Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities, 42167-42269 [2015-17207]
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Vol. 80
Thursday,
No. 136
July 16, 2015
Part II
Department of Health and Human Services
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 431, 447, et al.
Medicare and Medicaid Programs; Reform of Requirements for Long-Term
Care Facilities; Proposed Rule
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Federal Register / Vol. 80, No. 136 / Thursday, July 16, 2015 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 405, 431, 447, 482, 483,
485, and 488
[CMS–3260–P]
RIN 0938–AR61
Medicare and Medicaid Programs;
Reform of Requirements for LongTerm Care Facilities
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
revise the requirements that Long-Term
Care facilities must meet to participate
in the Medicare and Medicaid programs.
These proposed changes are necessary
to reflect the substantial advances that
have been made over the past several
years in the theory and practice of
service delivery and safety. These
proposals are also an integral part of our
efforts to achieve broad-based
improvements both in the quality of
health care furnished through federal
programs, and in patient safety, while at
the same time reducing procedural
burdens on providers.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on September 14, 2015.
ADDRESSES: In commenting, please refer
to file code CMS–3260–P. Because of
staff and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
You may submit comments in one of
four ways (please choose only one of the
ways listed):
1. Electronically. You may submit
electronic comments on this regulation
to https://www.regulations.gov. Follow
the ‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address only:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–3260–
P, P.O. Box 8010, Baltimore, MD 21244.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address only:
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Attention: CMS–3260–
P, Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
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SUMMARY:
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4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written comments only to the
following addresses prior to the close of
the comment period:
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H. Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
federal government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Sheila Blackstock, (410) 786–6633, for
issues related to Care transitions, QAPI.
Ronisha Blackstone, (410) 786–6633,
for issues related to Comprehensive care
planning, training.
Diane Corning, (410) 786–6633, for
issues related to Behavioral health,
infection control, facility assessment.
Lisa Parker, (410) 786–6633, for issues
related to the Regulatory Impact
Analysis.
Jeannie Miller, (410) 786–6633, for
General information.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: https://
www.regulations.gov. Follow the search
instructions on that Web site to view
public comments.
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Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 3 weeks after publication
of a document, at the headquarters of
the Centers for Medicare & Medicaid
Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday
through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an
appointment to view public comments,
phone 1–800–743–3951.
Acronyms
Because of the many terms to which
we refer by acronym in this proposed
rule, we are listing the acronyms used
and their corresponding meanings in
alphabetical order below:
AAA Area Agencies on Aging
ACL Administration for Community Living
ADL Activities of Daily Living
ADRCS Aging and Disability Resource
Center
AHCA American Health Care Association
AHLA American Health Lawyers
Association
ANSI American National Standards
Institute
ASPE Assistant Secretary for Planning and
Evaluation
BPSD Behavioral and Psychological
Symptoms of Dementia
CARIE Center for Advocacy Rights and
Interests
CASPER Certification and Survey Provider
Enhanced Reports
CIL Centers for Independent Living
CLIA Clinical Laboratory Improvement
Amendment
CMS Centers for Medicare & Medicaid
Services
CNS Clinical Nurse Specialist
CPR Cardiopulmonary Resuscitation
DON Director of Nursing
EHR Electronic Health Records
FDA Food and Drug Administration
GAO Government Accountability Office
HACCP Hazard Analysis and Critical
Control Point
HAI Healthcare-Associated Infection
HHS U.S. Department of Health and Human
Services
HIPAA Health Insurance Portability and
Accountability Act of 1996
ICN International Council of Nurses
IDT Interdisciplinary Team
IG Interpretive Guidance
IPCO Infection Prevention and Control
Officer
IPCP Infection Prevention and Control
Program
LSC Life Safety Code
LTC Long-Term Care
NATCEP Nurse Aide Training Competency
Evaluation Program
NCEA National Center on Elder Abuse
MAR Medication Administration Record
MDS Minimum Data Set
NA Nurse Aide
NF Nursing Facility
NP Nurse Practitioner
OIG Office of the Inspector General
OMB Office of Management and Budget
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ONC Office of the National Coordinator
PA Physician Assistant
PASARR Preadmission Screening and
Resident Review
PIPs Performance Improvement Projects
PEU Protein-Energy under Nutrition
QA Quality Assurance
QAA Quality Assessment and Assurance
QAPI Quality Assurance and Performance
Improvement
QIO Quality Improvement Organization
RFA Regulatory Flexibility Act
RN Registered Nurse
SMA State Medicaid Agency
SNF Skilled Nursing Facility
WHO World Health Organization
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Table of Contents
This proposed rule is organized as
follows:
I. Background
A. Executive Summary
1. Purpose
2. Summary of the Major Provisions
3. Summary of Costs and Benefits
a. Overall Impact
b. Section-by-Section Economic Impact
Estimates
B. Statutory and Regulatory Authority of
the Long-term care Requirements
C. Summary of Stakeholder Comments
D. Why revise the LTC requirements?
II. Provisions of the Proposed Regulation
A. Basis and scope. (§ 483.1)
B. Definitions (§ 483.5)
C. Resident rights (§ 483.10)
D. Facility responsibilities (§ 483.11)
E. Freedom from abuse, neglect, and
exploitation (§ 483.12)
F. Transitions of care (§ 483.15)
G. Resident assessments (§ 483.20)
H. Comprehensive resident-centered care
plans (§ 483.21)
I. Quality of care and quality of life
(§ 483.25)
J. Physician services (§ 483.30)
K. Nursing services (§ 483.35)
L. Behavioral health services (§ 483.40)
M. Pharmacy services (§ 483.45)
N. Laboratory, radiology, and other
diagnostic services (§ 483.50)
O. Dental services (§ 483.55)
P. Food and nutrition services (§ 483.60)
Q. Specialized rehabilitative services
(§ 483.65)
R. Outpatient Rehabilitative Services
(§ 483.67)
S. Administration (§ 483.70)
T. Quality assurance and performance
improvement (§ 483.75)
U. Infection control (§ 483.80)
V. Compliance and ethics program
(§ 483.85)
W. Physical environment (§ 483.90)
X. Training requirements (§ 483.95)
III. Long-Term Care Facilities Crosswalk
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impacts
I. Background
A. Executive Summary
1. Purpose
Consolidated Medicare and Medicaid
requirements for participation
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(requirements) for long term care (LTC)
facilities (42 CFR part 483, subpart B)
were first published in the Federal
Register on February 2, 1989 (54 FR
5316). These regulations have been
revised and added to since that time,
principally as a result of legislation or
a need to address a specific issue.
However, they have not been
comprehensively reviewed and updated
since 1991 (56 FR 48826, September 26,
1991), despite substantial changes in
service delivery in this setting.
Since the current requirements were
developed, significant innovations in
resident care and quality assessment
practices have emerged. In addition, the
population of nursing homes has
changed, and has become more diverse
and more clinically complex. Over the
last two to three decades, extensive,
evidence-based research has been
conducted and has enhanced our
knowledge about resident safety, health
outcomes, individual choice, and
quality assurance and performance
improvement. In light of these changes,
we recognized the need to evaluate the
regulations on a comprehensive basis,
from both a structural and a content
perspective. Therefore, we are reviewing
regulations in an effort to improve the
quality of life, care, and services in LTC
facilities, optimize resident safety,
reflect current professional standards,
and improve the logical flow of the
regulations. Specifically, we are
proposing to add new requirements
where necessary, eliminate duplicative
or unnecessary provisions, and
reorganize the regulations as
appropriate. Many of the revisions are
aimed at aligning requirements with
current clinical practice standards to
improve resident safety along with the
quality and effectiveness of care and
services delivered to residents.
Additionally, we believe that these
proposed revisions may eliminate or
significantly reduce those instances
where the requirements are duplicative,
unnecessary, and/or burdensome.
2. Summary of the Major Provisions
Basis and Scope (§ 483.1)
• The Patient Protection and
Affordable Care Act of 2010 (Pub. L.
111–148), as amended by the Health
Care and Education Reconciliation Act
of 2010 (Pub. L. 111–152) (collectively
known as the Affordable Care Act)
provisions: We propose to add the
statutory authority citations for sections
1128I(b) and (c) and section 1150B of
the Act to include the compliance and
ethics program, quality assurance and
performance improvement (QAPI), and
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reporting of suspicion of a crime
requirements.
Definitions (§ 483.5)
• Expanded Definitions: We propose
to add the definitions for ‘‘adverse
event’’, ‘‘documentation’’, ‘‘posting/
displaying’’, ‘‘resident representative’’,
‘‘abuse’’, ‘‘sexual abuse’’, ‘‘neglect’’,
‘‘exploitation’’, ‘‘misappropriation of
resident property’’, and ‘‘personcentered care’’.
Resident Rights (§ 483.10)
• Comprehensive Restructuring: We
propose to retain all existing residents’
rights but update the language and
organization of the resident rights
provisions to improve logical order and
readability, clarify aspects of the
regulation where necessary, and to
update provisions to include advances
such as electronic communications.
This includes—
Æ Eliminating language, such as
‘‘interested family member’’ and
replacing the term ‘‘legal
representative’’ with ‘‘resident
representative.’’
Æ Addressing roommate choice.
Æ Adding language regarding
physician credentialing to specify that
the physician chosen by the resident
must be licensed to practice medicine in
the state where the resident resides, and
must meet professional credentialing
requirements of the facility.
Facility Responsibilities (§ 483.11)
*New Section*
• New Section: We propose to add a
new section to subpart B that focuses on
the responsibilities of the facility (that
is, protecting the rights of their
residents, enhancing a resident’s quality
of life) and brings together many of the
facility responsibilities currently
dispersed throughout existing
regulations. This section parallels many
residents’ rights provisions.
• Visitation: We propose to revise
visitation requirements to establish
open visitation, similar to the hospital
conditions of participation (CoPs).
• Re-designation of Requirements: We
propose to—
Æ Relocate provisions from existing
Resident’s Rights (§ 483.10) section that
pertain to the responsibilities of the
facility into this section.
Æ Relocate the existing requirements
in Quality of Life (§ 483.15) into this
section.
Freedom From Abuse, Neglect, and
Exploitation (§ 483.12)
• Revised Title: Formerly ‘‘Resident
behavior and facility practices,’’ we
propose to revise the title to ‘‘Freedom
from abuse, neglect, and exploitation.’’
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• Prohibiting abuse, neglect, and
exploitation: We propose to—
Æ Specify that facilities cannot
employ individuals who have had a
disciplinary action taken against their
professional license by a state licensure
body as a result of a finding of abuse,
neglect, mistreatment of residents or
misappropriation of their property.
Æ Require facilities to develop and
implement written policies and
procedures that prohibit and prevent
abuse, neglect, and mistreatment of
residents or misappropriation of their
property.
Transitions of Care (§ 483.15)
• Revised Title: Formerly
‘‘Admission, transfer and discharge
rights,’’ we propose to revise the title to
reflect current terminology that applies
to all instances where care of a resident
is transferred.
• Transfers or Discharge: We propose
to require not only that a transfer or
discharge be documented in the clinical
record, but also that specific
information, such as history of present
illness, reason for transfer and past
medical/surgical history, be exchanged
with the receiving provider or facility
when a resident is transferred. We are
not proposing to require a specific form,
format, or methodology for this
communication.
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Resident Assessments (§ 483.20)
• Preadmission Screening and
Resident Review (PASARR): We
propose to clarify what constitutes
appropriate coordination of a resident’s
assessment with the PASARR program
under Medicaid.
• Technical Corrections:
Æ We propose to add references to
statutory requirements that were
inadvertently omitted from the
regulation when we first implemented
sections 1819 and 1919 of the Act.
D Section 1919(e)(7)(A)(ii) and (iii) of
the Act: We propose to add exceptions
to the preadmission screening
requirements for individuals with
mental illness and individuals with
intellectual disabilities for admittance
into a nursing facility, with respect to
transfer to or from a hospital.
D Section 1919(e)(7)(B)(iii) of the Act:
We propose to add a requirement that a
nursing facility must notify the state
mental health authority or intellectual
disability authority for resident
evaluation promptly after a significant
change in the mental or physical
condition of a resident with a mental
illness or intellectual disability.
Æ We propose to replace the term
‘‘mental retardation’’ with ‘‘intellectual
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disability’’ throughout the section, as
appropriate.
Comprehensive Person-Centered Care
Planning (§ 483.21) *New Section*
• Baseline Care Plan: We propose to
require facilities to develop a baseline
care plan for each resident, within 48
hours of their admission, which
includes the instructions needed to
provide effective and person-centered
care that meets professional standards of
quality care.
• PASARR: We propose to add a
requirement to include as part of a
resident’s care plan any specialized
services or specialized rehabilitation
services the nursing facility will provide
as a result of PASARR
recommendations. If a facility disagrees
with the findings of the PASARR, it
must indicate its rationale in the
resident’s medical record.
• Interdisciplinary Team (IDT):
Æ We propose to add a nurse aide, a
member of the food and nutrition
services staff, and a social worker to the
required members of the
interdisciplinary team that develops the
comprehensive care plan.
Æ We propose to require facilities to
provide a written explanation in a
resident’s medical record if the
participation of the resident and their
resident representative is determined to
not be practicable for the development
of the resident’s care plan.
• Discharge Planning:
Æ The Improving Medicare PostAcute Care Transformation Act of 2014
(IMPACT Act) (Pub. L. 113–185)
amended Title XVIII of the Social
Security Act by, among other things,
adding Section 1899B to the Social
Security Act. Section 1899B(i) requires
that certain providers, including long
term care facilities, take into account,
quality, resource use, and other
measures to inform and assist with the
discharge planning process, while also
accounting for the treatment preferences
and goals of care of residents. We
propose to implement the discharge
planning requirements mandated by the
IMPACT Act by revising, or adding
where appropriate, discharge planning
requirements for LTC facilities.
Æ We propose to require facilities to
document in a resident’s care plan the
resident’s goals for admission, assess the
resident’s potential for future discharge,
and include discharge planning in the
comprehensive care plan, as
appropriate.
