we are finalizing the substantive 
requirement at Sec.  442.43(d) as proposed, allowing States to meet 
this requirement by linking to individual MCO or PIHP websites. (We 
note that we are finalizing Sec.  442.43(d) with technical 
modifications to correct a grammatical error.)
    Although we decline to add technical specifications for the data 
format to the regulatory text, we do expect that States (or managed 
care plans, as applicable) will make this information available in a 
format that is accessible, downloadable, and otherwise usable for 
members of the public.
    Comment: A commenter noted support for the requirement that 
language on the website be clear and easy to understand.
    Response: We thank the commenter for their support. We are 
finalizing the requirement at Sec.  442.43(d)(1) as proposed.
    Comment: A few commenters supported quarterly review of the 
website. A commenter suggested we require that missing or inaccurate 
information be remedied within 2 weeks of the review. The commenter 
stated that delayed reviews can lead to the posting of inaccurate data, 
which hampers transparency initiatives. A commenter, noting the 
importance of transparency in reporting, stated that States should 
expect managed care plans to review their websites on a monthly basis 
at a minimum.
    Response: We are finalizing the review requirement at Sec.  
442.43(d)(2) as proposed. We agree with commenters that quarterly 
review is an appropriate review frequency that balances oversight with 
administrative burden, given that the data itself are updated annually. 
We note that States or managed care plans have discretion to review the 
website more frequently as needed. We also decline to require a 
specific deadline by which outdated or erroneous data or broken links 
are to be updated, noting that issues might take different amounts of 
time to resolve. We expect that States will ensure that outdated or 
erroneous information, or broken links, will be remedied as promptly as 
possible. In addition, if a State becomes aware that posted information 
is outdated or erroneous and the issue cannot be addressed very 
rapidly, we expect that the State (or managed care plan) will publish a 
notice on the web page identifying the information concerned and 
stating that revised information is expected to be published in the 
future, giving the timeframe if available, so that the public will be 
appropriately cautioned not to rely on the outdated or erroneous 
information.
    Comment: A few commenters stated that the accessibility standards 
outlined in the proposal appear sufficient to ensure access and 
availability of information, including to people with disabilities, 
people with limited English proficiency, and people who require the 
information in other languages. A few commenters also supported the 
requirement requiring prominent language that additional assistance is

[[Page 40933]]

available at no cost, with clear instructions for requesting assistance 
or additional accommodations. A commenter suggested that the website 
include the contact information for a ``designated individual within 
the State Medicaid agency responsible for nursing facility oversight 
who is available to address any accessibility concerns.'' One commenter 
recommended we require the website include the State Medicaid agency 
contact information so that members of the public can contact someone 
with questions about the data.
    Response: We are finalizing the accessibility requirements at Sec.  
442.43(d) introductory text and (d)(3) as proposed. We decline to 
formalize any additional requirements in the regulatory text but agree 
that including relevant contact information on the website is important 
for ensuring the information is available and accessible to the public. 
We also note that having contact information on the website for a 
relevant contact at the State Medicaid agency would aid in the 
quarterly review finalized at Sec.  442.43(d)(2) by allowing the public 
to notify the State of any errors or operational issues with the 
website. We encourage States to implement this practice, even though we 
are not formally requiring its adoption.
    Comment: A commenter did not support requiring the public posting 
of facilities' cost data. The commenter noted that this may be 
particularly problematic for ICFs/IID, which range in size and can be 
quite small. The commenter was concerned that publicizing facilities' 
cost data could lead to inaccurate (presumably negative) conclusions 
being drawn about the facilities.
    Response: The requirement is only for States to publish the percent 
of a facility's Medicaid payments that are going to worker 
compensation, not more detailed cost data (such as the amount of 
Medicaid payments or the amount paid to workers). While States may, at 
their discretion, decide to publish more detailed information, we 
believe the Federal requirement strikes a balance between promoting 
transparency and allowing for the sharing of aggregated (rather than 
granular) data about facilities' financial activities.
    We did not receive comments on our proposal at Sec.  442.43(e).
    After consideration of the comments received, we are finalizing 
Sec.  442.43(d) with minor technical modifications to change ``MCO and 
PIHP websites'' to ``MCO's and PIHP's websites.'' We are finalizing 
Sec.  442.43 (e) as proposed.

H. Applicability Date and Application to Managed Care

    For reasons discussed in 88 FR 61389 through 61390, we proposed, at 
Sec.  442.43(f), to provide States with 4 years to implement these 
requirements in FFS delivery systems following the effective date of 
the final rule. This proposed timeline reflects feedback from States 
and other interested parties that it could take 3 to 4 years for States 
to complete any necessary work to amend State regulations, policies, 
operational processes, information systems, and contracts to support 
implementation of the proposals outlined in this section. We invited 
comments on whether this timeframe is sufficient, whether we should 
require a shorter or longer timeframe (such as 3 or 5 years) to 
implement these provisions, and if a shorter or longer timeframe is 
recommended, the rationale for that shorter or longer timeframe.
    In the context of Medicaid coverage of nursing facility and ICF/IID 
services, we believe that the foregoing reasons for the reporting 
requirements proposed in this rule apply to the delivery of these 
services regardless of whether they are covered directly by the State 
on an FFS basis or by a managed care plan for its enrollees. 
Accordingly, we proposed to apply the requirements at Sec.  442.43 to 
both FFS and managed care delivery systems through adoption by 
reference in a new regulation in 42 CFR part 438, which generally 
governs Medicaid managed care programs. Specifically, we proposed to 
add a cross-reference to the requirements in proposed Sec.  438.72(a) 
to be explicit that States that include nursing facility and/or ICF/IID 
services in their MCO or PIHP contracts would have to amend their 
contracts to the extent necessary to comply with the requirements at 
Sec.  442.43 and proposed at Sec.  442.43(b) that payments from MCOs 
and PIHPs count as Medicaid payments for purposes of those 
requirements. We believe this would make the obligations of States that 
implement LTSS programs through a managed care delivery system clear 
and consistent with the State obligations for Medicaid FFS delivery 
systems. Additionally, for States with managed care delivery systems 
under the authority of section 1915(a), 1915(b), 1932(a), or 1115(a) of 
the Act and that include coverage of nursing facility services and/or 
ICF/IID services in the MCO's or PIHP's contract, we proposed to 
provide States until the first managed care plan contract rating period 
that begins on or after the date that is 4 years after the effective 
date of the final rule to implement these requirements. We solicited 
feedback on the proposed application of the reporting requirement to 
managed care delivery systems, and the proposed timeframe for 
compliance. We also invited comments on whether the proposed effective 
date timeframe is sufficient, whether we should require a longer 
timeframe (such as 5 years) to implement these provisions, and if a 
longer timeframe is recommended, the rationale for that longer 
timeframe.
    We received comments on these proposals. The following is a summary 
of these comments and our responses.
    Comment: A few commenters suggested that we shorten the timeframe 
for compliance, especially given the importance of the data being 
collected and the urgency of the understaffing in facilities. A 
commenter stated that 4 years was unnecessarily long and recommended 2 
years as a reasonable alternative. A few commenters recommended 3 
years, stating that States and facilities should already have much of 
the required data available.
    A few commenters recommended a longer timeframe than 4 years, such 
as 6 or 7 years. These commenters cited challenges such as limited 
State staff and financial resources to dedicate to completing this 
reporting requirement; obligations to comply with other new reporting 
obligations; a backlog of eligibility determinations following the end 
of the COVID-19 Public Health Emergency; support needed to help 
providers, especially smaller providers, update their systems to report 
the necessary data; and time and resources needed to update States' 
systems to collect, process, and audit the required data.
    One commenter supported the 4-year applicability date if the rule 
is finalized as proposed.
    Response: We are finalizing the 4-year applicability date that we 
proposed at Sec.  442.43(f). We believe that 4 years strikes an 
appropriate balance between obtaining these data as quickly as possible 
and acknowledging that some States and providers will need time to 
update systems. As noted in prior responses, we also intend to make the 
reporting methodology and reporting format available to the public 
through the Paperwork Reduction Act notice and comment process. We 
believe the 4-year delayed applicability date provides sufficient time 
for this process, as well as any subregulatory guidance or technical 
assistance needed to assist States to prepare for and be in compliance 
with the requirements.
    We did not receive specific comments on the proposal to add a 
cross-reference at Sec.  438.72(a) to apply the reporting requirements 
finalized at Sec.  442.43 to

[[Page 40934]]

managed care plans and the associated applicability date for MCOs and 
PIHPs.
    After consideration of the comments received, we are finalizing the 
substance of Sec.  442.43(f) as proposed, but with minor modifications 
to correct erroneous uses of the word ``effective.'' We are retitling 
the requirement at Sec.  442.43(f) Applicability date (rather than 
Effective date). We are also modifying the language at Sec.  442.43(f) 
to specify that States must comply with the requirements in Sec.  
442.43 beginning 4 years from the effective date of this final rule, 
rather than stating that Sec.  442.43 is effective 4 years after the 
effective date of the final rule.
    Additionally, we are finalizing both Sec. Sec.  442.43(f) and 
438.72(a) with technical modifications (discussed in the next 
paragraph) regarding the applicability date for States providing 
nursing facility and ICF/IID services through managed care plans. The 
purpose of these modifications is to streamline Sec.  438.72(a) and 
consolidate all applicability dates in Sec.  442.43(f). We also believe 
these modifications better align the structure of Sec. Sec.  438.72(a) 
and 442.43(f) with similar requirements finalized at Sec.  438.72(b) 
and a number of applicability dates in the Ensuring Access to Medicaid 
Services Final Rule published elsewhere in this Federal Register.
    As proposed, Sec.  438.72(a) included a requirement that States 
that included nursing facility or ICF/IID services in their MCO and 
PIHP contracts must comply with Sec.  442.43, as well as specifying 
that States must comply with Sec.  442.43 by the first rating period 
for contracts with the MCO or PIHP beginning on or after 4 years after 
the effective date of the final rule. We are striking the applicability 
date language from Sec.  438.72(a) and finalizing Sec.  438.72(a) with 
modified language that simply specifies that the State must comply with 
requirements at Sec.  442.43 for nursing facility and ICF/IID services. 
We are finalizing Sec.  442.43(f) with a modification to add (with 
minor modifications) the language that had been originally proposed at 
Sec.  438.72(a), specifying that in the case of the State that 
implements a managed care delivery system under the authority of 
section 1915(a), 1915(b), 1932(a), or 1115(a) of the Act and includes 
nursing facility services or ICF/IID services, States must comply 
beginning the first rating period for contracts with the MCO or PIHP 
beginning on or after 4 years after the effective date of the final 
rule.

I. Future Guidance and Interested Parties Advisory Group Comment 
Solicitation

    As noted in the proposed rule at 88 FR 61390, as a result of 
finalizing the proposals as discussed, we will establish new processes 
and forms for States to meet the reporting requirements, provide 
additional technical information on how States can meet the reporting 
requirements, and establish new templates consistent with requirements 
under the Paperwork Reduction Act. We invited comment on this approach, 
particularly regarding any additional guidance we would need to provide 
or actions we would need to take to facilitate States' implementation 
of these proposed provisions.
    Finally, in consideration of potential future rulemaking, we 
requested comment on whether we should propose that States implement an 
interested parties' advisory group in parallel with proposed 
requirements at Sec.  447.203(b)(6) finalized in the Ensuring Access to 
Medicaid Services rule published elsewhere in this Federal Register, 
which requires States to establish an interested parties advisory group 
to advise and consult on the sufficiency of FFS rates paid to direct 
care workers providing certain HCBS. We solicited comment from the 
public on whether we should consider developing requirements for States 
to establish a similar group to advise and consult on nursing facility 
and ICF/IID service rates.
    We received a few comments from the public that supported this 
proposal. We thank commenters for their feedback and will take the 
comments into consideration should we pursue rulemaking in the future.

IV. Provisions of the Final Regulations

    In this final rule, we are adopting the provisions of the September 
6, 2023, proposed rule with the following modifications:
     In Sec.  442.43(a)(1), we modified paragraph (a)(1)(ii) to 
specify that compensation includes benefits, such as health and dental 
benefits, life and disability insurance, paid leave, retirement, and 
tuition reimbursement.
     In Sec.  442.43(a)(2), we redesignated paragraphs 
(a)(2)(vi) through (x) as paragraphs (a)(2)(vii) through (xi), 
respectively, and added a new paragraph (a)(2)(vi) to include direct 
support professionals to the definition. Additionally, we are 
finalizing the newly redesignated paragraph (a)(2)(xi) with a 
modification to include nurses and other staff that providing that 
clinical supervision.
     In Sec.  442.43(a)(3), we redesignated paragraph 
(a)(3)(vi) as paragraph (a)(3)(vii) and added a new paragraph 
(a)(3)(vi) to add security guards to the definition of support staff.
     We are finalizing a new definition of excluded costs at 
Sec.  442.43(a)(4), which are costs reasonably associated with 
delivering Medicaid-covered nursing facility or ICF/IID services that 
are not included in the calculation of the percentage of Medicaid 
payments that is spent on compensation for direct care workers and 
support staff. Such costs are limited to: (1) costs of required 
trainings for direct care workers and support staff (such as costs for 
qualified trainers and training materials); (2) travel costs for direct 
care workers and support staff (such as mileage reimbursements and 
public transportation subsidies); and (3) costs of personal protective 
equipment for facility staff.
     In Sec.  442.43(b), we removed ``by delivery system and,'' 
added language specifying that the Medicaid payments used in the 
required calculation do not include excluded costs, and added a cross-
reference to Sec.  442.43(b)(3). We are also finalizing technical 
modifications to improve clarity and correct grammatical errors.
     We are finalizing a new Sec.  442.43(b)(3) to specify that 
States must exclude data from Indian Health Service and Tribal health 
program providers subject to 25 U.S.C. 1641.
     In Sec.  442.43(d), we made minor technical modifications 
for grammar and readability, including changing ``MCO and PIHP 
websites'' to ``MCO's and PIHP's websites.''
     In Sec.  442.43(f), we retitled the requirement 
Applicability date and made minor modifications to the language to 
specify that States must comply with Sec.  442.43 beginning 4 years 
after the effective date of this final rule. We also added to Sec.  
442.43(f) language (with minor modifications) that had been proposed in 
Sec.  438.72(a) specifying that in the case of the State that 
implements a managed care delivery system under the authority of 
section 1915(a), 1915(b), 1932(a), or 1115(a) of the Act and includes 
nursing facility services or ICF/IID services, States must comply 
beginning the first rating period for contracts with the MCO or PIHP 
beginning on or after 4 years after the effective date of the final 
rule.
     In Sec.  438.72(a), we struck the language specifying an 
applicability date; the substance of this language was added to Sec.  
442.43(f). We streamlined the language at Sec.  43.72(a) to specify 
that States must comply with requirements

[[Page 40935]]

at Sec.  442.43 for nursing facility and ICF/IID services.
     Throughout chapter 42 of the CFR we have updated 
references to ``Sec.  483.70(e)'' to replace them with ``Sec.  
483.71'', as appropriate to reflect the new designation for the 
facility assessment requirements.
     In Sec.  483.35, we redesignated the updates to existing 
paragraph (a)(1) as a new paragraph (b) entitled ``Total nurse staffing 
(licensed nurses and nurse aides)'' and renumbered the existing 
paragraphs in Sec.  483.35 accordingly.
     In Sec.  483.35, we added a requirement at new paragraph 
(b)(1) for facilities to meet a minimum of 3.48 HPRD for total nurse 
staffing. Requirements at new paragraphs (b)(1)(i) and (ii) require 
facilities to also have a minimum of RN HPRD of 0.55 and NA HPRD of 
2.45. In this redesignated paragraph we also are not including the 
proposed requirement for determinations of compliance with HPRD 
requirements to be made based on the most recent available quarter of 
PBJ system data submitted in accordance with Sec.  483.70(p).
     In Sec.  483.35, we revised newly redesignated paragraph 
(c)(1) to add that facilities may be exempted from 8 hours per day of 
the 24/7 RN onsite requirement if they meet the exemption criteria 
outlined in new paragraph (h).
     In Sec.  483.35, we added a new paragraph (c)(2) to 
require that during any periods when the onsite RN requirements in 
paragraph (c)(1) are exempted under paragraph (h), facilities must have 
a registered nurse, nurse practitioner, physician assistant, or 
physician available to respond immediately to telephone calls from the 
facility.
     In Sec.  483.35, we redesignated existing paragraphs (e) 
and (f) as paragraph (f) and (g), respectively. In newly redesignated 
paragraph (f), we revised the heading to read ``Nursing facilities: 
Waiver of requirement to provide licensed nurses and a registered nurse 
on a 24-hour basis.'' In newly redesignated paragraph (g), we revised 
the heading to read ``SNFs: Waiver of the requirement to provide 
services of a registered nurse for at least 112 hours a week''.
     In Sec.  483.35, we redesignated proposed new paragraph 
(g) as a new paragraph (h) and revised the heading to read ``Hardship 
exemptions from the minimum hours per resident day and registered nurse 
onsite 24 hours per day, for 7 days a week''.
     In Sec.  483.35, we revised new paragraph (h) to add that 
a facility may be exempted from both the minimum hours per resident day 
required in paragraph (b) and 8 hours per day of the 24/7 RN onsite 
requirement at paragraph (c)(1).
     In Sec.  483.35, we revised new paragraph (h) to withdraw 
the 20 mile distance qualifier for an exemption from the minimum hours 
per resident day requirement. Qualifying location criteria to be 
eligible for an exemption is based on workforce unavailability only.
     In Sec.  483.35, we revised new paragraph (h) to modify 
the transparency requirements that a facility must meet to receive an 
exemption from the minimum hours per resident day and 8 hours of the 
24/7 RN onsite requirements. In addition to demonstrating a good faith 
effort to hire and identifying the annual amount of funds dedicated to 
hiring efforts, facilities must also post in the facility and provide 
notices to residents and the LTC ombudsman of their exemption status 
and inability to comply with the minimum staffing requirements, 
including the degree to which they do not meet the staffing 
requirements.
     In new Sec.  483.71, we modified the proposal at paragraph 
(b) to clarify the required involvement of specific staff in the 
development of the facility assessment. LTC facility staff, including 
nursing home leadership (governing body, etc.) and direct care staff 
(RNs; LPN/LVNs; NAs; representatives of direct care staff, if 
applicable; and other specialties) must be offered the opportunity to 
actively participate. Facilities must also solicit and consider input 
from residents, and resident representatives.
     We revised the implementation timeframe to reflect the 
following:

++ Non-rural Facilities
++ Phase 1 (90 days after publication)--Facility Assessment Updates 
(Sec.  483.71)
++ Phase 2 (2 years after publication)--Minimum 3.48 HPRD for total 
nurse staffing and 24/7 RN Requirements (Sec.  483.35(b)(1) and (c)(1))
++ Phase 3 (3 years after publication)--Minimum .55 RN and 2.45 NA HPRD 
Requirements (Sec.  483.35(b)(1)(i) and (ii))
++ Rural Facilities (as defined by OMB)
--Phase 1 (90 days after publication)--Facility Assessment Updates 
(Sec.  483.71)
--Phase 2 (3 years after publication)--Minimum of 3.48 HPRD for total 
nurse staffing HPRD and 24/7 RN Requirements (Sec.  483.35(b)(1) and 
(c)(1))
--Phase 3 (5 years after publication)--Minimum .55 RN and 2.45 NA HPRD 
Requirements (Sec.  483.35(b)(1)(i) and (ii))

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 60-day notice in the Federal Register and solicit public 
comments before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act 
of 1995 requires that we solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    In analyzing information collection requirements (ICRs), we rely 
heavily on wage and salary information. Unless otherwise indicated, we 
obtained all salary information from the May 2022 National Occupational 
Employment and Wage Estimates, BLS at https://www.bls.gov/oes/current/oes_nat.htm. We have calculated the estimated hourly rates in this rule 
based upon the national mean salary for that particular position 
increased by 100 percent to account for overhead costs and fringe 
benefits. The wage and salary data from the BLS do not include health, 
retirement, and other fringe benefits, or the rent, utilities, 
information technology, administrative, and other types of overhead 
costs supporting each employee. The HHS wide guidance on preparation of 
regulatory and paperwork burden estimates states that doubling salary 
costs is a good approximation for including these overhead and fringe 
benefit costs.

[[Page 40936]]

    Table 5 presents the BLS occupation code and title, the associated 
LTC facility staff position in this regulation, the estimated average 
or mean hourly wage, and the adjusted hourly wage (with a 100 percent 
markup of the salary to include fringe benefits and overhead costs). 
Where available, the mean hourly wage for Nursing Care Facilities 
(Skilled Nursing Facilities) \93\ was used.
BILLING CODE 4120-01-C
[GRAPHIC] [TIFF OMITTED] TR10MY24.086

    We solicited public comments on each of these issues for the 
following sections of this document that contain information collection 
requirements (ICRs). Based upon our analysis of comments received, we 
are revising our burden estimates and adding a burden estimate for LTC 
facilities (LTCFs) to solicit and consider any input received by 
residents, resident representatives, and family members. These 
revisions and the addition are detailed below:
---------------------------------------------------------------------------

    \93\ https://www.bls.gov/oes/current/naics4_623100.htm.
---------------------------------------------------------------------------

A. ICRs Regarding Sec.  483.35 Nursing Services

    At Sec.  483.35(a), we proposed that each LTC facility would have 
to provide 0.55 HPRD for RNs and 2.45 HPRD for NAs.
    In the proposed rule, we analyzed the COI requirement as indicated 
below.

[[Page 40937]]

These proposed requirements would require each LTC facility to review 
and modify, as necessary, its policies and procedures regarding nurse 
staffing. The review and modifications to the necessary policies and 
procedures would require activities by the director of nursing (DON), 
an administrator, and an administrative assistant. The DON and the 
administrator would need to review the requirements, as well as the 
facility assessment, to determine if any changes are necessary to the 
policies and procedures and, if so, make those necessary changes. The 
DON would then need to work with a medical administrative assistant to 
ensure that those changes were made to the appropriate documents and 
ensure that all appropriate individuals in the facility were made aware 
of the changes. We estimated that these activities would require 2 
burden hours for an administrator at a cost of $200 ($100 x 2 hours), 3 
hours for the DON at a cost of $300 ($100 x 3 hours), and 1 hour for 
the administrative assistant at a cost of $41 ($41 x 1 hour). Hence, 
for each LTC facility the burden estimate would be 6 hours (2 + 3 + 1) 
at a cost of $ 541 ($200 + $300 + $41). There are currently 14,688 LTC 
facilities. Thus, the burden for all LTC facilities would be 88,128 
(14,688 x 6 hours) hours at a cost of $7,946,208 ($541 x 14,688 LTCFs).
    Comment: Numerous commenters generally contended the proposed 
requirements were too burdensome and expensive. One provider 
organization stated that the estimate for the ICR burden that included 
two hours for an administrator, three hours for the DON, and one hour 
for an administrative assistant were grossly underestimated. The 
commenter asserted that LTC facilities would be required to review and 
modify nurse staffing policies and procedures to become compliant with 
the requirements, develop and modify contracts with staffing agencies, 
engage in budget modification and staffing model reevaluations based on 
the staff available to meet the new requirements, and determine 
appropriate resident placement efforts when the facility cannot be 
compliant with the requirements. The commenter also noted that there 
were likely other activities that would be required as well.
    Response: We agree with the commenter that the burden estimated in 
the proposed rule for proposed Sec.  483.35(a) was understated. We note 
that as discussed in section II.B.3. of this rule, we are finalizing at 
Sec.  483.35(b) to require LTC facilities to provide a minimum total 
nurse staffing requirement of 3.48 HPRD (paragraph (b)(1) introductory 
text), which includes 0.55 HPRD of RNs (paragraph (b)(1)(i)) and 2.45 
HPRD of NAs (paragraph (b)(1)(ii)).
    We are revising and increasing the burden estimate particularly to 
account for additional activities addressed by the commenters, 
including the review and modification of contracts, staffing models, 
and contingency planning to address when staffing or other resource 
issues arise. Thus, we are revising our burden estimate to allow for 8 
hours at a cost of $800 ($100 x 8) for the administrator, 7 hours at a 
cost of $700 ($100 x 7 hours) for the DON, and 4 hours at a cost of 
$164 ($41 x 4 hours) for the administrative assistant. Hence, the total 
estimated burden for each LTC facility would be 19 hours at cost of 
$1,664. For all 14,688 LTC facilities, the total estimated burden would 
be 279,072 hours (19 hours x 14,688) at a cost of $24,440,832 ($1,664 x 
14,688).

