Rule2024-08273
Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 10, 2024
Effective
June 21, 2024
Issuing agencies
Health and Human Services DepartmentCenters for Medicare & Medicaid Services
Abstract
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.
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<title>Federal Register, Volume 89 Issue 92 (Friday, May 10, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
<bullet> The regulations at Sec. 483.71 must be implemented by
August 8, 2024, for all facilities.
<bullet> 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.
<bullet> 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.
<bullet> 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 <a href="/cdn-cgi/l/email-protection#e4ac818588908c858a80b7858281909dad8a95918d968d8197a4878997ca8c8c97ca838b92"><span class="__cf_email__" data-cfemail="743c111518001c151a1027151211000d3d1a05011d061d1107341719075a1c1c075a131b02">[email protected]</span></a> 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.<SUP>4 5</SUP> 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\ <a href="https://data.cms.gov/provider-data/dataset/4pq5-n9py">https://data.cms.gov/provider-data/dataset/4pq5-n9py</a>.
\2\ <a href="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/">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/</a>.
\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\ <a href="https://www.medicare.gov/care-compare/?redirect=true&providerType=NursingHome">https://www.medicare.gov/care-compare/?redirect=true&providerType=NursingHome</a>.
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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. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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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 <a href="https://www.beckershospitalreview.com/workforce/nurses-per-capita-ranked-by-state.html">https://www.beckershospitalreview.com/workforce/nurses-per-capita-ranked-by-state.html</a>.
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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\ <a href="https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-483#483.70">https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-483#483.70</a>.
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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. <a href="https://www.federalregister.gov/documents/2015/08/04/2015-18950/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities">https://www.federalregister.gov/documents/2015/08/04/2015-18950/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities</a>.
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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 (<a href="https://www.federalregister.gov/documents/2022/04/15/2022-07906/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities">https://www.federalregister.gov/documents/2022/04/15/2022-07906/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities</a>).
\16\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
\17\ <a href="https://www.federalregister.gov/documents/2023/09/06/2023-18781/medicare-and-medicaid-programs-minimum-staffing-standards-for-long-term-care-facilities-and-medicaid">https://www.federalregister.gov/documents/2023/09/06/2023-18781/medicare-and-medicaid-programs-minimum-staffing-standards-for-long-term-care-facilities-and-medicaid</a>.
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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, <a href="https://doi.org/10.1016/j.jamda.2020.06.021">https://doi.org/10.1016/j.jamda.2020.06.021</a>.
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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\ <a href="https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.16689">https://agsjournals.onlinelibrary.wiley.com/doi/epdf/10.1111/jgs.16689</a>.
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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.<SUP>23 24</SUP> 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 <a href="https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staffing-shortages-during-the-covid-19-pandemic">https://www.kff.org/coronavirus-covid-19/issue-brief/nursing-facility-staffing-shortages-during-the-covid-19-pandemic</a>.
\24\ <a href="https://data.bls.gov/timeseries/CES6562300001?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true">https://data.bls.gov/timeseries/CES6562300001?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true</a>.
\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 (<a href="http://nber.org">nber.org</a>).
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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.
<a href="https://oig.hhs.gov/oei/reports/oei-04-18-00450.asp">https://oig.hhs.gov/oei/reports/oei-04-18-00450.asp</a>.
\27\ <a href="https://www.nber.org/system/files/working_papers/w28474/w28474.pdf">https://www.nber.org/system/files/working_papers/w28474/w28474.pdf</a>.
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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.<SUP>28 29 30</SUP> 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.<SUP>31 32</SUP> 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\ <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3805666/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3805666/</a>.
\29\ <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4108174/">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4108174/</a>.
\30\ <a href="https://onlinelibrary.wiley.com/doi/epdf/10.1111/1475-6773.12079">https://onlinelibrary.wiley.com/doi/epdf/10.1111/1475-6773.12079</a>.
\31\ <a href="https://www.jamda.com/article/S1525-8610">https://www.jamda.com/article/S1525-8610</a>(21)00243-7/
fulltext.
\32\ <a href="https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094">https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094</a>.
\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\ <a href="https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094">https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0094</a>.
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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\ <a href="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/">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/</a>.
\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. <a href="https://www.federalregister.gov/documents/2022/04/15/2022-07906/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities">https://www.federalregister.gov/documents/2022/04/15/2022-07906/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities</a>.