Æ We propose to require that the
resident’s discharge summary include a
reconciliation of all discharge
medications with the resident’s pre-
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admission medications (both prescribed
and over-the-counter).
Æ We propose to add to the post
discharge plan of care a summary of
what arrangements have been made for
the resident’s follow up care and any
post-discharge medical and non-medical
services.
Quality of Care and Quality of Life
(§ 483.25)
• Overarching Principles: We propose
to clarify that quality of care and quality
of life are overarching principles in the
delivery of care to residents of nursing
homes and should be applied to every
service provided.
• Activities of Daily Living (ADLs):
We propose to clarify the requirements
regarding a resident’s ability to perform
ADLs.
• Director of Activities Qualifications:
We propose to solicit comments on
whether the requirements for the
director of the activities program remain
appropriate and what should serve as
minimum requirements for this
position. We are not proposing specific
changes at this time.
• Updating Current Practices: We
propose to modify existing requirements
for nasogastric tubes to reflect current
clinical practice, and to include enteral
fluids in the requirements for assisted
nutrition and hydration.
• Special Need Issues: We propose to
add a new requirement that facilities
must ensure that residents receive
necessary and appropriate pain
management.
• Re-designation of Requirements: We
propose to relocate the provisions
regarding unnecessary drugs,
antipsychotic drugs, medication errors,
and influenza and pneumococcal
immunizations to § 483.45 Pharmacy
services.
Physician Services (§ 483.30)
• In-person Evaluation: We propose
to require an in-person evaluation of a
resident by a physician, a physician
assistant, nurse practitioner, or clinical
nurse specialist before an unscheduled
transfer to a hospital.
• Delegation of Orders: We propose to
allow physicians to delegate dietary
orders to dietitians and therapy orders
to therapists.
Nursing Services (§ 483.35)
• Sufficient Staffing: We propose to
add a competency requirement for
determining sufficient nursing staff
based on a facility assessment, which
includes but is not limited to the
number of residents, resident acuity,
range of diagnoses, and the content of
care plans.
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Behavioral Health Services (§ 483.40)
*New Section*
• New Section: We propose to add a
new section to subpart B that focuses on
the requirement to provide the
necessary behavioral health care and
services to residents in accordance with
their comprehensive assessment and
plan of care.
• Staffing:
Æ Facility Assessment: We propose to
require facilities to determine their
direct care staff needs, based on the
facility’s assessment.
Æ Competency Approach: We propose
to require that staff must have the
appropriate competencies and skills to
provide behavioral health care and
services, which include caring for
residents with mental and psychosocial
illnesses and implementing nonpharmacological interventions.
Æ Social Worker: We propose to add
‘‘gerontology’’ to the list of possible
human services fields from which a
bachelor degree could provide the
minimum educational requirement for a
social worker.
Pharmacy Services (§ 483.45)
• Drug Regimen Review:
Æ We propose to add the requirement
that a pharmacist review a resident’s
medical chart at least every 6 months
and when the resident is new to the
facility, a prior resident returns or is
transferred from a hospital or other
facility, and during each monthly drug
regimen review when the resident has
been prescribed or is taking a
psychotropic drug, an antibiotic or any
drug the QAA Committee has requested
be included in the pharmacist’s monthly
drug review.
Æ We propose to require the
pharmacist to document in a written
report any irregularities noted during
the drug regimen review that lists at a
minimum, the resident’s name, the
relevant drug, and the irregularity
identified, to be sent to the attending
physician and the facility’s medical
director and director of nursing.
Æ We propose to require that the
attending physician document in the
resident’s medical record that he or she
has reviewed the identified irregularity
and what, if any, action they have taken
to address it. If there is to be no change
in the medication, the attending
physician should document his or her
rationale in the resident’s medical
record.
• Irregularities: We propose to add a
definition of ‘‘irregularities’’ that would
include, but not be limited to, the
definition of ‘‘unnecessary drugs.’’
• Psychotropic Drugs: We propose to
revise existing requirements regarding
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‘‘antipsychotic’’ drugs to refer to
‘‘psychotropic’’ drugs.
Æ We propose to require that facilities
ensure residents who have not used
psychotropic drugs not be given these
drugs unless medically necessary.
Æ We propose that residents who use
psychotropic drugs receive gradual dose
reductions, and behavioral
interventions, unless clinically
contraindicated, in an effort to
discontinue use of these psychotropic
drugs.
Æ We propose to define
‘‘psychotropic drug’’ as any drug that
affects brain activities associated with
mental processes and behavior.
Æ We propose that PRN (Pro re nata
or as needed) orders for psychotropic
drugs be limited to 48 hours. Orders
could not be continued beyond that
time unless the primary care provider
(for example, the resident’s physician)
reviewed the need for the medications
prior to renewal of the order, and
documented the rationale for the order
in the resident’s clinical record.
• Re-designation of Requirements: We
propose to relocate provisions in
§ 483.25 ‘‘Quality of Care’’ regarding
unnecessary drugs, antipsychotic drugs,
medication errors, and influenza and
pneumococcal immunizations into this
section.
Laboratory, Radiology, and Other
Diagnostic Services (§ 483.50) *New
Section*
• Ordering Services: We propose to
clarify that a physician assistant, nurse
practitioner or clinical nurse specialist
may order laboratory, radiology, and
other diagnostic services for a resident
in accordance with state law, including
scope of practice laws.
• Laboratory Services: We propose to
clarify that the ordering physician;
physician assistant; nurse practitioner
or clinical nurse specialist, be notified
of abnormal laboratory results when
they fall outside of clinical reference
ranges, in accordance with facility
policies and procedures for notification
of a practitioner or per the ordering
physician’s, physician assistant’s; nurse
practitioner’s or clinical nurse
specialist’s orders.
Dental Services (§ 483.55)
• For Skilled Nursing Facilities
(SNFs): We propose to prohibit SNFs
from charging a Medicare resident for
the loss or damage of dentures
determined in accordance with facility
policy to be the facility’s responsibility.
• For Nursing Facilities (NFs): We
propose to require NFs to assist
residents who are eligible to apply for
reimbursement of dental services as an
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incurred medical expense under the
Medicaid state plan.
• For both SNFs and NFs: We
propose to clarify that with regard to a
referral for lost or damaged dentures
‘‘promptly’’ means within 3 business
days unless there is documentation of
extenuating circumstances.
Food and Nutrition Services (§ 483.60)
• Staffing: We propose to require
facilities to employ sufficient staff with
the appropriate competencies and skills
sets to carry out the functions of the
dietary service while taking into
consideration resident assessments, and
individual plans of care, including
diagnoses and acuity, as well as the
facility’s resident census..
• Dietitian Qualification: We propose
to clarify that a ‘‘qualified dietitian’’ is
one who is registered by the
Commission on Dietetic Registration of
the Academy of Nutrition and Dietetics
or who meets state licensure or
certification requirements. For dietitians
hired or contracted with prior to the
effective date of these regulations, we
propose to allow up to 5 years to meet
the new requirements.
• Director of Food Service: We
propose to add to the requirement for
the designation of a director of food and
nutrition service that the person serving
in this position be a certified dietary
manager, certified food service manager,
or have a certification for food service
management and safety from a national
certifying body or have an associate’s or
higher degree in food service
management or hospitality from an
accredited institution of higher learning.
In states that have established standards
for food service managers, this person
must meet state requirements for food
service managers.
• Menus and Nutritional Adequacy:
We propose to add to the requirements
that menus reflect the religious, cultural
and ethnic needs and preferences of the
residents, be updated periodically, and
be reviewed by the facility’s qualified
dietitian or other clinically qualified
nutrition professional for nutritional
adequacy while not limiting the
resident’s right to make personal dietary
choices.
• Providing Food and Drink: We
propose to add to the requirements that
facilities provide food and drink that
take into consideration resident
allergies, intolerances, and preferences
and ensure adequate hydration.
• Ordering Therapeutic Diets: We
propose to allow the attending
physician to delegate to a registered or
licensed dietitian the task of prescribing
a resident’s diet, including a therapeutic
diet, to the extent allowed by state law.
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• Frequency of Meals: We propose to
require facilities to have available
suitable and nourishing alternative
meals and snacks for residents who
want to eat at non-traditional times or
outside of scheduled meal times in
accordance with the resident’s plan of
care.
• Use of Feeding Assistants: We
propose to require that facilities
document the clinical need of a feeding
assistant and the extent to which dining
assistance is needed in the resident’s
comprehensive care plan.
• Food Safety: We propose to—
Æ Clarify that facilities may procure
food items obtained directly from local
producers and are not prohibited from
using produce grown in facility gardens,
subject to compliance with applicable
safe growing and food-handling
practices.
Æ Clarify that residents are not
prohibited from consuming foods that
are not procured by the facility.
Æ Require facilities to have a policy
regarding the use and storage of foods
brought to residents by family and other
visitors.
Specialized Rehabilitative Services
(§ 483.65)
• Provision of Services. We propose
to—
Æ Add respiratory services to those
services identified as specialized
rehabilitative services.
Æ Clarify what constitutes as
rehabilitative services for mental illness
and intellectual disability.
Outpatient Rehabilitative Services
(§ 483.67)
Æ Address in the facility assessment
the facility’s resident population (that
is, number of residents, overall types of
care and staff competencies required by
the residents, and cultural aspects),
resources (for example, equipment, and
overall personnel), and a facility-based
and community-based risk assessment.
• Clinical Records: We propose to
establish requirements that mirror some
of those found in the HIPAA Privacy
Rule (45 CFR part 160, and subparts A
and E of part 164).
• Binding Arbitration Agreements:
We propose specific requirements for
the facility and the agreement itself to
ensure that if a facility presents binding
arbitration agreements to its residents
that the agreements be explained to the
residents and they acknowledge that
they understand the agreement; the
agreements be entered into voluntarily;
and arbitration sessions be conducted
by a neutral arbitrator in a location that
is convenient to both parties. Admission
to the facility could not be contingent
upon the resident or the resident
representative signing a binding
arbitration agreement. Moreover, the
agreement could not prohibit or
discourage the resident or anyone else
from communicating with federal, state,
or local health care or health-related
officials, including representatives of
the Office of the State Long-Term Care
Ombudsman.
Quality Assurance and Performance
Improvement (QAPI) (§ 483.75) *New
Section*
Administration (§ 483.70)
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• Providing Services: We propose to
establish new health and safety
standards for facilities that choose to
provide outpatient rehabilitative
therapy services.
• QAPI Program: In accordance with
the statute, we propose to require all
LTC facilities to develop, implement,
and maintain an effective
comprehensive, data-driven QAPI
program that focuses on systems of care,
outcomes of care and quality of life.
• Organization: We propose to largely
relocate various portions of this section
into other sections of subpart B as
deemed appropriate.
• Facility Assessment: We propose to
require facilities to—
Æ Conduct and document a facilitywide assessment to determine what
resources are necessary to care for its
residents competently during both dayto-day operations and emergencies. The
facility must review and update that
assessment, as necessary, and at least
annually.
Æ Review and update this assessment
whenever there is, or the facility plans
for, any change that would require a
substantial modification to any part of
this assessment.
Infection Control (§ 483.80)
• Infection Prevention and Control
Program (IPCP): We propose to require
facilities to have a system for
preventing, identifying, reporting,
investigating, and controlling infections
and communicable diseases for all
residents, staff, volunteers, visitors, and
other individuals providing services
under an arrangement based upon its
facility and resident assessments that is
reviewed and updated annually.
• Infection Prevention and Control
Officer (IPCO): We propose to require
facilities to designate an IPCO for whom
the IPCP is their major responsibility
and who would serve as a member of
the facility’s quality assessment and
assurance (QAA) committee.
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Compliance and Ethics Program
(§ 483.85) *New Section*
• Compliance and Ethics Program:
We propose to require the operating
organization for each facility to have in
operation a compliance and ethics
program that has established written
compliance and ethics standards,
policies and procedures that are capable
of reducing the prospect of criminal,
civil, and administrative violations in
accordance with section 1128I(b) of the
Act.
Physical Environment (§ 483.90)
• Resident Rooms: We propose to
require facilities initially certified after
the effective date of this regulation to
accommodate no more than two
residents in a bedroom.
• Toilet Facilities: We propose to
require facilities initially certified after
the effective date of this regulation to
have a bathroom equipped with at least
a toilet, sink and shower in each room.
• Smoking: We propose to require
facilities to establish policies, in
accordance with applicable federal,
state and local laws and regulations,
regarding smoking, including tobacco
cessation, smoking areas and safety.
Training Requirements (§ 483.95) *New
Section*
• We propose to add a new section to
subpart B that sets forth all the
requirements of an effective training
program that facilities must develop,
implement, and maintain for all new
and existing staff, individuals providing
services under a contractual
arrangement, and volunteers, consistent
with their expected roles. We propose
that training topics must include—
Æ Communication: We propose to
require facilities to include effective
communications as a mandatory
training for direct care personnel.
Æ Resident Rights and Facility
Responsibilities: We propose to require
facilities to ensure that staff members
are educated on the rights of the
resident and the responsibilities of a
facility to properly care for its residents
as set forth in the regulations.
Æ Abuse, Neglect, and Exploitation:
We propose to require facilities, at a
minimum, to educate staff on activities
that constitute abuse, neglect,
exploitation, and misappropriation of
resident property, and procedures for
reporting these incidents.
Æ QAPI & Infection Control: We
propose to require facilities to include
mandatory training as a part of their
QAPI and infection prevention and
control programs that educate staff on
the written standards, policies, and
procedures for each program.
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Æ Compliance and Ethics: In
accordance with section 1128I of the
Act, as added by the Affordable Care
Act, we would require the operating
organization for each facility to include
training as a part of their compliance
and ethics program. We propose to
require annual training if the operating
organization operates five or more
facilities.