B. ICRs Regarding Sec.  483.71 Facility Assessment

    At Sec.  483.71 Facility assessment, we proposed to relocate the 
existing requirements at Sec.  483.70(e) Facility assessment to the new 
Sec.  483.71. We also proposed to modify certain specific requirements 
and add a third section that will set forth the activities for which we 
expect LTC facilities to use their facility assessments.
    We proposed to relocate current Sec.  483.70(e)(1)(i) through (v) 
to Sec.  483.71(a)(1)(i) through (v). This section sets forth what the 
facility assessment must address or include, but is not limited to, 
regarding the facility's resident population. At Sec.  
483.71(a)(1)(ii), we proposed to add ``using evidence-based, data-
driven methods'' (such as the MDS resident assessments or data from 
QAPI activities) and ``behavioral health issues'' so that the 
requirement would then read, ``The care required by the resident 
population, using evidence-based, data driven methods that consider the 
types of diseases, conditions, physical and behavioral health issues, 
cognitive disabilities, overall acuity, and other pertinent facts that 
are present within that population.'' At Sec.  483.71(a)(1)(iii), we 
proposed to add ``and skill sets'' so the requirement would read, ``The 
staff competencies and skill sets that are necessary to provide the 
level and types of care needed for the resident population.'' These 
modifications constitute clarifications in the requirements and are not 
new requirements for which the LTC facilities must comply. Hence, we 
will not be analyzing any new or additional burden related to those 
changes.
    We proposed to relocate the current requirements at Sec.  
483.70(e)(2)(i) through (vi) to Sec.  483.71(a)(2)(i) through (vi). At 
Sec.  483.71(a)(2)(iii), we proposed to add ``behavioral health'' so 
that the requirement would read, ``Services provided, such as physical 
therapy, pharmacy, behavioral health, and specific rehabilitation 
therapies.'' Behavioral health services requirements are set forth at 
Sec.  483.40 and are integral to the health of residents. All LTC 
facilities should be considering the behavioral health care needs of 
their residents. Hence, this change does not constitute a new 
requirement but a clarification. Hence, we did not analyze any new or 
additional burden related to this change.
    We proposed to add a new requirement at Sec.  483.71(a)(4) for LTC 
facilities to incorporate the input of facility staff and their 
representatives into their facility assessment. These staff categories 
included, but were not limited to, nursing home leadership, management, 
direct care staff and representatives and other service workers. LTC 
facilities already include many of these categories of individuals when 
they conduct or update their facility assessments. Thus, this 
requirement constitutes a clarification and not a new requirement. 
Hence, we did not analyze any new or additional burden related to this 
change.
    We proposed to add new requirements at Sec.  483.71(b). These 
requirements set forth specific activities for which the LTC facilities 
would be expected to use their facility assessments. These assessments 
would inform staffing decisions to ensure that a sufficient number of 
staff with the appropriate competencies and skill sets necessary to 
care for its residents' needs as identified through resident 
assessments and plans of care as required in Sec.  483.35(a)(3); 
consider specific staffing needs for each resident unit in the 
facility, and adjust as necessary based on changes its to resident 
population; consider specific staffing needs for each shift, such as 
day, evening, night, and adjust as necessary based on any changes to 
its resident population; and, develop and maintain a plan to maximize 
recruitment and retention of direct care staff.
    LTC facilities are either already using their facility assessments 
for these activities or will be based upon the other requirements in 
the proposed rule, except for using their facility assessments to 
develop and maintain a plan to maximize recruitment and

[[Page 40938]]

retention of direct care staff. Based upon our experience with LTC 
facilities, these facilities are already working on recruitment and 
retention of direct care staff. However, these facilities would need to 
review their current efforts to determine if there are opportunities to 
improve their efforts and, if so, decide how to do so. The LTC 
facility's facility assessment would require the development of a plan 
to maximize recruitment and retention and accomplish the associated 
tasks and would also be an invaluable tool in assessing and maintaining 
sufficient staff for their facility.
    The staff involved in developing this plan would vary by the type 
of care and services provided by the individual facilities. Some LTC 
facilities might have various therapists on staff, such as physical and 
occupational therapists. Others might employ psychologists, social 
workers, or complementary medicine or American Indian/Alaska Native 
Traditional Healers who provide behavioral health services to 
residents. When developing a recruitment and retention plan, we 
encourage LTC facilities to include participation and input from the 
various types of direct care staff in their facilities and 
representatives of these workers. We note that the time spent by these 
staff to participate in the facility assessment process should not be 
substituted for the direct care minimums for RNs and NAs required under 
this rule. All LTC facilities provide 24-hour nursing services and the 
direct care nursing staff would include RNs, other licensed nurses 
(LPNs or LVNs), and nursing assistants (NAs). For the purpose of 
estimating the burden for developing a recruitment and retention plan, 
we estimated the burden for an administrator, the DON, and one 
individual from each of the nursing categories, an RN, LPN/LVN, and NA 
to develop the plan. These individuals would have to meet to develop a 
plan and then the administrator will need to obtain approval for the 
plan from the governing body. During the development process and after 
approval, an administrative assistant would need to provide support and 
ensure the plan is disseminated and saved appropriately in the 
facility's records. We estimated that developing a recruitment and 
retention plan would require 6 hours for an administrator at a cost of 
$600 ($100 x 6 hours); 6 hours for the DON at a cost of $600 ($100 x 6 
hours); 4 hours for a RN at a cost of $296 ($74 x 4 hours); 2 hours for 
a LPN/LVN at a cost of $112 ($56 x 2 hours); 2 hours for a nursing 
assistant at a cost of $68 ($34 x 2); and, 2 hours for an 
administrative assistant $82 ($41 x 2 hours). Thus, the burden for each 
LTC facility is 22 (6 + 6 + 4 + 2 + 2 + 2) hours at an estimated cost 
of $1,758 ($600 + $600 + $296 + $112 + $68 + 82). For all 14,688 LTC 
facilities the burden would be 323,136 hours (14,688 LTCFs x 22 hours) 
at an estimated cost of $25,821,504 ($1,758 x 14,688 LTCFs).
    Comment: Numerous commenters generally contended the proposed 
requirements regarding the facility assessment were too burdensome and 
expensive. One provider organization stated that the estimate of 22 
staff hours for the facility assessment requirement grossly 
underestimated the burden to a LTC facility. One provider organization 
stated that complying with this requirement would require multiple 
staff members a significant amount of time to comply. Also, compliance 
would require an ongoing effort by multiple staff members. The 
commenter acknowledged that estimating the burden is complicated since 
it depends upon the number of revisions and is influenced by the 
changes in the resident population and staff in each facility.
    Response: We agree with the commenter that there are more 
activities related to complying with the facility assessment 
requirement than were considered in the proposed rule. As discussed in 
detail in section II.B.6. of this rule, we are finalizing as proposed 
all of the proposed changes regarding the facility assessment, except 
for Sec.  483.71(b) that has been revised to require LTC facilities to 
require the active participation of the nursing home leadership and 
management, including but not limited to, a member of the governing 
body, the medical director, an administrator and the director of 
nursing; and direct care staff, including but not limited to, RNs, 
LPNs/LVNs, and NAs, and representatives of the direct care staff, if 
applicable. The LTC facility must also solicit and consider input 
received from residents, resident representatives, and family members.
    Based upon our review and analysis of comments related to this 
estimated burden and our substantive revisions in this final rule, we 
have revised the estimated burden for the facility assessment 
requirement as detailed below.
    In the proposed rule, for the development of this staffing plan the 
estimated burden was 22 hours at a cost of $1,758. Based upon the 
comments received and further analysis, we now estimate that developing 
a recruitment and retention plan would require 10 hours for an 
administrator at a cost of $1000 ($100 x 10 hours); 10 hours for the 
DON at a cost of $1000 ($100 x 10 hours); 8 hours for a RN at a cost of 
$592 ($74 x 8 hours); 4 hours for a LPN/LVN at a cost of $224 ($56 x 4 
hours); 5 hours for a nursing assistant at a cost of $170 ($34 x 5 
hours); and, 3 hours for an administrative assistant $123 ($41 x 3 
hours). Thus, the burden for each LTC facility is 407 (10 + 10 + 8 + 4 
+ 5 + 3 = 40) hours at an estimated cost of $ 3,109 ($ 1000 + $1000 + 
$592 + $224 + $170 + 123). For all 14,688 LTC facilities the burden 
would be 587,520 hours (14,688 LTCFs x 40) at an estimated cost of 
$45,664,992 ($3,109 x 14,688 LTCFs).
    In addition, this rule finalizes revisions to the facility 
assessment that would also require additional burden. For Sec.  
483.71(b), we proposed that LTC facilities would be required to include 
the input of facility staff, including, but not limited to nursing home 
leadership, management, direct care staff, the representatives of 
direct care employees, and staff providing other services. We did not 
assess a burden for this proposal because it was a clarification and 
not a new requirement. However, as finalized by this rule, Sec.  
483.71(b) now requires that the LTC facility ensure the active 
involvement of nursing home leadership and management, including but 
not limited to, a member of the governing body, the medical director, 
an administrator and the director of nursing; and, direct care staff, 
including but not limited to, RNs, LPNs/LVNs, NAs; and, representatives 
of direct care staff, if applicable. The LTC facility must also solicit 
and consider input from residents, resident representatives, and family 
members. We believe that many of the specifically named staff positions 
are already included by most LTC facilities in their facility 
assessment development, review, and updating process. We are also not 
estimating a burden for the active participation of representatives of 
direct care staff, if applicable, because assisting those they 
represent already falls within their responsibilities. If any of the 
direct care staff have representatives, the LTC facility should be 
aware of those individuals. However, soliciting and considering any 
input received by residents, resident representatives, family members 
is a new requirement. We are not estimating a burden for reviewing the 
input since this would be part of the facility assessment process. 
Thus, a burden estimate is being assessed for the activities required 
to comply with that requirement. These revisions are detailed below.

[[Page 40939]]

    For a LTC facility to solicit input from residents, resident 
representatives, and family members would require the LTC facility to 
identify all of these individuals, make them aware of the facility 
assessment process, and then solicit their input. LTC facilities would 
differ in how they communicate to the named individuals. Although LTC 
facilities are not required to establish resident or family groups, 
residents do have the right to organize and participate in resident 
groups (Sec.  483.10(f)(5)). If residents do form resident or family 
groups, the LTC facility must provide the group(s) with private space 
for them to meet and take reasonable steps, with the approval of the 
group, to make residents and family members aware of upcoming meetings 
in a timely manner. Based upon our experience, most LTC facilities have 
established resident or family groups. LTC facilities could easily use 
these established communications pathways, as well as posting notices 
and sending emails to solicit input for the facility assessment from 
the named individuals. To comply with the requirement to solicit the 
input of these individuals identified in the facility assessment 
requirement, we estimate this would require an administrator 1 hour at 
$100 per hour ($100 x 1 hour = $100) to draft the text of the 
communication and then an administrative assistant 2 hours at $41 per 
hour ($41 x 2 hours = $82) to forward the communication to the required 
individuals. The text of the communication should include a brief 
description of the facility assessment process, the opportunity to 
submit input, how that input can be submitted, and the deadline to 
submit the input. This would likely include posting of a notice in the 
LTC facility and forwarding the communication to the facility's 
resident or family group(s). The consideration of this input would then 
be part of the facility assessment review and updating process.
    Hence, the burden for each LTC facility would be 3 hours (1 + 2 = 
3) at an estimate cost of $182 ($100 + $82 = $182). For all 14,688 LTC 
facilities, the total estimated burden would be 44,064 hours (14,688 
LTCFs x 3 hours = 44,064) at a cost of $2,673,216 ($182 x 14,688 LTCFs 
= 2,673,216).
    The total estimated burden for the ICRs in part 483 is 910,656 
(279,072 + 587,520 + 44,064) hours at a cost of $72,779,040 
($24,440,832 + $45,664,992 + 2,673,216).
[GRAPHIC] [TIFF OMITTED] TR10MY24.087

    The burden will be included in this revised Information Collection 
Request under the OMB control number 0938-1363; Expiration date: April 
30, 2026.

C. ICR Related to Medicaid Institutional Payment Transparency

1. Wage Estimates
    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics (BLS) May 2022 National Occupational Employment and Wage 
Estimates for all salary estimates (https://www.bls.gov/oes/current/oes_nat.htm). In this regard, table 7 presents BLS's mean hourly wage, 
our estimated cost of fringe benefits and other indirect costs 
(calculated at 100 percent of salary), and our adjusted hourly wage.

[[Page 40940]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.088

    For States and the private sector, our employee hourly wage 
estimates have been adjusted by a factor of 100 percent. This is 
necessarily a rough adjustment, both because fringe benefits and other 
indirect costs vary significantly across employers, and because methods 
of estimating these costs vary widely across studies. Nonetheless, we 
believe that doubling the hourly wage to estimate total cost is a 
reasonably accurate estimation method.
    To estimate the financial burden on States related to the finalized 
Medicaid Institutional Payment Transparency Reporting provisions 
(discussed below), it was important to consider the Federal 
Government's contribution to the cost of administering the Medicaid 
program. The Federal Government provides funding based on a Federal 
medical assistance percentage (FMAP) that is established for each 
State, based on the per capita income in the State as compared to the 
national average. FMAPs range from a minimum of 50 percent in States 
with higher per capita incomes to a maximum of 83 percent in States 
with lower per capita incomes. For Medicaid, all States receive a 50 
percent FMAP for administration. States also receive higher Federal 
matching rates for certain systems improvements, redesign, or 
operations. Taking into account the Federal contribution to the costs 
of administering the Medicaid programs for purposes of estimating State 
burden with respect to collection of information, we elected to use the 
higher end estimate that the States would contribute 50 percent of the 
costs, even though the burden would likely be smaller given that some 
States contributions will be less than 50 percent. We requested comment 
on our estimated number of burden hours for the proposal for each of 
the activities and total annual burden and cost for each facility. We 
did not receive specific comments on these burden estimates.
3. Information Collection Requirements (ICRs)
    The following finalized changes will be submitted to OMB for their 
approval when our survey instrument has been developed; we are using 
feedback received during public comment on the proposed rule to inform 
the development of the survey instrument. The survey instrument and 
burden will be made available to the public for their review under the 
standard non-rule PRA process which includes the publication of 60- and 
30-day Federal Register notices. In the meantime, we are setting out 
our preliminary burden figures (see below) as a means of estimating the 
impact of this finalized rule. The availability of the survey 
instrument and more definitive burden estimates will be announced in 
both Federal Register notices. The CMS ID number for that collection of 
information request is CMS-10851 (OMB control number 0938-TBD). Since 
this would be a new collection of information request, the OMB control 
number has yet to be determined (TBD) but will be issued by OMB upon 
their approval of the new information collection request. Note that we 
intend that the following finalized changes associated with Sec.  
442.43(b), (c), and (d), discussed later in this section, will be 
submitted to OMB for review as a single PRA package under control 
number 0938-TBD (CMS-10851).
a. State and Provider Burden Under Sec.  442.43(b) and (c)--Payment 
Transparency Reporting
    As discussed in section III. of this final rule, under our Medicaid 
authority at sections 1902(a)(6) and 1902(a)(30)(A) of the Act with 
respect to FFS delivery systems, and sections 1902(a)(4) and 1932(c) of 
the Act with respect to managed care delivery systems, we proposed and 
are finalizing new reporting requirements at Sec.  442.43(b) for States 
to report annually on the percent of payments for Medicaid-covered 
services delivered by nursing facilities and ICFs/IID that are spent on 
compensation for direct care workers and support staff. (Our 
definitions of who is included in direct care workers and support 
staff, finalized at Sec.  442.43(a)(2) and (3), respectively, are 
discussed in the preamble in section III. of this rule.) The intent of 
this requirement is for States to report separately, at the facility 
level, on the percent of payments for nursing facility services that 
are spent on compensation to direct care workers, the percent of 
payments for nursing facility services that are spent on compensation 
to support staff, the percent of payments for ICF/IID services that are 
spent on compensation to direct care workers, and the percent of 
payments for ICF/IID services that are spent on compensation to support 
staff. We proposed and are finalizing a cross-reference to the 
requirements in Sec.  438.72 to specify that States that include 
nursing facility and ICF/IID services in their contracts with managed 
care organizations (MCOs) or prepaid inpatient health plans (PIHPs) 
would have to comply with the requirements at Sec.  442.43(b). Where 
they appear, references to the requirements at

[[Page 40941]]

Sec.  442.43(b) apply to both FFS and managed care delivery systems.
    We considered, but are not finalizing, additional requirements that 
States report on median hourly compensation for direct care workers and 
median hourly compensation for support staff, in addition to the 
percent of Medicaid payments going to overall compensation for these 
workers. We considered, but are not finalizing, adding at Sec.  
442.43(c) a provision requiring that States make publicly available 
information about the underlying FFS payment rates themselves for 
nursing facility and ICF/IID services. We note that our cost estimates 
in the proposed rule included estimated costs for both of these 
additional reporting requirements and are no longer reflected in this 
ICR. We also note that we are finalizing an additional requirement 
(discussed in section III. of this final rule) that will allow 
providers to exclude certain costs (such as certain costs related to 
training, travel, and PPE) from their Medicaid payments when 
calculating the percent of Medicaid payments spent on compensation to 
direct care workers and support staff. We anticipate that this may lead 
to a slight increase in the State's burden to develop guidance for 
providers on how to apply these excluded costs in facility settings and 
have adjusted the ICR accordingly.
(1) State Institutional Payment Transparency Reporting Requirements and 
Burden
    The burden associated with the reporting requirements finalized in 
this rule would affect all 51 States (including Washington, DC). While 
not all States cover ICF/IID services (because it is an optional 
Medicaid benefit), all States must offer Medicaid nursing facility 
services (because it is a mandatory Medicaid benefit). Thus, we 
anticipate that all 51 States (including Washington, DC) would 
participate in the reporting requirements proposed at Sec.  442.43(b). 
Additionally, three territories (Guam, Puerto Rico, and the U.S. Virgin 
Islands) are required to include nursing facility services in their 
State plans, and thus are included in these calculations as well.\94\ 
While we included these territories in our cost estimates, we continue 
to refer to the affected entities collectively as ``States''. We 
estimated both a one-time and ongoing burden to States to implement 
these requirements at the State level.
---------------------------------------------------------------------------

    \94\ Note that due to waiver under section 1902(j) of the Social 
Security Act, American Samoa and the Commonwealth of the Northern 
Marianas Islands are not required to include nursing facility 
services in their State plans and thus are not included in these 
estimates. Additionally, no territory currently includes the 
optional ICF/IID benefit in their State plan.
---------------------------------------------------------------------------

One-Time Reporting Requirements and Burden (Sec.  442.43(b)): States
    Under finalized Sec.  442.43(b) and (c), we anticipate as a one-
time burden that States, through their designated State Medicaid 
agency, would have to: (1) draft new policy describing the State-
specific reporting process (one-time); (2) update any related provider 
manuals and other policy guidance, including guidance on excluded costs 
(one-time); (3) build, design, and operationalize an electronic system 
for data collection and aggregation (one-time); and (4) develop and 
conduct an initial training for providers on the reporting requirement 
and State-developed reporting system (one-time). We note that we are 
not requiring that States update their Medicaid State plans as part of 
this reporting requirement, and thus we did not estimate a burden 
associated with State plan amendments.
    With regard to this one-time burden for States, we estimate it 
would take: 40 hours at $111.18/hr. for an administrative services 
manager to draft new policy describing the State-specific reporting 
process; 40 hours at $100.64/hr. for a management analyst to update any 
related provider manuals and other policy guidance; 40 hours at $98.84/
hr. for a computer programmer to build, design, and operationalize an 
electronic system for data collection on the percent of Medicaid 
payments going to compensation; 30 hours at $67.18/hr. for a training 
and development specialist to develop and conduct training for 
providers on the reporting requirement and system; 3 hours at $118.14/
hr. for a general and operations manager to review and approve policy 
updates, provider agreement updates, and training materials; and 1 hour 
at $236.96/hr. for a chief executive to review and approve all 
operations associated with this requirement.
    In addition to these activities outlined above, States may also 
have to update managed care contracts to reflect the new reporting 
requirement and provide managed care-specific guidance on the reporting 
requirement. Recent data indicates that 24 States provide at least some 
long-term services through a managed care delivery system.\95\ For the 
managed care-specific burden, we estimate 10 hours at $111.18/hr. for 
an administrative services manager to draft updates to managed care 
plan (that is, MCO and/or PIHP) contracts. (We anticipate that all 
other State activities associated with managed care plans would be 
reflected in the activities described previously in this section.)
---------------------------------------------------------------------------

    \95\ Data taken from Centers for Medicare & Medicaid Services, 
``Managed Long Term Services and Supports (MLTSS) Enrollees,'' 
available at https://data.medicaid.gov/dataset/5394bcab-c748-5e4b-af07-b5bf77ed3aa3.
---------------------------------------------------------------------------

    In aggregate, we estimate a one-time burden of 6,926 hours [(164 
hours x 54 States) + (10 x 24 States)]. We estimate a cost of $811,792 
(54 States x [(40 hr. x $111.18) + (40 hr. x $100.64) + (25 hr. x 
$98.84) + (30 hr. x $67.18) + (3 hr. x $118.14) + (1 hr. x $236.96)]), 
with an additional $26,683 for managed care-related costs (24 States x 
[10 hr. x $111.18]). The total cost is estimated at $838,475 ($811,792 
+ $26,683). Taking into account the Federal contribution to Medicaid 
administration, the estimated State share of the cost would be $419,237 
($838,475 x 0.50).
BILLING CODE 4120-01-P

[[Page 40942]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.089

BILLING CODE 4120-01-C
Ongoing Reporting Requirements and Burden (Sec.  442.43(b)): States
    Under finalized Sec.  442.43(b), we estimate as ongoing burdens 
that States would: (1) notify and train nursing facility and ICF/IID 
providers about the annual reporting requirement, including the State-
level process for collecting data (ongoing); (2) collect information 
from providers annually (ongoing); (3) aggregate or stratify data as 
needed (ongoing); (4) derive percentages for compensation (ongoing); 
and (5)

[[Page 40943]]

develop a report for CMS on an annual basis (ongoing).
    With regard to the ongoing burden, we estimate it would take: 8 
hours at $67.18/hr. for a training and development specialist to notify 
and train providers about annual reporting requirement; 2 hours at 
$100.64 for a management analyst to review and make any needed updates 
to guidance for nursing facility and ICF/IID services; 6 hours at 
$98.84/hr. for a computer programmer to collect information from 
providers, aggregate data as needed, derive percentages for 
compensation, and develop a report for the State; 2 hours at $118.14/
hr. by a general and operations manager to review, verify, and submit 
the report to CMS; and 1 hour at $236.96/hr. for a chief executive to 
review and approve all operations associated with this requirement.
    In aggregate, we estimate an ongoing burden of 1,026 hours (19 
hours x 54 States) at a cost of $97,470 (54 States x [(8 hr. x $67.18) 
+ (2 hr. x $100.64) + (6 hr. x $98.84) + (2 hr. x $118.14) + (1 hr. x 
$236.96)]. Taking into account the Federal contribution to Medicaid 
administration, the estimated State share of this cost would be $48,735 
($97,470 x 0.50) per year.
[GRAPHIC] [TIFF OMITTED] TR10MY24.090

(2) Nursing Facility and ICF/IID Institutional Payment Transparency 
Reporting Requirements and Burden
    The burden associated with this final rule would affect nursing 
facility and ICF/IID providers in both FFS and managed care systems. We 
estimate both a one-time and ongoing burden to implement the reporting 
requirement finalized at Sec.  442.43(b).
    To estimate the number of nursing facility and ICF/IID providers 
that are being impacted by this rule, we used data from the CMS Quality 
Certification and Oversight Reports (QCOR) system (qcor.cms.gov) to 
identify the total number of Medicaid-certified nursing facilities and 
ICFs/IID in all States (including Washington, DC) and the three 
territories that are required to include nursing facility services in 
their State plan. Data from QCOR indicates that in FY 2022, there were 
14,194 freestanding Medicaid-certified nursing facilities (including 
facilities dually certified for both Medicare and Medicaid, and 
Medicaid-only facilities). Additionally, in FY 2022, there were 5,713 
ICFs/IID. In total, we estimate 19,907 Medicaid-certified nursing 
facilities and ICFs/IID are impacted by this finalized reporting 
requirement and may need to provide data to the State on what 
percentage of their Medicaid reimbursements for nursing facility and 
ICF/IID services went to direct care worker and support staff 
compensation.
    Under finalized Sec.  442.43(b), we anticipate that nursing 
facilities and ICFs/IID would need to: (1) learn the State-specific 
reporting policies and process (one-time); (2) calculate compensation 
for each direct care worker and support staff if they do not

[[Page 40944]]

already have that information readily available (one-time); and (3) 
build, design and operationalize an internal system for developing the 
report for the State (one-time).
One-Time Reporting Requirements and Burden (Sec.  442.43(b)): Nursing 
Facility and ICF/IID Providers
    With regard to the one-time burden for providers, we estimate it 
would take: 10 hours at $73.00/hr. for a compensation, benefits, and 
job analysis specialist to learn the State-specific reporting policy 
and calculate compensation for each direct care worker and support 
staff; 10 hours at $98.84/hr. for a computer programmer to build, 
design, and operationalize an internal system for developing the report 
for the State; and 1 hour at $118.14/hr. for a general and operations 
manager to review and approve the reporting system. In aggregate, we 
estimate a one-time burden of 418,047 hours (19,907 facilities x 21 
hours) at a cost of $36,560,002 (19,907 providers x [(10 hr. x $73.00) 
+ (10 hr. x $98.84) + (1 hr. x $118.14)].
[GRAPHIC] [TIFF OMITTED] TR10MY24.091

Ongoing Reporting Requirements and Burden (Sec.  442.43(b)): Nursing 
Facility and ICF/IID Providers
    With regard to the ongoing burden, we anticipate nursing facilities 
and ICFs/IID will have to: (1) update compensation calculations to 
account for on-going staffing changes among direct care workers and 
support staff (in other words, ensure their system includes newly hired 
direct care workers or support staff and takes into account staff 
departures); (2) calculate the aggregated compensation of direct care 
workers and support staff as a percentage of their annual Medicaid 
claims (ongoing); and (3) report the information to the State annually 
(ongoing).
    We estimate it would take 8 hours at $73.00/hr. for a compensation, 
benefits, and job analysis specialist to update compensation 
calculations to account for staffing changes; 2 hours at $98.84/hr. for 
a computer programmer to calculate compensation, aggregate data, and 
report to the State as required; and 1 hour at $118.14/hr. for a 
general and operations manager to review, approve, and submit the 
report to the State. In aggregate, we estimate an on-going burden of 
218,977 hours (19,907 providers x 11 hours) at a cost of $17,912,717 
(19,907 facilities x [(8 hr. x $73.00) + (2 hr. x $98.84) + (1 hr. x 
$118.14)].