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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. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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<bullet> 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.
<bullet> 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.
<bullet> 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. <a href="https://www.cms.gov/newsroom/fact-sheets/fy-25-skilled-nursing-facility-prospective-payment-system-proposed-rule-cms-1802-p">https://www.cms.gov/newsroom/fact-sheets/fy-25-skilled-nursing-facility-prospective-payment-system-proposed-rule-cms-1802-p</a>.
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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\ <a href="https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2023-skilled-nursing-facility-prospective-payment-system-final-rule-cms-1765-f">https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2023-skilled-nursing-facility-prospective-payment-system-final-rule-cms-1765-f</a>.
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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\ <a href="https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationenforcement/nursing-home-enforcement">https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationenforcement/nursing-home-enforcement</a>.
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<bullet> Termination of the provider agreement;
<bullet> Temporary management;
<bullet> Denial of payment for all Medicare and/or Medicaid
individuals by CMS to a facility, for Medicare, or to a State, for
Medicaid;
<bullet> Denial of payment for all new Medicare and/or Medicaid
admissions;
<bullet> Civil money penalties;
<bullet> State monitoring;
<bullet> Transfer of residents;
<bullet> Transfer of residents with closure of facility;
<bullet> Directed plan of correction;
<bullet> Directed in-service training; and
<bullet> 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 <a href="http://Medicare.gov">Medicare.gov</a>. Find
and Compare Nursing Homes Providers near you <a href="https://www.medicare.gov/care-compare/?providerType=NursingHome&redirect=true">https://www.medicare.gov/care-compare/?providerType=NursingHome&redirect=true</a>.
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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\ <a href="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/">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/</a>.
\43\ <a href="https://www.cms.gov/newsroom/press-releases/biden-harris-administration-strengthens-oversight-nations-poorest-performing-nursing-homes">https://www.cms.gov/newsroom/press-releases/biden-harris-administration-strengthens-oversight-nations-poorest-performing-nursing-homes</a>.
\44\ <a href="https://www.cms.gov/newsroom/fact-sheets/disclosures-ownership-and-additional-disclosable-parties-information-skilled-nursing-facilities-and-0">https://www.cms.gov/newsroom/fact-sheets/disclosures-ownership-and-additional-disclosable-parties-information-skilled-nursing-facilities-and-0</a>.
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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, <a href="https://www.medicaid.gov/medicaid/long-term-services-supports/money-follows-person/index.html">https://www.medicaid.gov/medicaid/long-term-services-supports/money-follows-person/index.html</a>.
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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:
<bullet> ``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:
<bullet> ``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.''
<bullet> ``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' ''.
<bullet> ``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?''
<bullet> ``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.''
<bullet> ``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?''
<bullet> ``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.''
<bullet> ``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:
<bullet> ``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.''
<bullet> ``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.''
<bullet> ``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.''
<bullet> ``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. <a href="https://data.bls.gov/timeseries/CES6562300001?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true">https://data.bls.gov/timeseries/CES6562300001?amp%253bdata_tool=XGtable&output_view=data&include_graphs=true</a>. Accessed 02/28/24.
\47\ Executive Order on Increasing Access to High Quality Care
and Supporting Caregivers. White House. Accessed at <a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2023/04/18/executive-order-on-increasing-access-to-high-quality-care-and-supporting-caregivers/">https://www.whitehouse.gov/briefing-room/presidential-actions/2023/04/18/executive-order-on-increasing-access-to-high-quality-care-and-supporting-caregivers/</a>. 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: <a href="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/">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/</a>.
\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. <a href="https://doi.org/10.17226/26526">https://doi.org/10.17226/26526</a>.
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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. <a href="https://pr.mo.gov/boards/nursing/2022%20Missouri%20Nursing%20Workforce%20Report.pdf">https://pr.mo.gov/boards/nursing/2022%20Missouri%20Nursing%20Workforce%20Report.pdf</a>.
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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: <a href="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/">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/</a>.
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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\
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\52\ Comments of the Long Term Care Community Coalition at 10-
11.
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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.
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\53\ Abt Associates. (2022). Nursing Home Staffing Study
Comprehensive report. Report prepared for the Centers for Medicare &
Medicaid Services. <a href="https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf">https://edit.cms.gov/files/document/nursing-home-staffing-study-final-report-appendix-june-2023.pdf</a>.