Æ In-Service Training for Nurse
Aides: In accordance with sections
1819(f)(2)(A)(i)(I) and 1919(f)(2)(A)(i)(I)
of the Act, as amended by the
Affordable Care Act, we propose to
require dementia management and
resident abuse prevention training to be
a part of 12 hours per year in-service
training for nurse aides.
Æ Behavioral Health Training: We
propose to require that facilities provide
behavioral health training to its entire
staff, based on the facility assessment at
§ 483.70(e).
42173
3. Summary of Costs and Benefits
a. Overall Impact
We estimate the total projected cost of
this rule would be $729,495,614 in the
first year. This results in an estimated
first-year cost of approximately $46,491
per facility and a subsequent-year cost
of $40,685 per facility on 15,691 LTC
facilities.
b. Section-by-Section Economic Impact
Estimates
ESTIMATED COST TO COMPLY WITH ALL THE REQUIREMENTS OF THE PROPOSED RULE
Regulatory area
First year total
cost
Section
Total cost in year
2 and thereafter
483.10
483.11
483.15
483.21
483.30
483.35
483.60
483.75
483.80
483.85
483.95
483.95(a)
483.95(f)
483.95(g)
$10,436,051
1,935,785
3,331,225
118,184,092
35,660,786
3,640,312
1,788,774
118,419,977
283,944,336
139,356,716
..............................
7,280,624
1,876,624
3,640,312
$10,436,051
999,345
3,331,225
118,184,092
35,660,786
3,640,312
1,663,246
47,402,511
283,944,336
120,327,296
..............................
7,280,624
1,876,624
3,640,312
Total ....................................................................................................................
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Resident Rights .........................................................................................................
Facility Obligations .....................................................................................................
Transitions of Care ....................................................................................................
Comprehensive Resident Centered Care Planning ..................................................
Physician Services .....................................................................................................
Nursing Services ........................................................................................................
Food and Nutrition Services ......................................................................................
QAPI ..........................................................................................................................
Infection Control .........................................................................................................
Compliance and Ethics Program ...............................................................................
Training ......................................................................................................................
General Training Topics ............................................................................................
Compliance and Ethics Training ................................................................................
Dementia Management and Abuse Training .............................................................
..............................
729,495,614
638,386,760
B. Statutory and Regulatory Authority of
the Requirements for Long-Term Care
Facilities
In addition to specific statutory
requirements set out in sections 1819
and 1919 and elsewhere in the Social
Security Act, sections 1819(d)(4)(B) and
1919(d)(4)(B) of the Act permit the
Secretary of the Department of Health
and Human Services (the Secretary) to
establish any additional requirements
relating to the health, safety, and wellbeing of SNF and NF residents
respectively as the Secretary finds
necessary.
Under sections 1866 and 1902 of the
Act, providers of services seeking to
participate in the Medicare or Medicaid
program, or both, must enter into an
agreement with the Secretary or the
state Medicaid agency, as appropriate.
LTC facilities seeking to be Medicare
and Medicaid providers of services must
be certified as meeting federal
participation requirements. LTC
facilities include SNFs for Medicare and
NFs for Medicaid. The federal
participation requirements for SNFs,
NFs, or dually certified facilities, are set
forth in sections 1819 and 1919 of the
Act and codified in the implementing
regulations at 42 CFR part 483, subpart
B. Sections 1819(b)(1)(A) and
1919(b)(1)(A) of the Act provide that a
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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
quality of life of each resident. In
addition, the IMPACT Act (Pub. L. 113–
185) amended Title XVIII of the Act by,
among other things, adding Section
1899B to the Act. Section 1899B(i)
requires that certain providers,
including long term care facilities, take
into account, quality, resource use, and
other measures to inform and assist with
the discharge planning process, while
also accounting for the treatment
preferences and goals of care of
residents.
The Affordable Care Act made a
number of changes to the Medicare and
Medicaid programs. For instance, in an
effort to increase accountability for
SNFs and NFs, section 6102 of the
Affordable Care Act established a new
section 1128I of the Act. In general,
section 1128I(b) of the Act requires LTC
facilities to have in operation an
effective compliance and ethics program
that is effective in preventing and
detecting criminal, civil, and
administrative violations and in
promoting quality of care. Section
1128I(b)(2) of the Act specifies that the
Secretary, working jointly with the
Inspector General of the Department of
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Health and Human Services (HHS),
shall promulgate regulations for an
effective compliance and ethics program
for operating organizations, which may
include a model compliance program.
Further, section 1128I(c) of the Act adds
a requirement for a quality assurance
and performance improvement program
(QAPI). Lastly, in an effort to promote
dementia management and prevent
abuse, section 6121 of the Affordable
Care Act amended section
1819(f)(2)(A)(i)(I) and section
1919(f)(2)(A)(i)(I) of the Act by requiring
dementia and abuse prevention training
to be included as part of training
requirements for nurse aides.
C. Summary of Stakeholder Comments
In order to evaluate the need to
update the requirements for long term
care facilities, CMS provided LTC
stakeholders and members of the
general public with opportunities to
provide suggestions and
recommendations for our revision of the
requirements. Specifically, we reached
out to industry groups, advocates and
other stakeholders by announcing our
intention to conduct a comprehensive
review of the requirements during CMS
open door forums and other regularly
scheduled stakeholder calls. We
established an email box to receive
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Federal Register / Vol. 80, No. 136 / Thursday, July 16, 2015 / Proposed Rules
comments and feedback. In response to
our outreach, we received more than 20
comments from a variety of stakeholder
organizations and individuals.
Comments ranged from those who were
concerned that burden-reducing
changes would weaken important
protections for vulnerable seniors to
those who believe the existing
regulations are working well and no
changes were necessary. We also
received a number of comments that
included very detailed and
comprehensive recommendations for
changes to our regulations. One
consistent theme of the comments was
the need to address staffing levels. Most
comments suggested that we increase
the required number of registered nurse
(RN) hours of onsite duty per resident
day. They also suggested that we
strengthen our training requirements for
staff and require trainings for specific
skills and procedures. Another common
theme in the comments was the need to
revise the regulations so that they reflect
a person-centered care approach and
improve the quality of care and life for
the residents. For example, commenters
requested that residents be included in
the care planning process and given
complete control over their meal
choices. Commenters also requested that
we ensure the regulations are current
and consistent with federal privacy
legislation and the associated
implementing regulations, such as the
Health Insurance Portability and
Accountability Act of 1996 (HIPAA) and
the HIPAA Privacy Rule (45 CFR part
160 and subparts A and E of part 164).
We have reviewed all of the
stakeholder’s comments and have taken
them into consideration while drafting
this proposed rule. We note that some
commenters requested changes that
conflicted directly with statute.
Moreover, some of the comments we
received were outside the scope of our
review (that is, comments related to the
LTC facility survey process or the
interpretive guidance (IG)). However,
we have shared all of the stakeholder’s
comments with appropriate CMS staff
for their review and consideration. We
appreciate all of the stakeholders input
and responses to our outreach efforts
thus far and believe that this proposed
rule reflects our desire to promote
person-centered care and improve the
quality of care and services, while
further protecting resident’s safety,
choice and well-being.
D. Why revise the LTC requirements?
Although there have been many
discrete changes to specific provisions,
the requirements for LTC facilities have
not been comprehensively reviewed and
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updated since 1991. The number of
Medicare beneficiaries who accessed
care in a SNF increased from 636,000
(or 19 per 1,000 enrollees) in 1989 to
1,839,000 (or 52 per 1,000 enrollees) in
2010, not including managed care
enrollees (Data Compendium. 2002
edition. Centers for Medicare &
Medicaid Services [on-line]. https://
www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/DataCompendium/).
In addition to the increase in the
number of individuals accessing SNF
care, the health concerns of individuals
residing in LTC facilities have become
more clinically complex. The LTC
population includes a mix of elderly
individuals, younger residents with
intellectual or developmental
disabilities who are chronically ill, and
residents in need of post-acute
rehabilitation services. Since the 1980’s,
the nursing home resident population
has had some significant changes. Some
of these changes have resulted in
nursing homes having to care for many
residents that generally have a higher
acuity. One change has been a dramatic
increase in the number of residents who
are recuperating from an acute episode
of an illness or injury and who would
have usually been discharged from a
hospital to their homes. In 1983,
Medicare implemented the prospective
payment system for hospitals (Decker,
FH. Nursing homes, 1977–99: What has
changed, what has not? Hyattsville,
Maryland Center for Health Statistics.
2005, p. 3). In the subsequent years,
there have been shorter hospital stays
for Medicare beneficiaries and increased
Medicare-funding for post-acute stays in
nursing homes. Decker noted that while
the discharge rate for individuals who
had nursing home stays of 3 months or
more had not changed significantly, the
discharge rate for individuals who were
discharged after a nursing home stay of
90 days or less accounted for virtually
all of the increase. Thus, Decker used
this as a benchmark for short versus
long stays. The number of discharges
per 100 nursing home beds in 1977 and
1985 were 86 and 77, respectively.
However, by 1999, the discharge rate
per 100 nursing home beds had
increased by about 56 percent to 134
(Decker, p. 2). In addition, the
percentage of these stays in which
Medicare was the primary payer had
more than tripled from 11 percent in
1985 to 39 percent in 1999. Medicare
generally only covers the first 100 days
of a stay in a skilled nursing facility
(https://www.medicare.gov/Pubs/pdf/
10153.pdf).
Another factor that has resulted in a
higher acuity in the nursing home
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resident population has been the
increase in assisted-living facilities and
other alternatives to nursing home care,
such as home care (Decker, p. 5 and
Harris-Kojetin, L., Sengupta, M., ParkLee, E., and Valverde, R. Long-term care
services in the United States: 2013
overview. National health care statistics
reports; no 1. Hyattsville, MD: National
Center for Health Statistics, 2013). This
has resulted in nursing homes caring for
residents that require more medical care
and rehabilitation services. This is
supported by the significant decrease in
the percentage of residents that could
perform their ADLs independently. In
1977, almost 67 percent of residents
could eat independently (Decker, p. 5,
Figure 6). However, by 1999, that
percentage had decreased to almost 53
percent and by 2004 it was down to
only about 41 percent (Decker and
Jones, AL, Dwyer, LL, Bercovitz, AR,
Strahan, GW. The National Nursing
Home Survey: 2004 Overview. National
Center for Health Statistics. Vital Health
Stat 13(167). 2009, Figure 5.). In 1977,
almost 30 percent of residents were
independent in dressing; however, by
1999, that percent was down to almost
13 percent and by 2004 it was down to
about 10 percent (Decker and Jones). By
2004, more than 50 percent of all
nursing home residents either required
extensive assistance with bathing,
dressing, toileting, and transferring or
were totally dependent for these ADLs
(Jones, Figure 5 and Harris-Kojetin,
Figure 24). Only 1.6 percent of all
nursing home residents received no
assistance for any ADL (Jones, Figure 4).
Nursing homes are also caring for a
significant number of residents who
require behavioral health services. In
2004, over 16 percent of nursing home
residents received a primary diagnosis
of a mental disorder upon admission
(Jones, Figure 7). By the time residents
were interviewed for the National
Nursing Home Survey that percentage
increased to almost 22 percent. The
1999 estimate was about 18 percent. In
addition, nursing homes are caring for a
significant number of patients with
dementia and depression. By 2012, over
48 percent of nursing home residents
had a diagnosis of Alzheimer’s disease
or another dementia and/or depression
(Harris-Kojetin, p. 35, Figure 23).
Similiarly, in looking at the prevalence
of four mental health conditions
(depression, anxiety disorders, bipolar
disorder, and schizophrenia) in nursing
home residents 65 and older, the
Institute of Medicine (IOM) found
almost 50 percent had depression and
almost 57 percent had one or more of
those conditions (IOM (Institute of
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tkelley on DSK3SPTVN1PROD with PROPOSALS2
Medicine) 2012. The mental health and
substance use workforce for older
adults: In whose hands? Washington,
DC: The National Academies Press). In
addition, substance abuse disorders are
also increasing in the nursing home
population. Substance abuse disorders
are described in the Diagnostic and
Statistical Manual of Mental Disorders,
Fifth Edition (DSM–5) (https://
www.dsm5.org/Documents/Substance%
20Use%20Disorder%20Fact%
20Sheet.pdf Accessed on June 17, 2015).
Thus, in this rule, when we discuss
behavioral health or mental illness, we
are also discussing substance abuse
disorders.
To accommodate a more diverse
population, the current care and service
delivery practices of LTC facilities have
changed to meet these changing service
needs. These factors not only
demonstrated a need to
comprehensively review the regulations,
but also informed our approach for
revising the regulations. The following
discussion highlights our approach to
proposing revisions as well as some of
the most significant revisions set forth
in this proposed rule.
Facility Assessment and CompetencyBased Approach
One of our goals in revising our
minimum health and safety
requirements for LTC facilities is to
ensure that our regulations align with
current clinical practice and allow
flexibility to accommodate multiple care
delivery models to meet the needs of the
diverse populations that are provided
services in these facilities. We
considered prescriptive approaches,
such as requiring specific numbers and
types of staff based on facility size and
acuity of residents, but were concerned
that such an approach would conflict
with requirements already established
in many states, and would limit
flexibility and innovation in designing
new models of person-centered care
delivery for residents. Thus, we are
instead taking a competency-based
approach that focuses on achieving the
statutorily mandated outcome of
ensuring that each resident is provided
care that allows the resident to maintain
or attain their highest practicable
physical, mental, and psychosocial
well-being. Under this competencybased approach, we are proposing
requirements that are compatible with
existing state requirements and
consistent with what we believe are
already common practices by facilities.
As discussed in further detail in this
proposed rule in section II, ‘‘Provisions
of the Proposed Rule,’’ we propose to
require facilities to assess their facility
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capabilities and their resident
population. Using the information from
that assessment, facilities would be
required to provide sufficient staff with
the necessary competencies and skills to
meet each resident’s needs based on
acuity, diagnosis, and the resident’s
person-centered comprehensive care
plan. Based on our experience with LTC
facilities, we believe most facilities
already make these assessments, at least
informally, in order to determine
staffing needs; our revisions will ensure
it is consistently performed and
documented in all SNFs and NFs.