[[Page 40945]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.092

b. State Website Posting Requirements and Burden (Sec.  442.43(d))
    At Sec.  442.43(d), we are finalizing the requirement for States to 
operate a website that meets the availability and accessibility 
requirements at 42 CFR 435.905(b) and that provides the results of the 
finalized reporting requirements in Sec.  442.43(b). We also are 
finalizing at Sec.  442.43(d) that States must verify, no less than 
quarterly, the accurate function of the website and the timeliness of 
the information and links.
    As noted previously, we anticipate that this provision will affect 
all 51 States (including Washington, DC) and the territories required 
to have nursing facility services in their State plans which we refer 
to collectively as ``States.'' We estimate both a one-time and ongoing 
burden to implement these requirements at the State level, which would 
be the same regardless of whether the State offers nursing facility and 
ICF/IID services through FFS or managed care systems. In developing our 
burden estimate, we assumed that States would provide the data and 
information that States are required to report under newly proposed 
Sec.  442.43(d) by adding to an existing website, rather than 
developing an entirely new website to meet this requirement. We note 
that we are not requiring that States update their Medicaid State plans 
as part of this reporting requirement and are not estimating a burden 
associated with State plan amendments.
One Time Website Posting Requirements and Burden (Sec.  442.43(d)): 
States
    With regard to the one-time burden, based on the website 
requirements, we estimate it would take: 10 hours at $111.18/hr. for an 
administrative services manager to determine the content of the 
website; 30 hours at $98.84/hr. for a computer programmer to develop 
the website; 1 hour at $118.14/hr. for a general and operations manager 
to review and approve the website; and 1 hour at $236.96/hr. for a 
chief executive to review and approve the website. In aggregate, we 
estimate a one-time burden of 2,268 hours (54 States x 42 hours) at a 
cost of $239,333 (54 States x [(10 hr. x $111.18) + (30 hr. x $98.84) + 
(1 hr. x $118.14) + (1 hr. x $236.96)]. Taking into account the Federal 
contribution to Medicaid administration, the estimated State share of 
this cost would be $119,667 ($239,333 x 0.50) per year.

[[Page 40946]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.093

Ongoing Website Posting Requirements and Burden (Sec.  442.43(d)): 
States
    With regard to the States' ongoing burden related to the website 
requirement, per quarter we estimate it would take: 2 hours at $111.18/
hr. for an administrative services manager to provide any updated data 
and information for posting and to verify the accuracy of the website; 
8 hours at $98.84/hr. for a computer programmer to make any needed 
updates to the website; 1 hour at $118.14/hr. for a general and 
operations manager to review and approve the website; and 1 hour at 
$236.96/hr. for a chief executive to review and approve the website. In 
aggregate, we estimate an ongoing annual burden of 2,592 hours (12 
hours x 54 States x 4 quarters) at a cost of $295,527 (54 States x 4 
quarters x [(2 hr. x $111.18) + (8 hr. x $98.84) + (1 hr. x $118.14) + 
(1 hr. x $236.96)]. Taking into account the Federal contribution to 
Medicaid administration, the estimated State share of this cost would 
be $147,764 ($295,527 x 0.50) per year.
[GRAPHIC] [TIFF OMITTED] TR10MY24.094


[[Page 40947]]


4. Burden Estimate Summary
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR10MY24.095


[[Page 40948]]



VI. Regulatory Impact Analysis

A. Statement of Need

1. Minimum Nurse Staffing
    With respect to the requirements for minimum nurse staffing in LTC 
facilities, sections 1819 and 1919 of the Act authorize the Secretary 
to issue requirements for participation in Medicare and Medicaid, 
including such regulations as may be necessary to protect the health 
and safety of residents (sections 1819(d)(4)(B) and 1919(d)(4)(B) of 
the Act). Such regulations are codified in the implementing regulations 
at 42 CFR part 483, subpart B.
    Approximately 1.2 million Americans are residents in LTC facilities 
each day with Medicare and Medicaid serving as the payor for most 
residents.\96\ As we discussed in detail in detail in sections II. and 
III, a large body of quantitative and qualitative research suggests 
that adequate nurse staffing is vital for ensuring residents' health 
and safety. More specifically, there is a positive association between 
the number of hours of care that a resident receives each day and 
resident health and safety.97 98 99 Research also suggests 
that there is a relationship between inadequate staffing and nursing 
staff burnout, which can lead to high employee turnover.\100\ High 
employee turnover, in turn, can lead to lower continuity of resident 
care.
---------------------------------------------------------------------------

    \96\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-service-type-reports/cms-program-statistics-medicare-skilled-nursing-facility.
    \97\ 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/.
    \98\ Harrington, C., Carrillo, H., Garfield, R., Squires, E. 
Nursing Facilities, Staffing, Residents and Facility Deficiencies, 
2009 Through 2016. Apr 03, 2018. Kaiser Family Foundation. Accessed 
at https://www.kff.org/report-section/nursing-facilities-staffing-residents-and-facility-deficiencies-2009-through-2016-staffing-levels/.
    \99\ Min A, Hong HC. Effect of nurse staffing on 
rehospitalizations and emergency department visits among short-stay 
nursing home residents: A Cross-sectional study using the U.S. 
Nursing Home Compare database. Geriatr Nurs. 2019 Mar-Apr;40(2):160-
165. doi: 10.1016/j.gerinurse.2018.09.010. Epub 2018 Oct 4. PMID: 
30292528.
    \100\ 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.
---------------------------------------------------------------------------

    During our regular interactions with State Medicaid agencies, 
provider groups, and beneficiary advocates, we have observed that all 
these interested parties routinely express the concern that chronic 
understaffing in LTC facilities is making it difficult for residents to 
receive high quality care. Low quality care also has a negative impact 
on the Medicare and Medicaid programs, leading to higher spending due 
to more hospitalizations and unplanned Emergency Department 
visits.101 102 103 The available evidence suggests that 
various types of requirements for LTC facility staff could increase the 
quality of care in LTC facilities. We also recognize, however, that 
staffing in the long-term care sector is still recovering from the 
COVID-19 pandemic that saw a large number of employees leave the 
sector, leading to concerns about resident access to care. In response 
to these concerns, and after evaluating a wide range of research and 
stakeholder feedback, we are finalizing a 24/7 on-site RN requirement, 
minimum RN and NA HPRD requirements, and a total nurse staffing 
requirement or 3.48 HPRD, all of which aim to increase resident safety 
and quality of care while preserving resident access to care.
---------------------------------------------------------------------------

    \101\ 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/.
    \102\ Harrington, C., Carrillo, H., Garfield, R., Squires, E. 
Nursing Facilities, Staffing, Residents and Facility Deficiencies, 
2009 Through 2016. Apr 03, 2018. Kaiser Family Foundation. Accessed 
at https://www.kff.org/report-section/nursing-facilities-staffing-residents-and-facility-deficiencies-2009-through-2016-staffing-levels/.
    \103\ Min A, Hong HC. Effect of nurse staffing on 
rehospitalizations and emergency department visits among short-stay 
nursing home residents: A Cross-sectional study using the U.S. 
Nursing Home Compare database. Geriatr Nurs. 2019 Mar-Apr;40(2):160-
165. doi: 10.1016/j.gerinurse.2018.09.010. Epub 2018 Oct 4. PMID: 
30292528.
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    Specifically, we are requiring that LTC facilities provide RN 
coverage onsite 24 hours per day, 7 days a week (24/7 RN). In addition, 
we are requiring that they provide a minimum of 0.55 RN and 2.45 NA 
HPRD, and 3.48 total nurse staff HPRD. While the 0.55 RN HPRD, 2.45 NA 
HPRD, and 3.48 total nurse staff 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, 2.45 NA, and 3.48 total nurse 
staff HPRD standards, regardless of the individual facility's patient 
case-mix. Requiring 24/7 RN and a minimum number of hours of care for 
each resident will help protect resident health and safety by ensuring 
that all facilities provide a minimal level of staff care to address 
residents' health and safety needs. These standards reflect only the 
minimum level of staffing required and all LTC facilities must provide 
adequate staffing to meet their specific population's needs based on 
their facility assessments. In many cases, facilities will need higher 
levels of staffing as a result.
2. Medicaid Institutional Payment Transparency Reporting
    In response to concerns about the chronic understaffing and low 
wages for the institutional workforce (discussed in detail in our 
proposed rule at 88 FR 61398 and 61399), we proposed new Federal 
reporting requirements that are intended to promote public 
transparency. States have a statutory obligation under section 
1902(a)(30)(A) of the Act and the quality requirements in section 
1932(c) of the Act for services furnished through managed care 
organizations (MCOs) (as well as for prepaid inpatient health plans 
(PIHPs), under our authority at section 1902(a)(4)), to make Medicaid 
payments that are sufficient to enlist enough providers so that high-
quality LTSS are available to the beneficiaries who want and require 
such care. We also relied on our authority under section 1902(a)(6) of 
the Act, which requires State Medicaid agencies to make such reports, 
in such form and containing such information, as the Secretary may from 
time to time require, and to comply with such provisions as the 
Secretary may from time to time find necessary to assure the 
correctness and verification of such reports.
    As discussed in section III. of this final rule, we are finalizing 
(with some modifications) our proposal to require that State Medicaid 
agencies report annually, at the facility level, on the portion of 
payments to nursing facility and ICF/IID services that are spent on 
compensation for the direct care and support staff workforce.\104\ We 
also proposed, and are finalizing, that States make this information 
available to the public by posting the information on a website. As 
discussed in the proposed rule at 88 FR 61399, we developed the 
requirement to focus on compensation because many direct care workers 
and support staff earn low wages and receive limited benefits.\105\ 
Evidence suggests that there is a connection between wages and high 
rates of turnover among

[[Page 40949]]

some workers in the institutional workforce.\106\ To develop relevant 
policies to support high quality care for Medicaid beneficiaries, we 
first need clear, consistent data from States and facilities about the 
current percent of Medicaid payments going to the compensation of 
direct care workers and support staff. Data regarding the percent of 
Medicaid payments going to compensation of direct care workers and 
support staff are not currently being reported to CMS.
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    \104\ Throughout this discussion, we use the term ``States'' to 
include all States, Washington, DC, and any territories that include 
nursing facility services or ICF/IID services in their State plan.
    \105\ 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.
    \106\ Sharma, H. and Liu, X. Association between wages and 
nursing staff turnover in Iowa. Innov Aging. 2022; 6(4): igac004. 
Published online 2022 Feb 5. doi: 10.1093/geroni/igac004.
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B. Overall Impacts

    We have examined the impacts of this final rule as required by 
Executive Order 12866 on Regulatory Planning and Review (September 30, 
1993), Executive Order 13563 on Improving Regulation and Regulatory 
Review (January 18, 2011), the Regulatory Flexibility Act (RFA, 
September 19, 1980, Public Law 96-354), section 1102(b) of the Act, 
section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA, March 
22, 1995; Pub. L. 104-4), and Executive Order 13132 on Federalism 
(August 4, 1999).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 14094 (Modernizing Regulatory Review) amends section 3(f)(1) of 
Executive Order 12866 (Regulatory Planning and Review). The amended 
section 3(f) of Executive Order 12866 defines a ``significant 
regulatory action'' as an action that is likely to result in a rule: 
(1) having an annual effect on the economy of $200 million or more in 
any 1 year (adjusted every 3 years by the Administrator of the Office 
of Information and Regulatory Affairs (OIRA) for changes in gross 
domestic product), or adversely affect in a material way the economy, a 
sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, territorial, or 
Tribal governments or communities; (2) creating a serious inconsistency 
or otherwise interfering with an action taken or planned by another 
agency; (3) materially altering the budgetary impacts of entitlement 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or (4) raising legal or policy issues for which 
centralized review would meaningfully further the President's 
priorities or the principles set forth in this Executive order, as 
specifically authorized in a timely manner by the Administrator of OIRA 
in each case.
    A regulatory impact analysis (RIA) must be prepared for regulatory 
actions with significant effects as per section 3(f)(1) ($200 million 
or more in any 1 year). Accordingly, we have prepared a regulatory 
impact analysis that to the best of our ability presents the costs and 
benefits of the rulemaking.
    For this final rule, we have calculated the annual cost of the 
minimum staffing requirements in table 22 based on hours per resident 
day in CY 2021 dollars, assuming the implementation and enforcement of 
these hours per resident day requirements as being applied independent 
of a facility's case-mix. We estimate that the aggregate impact of the 
staffing-related provisions in this rule, which includes a phased-in 
implementation of the requirement for 24 hours per day, 7 days per week 
RN onsite coverage, the 0.55 RN and 2.45 NA minimum HPRD requirements, 
and the 3.48 HPRD total nurse staff requirement will result in an 
estimated cost of approximately $53 million in year 1, $1.43 billion in 
year 2, $4.38 billion in year 3, with costs increasing to $5.76 billion 
by year 10. We estimate the total cost over 10 years will be $43.0 
billion with an average annual cost of $4.30 billion.
    There is uncertainty about the degree to which LTC facilities would 
bear the cost of meeting the minimum staffing and 24/7 RN requirements 
and how much of the costs would be passed onto payors (including 
Medicaid, Medicare, private insurers, and nursing facility residents). 
We expect LTC facilities would generally have 3 possible approaches to 
addressing the increased costs associated with the higher staffing 
levels: (1) reduce their margin or profit; (2) reduce other operational 
costs; and (3) increase prices charged to payors. LTC facilities may 
use some combination of these approaches, and those approaches could 
vary by facility and over time. These decisions could depend on a 
number of factors, including: the current margin levels of a facility; 
the cost increase due to the staffing requirements relative to current 
costs and revenues; the current level of operational costs; and the 
ability to negotiate prices with payors.
    With regards to payors, we have facility level data on the 
percentage of resident days paid for by Medicaid, Medicare, and other 
payors for the estimates in this RIA. We used these data to estimate 
the potential share of costs for each payor by weighting each 
facility's increased costs by the percentage of resident days paid for 
by each payor type. As we show in table 23, the potential Medicaid 
share of costs excluding collection of information costs is 67 
percent--that is, if all of the costs of the staffing requirements were 
passed on to payors, Medicaid could be expected to pay about two-thirds 
of the total costs. Similarly, as we show in table 24, the potential 
Medicare share of costs is approximately 11 percent of the total costs, 
with other payors potentially bearing the other 22 percent of the total 
costs. As we note in our analysis below, however, our cost estimates 
assume that LTC facilities and not payors will bear the rule's costs.
    Additionally, we have estimated in table 21 the economic impact of 
the requirement that States report, by facility and by delivery system 
(if applicable), on the percentage of Medicaid payments being spent on 
compensation for direct care workers and support staff delivering 
Medicaid-covered nursing facility and ICF/IID services. Under this 
final rule the requirements become effective in 4 years. We estimate an 
initial implementation cost of $9,355,472 for years 1 to 4 (resulting 
in total initial implementation costs of $37,421,888) and ongoing 
annual costs of $18,305,713 per year starting in year 5.
    In response to the proposed rule (88 FR 61352-61429), we received 
approximately 46,520 total comments, of which more than 16,000 included 
comments related to the content of the regulatory impact analysis 
related to the minimum staffing standards. Commenters included numerous 
individuals who were LTC residents/families/caregivers/staff, industry, 
national advocates, national professional organizations, labor unions, 
and academic researchers. In this final rule, we provide a summary of 
the public comments received and our responses to them, including 
relevant changes in the RIA methodology and estimate.
    Comment: Many commenters expressed concern about the cost estimates 
and the estimates of the number of employees that facilities would need 
to hire to meet the proposed requirements, as well as the assumptions 
underlying these estimates. Some commenters stated CMS overestimated 
the cost of implementing the requirements since it assumed that nursing 
homes will retain LPNs/LVNs when the commenters expect that nursing 
homes will actually lay off

[[Page 40950]]

LPNs/LVNs and replace them with lower paid NAs to meet the 2.45 NA HPRD 
requirement, significantly reducing this requirement's cost. They also 
suggested that the cost of meeting the 24/7 RN and 0.55 RN HPRD 
requirements would be much lower than estimated since nursing homes 
would similarly lay off LPNs/LVNs and replace them with RNs, rather 
than maintaining LPN/LVNs at current level. These commenters noted that 
the rule's requirement would cost only a small portion of the 
industry's revenues and suggested that CMS should implement an even a 
higher minimum staffing standard of 4.2 HPRD, with one outside study 
showing a 4.2 HPRD requirement including 0.75 RN HPRD, 1.4 license 
nurse HPRD, and 2.8 NA HPRD, would cost $7.25 billion annually.
    Other commenters stated that CMS underestimated the costs for the 
requirements in the proposed rule and the number of nurse staff 
necessary to meet the requirements. Several commenters cited high 
growth in staff costs for the individual facilities in which they work 
or manage over the past few years, especially during the public health 
emergency (PHE). Commenters stated that Medicare and Medicaid 
reimbursement rates have not kept pace with rising costs. Other 
commenters suggested that CMS consider including the cost of using 
agency/contract staff in the impact analysis and consider not 
increasing staffing minimums but rather mandating the wages that 
staffing agencies can charge so that nursing homes are able to succeed 
financially. Other commenters stated that CMS used wage labor data from 
2019 that is no longer current to what facilities are paying and that 
assuming a 2.31 percent increase in real wage rates was underestimating 
future wage increases.
    Other commenters cited individual analyses they had done of 
staffing and cost data, which showed different costs than we estimated 
with estimates ranging from $4 billion to $7.1 billion annually. Many 
commenters cited an analysis of the proposed rule done by 
CliftonLarsonAllen (CLA), which estimated that the proposed 24/7 RN 
requirement, 0.55 RN HPRD requirement, and the 2.45 NA HPRD requirement 
would cost a total cost of $6.8 billion annually, even with exclusion 
of increases in real wage rates and higher wage rates for contract 
employees. This analysis also estimated that more RNs and NAs would 
need to be hired than what our analysis estimated. A large number of 
commenters also cited an analysis done by Leading Age, which estimated 
a total cost of $7.1 billion annually.
    One commenter indicated that they had been involved with creating 
the Leading Age cost estimate and, writing in a personal capacity, 
noted that a central reason for the difference in costs was due to 
growth in wage rates from 2021 to 2023 and that this $7.1 billion cost 
estimate is based on daily rather than quarterly nurse staffing data 
from the Payroll Based Journal (PBJ). This commenter also stated that 
CMS cost estimates failed to include a provider-based adjustment to 
account for the use of contract staff and that our estimated wage 
growth of 2.31 percent was too low. They suggested using more recent 
Medicare cost data and other wage source data and highlighted the need 
for a SNF-specific wage index based on audited cost reports. Finally, 
they noted that the cost estimate excludes some nursing homes where 
cost or staffing data were unavailable, including nursing homes in Guam 
and Puerto Rico, leading to an underestimation of the actual cost. 
Other commenters stated that the CMS analysis assumed no costs for 
facilities prior to each requirement going into effect and ignored the 
potential impact of these costs on Medicare, Medicaid, and non-
Medicare/Medicaid payors.
    Response: We appreciate the commenters sharing their insights into 
the costs that their facilities have accrued to hire staff in recent 
years, as well as the comments highlighting how using differing data 
sources, such as contract nursing wage rates, and assumptions, such as 
using daily rather than quarterly nurse staffing data from the PBJ, 
influence the estimated cost and the number of employees facilities 
would need to hire.
    We appreciate the commenters sharing their various hiring practices 
and information about their costs for hiring nurse staff in recent 
years. As we highlighted in the proposed rule through various 
breakdowns of the data by state, facility size, geographical location 
(rural vs. urban), and whether the facility is certified by Medicare, 
Medicaid, or dual certified, the cost for facilities to meet the 24/7 
RN and HPRD requirements varies.
    We also appreciate the commenters referring us to the CLA and 
Leading Age analyses showing an estimated $6.8 billion and $7.1 billion 
annual cost, respectively, when the rule is fully in effect and 
providing a copy of these analyses. In reviewing these alternative cost 
estimates, we have identified key differences between our estimation 
strategy and these estimation strategies that appear to have led to 
differing estimates and we provide additional information regarding why 
we have decided to retain our estimation strategy and model 
assumptions.
    CLA's $6.8 billion cost estimate indicates that it calculates the 
rule's cost using the median, or the wage rate including salaries and 
allocated benefits for the single employee who earns middle wage rate, 
for each staff type from Medicare cost reports released as of July 2023 
using form S-3, Part V, column 5. We would note, however, that column 5 
contains the loaded mean, or average wage rate including allocated 
benefits for the employee type. For example, for NAs, it contains the 
average loaded salaries for all NAs that the facility employs. In light 
of this inconsistency, we are unsure how this outside analysis 
calculated median wage rate using Medicare cost reports. Calculating 
the median hourly wage rate for each nurse staff type requires 
obtaining wage data on every NA, LPN/LVN, and RN in every facility, or 
alternatively, having each of the more 14,000 nursing homes share the 
data for the RN, LPN/LVN, and NA in their facility who earns the middle 
wage among all RNs, LPNs/LVNs, and NAs they employ. We do not have 
these data and do not know of a source that provides it. As such, we 
continue to use the loaded mean hourly wage to calculate costs for the 
final rule.
    In reviewing the $6.8 billion estimate, the provided documentation 
indicates that it is based on wage rates only for employees. In 
contrast, our estimate, as well as the Leading Age estimate, calculates 
costs based on average hourly wage rates for employees and contractors. 
Calculating costs based only on employee wages requires an assumption 
that hours that contract employees are currently working would not 
count toward the minimum requirements and lead to facilities needing to 
hire more staff to meet the requirement. This assumption leads to a 
higher cost for meeting the requirements. We would note, however, that 
all hours worked by both employees and contract staff count toward the 
requirements we are finalizing. In addition, including costs for both 
employees and contract staff provides a more accurate picture of the 
average hourly wage that each facility is paying to their nurse staff. 
As a result, in this final rule, we are maintaining the inclusion of 
all nursing hours worked by employees and contract staff to calculate 
additional employees needed and continue to use overall average hourly 
rates to calculate the cost.
    The CLA estimate indicates that the $6.8 billion cost was 
calculated based

[[Page 40951]]

on a combination of 2021 and 2022 Medicare cost reports, without 
specifying the share of reports that come from each fiscal year. Our 
analyses and all costs are measured in FY 2021 US dollars and costs 
each year are provided in real 2021 US dollars rather than nominal 
dollars. Adjusting for general inflation, $6.8 billion in 2022 Dollars 
is approximately $6.3 billion in 2021 US dollars.\107\ For Leading 
Age's $7.1 billion annual estimate, the authors indicate that it is 
based on 2023 US dollars, which they calculate by increasing costs from 
the 2021 cost reports by 13 percent to account for inflation. In 2021 
US dollars this would similarly be $6.3 billion.
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    \107\ Federal Reserve Bank of Minneapolis. Inflation Calculator. 
Accessed February 26, 2024. https://www.minneapolisfed.org/about-us/monetary-policy/inflation-calculator.
---------------------------------------------------------------------------

    In reviewing the CLA's $6.8 billion estimate, the authors indicated 
that using Q1 2023 PBJ data, nearly 80 percent of nursing homes would 
need to hire staff to meet the 24/7 RN requirement based on daily data. 
Our review of Nursing Home Care Compare data from March 2023, however, 
shows that for the facilities for which RN hours per day data are 
available, only 24.5 percent of facilities, or 3,578 facilities, would 
need to hire RNs using the following formula: Total RN Hours per 
Resident Day = Reported RN Staffing Hours per Resident Day x Average 
Number of Residents per Day. The same analysis of Nursing Home Care 
Compare data from January 2024 similarly shows that only 22.1 percent, 
or 3,202 facilities would need to hire RNs to meet this requirement. 
For Leading Age's $7.1 billion cost estimate, one commenter, writing in 
a personal capacity, indicated that they were involved in calculating 
this estimate and that the higher cost came by analyzing daily, rather 
than quarterly, data from the PBJ. While there may be days within a 
particular quarter where a nursing home that meets the requirements 
overall based on quarterly data did not meet it on an individual day, 
we estimate that they would reallocate their existing staffing 
resources to ensure compliance with the rule on a continual basis and 
to reflect resident census changes. As such, we disagree with the 
estimate that nearly 80 percent of nursing homes would need to hire 
staff to meet the 24/7 RN requirement. Our analysis estimates that only 
22.2 percent of nursing homes would need to hire staff to meet the 24/7 
RN requirement. We also assume that they would reallocate staff hours 
during the week to meet the 0.55 RN, 2.45 NA, and 3.48 total nurse 
staff HPRD requirements.
    We appreciate the comment about adjusting the cost based on the 
share of contract staff that a facility uses and taking into 
consideration the need to use contract staff to meet the requirements. 
We also appreciate the comment about taking into account facilities for 
which there are no salary or staffing data. As we have noted above, all 
cost estimates calculate facility wage rates for each nurse type based 
on wages for both employee and contract staff in each nurse (RNs, LPNs/
LVNs, and NAs) type. With regards to missing facilities, we note that 
our analysis includes data from all available facilities where there 
was staffing information available in the October 2021 Nursing Home 
Compare dataset. This included 14,688 facilities out of 15,270 
facilities, or approximately 96.1 percent (14,688/15,270). We believe, 
therefore, that the cost estimate would remain similar even if these 
additional nursing homes, for which staffing data were unavailable, 
were included in the analysis. We are, however, adding additional 
language in the detailed economic analysis below to clarify that wages 
are based on costs for both contract staff as well as employees, as 
well as to clarify how we imputed any missing data.
    We appreciate the commenters feedback on expected increase in wage 
rates for nurse staff. We note that all cost estimates are provided in 
2021 US dollars and the growth in wage rates we use, are real wage rate 
growth. That is, the estimates take into account annual inflation and 
assume that wages are meaningfully increasing above inflation. Over 10 
years, we are estimating a nearly 23 percent increase in real wage 
rates. We note that between 2001 and 2017, a 16-year period, real wage 
rates for nurses increased by only 9.92 percent.\108\ Reviewing Bureau 
of Labor Statistics data for more recent years also suggests that our 
estimated increase is reasonable. Between 2019 and 2022, average hourly 
nominal wages for NAs increased from $14.77 to $17.41, or 17.8 percent, 
while average hourly nominal wages for RNs increased from $37.24 to 
$42.80, or 7.6 percent. Taking into account inflation, however, real 
wages increased by approximately 3 percent for NAs and declined by 0.37 
percent for RNs. As such, we believe that our estimate of a 23 percent 
increase in real wage rates for nurse staff in 10 years does not 
underestimate growth in wage rates and we maintained this wage rate 
increase as cited in the proposed rule. In addition, we continue to use 
cost data from 2021 Medicare cost reports since our analysis provides 
all costs in 2021 US dollars addressing concerns that more recent wage 
data would provide a higher cost estimate in 2021 US dollars.
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    \108\ Barry J. Real wage growth in the U.S. health workforce and 
the narrowing of the gender pay gap. Human Resources for Health. 
2021;19: 105. doi: 10.1186/s12960-021-00647-3.
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    We appreciate the opportunity to provide clarification regarding 
costs that facilities may incur to hire staff prior to each 
requirement's effective date since facilities will likely start hiring 
staff to meet the requirements before the effective date. In the 
proposed rule, as well as this final rule, the cost estimates for each 
requirement includes costs that facilities may incur in the year before 
each requirement going into effect as they hire employees in 
anticipation of the requirement. For example, in the proposed rule, we 
proposed that for facilities located in urban areas, the 24/7 RN 
requirement would go into effect 2 years after the date of publication. 
This means that these facilities would be required to meet the 
requirement starting 2 years, or 24 months, from the date of 
publication. In the cost analysis, both in the proposed rule, as well 
as this final rule, however, we included costs for facilities to meet 
the 24/7 RN requirement during all of year 2 (12-24 months) after the 
date of publication, or 1 year before the requirement went into effect. 
We included costs for facilities prior to the requirement date to 
acknowledge that facilities will likely need to hire RNs for this 
requirement before 2 years after the date of publication, rather than 
instantaneously hiring them 2 years after the date of publication. We 
appreciate the commenter bringing this issue to our attention and have 
provided this clarification below in the detailed economic analysis.
    Finally, we acknowledge that costs could in theory be much lower 
than we estimated if, as suggested by some commenters, facilities 
transitioned away from LPNs/LVNs when hiring nurses to meet the 
proposed requirements. We would note, however, that there are 
transition costs of hiring and firing that have not been quantified. We 
would also note that facilities have the option to use any nurse staff 
type, including LPNs/LVNs, to meet the 3.48 total nurse staff HPRD 
requirement included in the final rule, which would reduce any 
incentive to transition from LPNs/LVNs to NAs and our intent is for 
facilities already meeting the minimum staffing requirements not to 
scale down or adjust staffing types as a result of this rule. As such, 
we believe that there is a low likelihood that facilities will