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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:_<a href="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/">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/</a>.
\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 (<a href="http://hrsa.gov">hrsa.gov</a>).
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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.
<bullet> Policy & Memos to States and CMS Locations [verbar] CMS:
<a href="https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/policy-memos-states-and-cms-locations">https://www.cms.gov/medicare/health-safety-standards/quality-safety-oversight-general-information/policy-memos-states-and-cms-locations</a>.
<bullet> Quality Safety & Oversight- Guidance to Laws & Regulations
[verbar] CMS: <a href="https://www.cms.gov/medicare/health-safety-standards/guidance-for-laws-regulations">https://www.cms.gov/medicare/health-safety-standards/guidance-for-laws-regulations</a>.
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) (<a href="https://www.cms.gov/medicare/provider-enrollment-and-certification/guidanceforlawsandregulations/downloads/appendix-pp-state-operations-manual.pdf">https://www.cms.gov/medicare/provider-enrollment-and-certification/guidanceforlawsandregulations/downloads/appendix-pp-state-operations-manual.pdf</a>).
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: <a href="https://www.cms.gov/medicare/quality/nursing-home-improvement/staffing-data-submission">https://www.cms.gov/medicare/quality/nursing-home-improvement/staffing-data-submission</a>.
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\ <a href="https://data.cms.gov/provider-data/dataset/4pq5-n9py">https://data.cms.gov/provider-data/dataset/4pq5-n9py</a>.
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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, <a href="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/">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/</a>.
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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\ <a href="https://www.cms.gov/newsroom/fact-sheets/medicare-and-medicaid-programs-minimum-staffing-standards-long-term-care-facilities-and-medicaid">https://www.cms.gov/newsroom/fact-sheets/medicare-and-medicaid-programs-minimum-staffing-standards-long-term-care-facilities-and-medicaid</a>.
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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\ <a href="https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes">https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/GuidanceforLawsAndRegulations/Nursing-Homes</a>.
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Comment: In addition to the proposed requirements, we also
solicited comments on the following issues:
<bullet> The benefits and trade-offs associated with different
staffing standards;
<bullet> 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;
<bullet> 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\
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\61\ California Department of Public Health, 3.2 Nursing Hours
Per Patient Day data as of November 6, 2019.
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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.
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\62\ 42 CFR 483.35, <a href="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/">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/</a>.
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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:
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\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.
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<bullet> 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?
<bullet> 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''?
<bullet> Should the DON be counted towards the 24/7 RN requirement
or should the DON only count in particular circumstances or with
certain guardrails?
<bullet> 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.
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\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.
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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:
<bullet> Capping the number of exemptions a facility can receive,
to avoid facilities that are perpetually exempted;
<bullet> Prohibiting any facility that does not meet the staffing
requirements from admitting new residents;
<bullet> Disqualifying facilities operating under an exemption from
any type of value-based purchasing initiatives within either the
Medicare or Medicaid programs;
<bullet> Requiring facilities with an exemption to demonstrate
progress on reducing turnover and increasing wages;
<bullet> Appointing an independent entity to monitor performance of
any facility with an exemption;
<bullet> 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;
<bullet> 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;
<bullet> 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;
<bullet> Requiring ``documentation of financial commitment to
staffing'' that includes investments in recruiting and retention, and
evidence of increased wages;
<bullet> Requiring an alternate viable plan for meeting the needs
of the residents in their care, not solely on financial difficulties;
<bullet> Establishing a sunset date for hardship exemptions; and
<bullet> 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 <a href="https://www.bls.gov/oes/current/msa_def.htm">https://www.bls.gov/oes/current/msa_def.htm</a>). 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 <a href="https://www.bls.gov/oes/">https://www.bls.gov/oes/</a> 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
<a href="https://data.bls.gov/oes/#/home">https://data.bls.gov/oes/#/home</a>). 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 <a href="https://www.census.gov/data/tables/time-series/demo/popest/2020s-counties-total.html#v2022">https://www.census.gov/data/tables/time-series/demo/popest/2020s-counties-total.html#v2022</a>). 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 recruitmen
[…truncated; see source link]Indexed from Federal Register on May 10, 2024.
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