Application of facility assessments
and competence-based staffing
decisions would involve every service
provided by a NF or SNF and apply to
all members of the staff, including the
interdisciplinary team. For example, a
facility that provides dementia care
would need to ensure it has sufficient
numbers of staff and that the staff has
the necessary training, education, and/
or experience to care for individuals
with dementia. These staff may be
nursing service staff, behavioral health
staff, or other appropriate care
providers. Similarly, adding a
competence-based requirement would
ensure that a facility serving residents
requiring post-acute rehabilitation care
had sufficient staff with the required
training, education and/or experience to
care for individuals requiring those
services. We propose that the focus be
on the competencies and skill sets of the
individuals delivering care and services
rather than just on the overall number
of care givers available. This
competence-based approach is
compatible with existing state
requirements and business practices,
and promotes both efficiency and
effectiveness in care delivery. In
addition to a competence-based
approach, this proposed rule is intended
to meet the spirit of current HHS quality
initiatives that cut across various
providers.
Current HHS Quality Initiatives
As an effective steward of public
funds, CMS is committed to
strengthening and modernizing the
nation’s health care system to provide
access to high quality care and
improved health at lower cost. This
includes improving the patient
experience of care, both quality and
satisfaction, improving the health of
populations, and reducing the per capita
cost of health care. In drafting the
proposed rule, we considered current
initiatives underway to support these
aims and improve care across providers
as well as initiatives targeted
specifically at nursing home residents.
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42175
As discussed below, we are proposing
several revisions consistent with these
efforts.
• Reducing Avoidable Hospitalization
Nearly two-thirds of nursing home
residents are enrolled in Medicaid, and
most are also enrolled in Medicare.
These Medicare-Medicaid enrollees are
among the most fragile and chronically
ill individuals served by both programs.
Although estimates vary, CMS research
found that approximately 45 percent of
hospitalizations among MedicareMedicaid enrollees receiving either
Medicare skilled nursing facility
services or Medicaid nursing facility
services could have been avoided
(https://innovation.cms.gov/initiatives/
rahnfr/). One goal of the HHS
Partnership for Patients Initiative is to
reduce the number of individuals who
experience a preventable complication
requiring rehospitalization. This effort
aims to improve the quality of care and
services for individuals cared for in LTC
facilities. In support of this initiative,
CMS has launched the ‘‘Initiative to
Reduce Avoidable Hospitalizations
among Nursing Facility Residents’’
(https://innovation.cms.gov/initiatives/
rahnfr/). CMS is supporting
organizations that partner with nursing
facilities to implement evidence-based
interventions that both improve care
and lower costs. The initiative is
focused on long-stay nursing facility
residents who are enrolled in the
Medicare and Medicaid programs.
Additional information and resources
are available at https://
innovation.cms.gov/initiatives/rahnfr/
index.html.
Consistent with the HHS focus on
reducing unnecessary hospitalization, in
drafting this proposed rule, we looked at
what, if any, minimum health and safety
standards could be developed or
strengthened that would contribute to a
reduction in unnecessary hospital
admissions of nursing home residents.
First, we considered many factors that
contribute to a decision to transfer a
nursing home resident to a hospital.
This is primarily a clinical decision, but
it may be impacted by environmental or
financial factors that are not amenable
to change based on regulatory
requirements. These concerns include
family and resident preferences and
demands, concern regarding the LTC
facility’s liability, and payment
incentives. We believe, however, that
there are some regulatory changes that
would help reduce avoidable
hospitalization of nursing home
residents. We discuss those changes in
section II, ‘‘Provisions of the Proposed
Rule’’.
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• Healthcare Associated Infections
HHS is also working to reduce the
incidence of healthcare associated
infections (HAIs) across providers. In
recognition of HAIs as an important
public health and patient safety issue,
HHS is sponsoring the ‘‘National Action
Plan to Prevent HAIs’’. This initiative
seeks to coordinate and maximize the
efficiency of prevention efforts across
the federal government (https://
www.hhs.gov/ash/initiatives/hai/action
plan/). Given the growing number of
individuals receiving care in LTC
settings and the presence of more
complex medical care, these individuals
are at an increased risk for HAIs.
Therefore, to advance these initiatives,
we have proposed revisions that we
believe will provide more opportunities
to achieve broad based improvement
and contribute to reduced healthcare
costs. We also believe this approach
would be flexible enough to be adapted
to any business model and would allow
for targeted interventions specific to the
facility.
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• Behavioral Health
On March 29, 2012, CMS launched an
initiative aimed at improving behavioral
healthcare and safeguarding nursing
home residents from the use of
unnecessary antipsychotic medications.
As part of the initiative, CMS has
developed a national action plan that
uses a multidimensional approach
including public reporting, raising
public awareness, regulatory oversight,
and technical assistance/training and
research. This plan is targeted at
enhancing person-centered care for
nursing home residents, particularly
those with dementia-related behaviors
(https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/NursingHomeQualityInits/
Spotlight/html).
Similarly, with regard to minimum
health and safety standards, we looked
at possible regulatory changes that
could lead to a reduction in the
unnecessary use of antipsychotic
medication and improvements in the
quality of behavioral healthcare. After
conducting a review of literature,
stakeholder comments, and available
Office of Inspector General (OIG) reports
we found that many residents are not
receiving the individualized quality of
care mandated by the current
requirements. We address this issue
further in section II, ‘‘Provisions of the
Proposed Rule’’.
• Health Information Technology
HHS also has a number of initiatives
designed to encourage and support the
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adoption of health information
technology and to promote nationwide
health information exchange to improve
health care. HHS believes all patients,
their families, and their healthcare
providers should have consistent and
timely access to their health information
in a standardized format that can be
securely exchanged between the patient,
providers, and others involved in the
patient’s care (HHS August 2013
Statement, ‘‘Principles and Strategies for
Accelerating Health Information
Exchange.’’). The Department is
committed to accelerating health
information exchange (HIE) through
initiatives including: (1) Establishing a
coordinated governance framework and
process for nationwide health IT
interoperability; (2) improving technical
standards and implementation guidance
for sharing and using a common clinical
data set; (3) enhancing incentives for
sharing electronic health information
according to common technical
standards, starting with a common
clinical data set; and (4) clarifying
privacy and security requirements that
enable interoperability. Ensuring that
individuals and care providers can
send, receive, find, and use a basic set
of essential health information across
the health care continuum will enhance
care coordination and enable health
system reform to improve care quality.
This strategy is described in greater
detail in ‘‘Connecting Health and Care
for the Nation: A Shared Nationwide
Interoperability Roadmap, available at
https://www.healthit.gov/sites/default/
files/nationwide-interoperabilityroadmap-draft-version-1.0.pdf.
Developed with significant stakeholder
input, this 10-year Roadmap describes
barriers to interoperability across the
current health IT landscape, the desired
future state that the industry believes
will be necessary to enable a learning
health system, and a suggested path for
moving from the current state to the
desired future state. In addition, ONC
has released the 2015 Interoperability
Standards Advisory (available at https://
www.healthit.gov/standards-advisory),
which provides a list of the best
available standards and implementation
specifications to enable priority health
information exchange functions. ONC
expects to annually update the Advisory
through a transparent and structured
process that includes advice from the
Health IT Standards Committee (ONC’s
federal advisory committee) and the
public at large.
HHS is committed to encouraging HIE
among all health care providers,
including those who are not eligible for
the EHR Incentive Programs, to improve
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care delivery and coordination across
the entire care continuum. Our revisions
to this rule are intended to recognize the
advent of electronic health information
technology and to accommodate and
support adoption of ONC certified
health IT and interoperable standards.
We believe that the use of such
technology can effectively and
efficiently help facilities and other
providers improve internal care delivery
practices, support the exchange of
important information across care team
members (including patients and
caregivers) during transitions of care,
and enable reporting of electronically
specified clinical quality measures
(eCQMs). For more information, we
direct stakeholders to the ONC guidance
for EHR technology developers serving
providers ineligible for the Medicare
and Medicaid EHR Incentive Programs
titled, ‘‘Certification Guidance for EHR
Technology Developers Serving Health
Care Providers Ineligible for Medicare
and Medicaid EHR Incentive
Payments,’’ which addresses use of the
2014 Edition of ONC certification
criteria (available at https://
www.healthit.gov/sites/default/files/
generalcertexchangeguidance_final_9–
9–13.pdf). ONC anticipates updating the
2014 Edition Certification Guidance
once the ONC 2015 Edition Certification
becomes final. Information on the
development of standards applicable to
the long-term care setting can be found
at: https://wiki.siframework.org/
LCC+LTPAC+Care+Transition+SWG
and https://wiki.siframework.org/
Longitudinal+Coordination+of+Care.
• Trauma-Informed Care
HHS has also undertaken broad-based
activities to support Americans that
have specific needs to be considered in
delivering health care and other
services. Activities include raising
awareness about the special care needs
of trauma survivors, including a targeted
effort to support the needs of Holocaust
survivors living in the United States.
Trauma survivors, including veterans,
survivors of large-scale natural and
human-caused disasters, Holocaust
survivors and survivors of abuse, are
among those who may be residents of
long-term care facilities. For these
individuals, the utilization of traumainformed approaches is an essential part
of person-centered care. For many
trauma survivors, the transition to living
in an institutional setting (and the
associated loss of independence) can
trigger profound re-traumatization. In
addition, aspects of institutional settings
can be significant triggers. While these
triggers are highly individualized, some
common triggers include: Experiencing
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a lack of privacy or confinement in a
crowded or small space; or being
exposed to certain loud noises, or
bright/flashing lights. It is also
important to note that cognitive
impairment, such as dementia, may
worsen or further complicate a trauma
survivor’s response to triggers and may
also introduce additional language
barriers as individuals return to their
first (non-English) languages. Culturallycompetent, trauma-informed approaches
that help to minimize triggers and retraumatization, including those that
address the unique care needs of
Holocaust survivors and survivors of
war, disasters, and other profound
trauma are an important aspect of
person-centered care for these
individuals. Person-centered care that
reflects the principles set forth in
SAMSHA’s Concept of Trauma and
Guidance for a Trauma-Informed
Approach, HHS Publication No. (SMA)
14–4884, available at https://
store.samhsa.gov/shin/content/
SMA14=4884/SMA14-4884.pdf, would
help advance the quality of care that a
resident receives and, in turn, can
substantially improve a resident’s
quality of life.
• Requirements for Long Stay Residents
Ninety five percent of nursing homes
in the United States are dually certified
as SNF/NFs. That is, they provide both
the Medicare SNF benefit, and the
Medicaid NF benefit. Both benefits
cover skilled nursing care and
rehabilitation services, with a few minor
differences, as noted in these proposed
regulations. In addition, Medicaid NFs
provide long term care for residents who
require support for activities of daily
living. Some residents covered by long
term care insurance or paying privately
may also be receiving long-term care in
the nursing home indefinitely. For these
residents, the facility is their home. For
both residents and facilities, making the
nursing facility a home is a different
experience and undertaking than is a
course of rehabilitation followed by
discharge to the individual’s residence
in the community. The requirements
have not reflected this distinction.
We received some comments that
would apply primarily to serving long
term residents. Some of the ideas and
practices, known collectively as
‘‘Culture Change,’’ are of benefit to all
nursing home residents by making
services and supports more personcentered, but are particularly crucial to
the quality of life of long stay facility
residents. Person-centered care is an
aspect of culture change that focuses on
the resident as the locus of control,
supported in making their own choices
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and having control over their daily
lives. According to the authors of the
‘‘Long-Term Care Improvement Guide,’’
‘‘culture change’’ refers to the
progression from institutional or
traditional models of care to more
individualized, consumer-directed
practices that embrace choice and
autonomy for care providers and
recipients (Frampton, Susan, et al.
‘‘Making the Case for Change’’ LongTerm Care Improvement Guide 2010,
retrieved from https://
www.residentcenteredcare.org/Pages/
About%20the%20guide.html). The
authors go on to explain that this kind
of care not only enhances quality for
consumers and staff but also creates
opportunities for the organization to
improve operational benchmarks in
areas such as quality of care, efficiency
of operation, revenue generation and
stabilized staffing. CMS has participated
in the culture change movement and we
are familiar with both the goals and
challenges of this effort. We note that
the many present efforts to serve
individuals in the community rather
than in an institution, for example, in
compliance with the Supreme Court
Olmstead decision (Olmstead v. L.C ex
rel. Zimring, 527 U.S. 581, 119 S. Ct.
2176 (1999)), are primarily directed at
long-stay nursing home residents rather
than those receiving rehabilitation or
skilled nursing care, and this
characteristic may be relevant to facility
requirements.
While CMS is engaged in the issues
around long stay nursing home
residents, we do not have enough
verifiable information to propose
specific changes to the regulations
specifically applicable to long-stay
situations at this time. We solicit
comments on how the requirements
could acknowledge the special needs of
the long stay resident. In addition,
because we also received comments
regarding the need to specifically
address the needs of short stay
residents, we solicit comments on how
the requirements could acknowledge the
special needs of short stay residents.
Nursing facility providers describe the
challenges of serving these two rather
different populations in a single model
of care. We are particularly interested in
any suggestions to improve existing
requirements, within the authority of
existing statute, where they make
serving one or the other population
difficult or less effective. The most
useful comments will be those that offer
suggestions to amend specific sections
of the existing requirements or offer
particular additions. For example,
should new construction or capitalized
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renovations be based on models of
effective long term residence?
In addition to the requirements for
participation, CMS is seeking comment
on a number of issues related to the
finalization and implementation of the
proposed rule: Unintended
consequences and unanticipated risks to
SNF and NF residents, the involvement
of stakeholders in developing subregulatory requirements and in
implementing changes, and the timeline
for proposed implementation following
finalization of the rule.