[[Page 40952]]

transition away from LPNs/LVNs to meet the requirements in this rule 
and of course, expect that facilities will not lay off staff necessary 
to serve patients with their existing case mix. We do not believe that 
we could accurately predict facility behaviors with respect to LPNs/
LVNs. Due to the role that LPNs/LVNs can play in meeting the 3.48 HPRD 
requirement and the related reduced likelihood of nursing homes ending 
employment of LPNs/LVNs in light of this policy change, it would 
understate the effects of the final rule to attempt to reduce 
overestimation of effects of the rule as proposed and thus we have 
decided to retain our assumption that facilities will retain LPNs/LVNs 
at their current level. Given these factors, we are retaining our 
estimation methodology as we believe it provides an accurate estimate 
of the rule's estimated economic cost. We would note, however, that we 
have modified the formula to estimate the cost over 10 years since in 
the proposed rule the cost estimate provided for the alternative 
policies that we are now finalizing was based on the 3.48 HPRD 
requirement going into effect the same time as the 0.55 RN HPRD and 
2.45 NA HPRD requirements. Since this final rule requires facilities 
located in urban areas to meet the 3.48 HPRD requirement 2 years 
following publication of this rule, which is 1 year prior to the 
implementation date of the 0.55 RN HPRD and 2.45 NA HPRD requirements, 
and for rural facilities to meet the 3.48 HPRD requirement 2 years 
prior to the implementation date of the 0.55 RN and 2.45 NA HPRD 
requirements, we modified the formula to take into account that nurse 
staff hired to meet the 3.48 total nurse HPRD requirement can also 
count toward meeting the individual NA requirement that will be 
implemented in future years. We detail these changes below in the 
detailed economic analysis section.
    Comment: Multiple commenters provided feedback on other effects 
apart from increased costs and the need to hire new nurse staff that 
would emerge from the staffing requirements. Some commenters said that 
nursing homes may lay off non-nurse staff members and cut resident 
activities, such as bingo night, which contribute to patients' quality 
of life, to fund the requirements since nursing homes are already 
struggling financially with the rising costs of inflation, food, 
insurance, and an already increased payroll. One commenter stated that 
the rule may also increase operating expenses more generally. Other 
commenters expressed concern that without additional Medicare and 
Medicaid funding, which varies by state, the rule could result in 
access to care issues, especially in rural and underserved communities. 
Specifically, commenters noted that the staffing requirements' costs 
could lead some facilities to close and other facilities to limit the 
numbers of residents they admit due to insufficient nurse staff to 
accept more residents. Commenters stated that this effect would likely 
be higher for nursing homes with a larger share of residents utilizing 
Medicaid, which are more likely to need to hire staff to meet one or 
more of the requirements, as well as nursing homes in rural areas that 
may have difficulty attracting nurse staff or contract employees. 
Commenters noted that for some rural communities, the closure of 
facilities could have far reaching impacts on the community leading 
individuals to leave or forcing nurse home employees to commute long 
distance to other cities for work, negatively impact the local economy 
and community life. Commenters suggested analyzing potential bed losses 
due to the rule, which in turn, could have adverse effects on hospitals 
who would be unable to discharge patients, leaving them with less space 
for new patients and increasing the government's cost for patients 
whose care was covered by Medicare or Medicaid. Commenters also 
suggested it could have a negative impact on other health care 
facilities, such as inpatient rehabilitation facilities, which could 
see greater struggles to find nursing home bed space for their 
patients. Commenters noted that facility closures could lead residents 
to be placed further away from the families negatively impacting their 
overall well-being, or alternatively, nursing homes could pass on the 
cost to consumers reducing consumers' savings and leading them to use 
Medicaid. Commenters also suggested that nursing homes may stop 
accepting patients using Medicaid due to low reimbursement rates, 
negatively impacting patients who utilize Medicaid.
    Other commenters challenged the idea that the rule will be a burden 
for facilities. They stated that many facilities are diverting funds 
away from resident care and toward corporate profits. As such, 
commenters suggested that CMS should not assume that facilities will 
have challenges meeting the staffing standard and additional actions 
should be taken to create transparency regarding facility spending. 
Some commenters expressed concern that phasing-in the nurse staffing 
requirements would negatively impact patients and staff members, 
specifically that phasing-in the requirements means a delay in improved 
quality of care for residents negatively affecting their health, 
safety, and quality of life. Commenters also suggested that low 
staffing levels will lead to continued employee burnout, making them 
more likely to quit resulting in increased difficulty for facilities to 
meet the requirements. Finally, multiple commenters noted that the rule 
does not include increased Medicare or Medicaid reimbursement rates for 
nursing home residents and that current reimbursement rates have not 
kept pace with rising costs in recent years. These commenters said that 
Medicaid reimbursement rates should be increased to ensure access to 
care and to pay staff a wage that can support a family. Other 
commenters noted that there is wide variation in Medicaid reimbursement 
rates across states and asked CMS to consider how this variation will 
impact facilities' ability to meet the requirements. Finally, some 
commenters said that they would be forced to hire agency staff at an 
inflated cost with no guarantee of quality care or positive patient 
outcomes.
    Response: We appreciate the thoughtful and insightful comments 
regarding additional effects that could emerge from the staffing rule. 
CMS requires facilities to provide appropriate staffing and 
extracurricular activities to ensure the highest quality of care for 
residents in accordance with resident assessment, care plans, and 
resident preferences (see existing requirements at Sec.  483.24(c)). In 
developing this rule, we sought to ensure resident health and safety 
while also maintaining access to care. While CMS agrees with commenters 
highlighting that phasing-in the requirements could lead to a delay in 
residents receiving higher quality care, as well as continued staff 
burnout, these effects are difficult to quantify and must be balanced 
with challenges associated with more rapid implementation of these 
requirements. As such, we have maintained our regulatory approach that 
phases in the different staffing requirements over 5 years.
    Taken broadly, access to care comments addressed two main issues: 
finding sufficient staff and the cost for hiring staff. According to 
the U.S. Bureau of Labor Statistics, in 2022 there were 3,072,700 RNs 
in the United States.\109\ As finalized, the rule would

[[Page 40953]]

require the hiring of approximately 16,000 RNs to meet both the 24/7 RN 
requirement and the 0.55 RN HPRD requirement. This is approximately 0.5 
percent of all non-self-employed RNs in the labor force. HRSA's 
National Center for Health Workforce Analysis uses a Health Workforce 
Simulation Model to project the supply and demand for health workers, 
including RNs.\110\ The National Center projects a 10 percent shortage 
of RN in 2026 and 2031, that will be reduced to 9 percent by 2036.\111\ 
Projected supply adequacy of RNs varies considerably across States, 
ranging from a shortage of 29 percent in Georgia to a projected 42 
percent oversupply in North Dakota in 2036.
---------------------------------------------------------------------------

    \109\ U.S. Bureau of Labor Statistics. Occupational Employment 
and Wages, May 2022: 29-1141 Registered Nurses. Accessed February 
26, 2024. https://www.bls.gov/oes/current/oes291141.html.
    \110\ Department of Health and Human Services, Health Resources 
and Services Administration, Health Workforce Projections. Available 
at https://data.hrsa.gov/topics/health-workforce/workforce-projections. April 2024.
    \111\ Nurse Workforce Projections, 2021-2036 (hrsa.gov) https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/nursing-projections-factsheet.pdf. March 2024.
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    Hiring necessary for facilities to meet the NA HPRD requirement 
will represent a larger portion of NAs available nationwide, and this 
rule has taken three steps to minimize the impact on access to care and 
to prevent the closure of facilities due to inadequate staff 
availability.
    The first is to allow facilities located in areas with nurse staff 
shortages to apply for an exemption from the staffing requirements. 
Facilities located in areas with nurse staff shortages, as defined in 
the regulatory text at Sec.  483.35(h), are eligible for exemptions 
that include: an 8-hour per day exemption from the 24/7 RN requirement, 
an exemption from the 0.55 RN HPRD requirement, an exemption from the 
2.45 NA HPRD requirement, and an exemption from the 3.48 total nurse 
staff HPRD requirement. These exemptions could reduce both the rule's 
cost as well as the number of nurse staff needed helping to ensure 
continued access to care. Based only on being located in an area with 
nurse staff shortage, a preliminary analysis of the data suggests that 
more than 29 percent of facilities would be eligible for an 8-hour 
exemption from the 24/7 RN requirement and the 0.55 RN HPRD 
requirement, 23 percent of facilities would be eligible for an 
exemption from the 2.45 NA HPRD requirement, and 22 percent of 
facilities would be eligible for an exemption from the total nurse 
staff requirement. Among rural facilities, more than 67 percent of 
facilities would be eligible for an 8-hour exemption from the 24/7 RN 
requirement and a total exemption from the 0.55 RN HPRD requirement, 19 
percent would be eligible for an exemption from the 2.45 NA HPRD 
requirement, and 40 percent would be eligible for an exemption from the 
3.48 total nurse staff HPRD requirement. Since facilities would also 
need to meet all other requirements to obtain an exemption, however, 
these numbers are not reflective of the number of facilities estimated 
to fully qualify for the exemptions as they only describe the number of 
facilities that would satisfy the workforce availability criterion. 
Second, CMS is launching an initiative to provide over $75 million in 
financial incentives, such as scholarships and tuition reimbursement, 
to make it easier for nurses to enter careers in nursing homes. CMS is 
also exploring the potential to provide additional technical assistance 
to LTC facilities regarding staffing through the Quality Improvement 
Organizations. Finally, rather than requiring facilities to immediately 
meet the staffing requirements, we have taken a phased-in approach to 
the requirements to help ensure that an adequate workforce is available 
and to reduce the cost. For facilities located in urban areas, the 
requirements will be phased in over 3 years. Specifically, these 
facilities will have 2 years to comply with the 3.48 total nurse HPRD 
and the 24 hours per day, 7 days a week RN requirement and have 3 years 
to comply with the 0.55 RN and 2.45 NA HPRD requirements. For 
facilities located in rural areas, requirements will be phased in over 
5 years. Specifically, these facilities will have 3 years to comply 
with the 3.48 total nurse HPRD and the 24 hours per day, 7 days per 
week RN requirement and will have 5 years to comply with the 0.55 RN 
and 2.45 NA HPRD requirements. While we view the exemptions and the 
phasing in of the nurse staff requirements as necessary to ensure 
access to care, we acknowledge that they do come with negative effects 
for residents and staff. Specifically, exemptions and phasing in of the 
individual staffing requirements will result in residents residing in 
nursing homes, which are not currently meeting these requirements, in 
receiving either less nurse care or a longer delay in receiving the 
full hours of care per day. Similarly, nursing home staff may 
experience a heavier workload, leading to higher burnout. As such, we 
believe that there will be minimum negative impact on workforce 
availability throughout the care continuum, minimal impact on nursing 
home bed availability, and minimal increased costs for Medicare and 
Medicaid due to hospitals being unable to discharge patients.
    We note that Medicare and Medicaid payment rates for nursing home 
care are outside the scope of this rule. With regards to a SNF-specific 
wage index, we refer commenters to the text regarding this issue and 
its feasibility on page 61411 in the proposed rule (88 FR 61410). 
Specifically, we note that section 315 of the Medicare, Medicaid, and 
SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 
106-554, enacted December 21, 2000) gave the Secretary the discretion 
to establish a geographic reclassification procedure specific to SNFs, 
but only after collecting the data necessary to establish a SNF PPS 
wage index that is based on wage data from nursing homes. To date, this 
has proven to be unfeasible due to the volatility of existing SNF wage 
data and the significant amount of resources that would be required to 
improve the quality of the data. More specifically, auditing all SNF 
cost reports, similar to the process used to audit inpatient hospital 
cost reports for purposes of the IPPS wage index, would place a burden 
on providers in terms of recordkeeping and completion of the cost 
report worksheet. Adopting such an approach would require a significant 
commitment of resources by CMS and the Medicare Administrative 
Contractors (MACs), potentially far in excess of those required under 
the IPPS, given that there are nearly five times as many SNFs as there 
are IPPS hospitals. We continue to believe that the development of such 
an audit process could improve SNF cost reports in such a manner as to 
permit us to establish a SNF-specific wage index, but we do not believe 
this undertaking is feasible at this time (88 FR 53212).
    Finally, while some commenters have questioned whether agency 
contract staff will increase quality care or positive patient outcomes 
and said that they may be forced to hire any available staff to meet 
the requirement, we would note that all nurse staff are required to 
meet applicable state requirements to be a nurse and are able to have a 
positive impact on patient health and quality of care. We would 
continue to encourage facilities to ensure that they are utilizing 
contract staff in a manner that best improves patient care. In 
addition, all other requirements governing LTC facilities continue to 
apply, and we expect facilities to deliver safe and high-quality care 
to all residents, regardless of the employment arrangement that nursing 
home use to procure staff.
    Comment: A few commenters, including the Small Business 
Administration's Office of Advocacy, suggested that CMS erroneously 
certified that the rule will not have a

[[Page 40954]]

significant economic impact on a substantial number of small entities 
and is violating the Regulatory Flexibility Act (RFA), which requires 
agencies to analyze options for regulatory relief of small entities, if 
a rule has a significant impact on a substantial number of small 
entities. Specifically, commenters pointed to an outside analysis by 
CLA estimating that the rule's actual annual cost will be closer to 
$6.8 billion when all requirements are in effect and when compared to 
revenues for skilled nursing facilities (NAICS 6231) and intellectual 
and developmental disabilities facilities (NAICS 6232) from the 2017 
Economic Census, would exceed the 3 to 5 percent threshold that HHS 
qualifies as economically significant. They also noted that the CMS 
should have included other LTC facilities that rely on nurses in the 
RFA certification. These include residential mental health and 
substance abuse facilities (NAICS 62322), Continuing Care Retirement 
Communities and Assisted Living Facilities for the Elderly (NAICS 
6233), Continuing Care Retirement Communities (NAICS 623311), Other 
Residential Care Facilities (NAICS 62399), and Services for the Elderly 
and Person with Disabilities (NAICS 62412). Finally, they noted that 
costs should have been analyzed on a per small entity basis to make it 
easier to understand the rule's true impact.
    Response: We appreciate the comments provided. We have discussed in 
detail in our comment response above regarding our estimated cost, and 
why we think that our estimate provides a more accurate calculation of 
the likely cost, and henceforth, are using it as the basis for our 
conclusion. In summary, the higher estimate from CLA uses median wages 
for nursing homes, which are not data that are publicly available and 
do not appear on Medicare cost reports, it does not appear to include 
hours worked by contract employees in the estimates, and it calculates 
costs in 2022 US dollars while we calculate costs in 2021 US dollars. 
Meanwhile, the higher estimate from Leading Age appears to calculate 
costs based on daily nurse staff levels and assumes that nursing homes 
would not reassign staff to different days in the week to meet the 
requirements and provides estimates in 2023 US dollars. We would also 
note that while one commenter indicated the wages from the CLA estimate 
were from 2023 when wages were higher, this is not the case. Rather, as 
the CLA document provided indicates, this $6.8 billion cost estimate is 
based on a combination of facility wage data from 2021 and 2022. We 
believe that they confused the Leading Age and CLA estimates.
    The rule also includes exemptions for facilities that are located 
in areas with nurse staff shortages that would allow facilities to 
receive an 8 hour a day exemption from the 24/7 RN requirement, as well 
as exemptions from the 0.55 RN HPRD requirement, the 2.45 NA 
requirement, and the 3.48 total nurse staff HPRD requirement. These 
exemptions could reduce both the rule's cost as well as the number of 
staff that will need to be hired and thus help supported continued 
access to care. Given these changes in the requirements, we maintain 
our certification that this final rule will not have a significant 
economic impact on a substantial number of small entities and do not 
analyze options for regulatory relief of small entities beyond the 
exemptions we have already finalized in this rule.
    With regards to the per facility analysis, we would note that the 
proposed rule provided multiple per facility cost analyses for 
facilities needing staff by state that include costs for (1) rural 
compared to urban facilities, (2) facilities of different sizes (<50 
beds, 50 to 100 beds, and >100 beds, and (3) Medicare, Medicaid, and 
Dual Acceptance Status. We would also note that analyzing the cost on a 
per facility basis would lead to the same percentage as we have 
estimated, since costs were calculated based on all facilities.
    We appreciate some commenters noting that our estimates of share of 
revenues were based on 2017 dollars that do not take into account cost 
increases. Therefore, to more accurately, estimate the estimated costs 
as a share of revenues, we take into account increases in the Consumer 
Price Index to more accurately measure annual revenues, which results 
in annual revenues rising to approximately $179 billion in 2021 US 
dollars. We also appreciate the suggestion to include other long term 
care facilities that rely on nurses in the analysis. We believe, 
however, that the impact on these other facility types would be minimal 
since the requirements of this rule do not apply to these other 
facility types. Moreover, we would note that including these additional 
facility types, with the exception of ``other residential care 
facilities'' that do not utilize significant amounts of nursing staff, 
in the analysis would increase total revenues for affected industries 
to approximately $275 billion in 2021 US dollars, which would not 
change the analysis that the rule does not have a significant economic 
impact on a substantial number of small entities.
    Comment: A few commenters expressed concern that CMS erroneously 
certified that the rule did not violate the Unfunded Mandates Reform 
Act (UMRA) since Tribal governments own nursing homes that this rule 
would affect.
    Response: We recognize that Tribal governments own nursing homes, 
as do states and local governments. As we have noted in the regulatory 
impact analysis for the proposed rule, this rule does not require 
Tribal governments to provide additional financial resources to meet 
any of the staffing requirements in this rule. As such, we maintain our 
certification that the rule will not impose new requirements for Tribal 
governments.
    Comment: A few commenters stated that CMS violated Federal law by 
not engaging in meaningful discussion or consult with Tribes before 
releasing the proposed regulation that affects tribally operated 
nursing homes in Indian Country. They indicate that CMS seems to have 
ignored detailed comments that Tribal leaders and the CMS Tribal 
Technical Advisory Group (TTAG) submitted in response to CMS' Request 
for Information last year.
    Response: Consistent with the CMS Tribal Consultation Policy, CMS 
seeks the guidance of Tribal leaders on the delivery of health care for 
American Indians/Alaska Natives (AI/AN) served by the Marketplace, 
Medicare, Medicaid, Children's Health Insurance Program, or any other 
health care program funded by CMS. We believe that we have followed the 
CMS Tribal Consultation Policy by engaging in meaningful discussions on 
this regulation that affects tribally-operated nursing homes. CMS 
reviewed and took into consideration all comments provided in the FY 
2023 SNF PPS RFI, including those comments specific to the impact of 
any staffing rule on Tribal nursing homes. As we outlined in the 
proposed rule, we held two listening sessions on June 27, 2022, and 
August 29, 2022, to allow all stakeholders, including those with 
concerns about the impact that a staffing standard will have on 
tribally-owned nursing homes, the opportunity to provide feedback on 
the approach utilized for establishing a minimum staffing standard (88 
FR 61364). In addition, we attended the CMS Tribal Technical Advisory 
Group (TTAG) quarterly meeting on October 18-19, 2023, to provide an 
overview of the NPRM and respond to questions and comments from the 
TTAG. We encouraged the TTAG to submit written comments as outlined in 
the proposed

[[Page 40955]]

rule and we have reviewed and considered those comments in issuing this 
final rule. Consistent with the government-to-government relationship, 
CMS is available to continue its dialogue with Tribal governments and 
the CMS TTAG and to provide technical assistance as needed in the 
implementation of this rule impacting Tribal nursing homes.
    Comment: One commenter noted that they believe that this policy has 
federalism implications and should be subject to applicable federalism 
requirements since the proposed rule is intended to and would preempt 
the applicability of any State or local law providing for a maximum 
staffing level, to the extent that such a State or local maximum 
staffing level would prohibit a Medicare and Medicaid certified LTC 
facility from meeting the minimum HPRD ratios and RN coverage levels. 
They also note that facilities would be required to meet applicable 
state and Federal staffing laws and that CMS failed to consult with 
state agencies and other organizations in violation of section 3(b) of 
Executive Order 13132.
    Response: As we noted in the federalism analysis section, to the 
extent Federal standards exceed State and local law minimum staffing 
standards, no Federal pre-emption is implicated because facilities 
complying with Federal law would also be in compliance with State law. 
We are not aware of any State or local law providing for a maximum 
staffing level. This final rule, however, is intended to and would 
preempt the applicability of any State or local law providing for a 
maximum staffing level, to the extent that such a State or local 
maximum staffing level would prohibit a Medicare, Medicaid, or dually 
certified LTC facility from meeting the minimum HPRD requirements and 
RN coverage levels finalized in this rule or from meeting higher 
staffing levels required based on the facility assessment provisions 
finalized in this rule. As we outlined in the proposed rule (88 FR 
61364), we held two listening sessions on June 27, 2022, and August 29, 
2022, to allow all stakeholders, including state agencies and other 
organizations to voice their concerns about the impact that a staffing 
standard, and took into consideration comments provided by state 
agencies.