The requirements for participation
have not been substantially updated
since the regulations implementing the
Omnibus Budget Reconciliation Act of
1987 were finalized. As such, the intent
of the proposed rule is modernization of
the regulation, harmonization with
other federal laws, and implementation
of certain provisions of the Affordable
Care Act. CMS is seeking comments on
the scope and type of changes proposed
here. Given the comprehensive nature of
our proposed revisions, we are soliciting
comments regarding potential
unintended consequences or
unanticipated risks to SNF and NF
residents, either related to a specific
proposal or in general, and what those
concerns might be. In addition, we are
interested in stakeholder comments
related to an appropriate timeframe for
nursing homes to implement these
regulations. CMS generally implements
changes to regulatory requirements for
the survey and certification process
within 12 months of a final rule.
Following finalization of this proposed
rule, CMS anticipates that it may require
a longer period of time to implement the
changes outlined in the final rule. The
additional time may be needed to
develop revised interpretive guidance
and survey processes, conduct surveyor
training on the changes, and implement
the software changes in the Quality
Indicator Survey (QIS) system, which
would include changing the underlying
framework of the QIS system as many of
the existing requirements have been reorganized. We also expect that it may
take a longer period for nursing facilities
to implement these changes and seek
stakeholder suggestions regarding an
appropriate implementation timeframes.
Lastly, we seek comment on additional
streamlining and reduction of outdated
policies as a means of balancing the new
policies being proposed.
Implementation of the Affordable Care
Act Provisions
We are proposing to implement
several provisions required by the
Affordable Care Act. First, section 6102
of the Affordable Care Act, which added
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new section 1128I to the Act requires
the operating organizations for facilities
(both SNFs and NFs as defined in
sections 1819(a) and 1919(a) of the Act)
to have in operation a compliance and
ethics program. The compliance and
ethics programs must be effective in
preventing and detecting criminal, civil,
and administrative violations under the
Act and in promoting quality of care
consistent with regulations that are
promulgated under this new section.
Second, section 1128I of the Act
requires the Secretary to establish and
implement Quality Assurance and
Performance Improvement (QAPI)
program requirements for facilities,
including multi-unit chains of facilities.
Under this requirement, the Secretary
must establish and implement standards
relating to QAPI and provide technical
assistance to facilities on the
development of best practices in order
to meet these standards. A facility must
submit to the Secretary a plan for the
facility to meet such standards and
implement the best practices, including
how to coordinate the implementation
of a plan with quality assessment and
assurance (QAA) activities already
required under sections 1819(b)(1)(B)
and 1919(b)(1)(B) of the Act as
implemented at 42 CFR 483.75(o). This
proposed rule would establish standards
relating to QAPI for SNFs and NFs, as
required by the Affordable Care Act.
Finally, section 6121 of the Affordable
Care Act, amending sections
1819(f)(2)(A)(i)(I) and 1919(f)(2)(A)(i)(I)
of the Act, requires dementia
management and abuse prevention to be
included as part of training
requirements for nurse aides. We are
proposing to amend the requirements
that an institution must meet in order to
participate as a SNF/NF in the Medicare
and Medicaid programs, by requiring
that the current mandatory on-going
training requirements for nurse aides
(NAs) include dementia management
and resident abuse prevention training.
This proposed rule would also clarify
that the definition of NA includes an
individual who provides NA services
through an agency or under contract
with a LTC facility, as provided in
sections 6121(a)(2) and (b)(2) of the
Affordable Care Act.
Executive Order 13563
In January 2011 the President issued
Executive Order 13563 ‘‘Improving
Regulation and Regulatory Review,’’
which directs agencies to select the least
burdensome approaches, to minimize
cumulative costs, to simplify and
harmonize overlapping regulations, and
to identify and consider flexible
approaches that maintain freedom of
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choice for the American public.
Executive Order 13563 also requires
agencies to engage in a process of
reviewing existing regulations to see if
those rules make sense and continue to
be justified. The provisions of this
proposed rule are intended to meet the
letter and spirit of Executive Order
13563, for reviewing existing
regulations to see if those rules make
sense and continue to be justified. The
provisions of this proposed rule also
meet the objectives of section 610 of the
Regulatory Flexibility Act (RFA), which
also requires agencies to review the
impact of existing rules on small
businesses or other small entities for
possible reforms to reduce burden and
costs. We conducted a general review of
the regulations for outdated, confusing,
and unnecessarily burdensome
requirements and considered areas for
improvement.
II. Provisions of the Proposed
Regulation
Reorganization of Part 483 Subpart B
In our comprehensive review of part
483 subpart B, we felt that
improvements could be made to the
overall readability and logical order of
the regulatory provisions. Therefore, we
propose to revise the order of the
regulatory provisions. As in the existing
subpart B, required sections including
basis and scope and definitions, would
come first. Similar to the existing
regulations, we propose to follow these
sections with provisions assuring
resident-centered care, including
resident rights, facility responsibilities,
freedom from abuse, neglect and
exploitation, transitions of care, and
individualized resident assessment and
care planning. We propose to then
include service-specific provisions,
including quality of care, starting with
physician services and concluding with
administration. We propose to conclude
subpart B with requirements for facilitywide programs such as infection
control, compliance and ethics, training,
and facility physical environment. We
believe our proposed revised order
significantly improves the readability
and logical order of the regulations and
would allow individuals less familiar
with the regulations to find information
they are seeking more easily. A
crosswalk of the current provisions to
the proposed provisions is included as
Table A in section III of this proposed
rule.
Cross Cutting Proposals
While some proposed changes require
revisions that are contained in one
specific section of the requirements,
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other issues apply across multiple
sections and thus would require
changes in several sections of the
regulations. These cross-cutting topics
include proposals regarding
unnecessary hospitalization, HAIs,
antipsychotic medications, care
planning, and QAPI. Below is a general
discussion of our approach to revising
the regulations to address these issues.
Specific changes to the regulatory text
are discussed in detail in the relevant
requirements.
• Unnecessary Hospitalization
The transfer to an acute care hospital
is a stressful event for a resident of a
SNF or NF. As noted by The Office of
the Assistant Secretary for Planning and
Evaluation (ASPE) in its June 2011
report on Hospitalizations of Nursing
Home Residents, such hospitalizations
impose a high personal cost on nursing
home residents, causing disruption, risk
of complications and infections, and
likelihood of reduced functioning on
return to the nursing home (Ouslander,
J.G., Lamb, G., Perloe, M., Givens, J.H.,
Kluge, L., Rutland, T., et al. (2010).
Potentially avoidable hospitalizations of
nursing home residents: Frequency,
causes, and costs. Journal of the
American Geriatrics Society, 58, 627–
635.). Nursing home residents are
especially vulnerable to the risks that
accompany hospitalizations and
transitions of care, including medication
errors and hospital-acquired infections.
Hospital episodes are even more
difficult for residents with dementia,
who become disoriented in new,
unfamiliar settings. Preventing
potentially avoidable hospitalizations of
nursing home residents is an important
quality-improvement initiative from the
standpoint of the residents and their
families, and also may yield cost
reductions (Polniaszek, Susan, Walsh,
Edith G. and Wiener, Joshua M. (2011)
Hospitalizations of Nursing Home
Residents: Background and Options.
U.S. Department of Health and Human
Services, Assistant Secretary for
Planning and Evaluation, Office of
Disability, Aging and Long-Term Care
Policy).
In order to decrease unnecessary
hospitalizations, the June 2011 report
from ASPE gives options such as
reporting potentially avoidable
hospitalization rates on the CMS
Nursing Home Compare Web site,
increasing registered nurse (RN) staffing
and the use of nurse practitioners (NPs),
modifying the Medicare 3-day
qualifying stay requirement, providing
education and care tools, and changing
Medicaid coverage policy to direct
incentives to reduce avoidable
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hospitalization of nursing home
residents (‘‘Hospitalizations of Nursing
Home Residents: Background and
Options’’ U.S. DHHS, Assistant
Secretary for Planning and Evaluation,
Office of Disability, Aging and LongTerm Care Policy. June 2011). Of these
options, we believe education is one of
the areas that is most amenable to
addressing through revising the
requirements. Young et al. conclude,
based on a cross-sectional survey of
randomly selected nursing homes in
New York State, that contributing
factors to unnecessary hospitalizations
amenable to change include
communication effectiveness training,
ensuring adequate access to prior
medical history, laboratory results and
ECGs, and encouraging physicians who
practice at nursing homes to treat
residents within the nursing home
whenever possible (Journal of the
American Geriatric Society, 58:901–907,
May 2010). The availability of patient
information, including resident medical
history, assessment of current condition
including recent laboratory and
radiology results, availability of
physicians or other practitioners to
evaluate the patient if needed, and
effective interdisciplinary team
communication are areas we can impact
through the requirements.
In this proposed rule, we propose to
take a multifaceted approach to
reducing unnecessary hospitalization
which includes:
• Requiring that a facility notify the
resident’s physician when there is a
change in a resident’s status, including
any pertinent information specified in
§ 483.15(b)(2)–(§ 483.11(e)(7)(ii))
• Addressing communication through
a robust interdisciplinary team,
comprehensive person-centered care
planning process and through training
requirements (§ 483.21).
• Proposing a requirement for
practitioner assessment prior to transfer
to a hospital, except in an emergency
situation (§ 483.30(e)).
• Enhancing nursing care through a
competency-based approach (§ 483.35).
• Strengthening the clinical record
requirements to ensure adequate and
appropriate information is available to
evaluating practitioners (§ 483.70(i)).
• Ensuring ongoing evaluation of care
process through implementation of a
robust QAPI plan (§ 483.75)
This multifaceted approach would
build on existing requirements and
standard business practices through
incremental change. We also believe
that this approach would not only have
a positive impact on reducing
unnecessary readmissions, but may also
improve other quality areas as well and
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is intended to be flexible enough to
encompass any care model and all
facility populations.
• Reduction in Inappropriate Use of
Antipsychotic Medications
Antipsychotic medications are
frequently prescribed off-label, which
means that the drug is being prescribed
for a use that is not approved by the
U.S. Food and Drug Administration
(FDA), to residents with behavioral and
psychological symptoms of dementia
(BPSD). This has led to increased
attention to the behavioral health
management of nursing home residents
with dementia and the potentially
inappropriate use of antipsychotics in
this population. Evidence suggests that
antipsychotics have limited benefits in
this population, and the potential to
lead to adverse consequences such as
the risk of movement disorders, falls,
hip fractures, cerebrovascular accidents,
and death. Additionally, the health
profiles of this population are often
medically complex and residents may
take multiple medications that increase
their risk of adverse effects and drug
interactions. A previous OIG study
found that when this population
received these drugs, about half of the
drugs were not given for medically
accepted indications as required for
Medicare coverage or recorded as being
administered to the resident and onefifth of the drugs were not given in
accordance with federal safeguards to
protect nursing facility residents from
unnecessary antipsychotic drug use
(OEI–07–08–00150). The potential
overuse of antipsychotic agents is a
symptom of a much larger problem—
namely, that many nursing facilities
may not have a systematic plan to
provide comprehensive behavioral
health care to residents with diagnoses
such as dementia and BPSD.
In this proposed rule, we would take
a multifaceted approach to reducing the
unnecessary use of antipsychotic
medications which would include:
• Requiring that each nursing home
conduct a comprehensive assessment,
including its physical characteristics
(that is, size, location, and number of
residents), its resident population
(including both a psychosocial and
mental health assessment), the
competencies and knowledge of its staff,
and the identification of any resources
or support, including training and
additional staff, that the facility would
need to ensure the appropriate care and
treatment for all residents (§ 483.70)
• Revising the current requirements
that apply to antipsychotic drugs to also
apply to any psychotropic drug; that is,
any drug that affects brain activities
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associated with mental processes and
behavior (§ 483.45)
• Including a requirement that once
the facility’s consultant pharmacist has
identified an irregularity (such as, a
drug given for an excessive duration of
time or prescribed without adequate
indications documented in the
resident’s medical record), or has
recommended a gradual dose reduction
for one or more medication, the
attending physician would be required
to document in the resident’s medical
record that he or she has reviewed the
identified irregularity and what, if any,
action they took to address it. If there is
to be no change in the medication, the
attending physician should document
his or her rationale in the resident’s
medical record (§ 483.45)
Similar to our proposals for reducing
unnecessary hospitalizations, this
multifaceted approach would build on
existing requirements and standard
health care practices through
incremental change. We believe that this
approach would provide the best
opportunity for a broad-based
improvement in the areas of mental,
behavioral, and psychosocial-related
health care concerns, while also
providing facilities with flexibility
regarding how to address the type of
staff and training or other resources and
support they need to provide care and
services in these areas.
• Healthcare Associated Infections
(HAIs)
Although estimates vary widely, there
are between 1.6 and 3.8 million HAIs in
nursing homes every year. Annually,
these infections result in an estimated
150,000 hospitalizations, 388,000
deaths, and between $673 million and
$2 billion dollars in additional
healthcare costs (Castle, et al. Nursing
home deficiency citations for infection
control, American Journal of Infection
Control, May 2011; 39, 4). In some ways,
the resident population in nursing
homes presents unique regulatory
challenges, particularly with respect to
infection control. Residents in nursing
homes not only receive skilled nursing
care in these facilities, but for many
individuals, these facilities are also their
homes. In addition, nursing homes are
required to provide social activities for
residents which may include group
activities or functions. These activities
or functions, such as dining, social
events, and religious services, may
increase the risk of transmission and
exposure to communicable diseases and
infections. The diversity of the nursing
home community presents each facility
with unique challenges to meet the
needs and choices of all of the
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individuals they serve, creating a much
harder task of regulating and managing
infection control and prevention
activities. Nursing home residents are
often frail, elderly individuals and
individuals with disabilities who have
increased susceptibility to infections
from malnutrition, dehydration,
comorbidities, or functional
impairments (for example, urinary and
fecal incontinence), and medications
that diminish immunity or immobility.
In addition, as patients are discharged
from hospitals to nursing homes sooner,
the nursing home population
increasingly has more residents with
greater medical needs, which not only
increases the acuity level but also likely
results in higher invasive device use (for
example, mechanical ventilators, central
venous catheters, and enteral feeding
tubes). Therefore, when developing our
approach to promote prevention and
control of HAIs, we took into
consideration this diverse resident
population, as well as the interaction
residents will have with staff, visitors,
and each other.
Similar to our approach to address
unnecessary hospitalizations, we
identified the following areas to
consider addressing HAIs when revising
the nursing home infection control
requirements:
• Requirements for the facility to
perform a facility-specific assessment of
their resident population and facility
(§ 483.70)
• Integration of the infection
prevention and control program (IPCP)
with the facility’s QAPI processes
(§ 483.75)
• Revising the description of the
infection control program and adding a
requirement to periodically review and
update the program (§ 483.80)
• Requiring an antibiotic stewardship
program that includes antibiotic use
protocols and a system for monitoring
antibiotic use (§ 483.80)
• Designation of specific infection
prevention and control officers (IPCOs)
(§ 483.80)
• Written policies and procedures for
the IPCP (§ 483.80)
• Education or training related to the
infection control program (§ 483.80)
Likewise, with the other cross-cutting
provisions, we believe that taking a
multifaceted approach when revising
the infection control requirements
would provide the best opportunity to
achieve broad-based improvement while
also being flexible enough to be adapted
to any health care delivery model. These
revisions may also result in positive
impacts in the care and services to
residents, reducing unnecessary
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hospitalizations and overall lowered
healthcare costs.
In the following sections we detail our
proposed revisions to the requirements.
The discussion follows our proposed
reorganization of subpart B.
A. Basis and Scope (§ 483.1)
We propose to revise § 483.1 ‘‘Basis
and Scope’’ to include references to
sections 1819(f), 1919(f), 1128I (b) and
(c), and 1150B of the Act. Sections
1819(f) and 1919(f) of the Act require
that the current mandatory on-going
training for NAs include dementia
management and resident abuse
prevention training. New section 1128I
(b) of the Act requires the operating
organizations for SNFs and NFs to have
a compliance and ethics program and
new section 1128I(c) of the Act requires
the Secretary to establish and
implement a QAPI program for
facilities. New section 1150B of the Act
establishes requirements for reporting to
law enforcement suspicion of crimes
occurring in federally funded LTC
facilities. In addition, we propose to
spell out the term ‘‘skilled nursing
facility’’.
B. Definitions (§ 483.5)
Current regulations at § 483.5 provide
definitions for terms commonly used in
the LTC requirements. We propose to
revise some of the existing terms for
clarity and define new terms that we
believe are widely used within the LTC
setting, and that we believe would add
value to the LTC requirements while
promoting resident choice and safety.
We have retained the existing
definitions for ‘‘facility’’ and ‘‘distinct
part’’. We are aware of stakeholder
concerns that defining ‘‘distinct part’’
and ‘‘composite distinct part’’ possibly
allow facilities to segregate residents by
payment source. On August 4, 2003, we
published a final rule entitled,
‘‘Medicare Program; Prospective
Payment System and Consolidated
Billing for Skilled Nursing FacilitiesUpdate’’ (68 FR 46036). Through this
final rule, the definitions of ‘‘distinct
part’’ and ‘‘composite distinct part’’
were added to this section and we
believe the rationale for the addition at
that time remains valid. While some
SNFs function as separate, independent
entities, we have recognized since the
inception of the Medicare program that
it is also possible for a SNF to operate
as a component, or ‘‘distinct part’’ or
‘‘composite distinct part’’ of a larger
organization. While we do not agree that
‘‘distinct part’’ and ‘‘composite distinct
part’’ should be removed from the
current regulations, based on concerns
raised by some stakeholders, we have
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modified the definition of ‘‘composite
distinct part’’ to make it clear that a
composite distinct part designation
cannot be used as a means to segregate
residents by payment status or on any
basis other than care needs. Such
segregation may violate a patient’s
privacy by implicitly revealing their
payment source and lends itself to
creating inequitable care situations. In
addition, we have retained the
definition of ‘‘major modification’’,
which was added to the LTC regulations
in the May 12, 2014 final rule,
‘‘Regulatory Provisions to Promote
Program Efficiency, Transparency, and
Burden Reduction; Part II’’ (79 FR
27106). We also propose to make minor
revisions to the definition of ‘‘common
area’’ to recognize that some facilities
have living rooms or other areas where
residents gather.
As discussed in detail below, based
on our internal review and feedback
from stakeholders, we propose to
expand this section to include the
following definitions: ‘‘abuse,’’ ‘‘adverse
event,’’ ‘‘exploitation,’’
‘‘misappropriation of resident
property,’’ ‘‘neglect,’’ ‘‘person-centered
care,’’ ‘‘resident representative,’’ and
‘‘sexual abuse’’. In addition, we propose
to relocate the definitions for ‘‘licensed
health professional’’ and ‘‘nurse aide’’ to
this section from the ‘‘Administration’’
section at § 483.75(e)(1). We believe that
these definitions apply broadly to the
regulations and would more
appropriately be defined in this section
of definitions. In addition, we propose
to revise the definition of ‘‘nurse aide’’
in accordance with amendments to
sections 1819(b)(5)(F) and 1919(b)(5)(F)
of the Act made by sections 6121(a)(2)
and (b)(2) of the Affordable Care Act.
‘‘Nurse aide’’ is currently defined as any
individual providing nursing or
nursing-related services to residents in a
facility who is not a licensed health
professional, a registered dietitian, or
someone who volunteers to provide
these services without pay. ‘‘Nurse
aides’’ do not include those individuals
who furnish services to residents only
as paid feeding assistants as defined in
§ 488.301. Section 6121 of the
Affordable Care Act added the following
clarification to the definition of ‘‘nurse
aide’’: ‘‘Such term includes an
individual who provides such services
through an agency or under a contract
with the facility.’’ We propose to amend
the regulatory definition accordingly.
We propose to add the term ‘‘adverse
event’’ to ensure clarity in our
requirements relating to proposed
requirements for QAPI. We discuss this
definition further in section II.T. of the
preamble and welcome comment on our
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proposed definition. We also propose
the addition of the term ‘‘resident
representative’’ because the use of a
representative is often common practice
within the nursing home setting. We
believe a resident can designate an
individual to have certain rights and/or
responsibilities, such as the ability to
make decisions about a resident’s care,
the ability to manage a resident’s
finances, or the ability to participate in
discussions about the residents care and
the ability to access a resident’s medical
information. For purposes of this
regulation, we would define the term
‘‘resident representative’’ broadly to
include both an individual of the
resident’s choice who has access to
information and participates in
healthcare discussions as well as
personal representative with legal
standing, such as a power of attorney for
healthcare, legal guardian, or health care
surrogate or proxy appointed in
accordance with state law to act in
whole or in part on the resident’s behalf.
One individual may or may not fulfill
both of these roles. We also note that the
same-sex spouse of a resident would be
afforded treatment equal to that afforded
to an opposite-sex spouse if the
marriage was valid in the jurisdiction in
which it was celebrated. Throughout
this proposed regulation, where we use
the term resident, it includes, as
applicable, the resident representative.
In addition, we propose to add a
definition of ‘‘person-centered care’’.
For purposes of this subpart, we would
define person-centered care as focusing
on the resident as the locus of control
and supporting the resident in making
their own choices and having control
over their daily lives.
The addition of the definitions of
‘‘abuse’’, ‘‘sexual abuse’’, ‘‘neglect’’,
‘‘exploitation’’, and ‘‘misappropriation
of resident’s property’’ are being
proposed to achieve clarity within the
current regulations and eliminate
confusion regarding what actions or
circumstances rise to the level of these
terms. For purposes of these regulations,
‘‘abuse’’ would include actions such as
the willful infliction of injury,
unreasonable confinement,
intimidation, or punishment with
resulting physical harm, pain or mental
anguish. As used in this definition of
‘‘abuse’’, ‘‘willful’’ means the individual
must have acted deliberately, not that
the individual must have intended to
inflict injury or harm. ‘‘Abuse’’ would
also include the deprivation by an
individual of goods or services that are
necessary to attain or maintain physical,
mental, and psychosocial well-being.
The term ‘‘sexual abuse’’ would extend
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the meaning of ‘‘abuse’’ to include nonconsensual sexual contact of any type
with a resident. We propose to define
the term ‘‘neglect’’ as ‘‘the failure of the
facility, its employees or service
providers to provide goods and services
to a resident that are necessary to avoid
physical harm, pain, mental anguish or
mental illness.’’ We would define
‘‘exploitation’’ as ‘‘the unfair treatment
or use of a resident or the taking of a
selfish or unfair advantage of a resident
for personal gain, through manipulation,
intimidation, threats, or coercion.’’
Based on internal discussions and
stakeholder input, we are aware of
industry concerns regarding certain
incidents that can take place within a
nursing home that are not easily
classified as abuse or neglect, but
nonetheless are inappropriate and
harmful. For example, there has been a
substantial increase in the use of
technology to exploit the elderly since
these regulations were first
implemented. When these regulations
were originally implemented, social
media and the wide use of cellular and
personal electronic devices were not a
major concern or topic of consideration
in the protection of residents. These
advances in technology have made it
easier to invade someone’s privacy and
therefore increase the risk of
exploitation. We feel that there is a need
to account for these technological
changes to ensure that all nursing home
residents are protected. We believe the
addition of the terms ‘‘abuse’’, ‘‘sexual
abuse’’, ‘‘neglect’’, and ‘‘exploitation’’
would help to eliminate confusion as to
what behaviors rise to the level of these
terms and promote resident safety and
would clarify that abuse includes abuse
facilitated or enabled through the use of
technology.
We also propose to add the term
‘‘misappropriation of resident property’’
to provide clarity. The term
‘‘misappropriation of resident property’’
is widely used throughout the
regulations and in our interpretive
guidance for surveyors of nursing
homes; therefore, we felt that there was
a need to ensure that the term was
clearly defined as ‘‘the deliberate
misplacement, exploitation, or
wrongful, temporary, or permanent use
of a resident’s belongings or money
without the resident’s consent.’’
Finally, we move the existing
definition of ‘‘transfer and discharge’’
from § 483.12(a)(1) to § 483.5(p).
C. Resident Rights (§ 483.10)
Current regulations at § 483.10
address a number of resident rights and
facility requirements, including those
establishing a resident’s right to exercise
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his or her rights, including rights
associated with a dignified existence,
self-determination, planning and
implementing care, access to
information, privacy and
confidentiality. Resident rights are also
addressed in existing § 483.15. Based on
a review of these regulations, we
propose to retain all existing residents’
rights but update the language and
organization of the resident rights
provisions to improve logical order and
readability, to clarify aspects of the
regulation that warrant it, and to update
provisions to include technological
advances such as electronic
communications. In order to achieve
these objectives, we propose to revise
existing § 483.10 to include only those
provisions specifying resident rights,
including a number of provisions that
are currently included in § 483.15. We
further propose to add a new § 483.11,
which would focus on the
responsibilities of the facility, including
relevant provisions currently included
in § 483.10 and § 483.15. We propose
multiple re-designations and revisions
to improve logical order and readability,
clarify aspects of the regulation that
warrant it, and reflect technological
advances such as electronic
communications. Under our proposal,
some existing provisions will have
components in both § 483.10 and
§ 483.11. A detailed crosswalk of all of
the proposed re-designations is
provided in Table A in section III of this
proposed rule. Re-designations without
substantive changes are not discussed in
detail below. We discuss below our
proposed revisions to those provisions
retained in or moved to § 483.10.
Regulatory citations have been updated
throughout to reflect the proposed new
structure.
We propose to revise § 483.10 to focus
specifically on resident rights. In
proposed § 483.10(a)(2), we would
clarify the resident’s right to be
supported in his or her exercise of rights
under this subpart. In proposed
§ 483.10(a)(3), we would clarify the
resident’s right to designate a
representative, the resident
representative’s limitation to those
rights delegated by the resident, and the
resident’s retention of those rights not
delegated, including the right to revoke
a delegation. We have heard concerns
that resident representatives may be
accorded more decision making
authority than their appointment or
delegation permits. Our proposed
clarification is intended to ensure that
facilities do not afford more decision
making authority to a resident
representative than is intended by the
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resident or permitted under applicable
law. We note that resident
representatives fall into three categories:
court-ordered or otherwise designated
under applicable law (e.g., state law),
supported by documentation (that is, an
advance directive), and informal/oral.
The scope of resident representative
authority may vary based on how they
are designated.
In § 483.10(a)(4) we would address
those residents who have been adjudged
incompetent under the laws of a state.
We would clarify the resident
representative’s limitation to exercising
only the rights delegated, and the
resident’s retention of rights not
delegated. Specifically, we would
clarify that the resident who has been
adjudged incompetent under the laws of
a state retains the right to exercise those
rights not addressed by a court order,
that the resident representative can only
exercise the rights that devolve to them
as a result of the court order, that the
resident’s wishes and preferences
should continue to be considered, and
that the resident should continue to be
involved in the care planning process to
the extent practicable, as the resident is
at the center of the care team. We
believe that it is important for a resident
who has been adjudicated incompetent
to be treated with respect and dignity
and to continue to make those decisions
that are appropriate for him or her to
make. Continuing to honor these
residents’ preferences and involving
them in care planning will improve both
quality of life and quality of care,
resulting in better outcomes. Lastly, in
our proposed rule ‘‘Medicare and
Medicaid Programs; Revisions to Certain
Patient’s Rights Conditions of
Participation and Conditions for
Coverage’’ (CMS–3302–P) (79 FR
73873), published on December 12,
2014, at § 483.10(a)(4), we proposed to
require that the same-sex spouse of a
resident must be afforded treatment
equal to that afforded to an opposite-sex
spouse if the marriage was valid in the
jurisdiction in which it was celebrated.
In this regulation, we are proposing to
redesignate this requirement from
§ 483.10(a)(4) (as set out in the
December 2014 proposed rule at 79 FR
73811) to § 483.10(a)(5). We believe that
this revision is necessary to implement
the Supreme Court decision in United
States v. Windsor, 570 U.S.12, 133 S.Ct.