C. Detailed Economic Analysis

1. Impacts for LTC Minimum Staff Requirement
a. Nursing Services (Sec.  483.35)
    We are finalizing two changes to the existing requirements for 
Nursing Services for LTC facilities at Sec.  483.35. We are requiring 
facilities to provide RN coverage onsite 24 hours per day, 7 days a 
week and to meet a minimum staffing standard of 0.55 RN, 2.45 NA, and 
3.48 HPRD for total nurse staffing. We note that these estimates do not 
include adjustments for any exemptions that we may provide, which could 
reduce the rule's cost (including cost associated with potential LTC 
facility closure or reduction in patient load capacity per facility) 
and benefits, based on the frequency of exemptions.
(1). RN Onsite 24 Hours a Day, 7 Days a Week (24/7 RN)
    To estimate the cost to the industry of full implementation of the 
requirement that a facility have an RN on site 24 hours a day, 7 days a 
week (24/7 RN), we first summed the current annual RN salary cost for 
each facility. We then subtracted this amount from the estimated annual 
RN salary cost that the facility will incur to meet the new 
requirement.
    To measure the current RN staff cost to the industry, we estimated 
the total number of RNs currently employed in LTC facilities and their 
loaded respective labor wages using data from the 2022 Nursing Home 
Staffing Study, which has information on 14,688 LTC facilities. This 
study uses the 2021 SNF--Medicare Cost Report data set to find the 
total facilities, the total number of reported LTC specific RNs and 
their loaded mean annual salaries, defined as salary and fringe 
benefits. Specifically, we calculated mean hourly wages for both 
employees and agency staff by using Column 3 in Worksheet S-3, Part V 
and dividing it by the sum of reported paid hours for RNs using data 
from Column 4 in Worksheet S-3, Part V.\112\ For nursing homes with 
missing or extreme values for hourly wages, we imputed the wage rate 
based on the state-level weighted hourly wage of non-outlier nursing 
homes within the state. Using this dataset, we were able to estimate 
the aggregate RN loaded salary costs and the cost per facility, 
including the cost for contract RNs.
---------------------------------------------------------------------------

    \112\ The cost report data utilized were from October 18, 2022, 
and are available at https://www.cms.gov/httpswwwcmsgovresearch-statistics-data-and-systemsdownloadable-public-use-filescostreportscost/2021-1.
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    To estimate the RN cost per resident census, we used the October 
2021 Care Compare data set that calculates average hours per resident 
day (HPRD) for RNs using the PBJ System data from 2021 Q2. Hours per 
resident day is defined as the average hours of RN care that each 
resident in the facility receives per day. For example, a facility that 
has an average HPRD of 0.5 for RNs would provide, on average, 0.5 hours 
(30 minutes) of RN care for each resident. We linked this dataset using 
the facility unique ID variable with the 2021 SNF--Medicare Cost Report 
data set to create a complete dataset. Using this combined dataset, we 
were also able to view the impact by resident census as well as the 
impact by LTC facility characteristics such as facility ownership, bed 
size, Five-Star Quality Rating System staffing ratings, payer mix, and 
location. This complete dataset helped provide an understanding of 
which types of LTC facilities would bear the largest cost burden of a 
new Federal 24/7 RN requirement.
    For each facility, we first calculated the total number of hours 
each day that an RN is on site by multiplying the average RN hours per 
resident day by the average number of residents in the facility (daily 
hours of RN care = RN HPRD x Residents in Facility). We then estimated 
the number of additional hours of RN care that facility would need to 
meet the 24/7 RN requirement by subtracting the current daily hours of 
RN care from 24 hours (additional daily RN hours needed = 24 - current 
daily hours of RN care). We then calculated the total number of 
additional RN hours needed per year by multiplying this amount by 365 
(additional yearly RN hours needed = additional daily RN hours needed x 
365). Finally, we estimated each facility's yearly cost for meeting the 
requirement by multiplying the total number of the yearly hours needed 
by the loaded hourly wage (yearly 24/7 RN cost = additional yearly RN 
hours needed x facility RN wage rate).
    For example, if a facility had an average of 0.4 RN HPRD and had 50 
residents it would provide 20 hours of total RN hours per day (0.4 HPRD 
x 50 residents = 20 total RN hours per day). To meet the 24/7 RN 
requirement, this facility would have to increase its total RN hours 
per day by 4 hours (24 hours needed - 20 hours current RN care = 4 
hours needed) and 1,460 hours (4 hours per day x 365 days/year) 
annually. Using the loaded mean hourly wage cost of $44 per hour, this 
facility would spend $64,240 per year ($44 x 4 RN hours per day x 365 
day per year = $64,240) to be in compliance with the 24/7 RN 
requirement.
    After estimating each facility's cost for meeting the 24/7 RN 
requirement, the next step was to sum the additional cost for all LTC 
facilities to meet the 24/7 RN requirement for an aggregate cost to the 
industry of $349 million per year. We also found approximately 78 
percent of LTC facilities had 24/7 RN coverage

[[Page 40956]]

within a 90-day window based on PBJ System data from 2021 Q2, showing 
that they provided at least 24 hours of RN care per day. We assumed 
this estimate for all quarters, for an annual estimate of approximately 
22 percent (100 percent - 78 percent = 22 percent) or 3,261 LTC 
facilities (0.222 x 14,688 LTC facilities = 3,261 LTC facilities) that 
would need to increase their RN staffing to comply with the 24/7 RN 
requirement. Among this 22 percent of facilities needing to increase RN 
staffing, there was an average of 0.43 hours of RN care per resident 
day.
    Table 15 summarizes the average annual cost for LTC facilities to 
meet the 24/7 RN Staffing Requirement over a 10-year period, which 
includes any associated collection of information costs as described in 
section IV. In estimating the cost, we take into account expected 
growth in wages that will result from greater demand for RNs in LTC 
facilities to meet the proposed 24/7 RN requirement, as well as the 
0.55 RN hours per resident day requirement that we discuss in more 
detail later in the analysis. All costs are reflected in 2021 US 
dollars.
    There is uncertainty about how much RN wages will change over the 
next 10 years due to changes in demand for RNs emerging due to both 
this final rule, as well as broader patterns of healthcare use in the 
United States. A 2009 study \113\ examined minimum licensed nurse (RN/
LPN) staffing standards in California for acute care hospitals that 
went into effect in March 2004. The authors found that compared to 
metropolitan areas outside of California that did not have the 
regulation, RN wage growth in California increased 12.8 percent more 
between 2000 and 2006. A more recent study \114\ found that real nurse 
wage rates increased by nearly 10 percent between 2001 and 2017, with 
changes in rates varying during years of U.S. economic growth and 
recession. During its strongest growth between 2001 and 2004, real 
wages increased at an average rate of 2.41 percent annually. Given the 
uncertainty in growth and increased demands for RNs, we assumed that 
real wages each year will increase at 2.31 percent.
---------------------------------------------------------------------------

    \113\ Mark B, Harless DW, and Spetz J. California's Minimum-
Nurse Staffing Legislation and Nurses' Wages. Health Affairs. 
2009;28 Supplement 1, w326-w334. doi: 10.1377/hlthaff.28.2.w326.
    \114\ Barry J. Real wage growth in the U.S. health workforce and 
the narrowing of the gender pay gap. Human Resources for Health. 
2021;19: 105. doi: 10.1186/s12960-021-00647-3.
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    We provide separate cost estimates for facilities in rural and 
urban areas since facilities in rural areas would have to meet the 
requirement 3 years after the final rule publication. Facilities in 
urban areas, in contrast, would need to meet the requirement 2 years 
after the final rule publication. This resulted in an average annual 
cost of approximately $366 million in 2021 US dollars without 
considering exemptions.
[GRAPHIC] [TIFF OMITTED] TR10MY24.096

(2) RN on Site 24 Hours a day, 7 Days a Week (24/7 RN)--State Level 
Analysis
    To provide a more in-depth understanding of the financial and 
staffing effects of the 24/7 RN requirement, we examined its impact for 
different groups of LTC facilities in each State, as well as Washington 
DC and Puerto Rico. We first assessed how many full-time RNs LTC 
facilities will need to hire to meet the finalized requirement. In this 
analysis, we defined a full-time employee as an employee who worked 
1,950 hours per year. This definition was based on a full-time employee 
working 5 days per week, 8 hours per day, with a 30-minute break (37.5 
hours/week x 52 weeks/year). To meet the 24/7 RN requirement, each 
facility will need to provide a minimum of 8,760 hours (24 hours/day x 
365 days) of RN care annually since we did not include any facility 
exemptions in these calculations. All calculations used the October 
2021 Nursing Home Care Compare data set that provides each nursing 
home's average daily resident census and HPRD for RNs using the PBJ 
system data for 2021 Q2.
    For each facility, we first calculated the total number of full-
time RNs in the facility using the following formula: (facility 
specific RN HPRD x average daily resident census x 365)/1,950. For 
example, if a facility has 100 residents and provides an average of 0.2 
RN HPRD, then during the year, it will provide a total of 7,300 hours 
of RN care (0.2 RN HPRD x 100 residents x 365 days = 7,300 hours) 
yearly and have 3.74 full-time RNs. We then calculated the number of 
additional full-time RNs needed by subtracting the total hours of RN 
care that the facility currently provides yearly from the 8,760 hours 
needed to ensure 24/7 RN coverage and dividing by 1,950, which is the 
number

[[Page 40957]]

of hours of yearly care provided by a full-time RN. Continuing with our 
example in this section, the nursing home will need to provide 1,460 
additional RN hours per year (8,760 hours-7,300 hours = 1,460 hours) 
and hire 0.75 additional full-time RNs.
    Table 16 shows the total number of RNs currently employed by LTC 
facilities in each State's urban and rural areas, the number of full-
time RNs that LTC facilities will need to hire, and the percent 
increase in RNs that LTC facilities in each State will need to meet the 
proposed minimum staffing standard barring any exemptions. Oklahoma 
will need the largest increase in RNs in percentage terms for rural 
facilities, needing to increase the size of its RN workforce by 27 
percent. Meanwhile, for urban facilities, the largest percentage 
increase in RNs will be in Louisiana at 17.6 percent. Facilities in 
Texas will need to hire the most overall RNs with the State needing 653 
additional full-time RNs. Across the United States, however, the number 
of RNs that facilities will need to meet the requirement varies widely 
with several States, including Florida and Illinois, needing to 
increase the size of their LTC facilities' RN labor force by less than 
1 percent.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR10MY24.098


[[Page 40958]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.099

    We then assessed the financial cost for facilities to implement the 
24/7 RN requirement. To estimate the yearly cost per State, we used the 
formulas described in section VI.C.1.(a) of this rule to first estimate 
each facility's yearly cost to meet the requirement. We also assumed 
that LTC facilities exceeding the minimum requirements for RNs will not 
reduce RNs to the minimum required level or lay off other staff to 
reduce costs. We then calculated the average cost per resident day by 
summing the total cost of meeting the requirement for all facilities in 
the State and dividing it by the total number of resident days for all 
facilities needing additional RNs. We estimated the average cost per 
resident day only for facilities needing staff to provide a more 
complete picture of the burden that the rule will impose on these 
facilities.
    Table 17 provides the yearly Statewide cost to implement the 
requirement, as well as the average cost per resident day for 
facilities in rural and urban areas that will need to hire additional 
staff to meet the requirement. Delaware has the highest cost per 
resident day with a single facility that is not meeting the 24/7 RN 
requirement and will need to spend $87.45 per resident day. The highest 
overall cost occurs in Texas where facilities will need to collectively 
spend more than $84 million to meet the minimum staffing requirement. 
The cost also varied across urban and rural areas. In New Hampshire, 
LTC facilities in urban areas that need staff will need to spend an 
average of $8.95 per resident day to meet the requirement, while in 
Hawaii, Puerto Rico, and Wyoming these facilities will occur no cost. 
Nevada will have the highest average cost for rural LTC facilities at 
$21.81 per resident day.

[[Page 40959]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.100


[[Page 40960]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.101

    Table 18 shows the average cost per resident day to implement the 
requirement for facilities in each State that will need additional RNs, 
dividing facilities based on their size into three groups: less than 50 
beds, 50 to 100

[[Page 40961]]

beds, and more than 100 beds. Within each group of LTC facilities, the 
cost varied widely by number of beds and State. In West Virginia, the 
average cost per resident day for facilities that have more than 100 
beds and need additional RNs will be $0.72, while in North Carolina, 
the average cost per resident day for facilities with fewer than 50 
beds will be $29.19.

[[Page 40962]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.102


[[Page 40963]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.103

    In table 19, we calculated the average cost by State for facilities 
needing staff to meet the minimum staffing requirement based on whether 
the facility accepted patients with Medicare, Medicaid, or both 
Medicare

[[Page 40964]]

and Medicaid. The highest per resident day cost will be for 14 
Medicaid-only facilities in Illinois that will need to spend an average 
of $29 per resident day to meet the staffing requirement. The lowest 
per resident day cost for facilities needing staff will be for a single 
Medicaid-only facility in South Dakota that will need to spend $0.33 
per resident day to meet the requirement.

[[Page 40965]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.104


[[Page 40966]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.105

BILLING CODE 4120-01-C

[[Page 40967]]

(3). Minimum Nurse Staffing Requirement of 3.48 Total Nurse Staffing 
HPRD, 0.55 RN HPRD, and 2.45 NA HPRD
    To estimate the incremental impact of the minimum nurse staffing 
requirement requirements of 2.45 NA HPRD, 0.55 RN HPRD, and 3.48 total 
nurse staffing HPRD, we first estimated the industry's aggregate annual 
cost for nurse staff (RNs, LPNs/LVNS, and NAs) at current staffing 
levels. We then estimated the aggregate annual cost for nurse staff 
(RNs, LPNs/LVNs, and NAs) for all facilities to meet these 
requirements. We note that these HPRD requirements are applied 
independent of a facility's individual case-mix, meaning the expected 
costs to a facility are based solely on the cost of facilities adding 
additional staff to meet these requirements, regardless of the 
facility's case-mix. Finally, we calculated the requirements' expected 
cost to the industry by subtracting the industry's current nurse staff 
cost from the estimated nurse staff cost for all facilities to meet the 
minimum requirements (Nurse Staff Cost for All Facilities to Meet 
Minimum Requirement--All Facilities' Current Nurse Staff Cost).
    To measure the current nurse staffing cost to the industry, we 
estimated the total number of nurse staff currently employed in LTC 
facilities and their loaded respective labor wages. This study used the 
2021 SNF--Medicare Cost Report dataset to find the total of facilities, 
the total number of reported LTC specific nurse-type staff and their 
loaded mean annual salaries, defined as salary and fringe benefits. 
Using this dataset, we were able to estimate the aggregate total nurse 
staffing salary costs and the cost per facility, including the cost for 
contract staff.
    To estimate the nurse staffing cost by staff type, that is, RNs, 
LPNs/LVNs, NAs, per resident census we used the October 2021 Care 
Compare data set that calculates average hours per resident day (HPRD) 
for each nurse type using the PBJ System data from 2021 Q2. Hours per 
resident day was defined as the average hours of care that each 
resident in the facility receives from that nurse type. For example, a 
facility that had an average HPRD of 0.5 for RNs would provide, on 
average, 0.5 hours (30 minutes) of RN care for each resident. We linked 
this dataset using the facility unique ID variable with the 2021 SNF--
Medicare Cost Report data set to create a complete dataset. Using this 
combined dataset, we were also able to view the impact by staff type 
per resident census as well as the impact by LTC facility 
characteristics such as facility ownership, bed size, Five-Star Quality 
Rating System staffing ratings, payer mix, and location. This complete 
dataset helped provide an understanding of which types of LTC 
facilities would bear the largest cost burden of a new Federal minimum 
staffing requirement.
    Using the above dataset, we estimated each facility's current total 
annual salary costs for each nurse type (RN, LPN/LVN, NA) as follows: 
[facility specific nurse type] loaded hourly wage x [facility specific 
nurse type] reported HPRD x facility-level average daily facility 
resident census x 365. For example, if a facility reported an average 
loaded hourly wage of $44 for its RNs, an average of 0.4 RN HPRD, and 
an average daily resident census of 100, its estimated annual salary 
costs for RNs would be calculated as: $44 x 0.4 x 100 x 365 = $642,400. 
Taking this example further, if this same facility reported a loaded 
average hourly wage of $21 for its NAs, an average of 2.1 NA HPRD, and 
an average daily resident census of 100, its estimated annual salary 
costs for NAs would be calculated as: $21 x 2.1 x 100 x 365 = 
$1,609,650. If this facility only employed RNs and NAs as part of its 
total nurse staff, then the facility's current total nurse staff cost 
would be $2,252,050 ($642,400 + $1,609,650 = $2,252,050). To estimate 
the aggregate current nurse staff cost across all facilities, the next 
step was to sum all facilities' current total (RN, LPN/LVN, and NA) 
nurse staff cost for an overall industry nurse staff cost of $43.4 
billion.
c. 3.48 Total Nurse Staffing Requirement
    To estimate the cost of the 3.48 total nurse staffing HPRD 
requirement, we subtracted the total current nurse staffing cost per 
facility from the total nurse staffing cost per facility with the 3.48 
total nurse staffing HPRD standard. For the purpose of the cost 
estimates, we continue the assumption stated in the proposed rule that 
facilities would hire NAs to meet the total nurse staffing requirement. 
The formula applied to calculate each facility's cost of meeting of 
meeting the requirement was: [[3.48 total nurse staffing HPRD] - 
[facility specific reported total nurse staffing HPRD]] x facility 
specific NA hourly wage x facility level average daily resident census 
x 365. Using the same LTC facility example from the paragraph above 
where the facility had an average of 0.4 RN HPRD and 2.1 NA HPRD, this 
LTC facility would have a total of 2.5 (0.4 + 2.1 = 2.5) total nurse 
staffing HPRD. To comply with the requirement, it would need to 
increase its NA HPRD from 2.1 to 3.08 adding an additional 0.98 (3.48 - 
2.5 = 0.98) HPRD. The cost for this requirement on this facility would 
thus be $751,170 ([3.48 - 2.5] x $21 x 100 x 365) = $751,170).
    When LTC facilities hire RNs to meet the 24/7 RN requirement, which 
goes into effect the same year as the 3.48 total nurse staffing HPRD 
requirement, the hours these RNs work will also count toward the 3.48 
total nurse staffing HPRD requirement. To avoid overestimating the 
number of nurse staff that LTC facilities will need to hire to meet the 
3.48 total nurse staffing requirement and the cost to hire them, if a 
LTC facility has less than 3.48 total nurse staff HPRD, we subtracted 
any staff hours that the facility will need to meet the 24/7 RN 
requirement up to the point where the LTC facility will meet the 3.48 
total nurse staff HPRD requirement.
    After accounting for any increase in RN hours per resident day to 
meet the 24/7 RN requirement, we then calculated the total number of 
additional hours per resident day of nurse care that LTC facilities 
would need to provide to meet the 3.48 HPRD total nurse staff 
requirement. We did this calculation by subtracting the total nurse 
staff hours (RN, LVN/LPN, and NA) provided from 3.48 using the 
following formula: [3.48 - (RN HPRD + LVN/LPN HPRD + NA HPRD)]. For any 
facilities that were below the 3.48 total nurse staff HPRD requirement, 
we assumed that they would hire NAs to fulfill any remaining hours.
    Once we apply this formula to each facility in our dataset, we 
summed each facility's total cost to obtain the requirement cost to the 
industry of approximately $1.37 billion. To factor in the 2.31 percent 
increase in real increase in wage rates and the different timeline for 
rural and urban facilities to meet these requirements, in table 20 we 
provide the estimated cost annually and over 10 years. Overall, we 
estimate that the requirement will cost an average of approximately 
$1.36 billion annually and $13.64 billion over 10 years.

[[Page 40968]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.106

c. Minimum Nurse Staffing Requirement of 0.55 RN and 2.45 NA HPRD
    When LTC facilities hire RNs to meet the 24/7 RN requirement, which 
goes into effect before the 0.55 RN HPRD requirement, the hours these 
RNs work will also count toward the 0.55 RN HPRD requirement. To avoid 
overestimating the number of RNs that LTC facilities will need to hire 
and the cost to hire them, if a LTC facility meets the 0.55 RN HPRD 
requirement with current staff including RNs hired for the 24/7 RN 
requirement, we estimate that its cost is $0. For facilities that still 
need to hire RNs to meet the 0.55 RN HPRD requirement we calculate 
costs using the following formula: [[0.55 RN HPRD] - [facility specific 
RN HPRD + facility specific RN HPRD resulting from 24/7 RN 
requirement]] x facility specific RN hourly wage x facility level 
average daily resident census x 365. Similarly, When LTC facilities 
hire NAs to meet the 3.48 total nurse staff HPRD requirement, which 
goes into effect before the 2.45 NA HPRD requirement, the hours these 
NAs work will also count toward the 2.45 NA HPRD requirement. To avoid 
overestimating the number of NAs that LTC facilities will need to hire 
and the cost to hire them, if a LTC facility meets the 2.45 NA HPRD 
requirement when including NAs hired to meet the 3.48 total nurse staff 
HPRD requirement, we estimate that its cost is $0. For facilities that 
still need to hire NAs to meet the 2.45 NA HPRD requirement we 
calculate costs using the following formula: [[2.45 NA HPRD] - 
[facility specific NA HPRD + facility specific NA HPRD resulting from 
3.48 total nurse staff requirement]] x facility specific NA hourly wage 
x facility level average daily resident census x 365.
    In table 21, we provide the estimated cost annually and over 10 
years for the 0.55 RN and 2.45 NA HPRD requirements. These requirements 
have a total cost of approximately $2.54 billion annually and $25.38 
billion over 10 years.
[GRAPHIC] [TIFF OMITTED] TR10MY24.107


[[Page 40969]]


    Table 22 summarizes the estimated total cost for the comprehensive 
minimum nurse staffing requirement which includes any associated 
collection of information costs as described in section IV., Collection 
of Information Requirements, but not the regulatory review costs which 
we discuss in more detail later in this section. To account for real 
growth in RN and NA wages over time, for each requirement we continue 
to assume that real wages for nurse staff, as well as collection of 
information costs, will increase at 2.31 percent annually. Since rural 
and urban LTC facilities have different phase-in periods to meet the 
24/7 RN and 3.48 total nurse staff HPRD requirement (2 years for 
facilities in urban areas and 3 years for facilities in rural areas) 
and the 0.55 RN and 2.45 NA HPRD requirements (3 years for facilities 
in urban areas and 5 years for facilities in rural areas) we provided 
separate cost estimates for facilities located in each area. Over a 10-
year period, we anticipate an average annual cost of approximately $4.3 
billion.
    We would note that the estimated $21.9 billion cost for the 0.55 RN 
and 2.45 NA HPRD requirements over 10 years differs from the estimated 
cost of $36.9 billion in the proposed rule. The reason for this 
difference is that with the 3.48 HPRD total nurse staff requirement, 
NAs hired to meet the requirement will also count toward the 2.45 NA 
HPRD requirement. As such, a large part of this cost difference is 
reflected in the calculated costs for the 3.48 total nurse staffing 
requirement.
BILLING CODE 4120-01-P

[[Page 40970]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.108

BILLING CODE 4120-01-C
    This final rule does not include any provisions requiring Medicare, 
Medicaid, or other non-Medicare/Medicaid payors to increase payment

[[Page 40971]]

rates to providers to meet any or all the expected costs of these 
finalized requirements. Below, however, we provide estimates of how 
much of the estimated cost is due to residents whose care is covered by 
three payor groups: Medicaid, Medicare, and other non-Medicare/Medicaid 
payors.
    Table 23 provides annual estimates and a 10-year total estimate for 
the share of facilities' increased staffing costs that is due to 
residents utilizing Medicaid. These estimates exclude all collection of 
information costs. Over a 10-year period, the average annual cost for 
facilities' due to residents whose stay is paid for by Medicaid is 
approximately $2.82 billion. If Medicaid were to fully cover these 
costs (although there is no expectation that it will), then States 
would pay approximately $1.17 billion, and the Federal Government would 
pay $1.65 billion.
    To build these estimates, we used a scenario where each facility's 
increased cost to meet the new minimum staffing and 24/7 RN 
requirements for residents utilizing Medicaid is equal to share of 
residents in the facility using Medicaid. More formally, we first 
calculated each facility's increased staffing cost for residents 
utilizing Medicaid for each of the four requirements (24/7 RN, 3.48 
total nurse staff, 0.55 RN HPRD, and 2.45 NA HPRD) using the following 
formula: Increased Facility Cost for Medicaid Residents = Individual 
requirement cost x % facility residents covered by Medicaid. We then 
summed all facilities' increased costs that is due to residents 
utilizing Medicaid and took into account the different timeline for 
each of the requirements to obtain a total estimated cost for Medicaid 
of $28.17 billion over 10 years.
BILLING CODE 4120-01-P

[[Page 40972]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.109

    Table 24 provides annual estimates and a 10-year estimate for the 
share of facilities' increased staffing costs that is due to residents 
whose care is covered by Medicare and other non-Medicare/Medicaid 
payors. These estimates

[[Page 40973]]

continue to exclude all collection of information costs. Over a 10-year 
period, facilities' average annual cost to meet the proposed 
requirements will be approximately $471 million for residents utilizing 
Medicare and $921 million for residents utilizing other non-Medicare/
Medicaid payors.
    To build these estimates, we used a scenario where the cost each 
facility will incur to meet the new minimum staffing and 24/7 RN 
requirements for residents utilizing Medicare is equal to the share of 
residents covered by Medicare and non-Medicare/Medicaid payors in each 
facility. More formally, we first calculated each facility's increased 
staffing cost for residents utilizing Medicare and other non-Medicare/
Medicaid payors for each of the four requirements (24/7 RN, 3.48 total 
nurse staff, 0.55 RN HPRD, and 2.45 NA HPRD) using the following 
formula: Increased Facility Cost for Medicare Residents = Individual 
requirement cost x % facility residents covered by Medicare. We then 
summed all facilities' increased costs that is due to residents 
utilizing Medicare and took into account the different timeline for 
each of the requirements to obtain a total estimated cost to facilities 
for Medicare-covered SNF stays of $4.71 billion over 10 years.
    To obtain the total cost due to residents utilizing other non-
Medicare/Medicaid payors, we first calculated each facility's increased 
staffing cost for residents utilizing other non-Medicare/Medicaid 
payors for each of the four requirements (24/7 RN, 3.48 total nurse 
staff HPRD, 0.55 RN HPRD, and 2.45 NA HPRD) using the following 
formula: Increased Facility Cost for Non-Medicare/Medicaid Payors = 
Individual requirement cost x % facility residents covered by non-
Medicare/Medicaid Payors. We then summed all facilities' increased 
costs that is due to residents utilizing other Non-Medicare/Medicaid 
payors and took into account the different timeline for each of the 
requirements to obtain a total estimated cost of $9.21 billion over 10 
years.