2675 (2013).
In proposed § 483.10(b), we have
included resident rights related to
planning and implementing care. It is
important for each resident to
understand his or her health conditions
and the care and services he or she will
receive and to be able to participate in
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the care planning process. These rights
are already included for the most part in
the regulations, but we would update
the language and co-locate related
provisions. Thus, we propose to redesignate and revise in this provision
current § 483.10(b)(3), § 483.10(b)(4) and
§ 483.10(b)(8), relating to the resident’s
right to be informed of his or her total
health status, including medical
conditions; the right to be informed in
advance of the risks and benefits of
proposed care, including treatment and
treatment alternatives or treatment
options so that the resident can choose
the alternative or option he or she
prefers; the right to request, refuse and/
or discontinue treatment, including
participating in or refusing to
participate in experimental research;
and the right to formulate advance
directives. We propose to add new
requirements in § 483.10(b)(5) to specify
that the resident has the right to
participate in the care planning process,
including the right to identify
individuals or roles to be included in
the planning process, the right to
request meetings and the right to request
revisions to the person-centered plan of
care. These requirements support the
standards set forth by the Secretary in
the ‘‘Guidance for Implementing
Standards for Person-Centered Planning
and Self-Direction in Home and
Community-Based Services Programs’’
on June 6, 2014 (see https://www.acl.gov/
Programs/CDAP/OIP/docs/2402-aGuidance.pdf). We further specify in
§ 483.10(b)(5)(iv) that the resident has
the right to receive the services and
items included in the plan of care. We
also propose to re-designate and revise
existing § 483.10(d)(2) to specify that the
resident has the right, in advance, to be
informed of and to participate in, his or
her care and treatment, including the
right to be informed, in advance, of the
care to be furnished and the disciplines
that will furnish care. In addition, we
propose to specify the resident’s right to
participate in the development of his or
her comprehensive care plan. We also
propose at § 483.10(b)(6) to include the
resident’s right to self-administer
medication if the interdisciplinary team
has determined that doing so would be
clinically appropriate. Finally, we
propose to add a new section at
§ 483.10(b)(7) to specify that these rights
cannot be construed as a right to receive
medical care that is not medically
necessary or appropriate.
The ability of the resident to select his
or her attending physician remains an
important right. However, it is also
important that the selected physician
meet licensure requirements and be
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willing and able to comply with the
requirements of this subpart. Therefore,
we propose to require that the facility
ensure that the attending physician is
appropriately licensed and credentialed
to provide care and meet the
requirements of applicable regulations.
In proposed § 483.10(c), we would add
new § 483.10(c)(1), (2) and (3) to specify
that the physician chosen by the
resident must be licensed to practice
medicine, and must meet professional
credentialing requirements of the
facility. If the physician chosen by the
resident refuses or is unable to meet
requirements specified in this part, we
specify that the facility has the right,
after informing and discussing with the
resident, to seek alternate physician
participation to assure the provision of
appropriate and adequate care and
treatment. If the resident chooses a new
physician that meets the necessary
requirements, the facility must respect
that choice.
As indicated earlier, NFs not only
provide medical care, but may also
serve as a resident’s home. This makes
issues of respect and dignity
particularly important. In § 483.10(d),
we propose to re-designate a number of
provisions relating to resident respect
and dignity, based on existing
§ 483.13(a) and § 483.15. We further
propose to add a new § 483.10(d)(5) to
specify that a resident has the right to
share a room with his or her roommate
of choice, when both residents live in
the same facility, both residents consent
to the arrangement, and the facility can
reasonably accommodate the
arrangement. We note that married
couples, whether opposite or same sex,
are addressed by § 483.10(d)(5). Our
proposed provision would provide for a
rooming arrangement that could include
a same-sex couple, siblings, other
relatives, long term friends or any other
combination as long as the requirements
above are met. We recognize that in
some instances, specific roommates
requests cannot be accommodated by a
facility for clinical, safety, or logistical
reasons. However, we believe it is an
important aspect of respect and dignity,
as well as self-determination, for
individuals to be able to choose who
they live with, especially for long-term
residents.
Self-determination is a critical
element in the care and treatment of
nursing home residents. In proposed
§ 483.10(e), we propose to revise a
number of provisions relating to
resident self-determination. We propose
to revise § 483.10(e)(3) to ensure not
only that specified individuals and/or
organizations have access to the
resident, but also to ensure that the
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resident can receive his or her visitors
of choice at the time of his or her
choosing. We discuss our rationale
further in our discussion of proposed
§ 483.11(d)(2). We propose to revise
§ 483.10(e)(4) and (5), clarifying that it
is the resident’s right to participate in
family groups and have his or her family
members or resident representatives
participate in family groups in the
facility.
The ability to have access to
information such as personal medical
records and facility-specific information
has changed significantly since the
promulgation of the original
requirements for long-term care
facilities. We propose to co-locate
provisions related to the resident’s right
to access facility specific information,
medical records, information about
advocacy and fraud control
organizations, Medicare and Medicaid
coverage, and notices that the facility is
required to provide to the resident.
These notices include, but are not
limited to a written description of legal
rights, a written description of the
facility’s policies to implement advance
directives and applicable state law
pertaining to advance directives, and
information on how to apply for and use
Medicare and Medicaid benefits. In
addition, we will update the provisions
as appropriate to take into account
electronic medical records and other
electronic communications.
Specifically, in proposed § 483.10(f), we
propose to re-designate and revise a
number of provisions relating to
resident access to information. First, we
propose to specify in § 483.10(f)(2) that
the resident has the right to receive
notices verbally (meaning spoken) and
in writing (including Braille) in a format
and a language he or she understands.
We note that effective communication
for some residents requires the use of
auxiliary aids and services and have
revised this provision to reflect that.
Next, we propose to add a new
§ 483.10(f)(2)(i) to reference required
notices and a new § 483.10(f)(2)(iv) to
ensure residents are aware of and can
contact an Aging and Disability
Resource Center or other No Wrong
Door program. The Aging and Disability
Resource Center Program (ADRC),
established under Section 202(20)(B)(iii)
of the Older Americans Act; is a
collaborative effort of the U.S.
Administration on Community Living
and the Centers for Medicare &
Medicaid Services (CMS). ADRCs serve
as single points of entry into the longterm supports and services system for
older adults and people with
disabilities. Sometimes referred to as a
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‘‘one-stop shops’’ or ‘‘no wrong door’’
systems, ADRCs address many of the
frustrations consumers and their
families experience when trying to find
needed information, services, and
supports. Through integration or
coordination of existing aging and
disability service systems, ADRC
programs raise visibility about the full
range of options that are available,
provide objective information, advice,
counseling and assistance, empower
people to make informed decisions
about their long term supports, and help
people more easily access public and
private long term supports and services
programs. Additional information on
ADRC programs is available at https://
www.adrc-tae.acl.gov/tikiindex.php?page_ref_id=1325.
Federal requirements and
expectations related to the privacy and
confidentiality of patient records,
especially with regard to protected
health information, changed
substantially with the enactment of the
Health Insurance Portability and
Accountability Act of 1996 (HIPAA) and
subsequent promulgation of the HIPAA
Privacy and Security Rules (see 45 CFR
part 160 and subparts A, C, and E of part
164) as well as the subsequent
enactment of the Health Information
Technology for Economic and Clinical
(HITECH) Act as title XIII of division A
and title IV of division B of the
American Recovery and Reinvestment
Act of 2009 (ARRA) and the
promulgation of the Omnibus HIPAA
Final Rule (78 FR 5566). For simplicity,
we will hereinafter collectively refer to
these laws and their implementing
regulations as ‘‘HIPAA.’’ We note that
administration and enforcement of the
privacy and security-related portions of
the HIPAA regulatory scheme are
delegated to the HHS Office for Civil
Rights (OCR) and more detailed
information related to these provisions
can be accessed through the OCR Web
site at https://www.hhs.gov/ocr/privacy.
We propose to retain the requirements
of current § 483.10(b)(2)(i) and (ii),
subject to the clarifying revisions
described below, at new § 483.10(f)(3).
In doing so, we recognize that the
HIPAA Rules establish a federal floor of
privacy and security protections and
individual rights with respect to
protected health information held by
covered entities (and their business
associates), and the rights granted in
this proposed regulation are not
intended to conflict in any way with
those HIPAA regulations. In addition, to
the extent that HIPAA provides
additional rights to individuals (that is,
residents, in the long-term care context)
beyond what is provided in this
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proposal, this proposed regulation
would not diminish those rights.
Therefore, we propose revisions that
would clarify the relationship between
the requirements of 45 CFR 164.524 and
the revised version of § 483.10(f)(3)(i)
and (ii). We propose to specify in
paragraph (f)(3) that the resident has the
right to access medical records
pertaining to him or herself and to
further specify in proposed (f)(3)(i) that
the resident, upon oral or written
request, has the right to receive
requested medical records in the form
and format requested by the resident, if
it is readily producible in such form and
format (including in an electronic form
or format when such records are
maintained electronically); or, if not, in
a readable hard copy form or such other
form and format as agreed to by the
facility and the individual. This is
consistent with the requirements of 45
CFR 164.524(c)(2). Finally, we propose
to specify in paragraph (f)(3)(ii) that the
facility may impose a reasonable, costbased fee for providing copies of the
medical records, provided that the fee
includes only the cost of labor for
copying the health information
requested by the individual, whether in
paper or electronic form; the supplies
for creating the paper copy or electronic
media if the individual requests that the
electronic copy be provided on portable
media; and postage, when the
individual has requested the copy be
mailed. This is consistent with 45 CFR
164.524(c)(4).This proposal does not
address the creation or provision of
summary reports, which may be
provided in accordance with applicable
law.
In § 483.10(g)(1) we propose to revise
a number of provisions related to
resident privacy and confidentiality to
update the language to accommodate
electronic communications. We propose
to retain existing § 483.10(c)(1) at
proposed § 483.10(g)(2), reiterate the
residents’ right to a secure and
confidential medical record at proposed
§ 483.10(g)(3) and, in proposed
§ 483.10(g)(4), we would retain the
provisions of existing § 483.10(e)(2) and
(3).
Today, individuals have a number of
electronic options for communicating
with others that are not addressed in the
existing regulations for LTC facilities.
Thus, we propose to update these
regulations to take into consideration
widespread advances in electronic
communications technologies. In
proposed § 483.10(h), we propose to redesignate and revise a number of
provisions relating to resident
communications. Specifically, we
propose a new § 483.10(h)
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Communications, with § 483.10(h)(1)
revised to include TTY and TDD
services and cellular telephones; and a
new § 483.10(h)(2) to provide reasonable
access and privacy for electronic
communications such as email or
internet-based interpersonal video
communications. We also include
internet access, which can serve as a
communications medium as well as a
means for residents to interact with
entities and persons outside of the
facility or to use various programs and
tools for entertainment, shopping,
conducting research and obtaining
information.
In proposed § 483.10(i), we propose to
revise the language to state that the
resident has a right to a safe, clean,
comfortable, homelike environment,
and a right to receive treatment safely.
In proposed § 483.10(j), we propose to
revise language relating to resident
grievances to add that a resident cannot
be deterred from voicing a grievance for
fear of reprisal or discrimination. This
clarifies that even when no actual
reprisal or discrimination occurs,
intimidation and threats of reprisal or
discrimination are not permissible.
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D. Facility Responsibilities (§ 483.11)
We propose a new § 483.11 ‘‘Facility
Responsibilities,’’ in which we combine
many of the regulations addressing
facility responsibilities which are
currently dispersed throughout the
existing provisions regarding resident
rights and quality of life. This proposed
revision is consistent with our overall
objectives of updating the language and
organization of the resident rights
provisions to improve the logical order
and readability, clarifying aspects of the
regulation, and updating provisions to
include advances such as electronic
communications.
Consistent with § 483.10, the
introductory language for proposed
§ 483.11 would establish, based on
existing requirements, that the facility
must treat its residents with respect and
dignity and provide care and services
for its residents in a manner and in an
environment that promotes maintenance
or enhancement of the resident’s quality
of life and must protect and promote the
resident’s rights as specified in § 483.10.
Further, the facility must recognize each
resident’s individuality and provide
services in a person-centered manner.
We propose to establish sections similar
to those proposed in § 483.10. The
proposed sections are ‘‘Exercise of
Rights,’’ ‘‘Planning and Implementing
Care,’’ ‘‘Attending Physician,’’ ‘‘SelfDetermination,’’ ‘‘Information and
Communication,’’ ‘‘Privacy and
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Confidentiality,’’ ‘‘Safe Environment,’’
and Grievances.’’
In a new section proposed at
§ 483.11(a), ‘‘Exercise of Rights,’’ we
establish our expectation that the
facility promote and protect the rights of
the resident. These expectations are not
new requirements, and are already set
out in our regulations as resident’s
rights. In order to ensure clarity, we
have restated them clearly in this
provision as the responsibility of the
facility to recognize and effectuate those
rights. Proposed § 483.11(a)(1) would
provide that the facility ensure that the
resident can exercise his or her rights
without interference, coercion,
discrimination, or reprisal from the
facility. We propose to re-designate
current § 483.12(c)(1) as new
§ 483.11(a)(2) and move to this section
the requirement that the facility provide
equal access to quality care regardless of
diagnosis, severity of condition, or
payment source and establish and
maintain identical policies and
practices regarding transfer, discharge,
and the provision of services for all
residents regardless of source of
payment. In proposed § 483.11(a)(3) and
(4), we would specify that the facility
must treat the decisions of a resident
representative as the decisions of the
resident to the extent required by the
court or as delegated by the resident,
with the condition that the facility
could not extend greater authority to the
resident representative than is permitted
under applicable law. We reiterate this
point in the proposed regulation as we
respect the need to establish alternative
decision makers under certain
circumstances. However, we received
and are concerned by external input
suggesting that some facilities or staff
members defer to resident
representatives for decisions that exceed
the scope of a court order, resident
delegation, or other applicable law.