[[Page 40974]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.110

BILLING CODE 4120-01-C
    Sources of uncertainty about the cost estimate for the 24/7 RN, 
3.48 Total Nurse Staffing HPRD, 0.55 RN and 2.45 NA HPRD requirements 
include:

[[Page 40975]]

    The cost estimates assumed that LTC facilities needing RNs and/or 
NAs to meet these requirements will hire them without laying off other 
direct care or support staff. Some research,115 
116 however, has found that when States implemented minimum 
hour per day requirements for direct care staff (RNs, LPNs, and NAs), 
LTC facilities responded by reducing indirect care staff, such as 
housekeeping, food service, and activities staff. If LTC facilities 
respond to the 24/7 RN, 3.48 total nurse staff HPRD, 0.55 RN HPRD, and 
2.45 NA HPRD requirements in similar ways, then a facility's total cost 
for the requirements could decline significantly relative to what was 
presented above (see earlier discussion about appropriate accounting of 
costs depending on consistency between benefit and cost analytic 
approaches). The intent of this rule, however, is that facilities will 
maintain levels of indirect care staff necessary to meet their 
residents' needs, while also scaling up direct care staff if needed to 
meet the minimums.
---------------------------------------------------------------------------

    \115\ Thomas, Kali S., Kathryn Hyer, Ross Andel, and Robert 
Weech-Maldonado. The Unintended Consequences of Staffing Mandates in 
Florida Nursing Homes: Impacts on Indirect-Care Staff, 2010, 
Medicare Care Research and Review, Volume 67, Issue 5, Pages 555-
573.
    \116\ Bowblis, John R., and Kathryn Hyer. Nursing Home Staffing 
Requirements and Input Substitution: Effects on Housekeeping, Food 
Service, and Activities Staff, 2013, Health Services Research, 
Volume 48, Issue 4, Pages: 1539-1550.
---------------------------------------------------------------------------

    The cost estimates assumed that real wages for RNs and NAs will 
grow at a real annual rate of 2.31 percent due to increasing demand for 
these direct care staff. Differences in demand for RNs and NAs across 
geographical areas, however, could lead to wages in different areas to 
increase at different rates, altering the cost for LTC facilities.
    The cost estimates assumed that the nursing home resident 
population will remain stable over the next 10 years. There is some 
evidence, however, that the resident population is declining. CMS Care 
Compare data shows that between February 2017 and February 2024, the 
average number of residents in nursing homes per day declined from 
1,346,712 residents to 1,207,726.\117\ If the resident population 
continues to decrease, then the costs could be lower than what we have 
estimated. Similarly, if the pattern changes and the nursing home 
resident population increases, costs could be higher than what we have 
estimated.
---------------------------------------------------------------------------

    \117\ CMS. (2024). Nursing homes including rehab services 
archived data snapshots. Accessed March 19, 2024. Available at: 
https://data.cms.gov/provider-data/archived-data/nursing-homes.
---------------------------------------------------------------------------

    The 24/7 RN cost estimate assumed that RNs hired to meet the 
requirement will make the loaded average hourly rate for RNs in the 
facility. If, however, LTC facilities need to hire RNs to work 
overnight shifts, which typically command a higher hourly rate, the 
costs for LTC facilities to meet this requirement could increase.
    The cost estimate for the 3.48 total nurse staff requirement 
assumes that facilities will hire NAs to fill the necessary hours. If, 
however, they hire LPNs/LVNs, then the cost could increase since LPNs/
LVNs command a higher hourly wage than NAs.
    The cost estimate assumed that no LTC facilities will obtain 
exemptions from the 24/7 RN requirement, the 3.48 total nurse staffing 
HPRD requirement, or the 0.55 RN and 2.45 NA HPRD requirements, 
although some facilities could obtain exemptions. Depending on the 
number of facilities that obtain exemptions from the requirements and 
their expected cost to meet the requirements, the total cost of the 
rule for LTC facilities could be lower than what is estimated.
    In addition to uncertainty about the magnitude of costs, there is 
uncertainty about whether LTC facilities or other payors would bear the 
cost of meeting the minimum staffing and 24/7 RN requirements. As we 
highlighted earlier in this RIA, we expect that LTC facilities would 
generally have 3 possible approaches to addressing the increased costs 
associated with the higher staffing levels: (1) reduce their margin or 
profit; (2) reduce other operational costs; and (3) increase prices 
charged to payors. LTC facilities may use some combination of these 
approaches, and those approaches could vary by facility and over time. 
These decisions could depend on a number of factors, including: the 
current margin levels of a facility; the cost increase due to the 
staffing requirements relative to current costs and revenues; the 
current level of operational costs; and the ability to negotiate prices 
with payors. If payors did increase payment rates to meet some or all 
the rule's cost, the cost for LTC facilities could be lower relative to 
what is estimated above.
(4). Impact of 3.48 Total Nurse Staff, 0.55 RN, and 2.45 NA HPRD 
Requirements on States
    To provide a more in-depth understanding of the financial and 
staffing effects of the 3.48 total nurse staff HPRD, 0.55 RN HPRD, and 
2.45 NA HPRD minimum staffing requirements, we examined their impact on 
different groups of LTC facilities in each State, as well as 
Washington, DC, and Puerto Rico. We first assessed how many full-time 
employees LTC facilities will need to hire to meet the finalized 
requirements. In this analysis, we defined a full-time employee as an 
employee who worked 1,950 hours per year. This definition was based on 
a full-time employee working 5 days per week, 8 hours per day, with a 
30-minute break (37.5 hours/week x 52 weeks/year).
    We continued to assume that no facilities will obtain exemptions 
from these minimum staffing requirements. For the 3.48 total nurse 
staff HPRD requirement, we continued to subtract any costs that 
facilities will incur and employees they will need to meet the 24/7 RN 
requirement since RNs that facilities hire to meet the 24/7 RN 
requirement will also count toward the 3.48 total nurse staff HPRD 
requirement. For the 0.55 RN HPRD requirement, we continue to subtract 
any costs that facilities will incur and employees they will need to 
hire to meet the 24/7 RN requirements since RNs that facilities hire 
for the 24/7 RN requirement will also count toward the 0.55 RN HPRD 
requirement. Finally, for the 2.45 NA HPRD requirement, we continue to 
subtract any NAs hired to meet the 3.48 total nurse staff requirement 
since NAs that facilities hire for the 3.48 total nurse staff 
requirement will also count toward the 2.45 NA HPRD requirement. All 
calculations used the October 2021 Care Compare data set that provided 
each LTC facility's average daily resident census and average HPRD for 
RNs, LPNs/LVNs and NAs using the PBJ System data from 2021 Q2.For each 
facility, we first calculated the total number of full-time RNs, LPN/
LVNs, and NAs working in a facility using the following formula: 
(facility specific care type HPRD x Average daily resident census x 
365)/1,950. For example, if a facility has 10 residents and provides an 
average of 0.1 RN HPRD, then during the year, it will provide a total 
of 365 hours of RN care (0.1 RN HPRD x 10 residents x 365 days) yearly 
and have 0.187 full-time RNs. We then calculated the number of 
additional RNs needed by subtracting the current average hours per 
resident day for RNs from the minimum required RN hours per resident 
day. Continuing with our example in this section and assuming the 
facility did not need to hire any RNs to meet the 24/7 RN requirement, 
the LTC facility would need to provide 1,642.5 additional RN hours per 
year ([0.55 RN HPRD - 0.1 HPRD] x 10 residents x 365 days = 1642.5 
hours) and hire 0.84 additional full-time RNs.
    To calculate the total number of additional NAs needed to meet the 
3.48

[[Page 40976]]

total nurse staff requirement, we subtracted the current average hours 
per resident day for all nurse staff (RNs, LPNs/LVNs, and NAs) from the 
minimum required hours per resident day. For example, if the same 
facility as previously mentioned with 10 residents provided an average 
of 2.2 NA HPRD, 0.187 RN HPRD, and no LPN/LVN HPRD, then to meet the 
3.48 HPRD requirement it would need to provide 3,989.5 additional NA 
hours per year ([3.48 Total Nurse Staff HPRD-2.2 NA HPRD-.187 RN HPRD] 
x 10 residents x 365 days = 3,989.5 hours) and hire 2.05 (3,989.5 hours 
needed/1,950 hours yearly per full-time employee) full-time NAs. This 
equals an average increase of 1.09 NA HPRD (3,989.5/10 residents/365 
days = 1.09 HPRD). We note, however, that facilities may also wish to 
use other types of staff such as LPNs/LVNs to meet the total staffing 
standard.
    Finally, to calculate the total number of additional NAs needed to 
meet the 2.45 NA HPRD requirement, we added together the current 
average hours per resident day for NAs and the average additional hours 
per resident day that NAs will work to meet the 3.48 total nurse staff 
requirement. We then subtracted this new total NA HPRD from the 2.45 NA 
HPRD minimum required hours per resident day. For example, the same 
facility that we discussed above would provide a total of 3.29 NA HPRD 
(2.2 HPRD from current average NA HPRD + 1.09 HPRD from the 3.48 total 
nurse staff requirement = 3.29 NA HPRD). Therefore, it would have 
already met the 2.45 NA HPRD requirement and would incur no additional 
costs and would not need to hire any NAs to meet the 2.45 NA HPRD 
requirement.
    Table 25 shows the total number of RNs and NAs employed by LTC 
facilities in each State's urban areas, the number of full-time RNs and 
NAs that LTC facilities will need to hire to meet each requirement, and 
the percent increase in RNs and NAs that LTC facilities in each State 
will need to meet the proposed minimum staffing standards. Table 26 
provides the same information for LTC facilities located in each 
State's rural areas.
    Louisiana will need the largest increase in RNs in percentage 
terms. The number of full-time RNs in urban LTC facilities will need to 
increase by nearly 96 percent, while rural LTCs will need to increase 
the number of RNs by more than 73 percent to meet minimum standard. 
Facilities in Texas will need to hire the most overall RNs with the 
State needing 1,615 additional full-time RNs in urban areas and more 
than 311 RNs in rural areas. Across the United States, however, the 
number of RNs that facilities will need to hire varies widely, with 
several States, including Delaware and Hawaii, not needing to hire any 
RNs to meet the requirement.
    Illinois will need the largest percentage increase for NAs in urban 
areas to meet the 3.48 total nurse staff requirement. The State will 
need to add 4,350 full-time NAs and increase the overall number of NAs 
working in LTC facilities by more than 31 percent. Similar to RNs, 
however, there is wide variation in the percentage increase in NAs 
needed for the 3.48 total nurse staff requirement across States. For 
example, Alaska, North Dakota, the District of Columbia, Delaware, 
Florida, Hawaii, Idaho, Florida, Maine, and Vermont, will need to 
increase the size of their NA labor force in urban LTC facilities by 
less than 1 percent to meet the requirement.
    Delaware will need the largest percentage increase for NA in urban 
areas to meet the 2.45 NA HPRD requirement, increasing the number of 
NAs by 18.3 percent. For rural areas, Georgia will need the largest 
percentage increase at 19.5 percent. Across States, however, the number 
of NAs that facilities will need to hire continues to vary widely.
BILLING CODE 4120-01-P

[[Page 40977]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.111


[[Page 40978]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.112


[[Page 40979]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.113


[[Page 40980]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.114

    We then assessed the financial cost for facilities to implement the 
3.48 total nurse staff, 0.55 RN, and 2.45 NA HPRD minimum staffing 
requirements. To estimate the yearly cost per State, we used the 
formulas described in section

[[Page 40981]]

VI.C.1.(a) to first estimate each facility's yearly cost to meet each 
requirement. We also assumed that LTC facilities exceeding the minimum 
requirements for total nurse staff, RNs and/or NAs will not reduce 
staff to the minimum required level or lay off other staff to reduce 
costs. We then calculated the average cost per resident day by summing 
the total cost of meeting each requirement for all facilities in the 
State and dividing it by the total number of resident days for all 
facilities in the state needing to hire staff to meet the requirements. 
We estimated the average cost per resident day only for facilities 
needing staff to provide a more complete picture of the burden that the 
rule will impose on these facilities.
    Table 27 provides the yearly Statewide cost to implement the 3.48 
total nurse staff, 2.45 NA, and 0.55 RN HPRD requirements, as well as 
the average cost per resident day for facilities in rural and urban 
areas that will need to hire staff to meet the requirements. Facilities 
in Illinois that are not meeting the minimum staffing standards will 
need to spend the most with an average cost of $21.01 per resident day. 
The highest overall cost occurs in New York where facilities will need 
to collectively spend nearly $421 million to meet the minimum staffing 
requirements. The cost also varies across urban and rural areas. In 
Illinois, LTC facilities in urban areas that need staff will need to 
spend an average of $22.34 per resident day to meet the requirement, 
while in Florida, they will need to spend than $5.25 per resident day. 
Virginia had the highest average cost for rural LTC facilities at 
$17.65 per resident day.

[[Page 40982]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.115


[[Page 40983]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.116

    Table 28 shows the average cost per resident day for facilities in 
each State that need additional staff, dividing facilities based on 
their size into three groups: less than 50 beds, 50 to 100 beds, and 
more than 100 beds. Within

[[Page 40984]]

each group of LTC facilities, the cost varied widely by the number of 
beds and State. In Oklahoma, the average cost per resident day for 
facilities that have fewer than 50 beds and need additional nurse will 
be $1.84, while in Illinois, the average cost per resident day for 
facilities with more than 100 beds will be $22.78.
[GRAPHIC] [TIFF OMITTED] TR10MY24.117


[[Page 40985]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.118

    In table 29, we calculated the average cost by State for facilities 
needing staff to meet the minimum staffing requirements based on 
whether the facility accepted patients with Medicare, Medicaid, or both 
Medicare and Medicaid. The highest per resident day cost will be for 14 
Medicaid-only facilities in North Dakota that will need to spend an 
average of $42.48 per resident day to meet the staffing requirements. 
The lowest per resident day cost for facilities needing staff will be 
for two Medicare-only facilities in West Virginia that will need to 
spend $0.59 per resident day to meet the requirements.

[[Page 40986]]

[GRAPHIC] [TIFF OMITTED] TR10MY24.119


[[Page 40987]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.120

BILLING CODE 4120-01-C
b. Benefits of LTC Minimum Staff Requirement
    Evidence in the literature suggests that higher staffing is 
associated with better quality of patient care and patient health 
outcomes.118 119 120 While many of these benefits are 
difficult to quantify, research suggests a positive correlation between 
higher RN HPRD and more community discharges, as well as fewer 
hospitalizations and emergency department visits that result in 
significant savings for Medicare. An example of such evidence comes 
from the 2022 Nursing Home Staffing Study that analyzes the Medicare 
savings that are likely to result from different case-mix adjusted RN 
hours per resident day (HPRD) requirements.
---------------------------------------------------------------------------

    \118\ Cai, S., Yan, D., & Intrator, O. (2021). COVID-19 cases 
and death in nursing homes: The role of racial and ethnic 
composition of facilities and their communities. Journal of the 
American Medical Directors Association, 22(7), 1345-1351.
    \119\ Harris, J.A., Engberg, J., & Castle, N.G. (2020). 
Organizational and geographic nursing home characteristics 
associated with increasing prevalence of resident obesity in the 
United States. Journal of Applied Gerontology, 39(9), 991-999. 
https://doi.org/10.1177/07464819843045 https://doi.org/10.1177/07464819843045.
    \120\ Min, A., & Hong, H.C. (2019). Effect of nurse staffing on 
rehospitalizations and emergency department visits among short-stay 
nursing home residents: A cross-sectional study using the U.S. 
Nursing Home Compare database. Geriatric Nursing, 40(2), 160-165. 
https://doi.org/10.1016/j.g.
---------------------------------------------------------------------------

    The study first used the PBJ system, which contains data on daily 
hours worked by RNs, and data from the Minimum Data Set (MDS) on 
resident acuity and the number of residents in the facility, to 
calculate the acuity-adjusted RN HPRD for 14,140 LTC facilities based 
on data from 2022 Q2.\121\ We would note, as discussed above, that 
while the benefits described in this section were calculated on the 
basis of acuity-adjusted data, the minimum staffing requirements being 
finalized in this rule will be applied independent of an individual 
facility's case-mix. We understand that this may impact the 
comparability of the benefits described in this section to those which 
may occur with the finalization of these requirements, but we also 
believe that the acuity adjusted data more accurately reflect that 
which is publicly reported through Care Compare and the PBJ System. 
Registered nurses included RNs, RNs with administrative duties, and RN 
directors of nursing. The 2022 Study then used Nurse Home Compare Data 
from 2021 Q2 to 2022 Q1 to examine the impact of different RN staffing 
levels on five claims-based measures: short-stay hospital readmission, 
short-stay emergency department (ED) visits, long-stay hospitalizations 
per 1,000 long-stay resident days, long-stay ED visits per 1,000 long-
stay resident days, and the rate of successful return to home or 
community. More specifically, the study ran a multivariate regression 
model that used the 1st and 2nd RN staffing decile as the reference 
group and included the 3rd through the 10th deciles of RN staffing as 
covariates in the model. The model also includes several additional 
covariates that take into account LTC facility specific characteristics 
that include: (1) facility size (number of certified beds), (2) 
ownership type (for-profit, non-profit or government owned), (3) 
whether the facility is located in a rural area, (4) the facility's 
Medicaid population quartile, (5) whether the facility is hospital-
based, (6) the facility's status in the Special Focus Facility Program, 
and (7) whether the facility is part of a continuing care retirement 
community. The study then used the model coefficients to identify the 
mean outcomes that were associated with each staffing level above the 
1st and 2nd RN staffing deciles.
---------------------------------------------------------------------------

    \121\ In the study, appendix E, section E.1.1 provides details 
on the criteria used for the acuity adjustment.
---------------------------------------------------------------------------

    After identifying the mean outcome rate for each of the five 
measures that was associated with each staffing level, they compared it 
to the adjusted mean outcome rate for each facility to the rate the 
facility would have if it met the minimum required RN staffing level. 
For those facilities above the minimum RN staffing level, the study 
assumed that facilities would maintain their current RN staffing level. 
Based on the facility's number of short-stay residents, as well as 
long-stay resident days, the study then estimated the total savings at 
the facility level. To measure costs savings for Medicare, the study 
used an average estimated cost of $20,400 per hospitalization, $2,500 
per ED visit, and for community and home discharge, the reduction in 
the number of Medicare-covered SNF days multiplied by the average daily 
payment amount. Using these criteria, the study estimates that a 
minimum RN requirement of between 0.52 and 0.60 HPRD would result in 
$318,259,715 in annual Medicare savings.\122\
---------------------------------------------------------------------------

    \122\ Abt Associates. (2022). Nursing Home Staffing Study 
Comprehensive report. Page 110. 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.
---------------------------------------------------------------------------

    Given that our final RN HPRD level is 0.55 we consider this amount 
to be our best estimate of the rule's financial benefits. There are 
also likely to be cost savings for Medicaid due to fewer 
hospitalizations and emergency department visits, although the 2022 
Nursing Home Staffing Study did not quantify them. Additionally, while 
the savings estimate above reflects an acuity-adjusted standard, given 
variability in acuity across facilities, we believe that these savings 
estimates

[[Page 40988]]

provide guidance on the impact of applying the minimum staffing 
requirements independent of a facility's case-mix.
    Table 30 provides the estimated quantifiable benefits annually and 
over 10 years. Since the 0.55 RN HPRD requirement will not go into 
effect until Year 3, we estimate no reduction in Emergency Department 
visits and hospitalizations, as well as increase in discharges to home 
or the community for the first 2 years. Over 10 years, we estimate a 
total of approximately $2.55 billion in Medicare cost savings.
[GRAPHIC] [TIFF OMITTED] TR10MY24.121

    We expect that the 24/7 RN, 3.48 total nurse staff, and 2.45 NA 
HPRD requirements will also bring substantial benefits for residents, 
staff and LTC facilities. As we noted in the statement of need for this 
regulatory impact analysis, there is a positive association between the 
number of hours of care that a resident receives each day and resident 
health and safety.123 124 125 The higher staffing standards 
we are finalizing and the resultant improvements in quality and safety 
will also provide greater assurance to residents' families--an 
important, but difficult to quantify, measure.
---------------------------------------------------------------------------

    \123\ 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/.
    \124\ Harrington, C., Carrillo, H., Garfield, R., Squires, E. 
Nursing Facilities, Staffing, Residents and Facility Deficiencies, 
2009 Through 2016. Apr 03, 2018. Kaiser Family Foundation. Accessed 
at https://www.kff.org/report-section/nursing-facilities-staffing-residents-and-facility-deficiencies-2009-through-2016-staffing-levels/.
    \125\ Min A., Hong, H.C., Effect of nurse staffing on 
rehospitalizations and emergency department visits among short-stay 
nursing home residents: A Cross-sectional study using the U.S. 
Nursing Home Compare database. Geriatr Nurs. 2019 Mar-Apr;40(2):160-
165. doi: 10.1016/j.gerinurse.2018.09.010. Epub. 2018 Oct. 4. PMID: 
30292528.
---------------------------------------------------------------------------

    Research also suggests that there is a positive relationship 
between inadequate staffing and nursing staff burnout, which can lead 
to high employee turnover, and conversely, higher nurse staffing levels 
is associated with lower nurse staff turnover rates, suggesting that 
higher staffing levels will benefit employees by providing a better 
work environment.126 127 LTC facilities are likely to 
benefit from the higher staffing levels in the long-term with a 
reduction in the number of new staff they will need to hire and train, 
and lowered dependence on temporary workers, who often command higher 
hourly wages.
---------------------------------------------------------------------------

    \126\ Kelly, L.A., Gee, P.M., Butler, R.J. 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.
    \127\ Donoghue, C. (2010). Nursing Home Staff Turnover and 
Retention: An Analysis of National Level Data. Journal of Applied 
Gerontology, 29(1), 89-106. https://doi.org/10.1177/0733464809334899.
---------------------------------------------------------------------------

    Lower turnover rates will also benefit residents and LTC facility 
operators. Higher turnover rates are associated with a variety of 
problems in LTC facilities including lower quality of resident care, 
worse performance on claims-based quality measures, a greater 
likelihood of LTC facilities receiving an infection control deficiency 
citation, and more overall survey deficiency citations, while higher 
long-term licensed nurse (RN and LPN) retention rates are correlated 
with lower 30-day rehospitalization rates and higher nursing assistant 
(NA) retention rates are associated with fewer overall deficiency 
citations, quality of care deficiency citations, and deficiencies that 
pose an immediate jeopardy to resident health or 
safety.128 129 130 131 132 133 134
---------------------------------------------------------------------------

    \128\ Harrington, C., Swan, J.H. Nursing home staffing, 
turnover, and case mix. Med. Care Res. Rev. 2003;60(3):366-92; 
discussion 393-9. DOI: 10.1177/1077558703254692.
    \129\ Castle, N.G., Engberg, J. Staff Turnover and Quality of 
Care in Nursing Homes. Medical Care 2005;43(6):616-626.
    \130\ Zheng, Q., Williams, C.S., Shulman, E.T., White, A.J. 
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.
    \131\ Loomer, L., Grabowski, D.C., Yu, H., Gandhi, A. 
Association between nursing home staff turnover and infection 
control citations. Health Serv. Res. 2022;57(2):322-332. DOI: 
10.1111/1475-6773.13877.
    \132\ Lerner, N.B., Johantgen, M., Trinkoff, A.M., Storr, C.L., 
Han, K. Are nursing home survey deficiencies higher in facilities 
with greater staff turnover. J. Am. Med. Dir. Assoc. 2014;15(2):102-
7. DOI: 10.1016/j.jamda.2013.09.003.
    \133\ Thomas, K.S., Mor, V., Tyler, D.A., Hyer, K. The 
relationships among licensed nurse turnover, retention, and 
rehospitalization of nursing home residents. Gerontologist 
2013;53(2):211-21. DOI: 10.1093/geront/gns082.
    \134\ Castle, N.G., Hyer, K., Harris, J.A., Engberg, J. Nurse 
Aide Retention in Nursing Homes. Gerontologist 2020;60(5):885-895. 
DOI: 10.1093/geront/gnz168.
---------------------------------------------------------------------------

    Sources of uncertainty about the benefits of the 24/7 RN, 3.48 
total nurse staff, 0.55 RN, and 2.45 NA HPRD requirements parallel the 
cost uncertainty discussed earlier but with some differences:
    The benefits estimate assumed that LTC facilities needing RNs and/
or NAs to meet these requirements will hire the necessary staff. It 
does not, however,

[[Page 40989]]

take into account how changes in the number of hours per resident day 
of other direct care or support staff that occur in response to the 
finalized requirements might affect the impact that increasing the RN 
HPRD will have on Medicare cost savings. Some research, however, has 
found that when States implemented minimum hour per day requirements 
for direct care staff (RNs, LPNs, and NAs), LTC facilities responded by 
reducing indirect care staff, such as housekeeping, food service, and 
activities staff.135 136 If LTC facilities respond to the 
24/7 RN, 3.48 total nurse staff HPRD, the 0.55 RN HPRD, and the 2.45 NA 
HPRD requirement in similar ways, then benefits of the requirements 
would be lower than what is presented above (see earlier discussion 
about appropriate accounting depending on the consistency between 
benefit and cost analytic approaches).
---------------------------------------------------------------------------

    \135\ Thomas, Kali S., Kathryn Hyer, Ross Andel, and Robert 
Weech-Maldonado. The Unintended Consequences of Staffing Mandates in 
Florida Nursing Homes: Impacts on Indirect-Care Staff, 2010, 
Medicare Care Research and Review, Volume 67, Issue 5, Pages 555-
573.
    \136\ Bowblis, John R., and Kathryn Hyer. Nursing Home Staffing 
Requirements and Input Substitution: Effects on Housekeeping, Food 
Service, and Activities Staff, 2013, Health Services Research, 
Volume 48, Issue 4, Pages: 1539-1550.
---------------------------------------------------------------------------

    The benefits estimate assumed that LTC facilities that exceed the 
24/7 RN, 3.48 total nurse staff, 0.55 RN HPRD, and 2.45 NA HPRD 
requirements would maintain RN, NA, and total staffing at their current 
levels. Research examining how LTC facilities have responded to State 
level staffing mandates provides mixed evidence for this assumption, 
with some research finding no evidence that LTC facilities exceeding 
minimum requirements reduce staffing, while other research suggests 
that they do.\137\ If LTC facilities reduced RN, NA, and total nurse 
staffing levels to a level that is closer to the minimum requirement, 
then benefits would be lower than what is estimated above.
---------------------------------------------------------------------------

    \137\ Chen, Min M., and David C. Grabowski. Intended and 
Unintended Consequences of Minimum Staffing Standards for Nursing 
Homes, 2015, Volume 24, Pages 822-839.
---------------------------------------------------------------------------

    The benefits estimate assumed no real growth in the financial value 
of reduced Emergency Department visits and hospitalizations, as well as 
increase in discharges to home or the community. If, however, the cost 
of Emergency Department visits and hospitalizations grows faster than 
the rate of inflation, then value of these benefits will be higher than 
what we have estimated here.
    The benefit estimates assumed that the nursing home resident 
population will remain stable over the next 10 years. There is some 
evidence, however, that the resident population is declining. CMS Care 
Compare data shows that between February 2017 and February 2024, the 
average number of residents in nursing homes per day declined from 
1,346,712 residents to 1,207,726.\138\ If the resident population 
continues to decrease, then the benefits could be lower than what we 
have estimated. Similarly, if the pattern changes and the nursing home 
resident population increases, the benefits could be higher than what 
we have estimated.
---------------------------------------------------------------------------

    \138\ CMS. (2024). Nursing homes including rehab services 
archived data snapshots. Accessed March 19, 2024. Available at: 
https://data.cms.gov/provider-data/archived-data/nursing-homes.
---------------------------------------------------------------------------

    The benefits estimate assumed that no LTC facilities would obtain 
exemptions from the 24/7 RN, 3.48 total nurse staff HPRD, 0.55 RN HPRD, 
and 2.45 NA HPRD requirements, although some facilities could obtain 
such an exemption. Based only on being located in an area with a nurse 
staffing shortage, a preliminary analysis of the data suggests that 
more than 29 percent of facilities would be eligible for an 8-hour 
exemption from the 24/7 RN requirement and the 0.55 RN HPRD 
requirement, 23 percent of facilities would be eligible for an 
exemption from the 2.45 NA HPRD requirement, and 22 percent of 
facilities would be eligible for an exemption from the 3.48 HPRD total 
nurse staff requirement. Since facilities would also need to meet all 
other requirements to obtain an exemption, however, these numbers are 
not reflective of the number of facilities estimated to fully qualify 
for the exemptions as they only describe the number of facilities that 
would satisfy the workforce availability criterion. Depending on the 
number of facilities that obtain an exemption, the total benefits of 
the rule could be lower than what is presented above.
    States could vary in how they respond to the increased staffing 
requirement, including whether they pay at least some of the additional 
nursing staffing costs with Medicaid funds. Benefits consequences are 
contingent upon such choices. For example, if overall Medicaid spending 
does not increase, but funds are shifted from other uses to increased 
LTC facility staffing, there would be negative health benefits for the 
patients experiencing reduced Medicaid coverage.
d. Transfers Associated With the 24/7 RN and 0.55 RN and 2.45 NA HPRD 
Minimum Staffing Requirements
    We do not estimate transfers associated with the 24/7 RN, 3.48 
total nurse staff HPRD, 0.55 RN HPRD, and the 2.45 NA HPRD minimum 
staffing portion of this rule since there are no requirements that 
Medicare, Medicaid, and other non-Medicare/Medicaid payors increase 
payment rates in response to these requirements.
(5) Medicaid Institutional Payment Transparency Reporting Provision 
Impacts
    Under our authority at sections 1902(a)(6) and (a)(30) of the Act 
with regard to fee-for-service delivery systems, and sections 
1902(a)(4) and 1932(c) of the Act with regard to managed care delivery 
systems, we are finalizing new reporting requirements at Sec.  
442.43(b) and (c) for States to report annually by facility on the 
percent of payments for Medicaid-covered services delivered by nursing 
facilities and ICFs/IID that are spent on compensation for direct care 
workers and support staff.
    As finalized, States are required to report annually to CMSs on the 
percent of payments for nursing facility and ICF/IID services that are 
spent on compensation for direct care workers and support staff. We are 
finalizing that States are required to post all reported data on a 
State-maintained website (or link to such information on an MCO's or 
PIHP's website, as applicable), which States must ensure is reviewed 
quarterly to verify the accurate function of the website and that the 
information remains accurate and up to date. We believe that gathering 
and sharing data about the amount of Medicaid dollars that are going to 
the compensation of workers is a critical step in the larger effort to 
understand the ways we can enact policies that support the 
institutional care workforce and thereby help advance access to high 
quality care for Medicaid beneficiaries.
a. Costs of Medicaid Institutional Payment Transparency Reporting
    The following discussion is based on costs to States, the Federal 
Government, and providers that were summarized in table 24 and 
described in detail in the Collection of Information (section V. of 
this final rule). As outlined in section V., we estimate one-time 
implementation costs of $838,475 for States to come into compliance 
with the reporting requirements finalized at Sec.  442.43(b) and (c). 
As discussed in section V., the Federal Government, through Federal 
Financial Participation,

[[Page 40990]]

has a share in Medicaid expenditures, which for the purposes of these 
burden estimates is 50 percent of Medicaid expenditures. Thus, we 
estimate the one-time costs of the reporting requirement finalized at 
Sec.  442.43(b) and (c) as $419,237 for States and $419,237 for the 
Federal Government. We estimate an annual total cost of $97,470 once 
the reporting requirement goes into effect; again, as the costs will be 
split between States and the Federal Government, we estimate the annual 
ongoing costs as $48,735 for States and $48,735 for the Federal 
Government. A breakdown of these figures may be found in tables 18 and 
19 in the Collection of Information (section V. of this final rule.)
    Additionally, under finalized Sec.  442.43(d), States are required 
to make this information available on a public website; as outlined in 
the Collection of Information (section V. of this rule), we estimate a 
one-time implementation costs of $239,333 for States to come into 
compliance with this requirement; as the costs will be split between 
States and the Federal Government, we estimate the one-time cost for 
States as $119,667 and $119,667 for the Federal Government. We estimate 
an ongoing annual cost of $295,527 once reporting starts; as the costs 
will be split between States and the Federal Government, we estimate 
the one-time cost as $147,764 for States and $147,764 for the Federal 
Government. A breakdown of these figures may be found in tables 22 and 
23 in section V.
    The total State and Federal costs for both the reporting and 
website requirements are thus estimated at $1,077,808 for 
implementation costs ($838,475 + $239,333) and $392,997 ongoing annual 
costs once the reporting starts ($97,470 + $295,527).
    As discussed in the Collection of Information (section V. of this 
rule), we estimate that the total cost to providers to prepare for 
compliance with the reporting requirement finalized at Sec.  442.43(b) 
and (c) will be $36,560,002, and an annual total cost to providers of 
$17,912,717. A breakdown of these figures may be found in tables 30 and 
31 in section V.
    We do not estimate a cost to providers for the website posting 
requirement finalized at Sec.  442.43(d). We also do not anticipate 
costs to beneficiaries associated with these requirements.
    Table 31 provides a detailed summary of the estimated costs of each 
of the requirements for States, the Federal Government, and providers. 
Table 32 summarizes the estimated costs of the requirements in Sec.  
442.43 for States, the Federal Government, and providers (Nursing Care 
Facilities (NAICS 623110) and Residential Intellectual and 
Developmental Disabilities Facilities (NAICS 623210)), over 10 years. 
Aside from regulatory review costs (discussed in the next section) this 
comprises the entirety of anticipated quantifiable costs associated 
with the finalized changes to part 442, subpart B. The implementation 
costs associated with the finalized reporting and website posting 
requirements are split evenly over the years leading up to the 
finalized effective date, which is 4 years from this final rule's 
publication. For States and the Federal Government, this means that the 
implementation costs are represented as $107,736 per year for 4 years 
($430,942 estimated implementation costs/4 years). For providers, the 
implementation costs are represented as $9,140,000 per year for 4 years 
($36,560,002 estimated implementation costs/4 years). We also 
anticipate that once the rule goes into effect in Year 5, the ongoing 
annual costs will be relatively stable. We have shown the recurring 
annual estimate for Years 5 to 10 in table 32. The estimates below do 
not account for higher costs associated with medical care; the costs 
calculated here are related exclusively to reporting and website 
posting costs. Per OMB guidelines, the projected estimates for future 
years are reported in real (inflation-indexed) dollars.
    As discussed in the Collection of Information (section V. of this 
rule), costs were based on: (1) the number of States (including 
Washington, DC, and certain territories) that currently operate 
Medicaid programs that cover nursing facility or ICF/IID services; (2) 
the number of States that deliver long-term services and supports 
through a managed care delivery system; and (3) the total number of 
freestanding Medicaid-certified nursing facility and ICF/IID facilities 
in all States. We do not anticipate the number of entities changing 
significantly over the 10 years included in the cost calculations.
[GRAPHIC] [TIFF OMITTED] TR10MY24.122


[[Page 40991]]


[GRAPHIC] [TIFF OMITTED] TR10MY24.123

b. Benefits of Medicaid Institutional Payment Transparency Reporting
    Our finalized requirements are intended to support the sufficiency 
of the direct care and support staff workforce through public reporting 
of compensation to these workers. While we believe this finalized 
provision will provide benefits, we are not able to quantify these 
benefits at this time.
    There are many factors that contribute to understaffing in 
institutional settings. We are constantly seeking opportunities to 
address these challenges through guidance, policies, and rulemaking. 
These finalized requirements are intended to promote transparency 
around compensation for direct care workers and support staff. We 
believe that gathering and sharing data about the amount of Medicaid 
payments going to the compensation of workers is a critical step in the 
larger effort to understand the ways we can enact future policies that 
support the institutional care workforce.
c. Transfers Associated With Medicaid Institutional Payment 
Transparency Reporting
    We do not estimate transfers associated with these finalized 
provisions.

D. Alternative Direct Care Staff HPRD Requirement Considered

    As detailed earlier in this final rule, despite the existing 
requirements and the efforts to improve safety, as well as residents' 
quality of care and quality of life through the revisions in the 2016 
final rule, understaffing in LTC facilities continues to be a concern. 
We believe the changes we are finalizing are consistent with current 
standards of practice and necessary to increase resident safety and 
quality of care. We acknowledge, however, that there were multiple 
avenues for establishing a minimum nurse staffing requirement and in 
the proposed rule we solicited comments on alternative policy options, 
including a specific comment solicitation in the ``Provisions of the 
Proposed Regulation'' section.
    In developing the final rule, we considered varying staffing models 
that were available and different approaches we could have adopted for 
the proposed minimum nurse staffing requirement. We could have adopted 
multiple different types of combinations of a staffing requirement such 
as separate requirements for RNs, LVNs/LPNs, and NAs or creating 
standards for NAs only. We could also have implemented individual HPRD 
requirements for RNs and NAs together with a 24/7 RN requirement but 
excluded any requirement for an overall nurse staffing HPRD level, 
which was a policy discussed in detail in the proposed rule. 
Alternatively, we could have adopted non-nurse staffing requirements 
such as social workers, therapists, feeding assistants and other non-
nurse staffing types in the minimum staffing requirement. Alternative 
minimum staffing policy options could have also focused on the need to 
increase or decrease the number of HPRD or FTEs by nurse staff and/or 
type or on specifying the number of staff by shift (including day, 
evening, night, or weekends or over a 24-hour period).
    Ultimately, we chose the comprehensive 24/7 RN, 3.48 total nurse 
staff HPRD, 0.55 RN HPRD, and 2.45 NA HPRD requirements in this final 
rule to strike a balance between ensuring resident health and safety, 
while preserving access to care, including discharge to community-based 
services. We considered a staffing standard that would maintain the 24/
7 RN and 2.45 NA HPRD requirements but would have a lower RN HPRD 
requirement. We found, however, that even a small reduction in the RN 
HPRD requirement compared to baseline RN HPRD levels that are in the 
two lowest deciles for nursing homes nationwide would lead to a large 
decline in quality of care. For example, the 2022 Nursing Home Staffing 
Study \139\ found that reducing the case-mix adjusted RN HPRD 
requirement to between 0.45 and 0.52 hours per resident day would lead 
the staffing standard to have a smaller impact on Medicare savings, 
reduced hospitalizations and ED visits, and fewer community discharges. 
More specifically, the number of reduced hospitalizations would decline 
from 10,445 to 5,781, the number of reduced ED visits would decline 
from 7,525 to 4,466, increased community discharges would decline from 
5,798 to 3,930, and Medicare savings would decline by more than $130 
million annually. We also considered alternative minimum staffing 
requirements at the same level we are finalizing but with a longer 
phase-in period for the 3.48 total nurse staff HPRD requirement. We 
ultimately decide to provide a shorter phase-in period for the 3.48 
total nurse staff HPRD requirement to ensure resident health and 
safety.
2. Medicaid Institutional Payment Transparency Reporting
    We considered, but did not finalize, a proposal to require States 
to report per diem FFS rate for nursing facility and ICF/IID services; 
we did not finalize this proposal as we believed it would duplicate 
other reporting requirements.

[[Page 40992]]

We also considered, but did not finalize, a proposal to require States 
to report on median hourly wage and to require that States report data 
by job title. We did not finalize this proposal because we expected 
that this would increase reporting burden for States and providers 
without giving us additional information necessary for determining the 
percent of payments that are going to the workforce.

E. Regulatory Review Costs

1. Regulatory Review Costs of 24/7 RN, 3.48 Total Nurse Staff, 0.55 RN 
and 2.45 NA HPRD Minimum Nurse Staffing Requirements
    If the 24/7 RN and the Minimum Nurse staffing requirements impose 
administrative costs on private entities, such as the time needed to 
read and interpret this final rule, we should estimate the cost 
associated with regulatory review. As discussed in the Collection of 
Information (section V. of this final rule), 14,688 LTC facilities will 
be impacted by the finalized requirements. We assume that all 14,688 
LTC facilities will proactively review this final rule. (We note that 
the FY 2023 SNF PPS proposed rule, 87 FR 22720, had around 18,000 
views, as shown at https://www.federalregister.gov/documents/2022/04/15/2022-07906/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities. Some of these 
views were likely multiple views by the same reader.) We acknowledge 
that this assumption may understate the costs of reviewing this rule. 
It is possible that there may be more than one individual reviewing the 
rule for some LTC facilities. It is also possible that entities other 
than LTC facilities, such as beneficiary advocacy groups, may review 
this rule.
    We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of some final rules, or 
that some entities may not find it necessary to fully read each rule, 
and therefore for the purposes of our estimate we assume that each 
reviewer will read approximately 50 percent of the section of the rule 
discussing the 24/7 RN requirement and the 3.48 total nurse staff, 0.55 
RN, and 2.45 NA HPRD requirements.
    Using the wage information from the Bureau of Labor Statistics, May 
2022 National Occupational Employment and Wage Estimates, https://www.bls.gov/oes/current/oes_nat.htm, for medical and health service 
managers (Code 11-9111), we estimate that the cost of reviewing this 
rule is $123.06 per hour, including overhead and fringe benefits. 
Assuming an average reading speed of 250 words per minute, and assuming 
that two-thirds (67 percent) of this final rule pertains to the 24/7 
RN, 3.48 total nurse staff HPRD, 0.55 RN HPRD, and 2.45 NA HPRD 
requirements, with approximately 40,000 words (of which we estimate 
20,000 words will be read by reviewers), we estimate that it would take 
80 minutes or 1.33 hours for the staff to review all the sections of 
the final rule pertaining to the 24/7 RN and the 3.48 total nurse staff 
HPRD, 0.55 RN HPRD, and 2.45 NA HPRD requirements. For each employee 
that reviews the rule, the estimated cost is $163.67 (1.33 hours x 
$123.06). Therefore, we estimate that the total one-time cost of 
reviewing this regulation is $2,403,985 ($163.67 x 14,688).
2. Regulatory Review Costs of Medicaid Institutional Payment 
Transparency Reporting
    As discussed in the Collection of Information (section IV. of the 
proposed rule at 88 FR 61393 and 61395), 54 State Medicaid agencies and 
approximately 19,907 nursing facilities and ICFs/IID would be impacted 
by the requirements, totaling 19,961 interested parties. We note that 
there was an error in the proposed rule at 88 FR 64124 that stated 
incorrectly that 52, rather than 54 State Medicaid agencies were 
affected by the rule; we have corrected that figure here.
    As discussed in the proposed rule at 88 FR 64124, we estimated that 
75 percent of these affected entities would proactively review the 
final rule. We welcomed any comments on this approach but did not 
receive any comments. Therefore, we are calculating the regulatory 
review burden associated with the provision finalized at Sec.  442.43 
using this assumption. We estimate that 14,971 entities read the rule 
for the purpose of reviewing the provision finalized at Sec.  442.43 
([54 + 19,907] x 75 percent.)
    Using the wage information from the Bureau of Labor Statistics, May 
2022 National Occupational Employment and Wage Estimates, https://www.bls.gov/oes/current/oes_nat.htm, for medical and health service 
managers (Code 11-9111), we estimated that the cost of reviewing this 
rule is $123.06 per hour, including overhead and fringe benefits. 
Assuming an average reading speed of 250 words per minute, and assuming 
that one-third of this rule pertains to Medicaid Institutional Payment 
Transparency Reporting, with approximately 20,000 words (of which we 
estimated 10,000 words were read by reviewers), we estimated that it 
would take 40 minutes or 0.67 hours for the staff to review portions of 
the sections of the final rule pertaining to the Medicaid Institutional 
Payment Transparency Reporting. For each employee that reviewed the 
rule, the estimated cost is $82.45 (0.67 hours x $123.06). Therefore, 
we estimated that the total one-time cost of reviewing this regulation 
is $1,234,359 ($82.45 x 14,971).
    Table 33 provides the total estimated regulatory review costs for 
the rule, which is $3,638,344.
[GRAPHIC] [TIFF OMITTED] TR10MY24.124

F. Accounting Statement

    As required by OMB Circular A-4 (available online at https://obamawhitehouse.archives.gov/omb/circulars_a004_a-4/), we have prepared 
an accounting statement in table 34 showing classification of the costs 
and benefits associated with the provisions of this final rule. This 
includes the total cost for the 24/7 RN and the 3.48 total nurse staff 
HPRD, 0.55 RN HPRD, and 2.45 NA HPRD requirements as provided in table 
22, the total cost for the Medicaid Institutional Transparency 
Reporting as provided in table 18, the total cost for the regulatory 
review as provided in table 33, and Medicare savings due to fewer 
hospitalizations

[[Page 40993]]

and emergency department visits, as well as greater return to home and 
community, as provided in table 30. There are $0 in transfer estimates 
in the statement. This statement provides our best estimate for the 
Medicare and Medicaid provisions of this rule.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR10MY24.125

BILLING CODE 4120-01-C

G. Regulatory Flexibility Act Analysis (RFA)

    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. For purposes of the RFA, we estimate that 
almost all Skilled Nursing Facilities (NAICS 6231) and Intellectual and 
Developmental Disabilities Facilities (NAICS 6232) are small entities, 
as that term is used in the RFA (including small businesses, nonprofit 
organizations, and small governmental jurisdictions). The great 
majority of hospitals and most other health care providers and 
suppliers are small entities, either by being nonprofit organizations 
or by meeting the Small Business Administration (SBA)

[[Page 40994]]

definition of a small business (that is, having revenues of less than 
$9.0 million to $47.0 million in any 1 year).
    We utilized the revenues of individual SNF providers (from recent 
Medicare Cost Reports) to classify a small business, and not the 
revenue of a larger firm with which they may be affiliated. As a 
result, for the purposes of the RFA, we estimate that almost all SNFs 
are small entities as that term is used in the RFA, according to the 
Small Business Administration's latest size standards, with total 
revenues of $34 million or less in any 1 year. In addition, 
approximately 20 percent of SNFs classified as small entities are non-
profit organizations. Therefore, approximately 95 percent of the health 
care entities impacted are considered small businesses according to the 
Small Business Administration's size standards with total revenues of 
$47 million or less in any 1 year. Individuals and States are not 
included in the definition of a small entity. According to the 2017 
Economic Census, Skilled Nursing Facilities (NAICS 6231) and 
Intellectual and Development Disabilities Facilities (NAICS 6232) 
together earned approximately $162 billion annually, with Skilled 
Nursing Facilities earning nearly $119 billion and Intellectual and 
Development Disabilities Facilities earning approximately $44 billion. 
Overall, the cost is estimated to be between 2.30 and 2.42 percent of 
revenues.
    Adjusting this amount for inflation, as measured by the Consumer 
Price Index, combined revenues in 2021 Dollars are approximately $179.5 
billion. Overall, the cost is estimated to be between 2.23 and 2.32 
percent of revenues.
[GRAPHIC] [TIFF OMITTED] TR10MY24.150

    This rule will not have a significant impact as measured by a 
change in revenue of 3 to 5 percent on a substantial number of small 
businesses or other small entities. As its measure of significant 
economic impact on a substantial number of small entities, HHS uses a 
change in revenue of more than 3 to 5 percent. At this time, we do not 
believe that this threshold will be reached by the requirements in this 
final rule. Therefore, the Secretary has certified that this final rule 
will not have a significant economic impact on a substantial number of 
small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis if a rule may have a significant impact on 
the operations of a substantial number of small rural hospitals. This 
analysis must conform to the provisions of section 604 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of an MSA and has fewer 
than 100 beds. These proposals pertain solely to SNFs and NFs. 
Therefore, the Secretary has determined that these provisions will not 
have a significant impact on the operations of a substantial number of 
small rural hospitals.

H. Unfunded Mandates Reform Act Analysis

    Section 202 of the Unfunded Mandates Reform Act (UMRA) of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2023, that 
threshold is approximately $183 million. Based on the cost estimates 
discussed in this section, we have assessed the various costs and 
benefits of the final updates to the requirements for participation for 
LTC facilities. These final updates will not impose new requirements 
for State, local, or Tribal governments. For the private sector 
facilities, the regulatory impact section, together with the remainder 
of the preamble, constitutes the analysis required under UMRA.

I. Federalism Analysis

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a final rule that imposes substantial 
direct requirement costs on State and local governments, preempts State 
law, or otherwise has federalism implications. With regard to the 
updates to the requirements for participation for LTC facilities, the 
provisions in this final rule are not intended to, and would not 
preempt the applicability of any State or local law providing a higher 
standard (in this case, a higher HPRD requirement for total nurse 
staff, RNs and/or NAs or an RN coverage requirement in excess of at 
least one RN on site 24-hours per day, 7 days a week) than we are 
requiring in this final rule. To the extent Federal standards exceed 
State and local law minimum staffing standards, no Federal pre-emption 
is implicated because facilities complying with Federal law would also 
be in compliance with State law. We are not aware of any State or local 
law providing for a maximum staffing level. This final rule, however, 
is intended to and would preempt the applicability of any State or 
local law providing for a maximum staffing level, to the extent that 
such a State or local maximum staffing level would prohibit a Medicare, 
Medicaid, or dually certified LTC facility from meeting the minimum 
HPRD requirements and RN coverage levels finalized in this rule or from 
meeting higher staffing levels required based on the facility 
assessment provisions finalized in this rule.
    In accordance with the provisions of Executive Order 12866, this 
final rule was reviewed by the Office of Management and Budget.
    Chiquita Brooks-LaSure, Administrator of the Centers for

[[Page 40995]]

Medicare & Medicaid Services, approved this document on April 10, 2024.

List of Subjects

42 CFR Part 438

    Administrative practice and procedure, Grant programs--health, 
Health professions, Medicaid, Older adults, People with disabilities, 
Reporting and recordkeeping requirements.

42 CFR Part 442

    Administrative practice and procedure, Grant programs--health, 
Health professions, Medicaid, Older adults, People with disabilities, 
Reporting and recordkeeping requirements.

42 CFR Part 483

    Grant programs--health, Health facilities, Health professions, 
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting 
and recordkeeping requirements, Safety.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 438--MANAGED CARE

0
1. The authority citation for part 438 continues to read as follows:

    Authority: 42 U.S.C. 1302.


0
2. Section 438.72 is added to subpart B to read as follows:


Sec.  438.72  Additional requirements for long-term services and 
supports.

    (a) Nursing facility services and services delivered in 
intermediate care facilities for individuals with intellectual 
disabilities (ICFs/IID). The State must comply with the requirements in 
Sec.  442.43 for nursing facility and ICF/IID services.
    (b) [Reserved]

PART 442--STANDARDS FOR PAYMENT TO NURSING FACILITIES AND 
INTERMEDIATE CARE FACILITIES FOR INDIVIDUALS WITH INTELLECTUAL 
DISABILITIES

0
3. The authority citation for part 442 is revised to read as follows:

    Authority: 42 U.S.C. 1302.


0
4. Section 442.43 is added to subpart B to read as follows:


Sec.  442.43  Payment transparency reporting.

    (a) Definitions. (1) Compensation means, with respect to direct 
care workers and support staff delivering services authorized under 
this part:
    (i) Salary, wages, and other remuneration as defined by the Fair 
Labor Standards Act and implementing regulations (29 U.S.C. 201 et 
seq., 29 CFR parts 531 and 778);
    (ii) Benefits (such as health and dental benefits, life and 
disability insurance, paid leave, retirement, and tuition 
reimbursement); and
    (iii) The employer share of payroll taxes.
    (2) Direct care worker means one of the following individuals who 
provides services to Medicaid-eligible individuals receiving services 
under this part, who may be employed by or contracted or subcontracted 
with a Medicaid provider or State or local government agency:
    (i) A registered nurse, licensed practical nurse, nurse 
practitioner, or clinical nurse specialist;
    (ii) A certified nurse aide who provides services under the 
supervision of a registered nurse, licensed practical nurse, nurse 
practitioner, or clinical nurse specialist;
    (iii) A licensed physical therapist, occupational therapist, 
speech-language pathologist, or respiratory therapist;
    (iv) A certified physical therapy assistant, occupational therapy 
assistant, speech-language therapy assistant, or respiratory therapy 
assistant or technician;
    (v) A social worker;
    (vi) A direct support professional;
    (vii) A personal care aide;
    (viii) A medication assistant, aide, or technician;
    (ix) A feeding assistant;
    (x) Activities staff; or
    (xi) Any other individual who is paid to provide clinical services, 
behavioral supports, active treatment (as defined at Sec.  483.440 of 
this chapter) or address activities of daily living (such as those 
described in Sec.  483.24(b) of this chapter) for Medicaid-eligible 
individuals receiving Medicaid services under this part, including 
nurses and other staff providing clinical supervision.
    (3) Support staff means an individual who is not a direct care 
worker and who maintains the physical environment of the care facility 
or supports other services for residents. Support staff may be employed 
by or contracted or subcontracted with a Medicaid provider or State or 
local government agency. They include any of the following individuals:
    (i) A housekeeper;
    (ii) A janitor or environmental services worker;
    (iii) A groundskeeper;
    (iv) A food service or dietary worker;
    (v) A driver responsible for transporting residents;
    (vi) A security guard; or
    (vii) Any other individual who is not a direct care worker and who 
maintains the physical environment of the care facility or supports 
other services for Medicaid-eligible individuals receiving Medicaid 
services under this part.
    (4) Excluded costs means costs reasonably associated with 
delivering Medicaid-covered nursing facility or ICF/IID services that 
are not included in the calculation of the percentage of Medicaid 
payments to providers that is spent on compensation for direct care 
workers and support staff. Such costs are limited to:
    (i) Costs of required trainings for direct care workers and support 
staff (such as costs for qualified trainers and training materials);
    (ii) Travel costs for direct care workers and support staff (such 
as mileage reimbursement or public transportation subsidies); and
    (iii) Costs of personal protective equipment for facility staff.
    (b) Reporting requirements. The State must report to CMS annually, 
by facility, the percentage of Medicaid payments (not including 
excluded costs) for services specified in paragraph (b)(1) of this 
section, that is spent on compensation for direct care workers and on 
compensation for support staff, at the time and in the form and manner 
specified by CMS. For the purposes of this part, Medicaid payment for 
fee-for-service (FFS) includes base and supplemental payments as 
defined in section 1903(bb)(2) of the Social Security Act, and for 
payments from a managed care organization (MCO) or prepaid inpatient 
health plan (PIHP) (as these entities are defined in Sec.  438.2 of 
this chapter) includes the MCO's or PIHP's contractually negotiated 
rate, State directed payments as defined in Sec.  438.6(c) of this 
chapter, pass-through payments as defined in Sec.  438.6(a) of this 
chapter for nursing facilities, and any other payments from the MCO or 
PIHP.
    (1) Services. Except as provided in paragraphs (b)(2) and (3) of 
this section, reporting must be based on all Medicaid payments 
(including but not limited to FFS base and supplemental payments, and 
payments from an MCO or PIHP, as applicable) made to nursing facility 
and ICF/IID providers for Medicaid-covered services, with the exception 
of services provided in swing bed hospitals as defined in Sec.  
440.40(a)(1)(ii)(B) of this chapter.
    (2) Exclusion of specified payments. The State must exclude from 
its reporting to CMS payments claimed by the State for Federal 
financial participation under this part for which Medicaid is not the 
primary payer.

[[Page 40996]]

    (3) Exclusion of data from the Indian Health Service and Tribal 
health programs. States must exclude data from the Indian Health 
Service and Tribal health programs subject to the requirements at 25 
U.S.C. 1641 from the reporting required in paragraph (b) of this 
section.
    (c) Report contents and methodology--(1) Contents. Reporting must 
provide information necessary to identify, at the facility level, the 
percent of Medicaid payments spent on compensation to:
    (i) Direct care workers at each nursing facility;
    (ii) Support staff at each nursing facility;
    (iii) Direct care workers at each ICF/IID; and
    (iv) Support staff at each ICF/IID.
    (2) Methodology. The State must provide information according to 
the methodology, form, and manner of reporting stipulated by CMS.
    (d) Availability and accessibility requirements. The State must 
operate a website consistent with Sec.  435.905(b) of this chapter that 
provides the results of the reporting requirements specified in 
paragraphs (b) and (c) of this section. In the case of a State that 
implements a managed care delivery system under the authority of 
sections 1915(a), 1915(b), 1932(a), and/or 1115(a) of the Act and that 
includes nursing facility and/or ICF/IID services in their MCO or PIHP 
contracts, the State may meet this requirement by linking to individual 
MCO's or PIHP's websites. The State must:
    (1) Include clear and easy to understand labels on documents and 
links;
    (2) Verify no less than quarterly, the accurate function of the 
website and the current accuracy of the information and links; and
    (3) Include prominent language on the website explaining that 
assistance in accessing the required information on the website is 
available at no cost and include information on the availability of 
oral interpretation in all languages and written translation available 
in each non-English language, how to request auxiliary aids and 
services, and a toll-free and TTY/TDY telephone number.
    (e) Information reported by States. CMS must report on its website 
the results of the reporting requirements specified in paragraphs (b) 
and (c) of this section that the State reports to CMS.
    (f) Applicability date. States must comply with the requirements in 
this section beginning 4 years after June 21, 2024; and in the case of 
the State that implements a managed care delivery system under the 
authority of section 1915(a), 1915(b), 1932(a), or 1115(a) of the Act 
and includes nursing facility services or ICF/IID services, the first 
rating period for contracts with the MCO or PIHP beginning on or after 
4 years after June 21, 2024.

PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES

0
5. The authority citation for part 483 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r.


0
6. Section 483.5 is amended by adding the definitions of ``Hours per 
resident day'' and ``Representative of direct care employees'' in 
alphabetical order to read as follows:


Sec.  483.5  Definitions.

* * * * *
    Hours per resident day. 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.
* * * * *
    Representative of direct care employees. A representative of direct 
care employees is an employee of the facility or a third party 
authorized by direct care employees at the facility to provide 
expertise and input on behalf of the employees for the purposes of 
informing a facility assessment.
* * * * *

0
7. Section 483.10 is amended by revising paragraph (h)(3)(i) to read as 
follows:


Sec.  483.10  Resident rights.

* * * * *
    (h) * * *
    (3) * * *
    (i) The resident has the right to refuse the release of personal 
and medical records except as provided at Sec.  483.70(h)(2) or other 
applicable Federal or State laws.
* * * * *

0
8. Section 483.15 is amended by revising paragraph (c)(8) to read as 
follows:


Sec.  483.15  Admission, transfer, and discharge rights.

* * * * *
    (c) * * *
    (8) Notice in advance of facility closure. In the case of facility 
closure, the individual who is the administrator of the facility must 
provide written notification prior to the impending closure to the 
State Survey Agency, the Office of the State Long-Term Care Ombudsman, 
residents of the facility, and the resident representatives, as well as 
the plan for the transfer and adequate relocation of the residents, as 
required at Sec.  483.70(k).
* * * * *

0
9. Section 483.35 is revised to read as follows:


Sec.  483.35  Nursing services.

    The facility must have sufficient nursing staff with the 
appropriate competencies and skills sets to provide nursing and related 
services to assure resident safety and attain or maintain the highest 
practicable physical, mental, and psychosocial well-being of each 
resident, as determined by resident assessments and individual plans of 
care and considering the number, acuity, and diagnoses of the 
facility's resident population in accordance with the facility 
assessment required at Sec.  483.71.
    (a) Sufficient staff. (1) The facility must provide services by 
sufficient numbers of each of the following types of personnel on a 24-
hour basis to provide nursing care to all residents in accordance with 
resident care plans:
    (i) Except when waived under paragraph (f) of this section, 
licensed nurses; and
    (ii) Other nursing personnel, including but not limited to nurse 
aides.
    (2) Except when waived under paragraph (f) of this section, the 
facility must designate a licensed nurse to serve as a charge nurse on 
each tour of duty.
    (3) The facility must ensure that licensed nurses have the specific 
competencies and skill sets necessary to care for residents' needs, as 
identified through resident assessments, and described in the plan of 
care.
    (4) Providing care includes but is not limited to assessing, 
evaluating, planning, and implementing resident care plans and 
responding to resident's needs.
    (b) Total nurse staffing (licensed nurses and nurse aides). (1) The 
facility must meet or exceed a minimum of 3.48 hours per resident day 
for total nurse staffing including but not limited to--
    (i) A minimum of 0.55 hours per resident day for registered nurses; 
and
    (ii) A minimum of 2.45 hours per resident day for nurse aides.
    (2) One or more of the hours per resident day requirements at 
paragraph (b)(1) of this section may be exempted for facilities found 
non-compliant and who meet the eligibility criteria defined at 
paragraph (h) of this section as determined by the Secretary.
    (3) Compliance with minimum total nurse staffing hours per resident 
day as

[[Page 40997]]

set forth in one or more of the hours per resident day requirements of 
paragraph (b)(1) of this section should not be construed as approval 
for a facility to staff only to these numerical standards. Facilities 
must ensure there are a sufficient 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 at Sec.  483.71.
    (c) Registered nurse. (1) Except when waived or exempted under 
paragraph (f), (g), or (h) of this section, the facility must have a 
registered nurse (RN) onsite 24 hours per day, for 7 days a week that 
is available to provide direct resident care.
    (2) For any periods when the onsite RN requirements in paragraph 
(c)(1) of this section are exempted under paragraph (h) of this 
section, facilities must have a registered nurse, nurse practitioner, 
physician assistant, or physician available to respond immediately to 
telephone calls from the facility.
    (3) Except when waived under paragraph (f) or (g) of this section, 
the facility must designate a registered nurse to serve as the director 
of nursing on a full time basis.
    (4) The director of nursing may serve as a charge nurse only when 
the facility has an average daily occupancy of 60 or fewer residents.
    (d) Proficiency of nurse aides. The facility must ensure that nurse 
aides are able to demonstrate competency in skills and techniques 
necessary to care for residents' needs, as identified through resident 
assessments, and described in the plan of care.
    (e) Requirements for facility hiring and use of nursing aides--(1) 
General rule. A facility must not use any individual working in the 
facility as a nurse aide for more than 4 months, on a full-time basis, 
unless--
    (i) That individual is competent to provide nursing and nursing 
related services; and
    (ii)(A) That individual has completed a training and competency 
evaluation program, or a competency evaluation program approved by the 
State as meeting the requirements of Sec. Sec.  483.151 through 
483.154; or
    (B) That individual has been deemed or determined competent as 
provided in Sec.  483.150(a) and (b).
    (2) Non-permanent employees. A facility must not use on a 
temporary, per diem, leased, or any basis other than a permanent 
employee any individual who does not meet the requirements in 
paragraphs (e)(1)(i) and (ii) of this section.
    (3) Minimum competency. A facility must not use any individual who 
has worked less than 4 months as a nurse aide in that facility unless 
the individual--
    (i) Is a full-time employee in a State-approved training and 
competency evaluation program;
    (ii) Has demonstrated competence through satisfactory participation 
in a State-approved nurse aide training and competency evaluation 
program or competency evaluation program; or
    (iii) Has been deemed or determined competent as provided in Sec.  
483.150(a) and (b).
    (4) Registry verification. Before allowing an individual to serve 
as a nurse aide, a facility must receive registry verification that the 
individual has met competency evaluation requirements unless--
    (i) The individual is a full-time employee in a training and 
competency evaluation program approved by the State; or
    (ii) The individual can prove that he or she has recently 
successfully completed a training and competency evaluation program or 
competency evaluation program approved by the State and has not yet 
been included in the registry. Facilities must follow up to ensure that 
such an individual actually becomes registered.
    (5) Multi-State registry verification. Before allowing an 
individual to serve as a nurse aide, a facility must seek information 
from every State registry established under section 1819(e)(2)(A) or 
1919(e)(2)(A) of the Act that the facility believes will include 
information on the individual.
    (6) Required retraining. If, since an individual's most recent 
completion of a training and competency evaluation program, there has 
been a continuous period of 24 consecutive months during none of which 
the individual provided nursing or nursing-related services for 
monetary compensation, the individual must complete a new training and 
competency evaluation program or a new competency evaluation program.
    (7) Regular in-service education. The facility must complete a 
performance review of every nurse aide at least once every 12 months, 
and must provide regular in-service education based on the outcome of 
these reviews. In-service training must comply with the requirements of 
Sec.  483.95(g).
    (f) Nursing facilities: Waiver of requirement to provide licensed 
nurses and a registered nurse on a 24-hour basis. To the extent that a 
facility is unable to meet the requirements of paragraphs (a)(1), 
(b)(1)(i), and (c)(1) of this section, a State may waive such 
requirements with respect to the facility if--
    (1) The facility demonstrates to the satisfaction of the State that 
the facility has been unable, despite diligent efforts (including 
offering wages at the community prevailing rate for nursing 
facilities), to recruit appropriate personnel;
    (2) The State determines that a waiver of the requirement will not 
endanger the health or safety of individuals staying in the facility;
    (3) The State finds that, for any periods in which licensed nursing 
services are not available, a registered nurse or a physician is 
obligated to respond immediately to telephone calls from the facility;
    (4) A waiver granted under the conditions listed in this paragraph 
(f) is subject to annual State review;
    (5) In granting or renewing a waiver, a facility may be required by 
the State to use other qualified, licensed personnel;
    (6) The State agency granting a waiver of such requirements 
provides notice of the waiver to the Office of the State Long-Term Care 
Ombudsman (established under section 712 of the Older Americans Act of 
1965) and the protection and advocacy system in the State for 
individuals with a mental disorder who are eligible for such services 
as provided by the protection and advocacy agency; and
    (7) The nursing facility that is granted such a waiver by a State 
notifies residents of the facility and their resident representatives 
of the waiver.
    (g) SNFs: Waiver of the requirement to provide services of a 
registered nurse for at least 112 hours a week. (1) The Secretary may 
waive the requirement that a SNF provide the services of a registered 
nurse for more than 40 hours a week, including a director of nursing 
specified in paragraph (c) of this section, if the Secretary finds 
that--
    (i) The facility is located in a rural area and the supply of 
skilled nursing facility services in the area is not sufficient to meet 
the needs of individuals residing in the area;
    (ii) The facility has one full-time registered nurse who is 
regularly on duty at the facility 40 hours a week; and
    (iii) The facility either--
    (A) Has only patients whose physicians have indicated (through 
physicians' orders or admission notes) that they do not require the 
services of

[[Page 40998]]

a registered nurse or a physician for a 48-hours period; or
    (B) Has made arrangements for a registered nurse or a physician to 
spend time at the facility, as determined necessary by the physician, 
to provide necessary skilled nursing services on days when the regular 
full-time registered nurse is not on duty;
    (iv) The Secretary provides notice of the waiver to the Office of 
the State Long-Term Care Ombudsman (established under section 712 of 
the Older Americans Act of 1965) and the protection and advocacy system 
in the State for individuals with developmental disabilities or mental 
disorders; and
    (v) The facility that is granted such a waiver notifies residents 
of the facility and their resident representatives of the waiver.
    (2) A waiver of the registered nurse requirement under paragraph 
(g)(1) of this section is subject to annual renewal by the Secretary.
    (h) Hardship exemptions from the minimum hours per resident day and 
registered nurse onsite 24 hours per day, for 7 days a week 
requirements. A facility may be exempted by the Secretary from one or 
more of the requirements of paragraphs (b)(1) and (c)(1) of this 
section if a verifiable hardship exists that prohibits the facility 
from achieving or maintaining compliance. The facility must meet the 
four following criteria to qualify for and receive a hardship 
exemption:
    (1) Location. The facility is located in an area where the supply 
of applicable healthcare staff (RN, nurse aide (NA), or total nurse 
staffing, as indicated in paragraphs (h)(1)(i), (ii), and/or (iii) of 
this section) is not sufficient to meet area needs as evidenced by a 
provider to population ratio for nursing workforce that is a minimum of 
20 percent below the national average, as calculated by CMS, by using 
data from the Bureau of Labor Statistics and Census Bureau.
    (i) The facility may receive an exemption from the total nurse 
staffing requirement of 3.48 hours per resident day at paragraph (b)(1) 
of this section if the combined licensed nurse, which includes both RNs 
and licensed vocational nurses (LVN)/licensed practical nurses (LPNs) 
and nurse aide to population ratio in its area is a minimum of 20 
percent below the national average.
    (ii) The facility may receive an exemption from the 0.55 registered 
nurse hours per resident day requirement at paragraph (b)(1)(i) of this 
section and an exemption of 8 hours a day from the registered nurse on 
site 24 hours per day, for 7 days a week requirement at paragraph 
(c)(1) of this section if the registered nurse to population ratio in 
its area is a minimum of 20 percent below the national average.
    (iii) The facility may receive an exemption from the 2.45 nurse 
aide hours per resident day requirement at paragraph (b)(1)(ii) of this 
section if the nurse aide to population ratio in its area is a minimum 
of 20 percent below the national average.
    (2) Good faith efforts to hire. The facility demonstrates that it 
has been unable, despite diligent efforts, including offering at least 
prevailing wages, to recruit and retain appropriate personnel. The 
information is verified through:
    (i) Job listings in commonly used recruitment forums found online 
at American Job Centers (coordinated by the U.S. Department of Labor's 
Employment and Training Administration), and other forums as 
appropriate;
    (ii) Documented job vacancies including the number and duration of 
the vacancies and documentation of offers made, including that they 
were made at least at prevailing wages;
    (iii) Data on the average wages in the Metropolitan Statistical 
Area in which the facility is located and vacancies by industry as 
reported by the Bureau of Labor Statistics or by the State's Department 
of Labor; and
    (iv) The facility's staffing plan in accordance with Sec.  
483.71(b)(4); and
    (3) Demonstrated financial commitment. The facility demonstrates 
through documentation the amount of financial resources that the 
facility expends on nurse staffing relative to revenue.
    (4) Disclosure of exemption status. The facility:
    (i) Posts, in a prominent location in the facility, and in a form 
and manner accessible and understandable to residents, and resident 
representatives, a notice of the facility's exemption status, the 
extent to which the facility does not meet the minimum staffing 
requirements, and the timeframe during which the exemption applies; and
    (ii) Provides to each resident or resident representative, and to 
each prospective resident or resident representative, a notice of the 
facility's exemption status, including the extent to which the facility 
does not meet the staffing requirements, the timeframe during which the 
exemption applies, and a statement reminding residents of their rights 
to contact advocacy and oversight entities, as provided in the notice 
provided to them under Sec.  483.10(g)(4); and
    (iii) Sends a copy of the notice to a representative of the Office 
of the State Long-Term Care Ombudsman.
    (5) Exclusions. Facilities must not:
    (i) Be a Special Focus Facility, pursuant to the Special Focus 
Facility Program established under sections 1819(f)(8) and 1919(f)(10) 
of the Act; or
    (ii) Have been cited for having widespread insufficient staffing 
with resultant resident actual harm or a pattern of insufficient 
staffing with resultant resident actual harm, or cited at the immediate 
jeopardy level of severity with respect to insufficient staffing as 
determined by CMS, within the 12 months preceding the survey during 
which the facility's non-compliance is identified; or
    (iii) Have failed to submit Payroll Based Journal data in 
accordance with Sec.  483.70(p).
    (6) Determination of eligibility. The Secretary, through CMS or the 
State, will determine eligibility for an exemption based on the 
criteria in paragraphs (h)(1) through (5) of this section. The facility 
must provide supporting documentation when requested.
    (7) Timeframe. The term for a hardship exemption is from grant of 
exemption until the next standard recertification survey, unless the 
facility becomes a Special Focus Facility, is cited for widespread 
insufficient staffing with resultant resident actual harm or a pattern 
of insufficient staffing with resultant resident actual harm, or is 
cited at the immediate jeopardy level of severity with respect to 
insufficient staffing as determined by CMS, or fails to submit Payroll 
Based Journal data in accordance with Sec.  483.70(p). A hardship 
exemption may be extended on each standard recertification survey, 
after the initial period, if the facility continues to meet the 
exemption criteria in paragraphs (h)(1) through (5) of this section, as 
determined by the Secretary.
    (i) Nurse staffing information--(1) Data requirements. The facility 
must post the following information on a daily basis:
    (i) Facility name.
    (ii) The current date.
    (iii) The total number and the actual hours worked by the following 
categories of licensed and unlicensed nursing staff directly 
responsible for resident care per shift:
    (A) Registered nurses.
    (B) Licensed practical nurses or licensed vocational nurses (as 
defined under State law).
    (C) Certified nurse aides.
    (iv) Resident census.

[[Page 40999]]

    (2) Posting requirements. (i) The facility must post the nurse 
staffing data specified in paragraph (i)(1) of this section on a daily 
basis at the beginning of each shift.
    (ii) Data must be posted as follows:
    (A) Clear and readable format.
    (B) In a prominent place readily accessible to residents, staff, 
and visitors.
    (3) Public access to posted nurse staffing data. The facility must, 
upon oral or written request, make nurse staffing data available to the 
public for review at a cost not to exceed the community standard.
    (4) Facility data retention requirements. The facility must 
maintain the posted daily nurse staffing data for a minimum of 18 
months, or as required by State law, whichever is greater.

0
10. Section 483.40 is amended by revising paragraphs (a) introductory 
text, (a)(1), and (c)(2) to read as follows:


Sec.  483.40  Behavioral health services.

* * * * *
    (a) The facility must have sufficient staff who provide direct 
services to residents with the appropriate competencies and skills sets 
to provide nursing and related services to assure resident safety and 
attain or maintain the highest practicable physical, mental and 
psychosocial well-being of each resident, as determined by resident 
assessments and individual plans of care and considering the number, 
acuity and diagnoses of the facility's resident population in 
accordance with Sec.  483.71. These competencies and skills sets 
include, but are not limited to, knowledge of and appropriate training 
and supervision for:
    (1) Caring for residents with mental and psychosocial disorders, as 
well as residents with a history of trauma and/or post-traumatic stress 
disorder, that have been identified in the facility assessment 
conducted pursuant to Sec.  483.71; and
* * * * *
    (c) * * *
    (2) Obtain the required services from an outside resource (in 
accordance with Sec.  483.70(f)) from a Medicare and/or Medicaid 
provider of specialized rehabilitative services.
* * * * *

0
11. Section 483.45 is amended by revising the introductory text to read 
as follows:


Sec.  483.45  Pharmacy services.

    The facility must provide routine and emergency drugs and 
biologicals to its residents, or obtain them under an agreement 
described in Sec.  483.70(f). The facility may permit unlicensed 
personnel to administer drugs if State law permits, but only under the 
general supervision of a licensed nurse.
* * * * *

0
12. Section 483.55 is amended by revising paragraphs (a) introductory 
text, (a)(1), (b) introductory text, and (b)(1) introductory text to 
read as follows:


Sec.  483.55  Dental services.

* * * * *
    (a) Skilled nursing facilities. A facility:
    (1) Must provide or obtain from an outside resource, in accordance 
with Sec.  483.70(f), routine and emergency dental services to meet the 
needs of each resident;
* * * * *
    (b) Nursing facilities. The facility:
    (1) Must provide or obtain from an outside resource, in accordance 
with Sec.  483.70(f), the following dental services to meet the needs 
of each resident:
* * * * *

0
13. Section 483.60 is amended by revising paragraph (a) introductory 
text to read as follows:


Sec.  483.60  Food and nutrition services.

* * * * *
    (a) Staffing. The facility must employ sufficient staff with the 
appropriate competencies and skills sets to carry out the functions of 
the food and nutrition service, taking into consideration resident 
assessments, individual plans of care and the number, acuity and 
diagnoses of the facility's resident population in accordance with the 
facility assessment required at Sec.  483.71. This includes:
* * * * *

0
14. Section 483.65 is amended by revising paragraph (a)(2) to read as 
follows:


Sec.  483.65  Specialized rehabilitative services.

    (a) * * *
    (2) In accordance with Sec.  483.70(f), obtain the required 
services from an outside resource that is a provider of specialized 
rehabilitative services and is not excluded from participating in any 
Federal or State health care programs pursuant to section 1128 and 1156 
of the Act.
* * * * *


Sec.  483.70  [Amended]

0
15. Section 483.70 is amended by--
0
a. Removing paragraph (e); and
0
b. Redesignating paragraphs (f) through (q) as paragraphs (e) through 
(p), respectively.

0
16. Add Sec.  483.71 to subpart B to read as follows:


Sec.  483.71  Facility assessment.

    The facility must conduct and document a facility-wide assessment 
to determine what resources are necessary to care for its residents 
competently during both day-to-day operations (including nights and 
weekends) and emergencies. The facility must review and update that 
assessment, as necessary, and at least annually. The facility must also 
review and update this assessment whenever there is, or the facility 
plans for, any change that would require a substantial modification to 
any part of this assessment.
    (a) The facility assessment must address or include the following:
    (1) The facility's resident population, including, but not limited 
to:
    (i) Both the number of residents and the facility's resident 
capacity;
    (ii) The care required by the resident population, using evidence-
based, data-driven methods that consider the types of diseases, 
conditions, physical and behavioral health needs, cognitive 
disabilities, overall acuity, and other pertinent facts that are 
present within that population, consistent with and informed by 
individual resident assessments as required under Sec.  483.20;
    (iii) The staff competencies and skill sets that are necessary to 
provide the level and types of care needed for the resident population;
    (iv) The physical environment, equipment, services, and other 
physical plant considerations that are necessary to care for this 
population; and
    (v) Any ethnic, cultural, or religious factors that may potentially 
affect the care provided by the facility, including, but not limited 
to, activities and food and nutrition services.
    (2) The facility's resources, including but not limited to the 
following:
    (i) All buildings and/or other physical structures and vehicles;
    (ii) Equipment (medical and non-medical);
    (iii) Services provided, such as physical therapy, pharmacy, 
behavioral health, and specific rehabilitation therapies;
    (iv) All personnel, including managers, nursing and other direct 
care staff (both employees and those who provide services under 
contract), and volunteers, as well as their education and/or training 
and any competencies related to resident care;

[[Page 41000]]

    (v) Contracts, memorandums of understanding, or other agreements 
with third parties to provide services or equipment to the facility 
during both normal operations and emergencies; and
    (vi) Health information technology resources, such as systems for 
electronically managing patient records and electronically sharing 
information with other organizations.
    (3) A facility-based and community-based risk assessment, utilizing 
an all-hazards approach as required in Sec.  483.73(a)(1).
    (b) In conducting the facility assessment, the facility must 
ensure:
    (1) Active involvement of the following participants in the 
process:
    (i) Nursing home leadership and management, including but not 
limited to, a member of the governing body, the medical director, an 
administrator, and the director of nursing; and
    (ii) Direct care staff, including but not limited to, RNs, LPNs/
LVNs, NAs, and representatives of the direct care staff, if applicable.
    (iii) The facility must also solicit and consider input received 
from residents, resident representatives, and family members.
    (2) [Reserved]
    (c) The facility must use this facility assessment to:
    (1) Inform staffing decisions to ensure that there are a sufficient 
number of staff with the appropriate competencies and skill sets 
necessary to care for its residents' needs as identified through 
resident assessments and plans of care as required in Sec.  
483.35(a)(3).
    (2) Consider specific staffing needs for each resident unit in the 
facility and adjust as necessary based on changes to its resident 
population.
    (3) Consider specific staffing needs for each shift, such as day, 
evening, night, and adjust as necessary based on any changes to its 
resident population.
    (4) Develop and maintain a plan to maximize recruitment and 
retention of direct care staff.
    (5) Inform contingency planning for events that do not require 
activation of the facility's emergency plan, but do have the potential 
to affect resident care, such as, but not limited to, the availability 
of direct care nurse staffing or other resources needed for resident 
care.

0
17. Section 483.75 is amended by revising paragraphs (c)(2) and (e)(3) 
to read as follows:


Sec.  483.75  Quality assurance and performance improvement.

* * * * *
    (c) * * *
    (2) Facility maintenance of effective systems to identify, collect, 
and use data and information from all departments, including but not 
limited to the facility assessment required at Sec.  483.71 and 
including how such information will be used to develop and monitor 
performance indicators.
* * * * *
    (e) * * *
    (3) As a part of their performance improvement activities, the 
facility must conduct distinct performance improvement projects. The 
number and frequency of improvement projects conducted by the facility 
must reflect the scope and complexity of the facility's services and 
available resources, as reflected in the facility assessment required 
at Sec.  483.71. Improvement projects must include at least annually a 
project that focuses on high risk or problem-prone areas identified 
through the data collection and analysis described in paragraphs (c) 
and (d) of this section.
* * * * *

0
18. Section 483.80 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  483.80  Infection control.

* * * * *
    (a) * * *
    (1) A system for preventing, identifying, reporting, investigating, 
and controlling infections and communicable diseases for all residents, 
staff, volunteers, visitors, and other individuals providing services 
under a contractual arrangement based upon the facility assessment 
conducted according to Sec.  483.71 and following accepted national 
standards.
* * * * *

0
19. Section 483.95 is amended by revising the introductory text to read 
as follows:


Sec.  483.95  Training requirements.

    A facility must develop, implement, and maintain an effective 
training program for all new and existing staff; individuals providing 
services under a contractual arrangement; and volunteers, consistent 
with their expected roles. A facility must determine the amount and 
types of training necessary based on a facility assessment as specified 
at Sec.  483.71. Training topics must include but are not limited to--
* * * * *

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2024-08273 Filed 4-22-24; 4:15 pm]
BILLING CODE 4120-01-P