Proposed § 483.11(a)(3) and (4) would
clarify our expectations. In addition, we
propose to add a new § 483.11(a)(5) that
would clarify for facilities that if facility
staff believed that a resident
representative was making decisions or
taking actions that are not in the best
interest of the resident, we would
expect the facility to comply with any
state reporting requirements that might
apply. We understand that there is the
potential for abuse and neglect in this
relationship and want to ensure that
facilities recognize their role in
appropriately identifying and reporting
concerns that rise to the level of abuse,
neglect or exploitation. The United
States Government Accountability
Office (GAO) has published two reports
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related to abuses that occur specifically
in the context of guardianships. In
September 2010, the GAO published
‘‘Guardianships: Cases of Financial
Exploitation, Neglect and Abuse of
Seniors’’ (GAO–10–1046). In July 2011,
the GAO published ‘‘Incapacitated
Adults: Oversight of Federal Fiduciaries
and Court-Appointed Guardians Needs
Improvement’’ (GAO–11–678). While
these reports focus on the need for
improved screening and monitoring of
guardians, they also highlight the
potential for abuse and neglect in this
relationship. According to the National
Center on Elder Abuse in the
Administration on Aging, ‘‘the laws in
most states require helping professions
in the front lines—such as doctors and
home health providers—to report
suspected abuse or neglect. . . . Under
the laws of eight states, ‘any person’ is
required to report a suspicion of
mistreatment’’ (https://
www.ncea.aoa.gov/Stop_Abuse/Get_
Help/Report/index.aspx). These
reporting requirements may apply to
abuse, neglect or exploitation by
resident representatives.
In proposed § 483.11(b), facility
responsibilities include ensuring that
the resident is informed of, and
participates in, his or her treatment to
the extent practicable, consistent with
§ 483.10(b), and that the resident
participates in care planning, making
informed decisions, and selfadministering drugs when appropriate.
In addition to the self-administration of
drugs, residents may also selfadminister or take part in other health
care practices, such as dialysis. We also
expect that the facility, through the IDT
and the care planning process, would
determine if, and under what
circumstances, this is appropriate. We
also propose new requirements in
§ 483.11(b)(1) to require that the facility
ensures that the care planning process
facilitates the inclusion of the resident
or resident representative, includes an
assessment of the resident’s strengths
and needs, and incorporates the
resident’s personal and cultural
preferences in developing goals of care.
We note that person-centered planning
involves providing those services and
supports that assist individuals to live
with dignity and to support their goals
(including, but not limited to, goals to
potentially return to a community
setting). The Department of Health and
Human Services has issued guidance for
implementing person-centered planning
and self-direction in home and
community-based services programs, as
set forth in section 2402(a) of the
Affordable Care Act. The principles in
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that guidance regarding dignity and selfdirection apply equally to individuals
who reside in a nursing facility.
https://www.acl.gov/Programs/CDAP/
OIP/docs/2402-a-Guidance.pdf. Our
proposed requirements support those
principles.
We propose to re-designate
§ 483.10(b)(9) as § 483.11(c)(1) and
revise it to add other primary care
providers to ensure that the resident
knows the name, specialty and means of
contacting the professionals officially
responsible for his or her care, whether
that provider is a physician, nurse
practitioner, physician assistant, or
clinical nurse specialist. We further
propose to add a new § 483.11(c)(2),
consistent with our proposed
§ 483.10(c)(1), (2) and (3), to clarify that
the facility has a responsibility to ensure
that the resident’s attending physician
has appropriate professional credentials
and meets the requirements of this
subpart. If the physician was not
appropriately credentialed or was
unwilling or unable to meet the
requirements of this subpart, the facility
could seek an alternate physician after
informing and discussing this matter
with the resident. In order to ensure that
the resident could seek out a suitable
alternative, we propose to add a new
§ 483.11(c)(3) to specify that if the
resident subsequently finds a new
physician who meets the necessary
requirements, the facility would be
required to honor that selection.
We propose a new § 483.11(d) to
address the facility’s responsibilities
related to resident self-determination.
We propose to re-designate § 483.10(j),
regarding access to the resident, as
§ 483.11(d)(1), and revise it to include
visitors as specified in our ‘‘Resident
Rights’’ provision, including immediate
access to the resident by the resident
representative, and to update the
languages and references for the Office
of the State long term care ombudsman
and the protection and advocacy
system. This would be an addition to
the current requirement which provides
a right of access to any entity or
individual that provides health, social,
legal, or other services to the resident,
subject to the resident’s right to deny or
withdraw consent at any time. This is
consistent with our approach in other
settings such as acute care hospitals,
and in keeping with the person-centered
focus of this proposed rule. In addition,
we propose to add a new § 483.11(d)(2)
to require that the facility have written
policies and procedures regarding
visitation rights of residents. This
requirement would support resident
self-determination, consistent with the
person-centered focus of this proposed
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rule, and would follow the requirements
established for inpatient hospitals. As
noted in the November 19, 2010 final
rule (75 FR 70831 at 70832), regarding
hospital visitation rights, physicians,
nurses, and other staff caring for the
resident might miss an opportunity to
gain valuable information from those
who may know the resident best with
respect to the resident’s medical history,
conditions, medications, and allergies,
particularly if the resident had
difficulties recalling or articulating, or is
totally unable to recall or articulate, this
vital personal information. Many times,
these individuals who may know the
resident best can act as an intermediary
for the resident, helping to
communicate the resident’s needs to
facility staff. As stated in that November
19, 2010 final rule, we believe that
restrictive visitation policies can
effectively eliminate these advocates for
many residents, potentially to the
detriment of the resident’s health and
safety. Further, given that the facility is
often the resident’s home, we suggest
that, as in hospitals, the hazards and
challenges regarding open visitation are
manageable. In fact, we believe an open
visitation policy helps residents by
providing a better support system and a
more homelike environment. Moreover,
this policy may create more trust and a
better working relationship between
facility staff, the resident, and the
resident’s support system. Thus, we
believe it is vital to establish open
visitation in SNFs and NFs.
We propose to re-designate
§ 483.15(c)(5) as § 483.11(d)(3)(ii) and
revise it to clarify that the facilitydesignated staff person who participates
in a resident or family group must be
approved by the resident or family
group and the facility. It is important
that the facility representative be an
individual who the group can work with
and who does not have a chilling effect
on the function of the group. We further
clarify that this provision does not
require a facility to implement every
recommendation of a resident or family
group, but that the facility should be
able to provide the rationale for their
response. We propose a new
§ 483.11(d)(4), which would incorporate
requirements currently specified in
§ 483.10(h) and would specify that the
facility is responsible for ensuring that
a resident is not required to perform
services for the facility.
We propose a new § 483.11(d)(5),
which would incorporate requirements
from § 483.10(c) that focus on the
facility’s responsibility related to the
protection of resident funds.
Specifically, we propose in
§ 483.11(d)(5)(ii) to reflect the different
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dollar threshold requirements of
sections 1819(c)(6)(B)(i) and
1919(c)(6)(B)(i) of the Act and establish
the statutory requirement for deposit of
resident funds in excess of $100 in an
interest-bearing account for Medicare
and other non-Medicaid SNF residents,
consistent with section 1819(c)(6)(B)(i)
of the Act, and funds in excess of $50
for Medicaid beneficiaries, consistent
with section 1919(c)(6)(B)(i) of the Act.
We propose in § 483.11(d)(5)(v) to
include the return of funds to residents
upon discharge or eviction, in
accordance with state law in addition to
the already existing regulatory
requirement for conveyance to the estate
upon death. We received suggestions to
reduce the time frame for these
conveyances. We researched common
time frames for the return of security
deposits and found that most states (at
least 33) allow 30-days, and sometimes
longer for the return of security
deposits. Therefore, we determined the
current time frame is reasonable and we
do not propose to make any changes to
this section.
We propose to add a new
§ 483.11(d)(6)(i)(G) to indicate that the
facility may not charge the resident for
hospice services elected by the resident
and paid for under the Medicare
Hospice Benefit or paid for by Medicaid
under a state plan, whether provided
directly by the SNF/NF or by a hospice
provider under agreement with the
SNF/NF.
We propose in § 483.11(d)(6)(ii), redesignated from § 483.10(c)(8)(ii), to add
to the limitations on charges to
residents’ funds. This provision
currently provides general categories
and examples of items and services that
the facility may charge to residents’
funds if the items are requested by a
resident, and are not required to achieve
the goals stated in the resident’s care
plan. In these instances, the resident is
informed that there will be a charge and
that the items are not paid for by
Medicare or under a state plan. We
propose to add new
§ 483.11(d)(6)(ii)(L)(1) and (2) to clarify
that the facility may not charge for
special food and meals ordered for a
resident by a physician, physician
assistant, nurse practitioner, clinical
nurse specialist, dietitian or other
clinically qualified nutrition
professional and to cross-reference to
provisions regarding the expectation
that the foods and meals a facility
generally prepares should be developed
taking into consideration residents’
needs and individual preferences in
addition to the overall cultural and
religious make-up of the facility’s
population. Refer to our discussion in
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Section II. P. ‘‘Food and Nutrition
Services for additional information. We
propose a clarification in proposed
§ 483.11(d)(6)(iii) by adding the term
‘‘non-covered’’ before ‘‘item or service,’’
as this provision would only apply to
non-covered items or services.
We propose to establish a new
§ 483.11(e) to incorporate multiple
provisions related to information and
communication. With the exception of
medical records, we propose in
§ 483.11(e)(1) to specify that the facility
is responsible for ensuring that
information provided to the resident is
provided in a form and manner that the
resident can access and understand,
including in a language that the resident
can understand. Medical records are
addressed in proposed § 483.11(e)(2), As
noted earlier, this proposal does not
address the creation or provision of
summary reports of medical records.
Summary reports of medical records
may be provided in accordance with
applicable law. The language
requirement is already a requirement for
specific types of notices and
information (see § 483.10(b)(1),
§ 483.10(b)(3), and § 483.12(a)(4)(i)).
However, language is not the only
barrier to effective communication and
it is important for the resident to have
the opportunity to understand all
information that is provided. We also
hope to provide facilities with some
flexibility to implement this
requirement. For example, in some
cases, a resident representative may
prefer to access information on the
internet rather than receive a paper
copy, or it may be more effective and
efficient for a resident who is blind or
visually impaired to listen to an audio
file explaining resident rights. Some
residents may require assistive
technology or alternative formats. The
key to this provision is ensuring that
when there is a requirement to provide
information, it is provided in a way to
ensure both resident access and
understanding.
We propose in § 483.11(e)(2) to revise
facility requirements currently in
§ 483.10(b)(2)(i) through (ii), consistent
with our proposal at § 483.10(f)(3).
Proposed (e)(2)(i) would require that
facilities provide residents with access
to his or her medical records in the form
and format requested by the individual,
if it is readily producible in such form
and format (including in an electronic
form or format when such medical
records are maintained electronically);
or, if it is not readily producible in such
form and format, in a readable hard
copy form or other form and format as
may be agreed to by the facility and the
individual. This provision would
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include the existing requirement that
access be provided upon oral or written
request, redesignated from
§ 483.10(b)(2)(i), and that this access be
provided within 24 hours, excluding
weekends and holidays, as required by
sections 1819(c)(1)(A)(iv) and
1919(c)(1)(A)(iv) of the Act. We believe
in some circumstances an electronic
copy may be a preferable and more
efficient option for both the facility and
the resident or resident’s representative,
particularly where the record already
exists in an electronic format. We
propose at (e)(2)(i) to require that the
facility allow the resident, after receipt
of his or her medical records for
inspection, to purchase a copy of the
medical records or any portion thereof
upon request and with 2 working days
advance notice to the facility. We
further propose at § 483.11(e)(2)(iii) to
revise the standard for the fee a facility
may charge for the requested
information from a community standard
to a cost-based standard under which
the fee includes only the cost of labor
for copying the requested health
information, whether in paper or
electronic form; the supplies for creating
the paper copy or electronic media if the
individual requests that the electronic
copy be provided on portable media,
postage when the individual requested
the copy be mailed. This is consistent
with the requirements of 45 CFR
164.524(c)(4).
We propose to add a new
§ 483.11(e)(3), incorporating and redesignating part of existing
§ 483.10(g)(1), with revisions required
by section 6103(c) of the Affordable
Care Act, which added new sections
1819(d)(1)(C) and 1919(d)(1)(V). Those
provisions require that individuals have
access to surveys of the facility
conducted by federal or state surveyors
and any plan of correction in effect with
respect to the facility for the preceding
3 years. We note that this provision does
not require a specific format, but
consistent with our proposed
§ 483.11(e)(1), it must be in a form and
manner accessible to and
understandable by the resident.
We propose to add a new
§ 483.11(e)(4)(i) and (ii) to require the
facility to post, in a form and manner
easily accessible and understandable to
residents, resident representatives and
support persons, information that would
allow individuals to contact pertinent
client advocacy groups, including the
state survey and certification agency,
the state licensure office, the State LongTerm Care Ombudsman Program, the
Protection and Advocacy Network, and
the Medicaid Fraud Control Unit. We
also propose to require that the facility
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post a statement that a resident may file
a complaint with the state survey and
certification agency. The facility is
already required at existing
§ 483.10(b)(7), which would be redesignated at proposed § 483.11(e)(12),
to provide this information in the
written description of legal rights
provided to the resident. However, we
believe that posting this information
will ensure that resident representatives
as well as other support persons and
residents continue to have access to
updated and readily understandable
information.
We propose to add a new paragraph
§ 483.11(e)(7)(i) to specify that when a
facility notifies a physician of a change
in a resident’s status, the facility must
ensure that certain pertinent
information is available and is provided
to the physician upon request. The
required information would be the same
information we propose to require
under new § 483.15(b)(2) (information
in transfer or discharge). This
requirement, in concert with proposals
to improve transitions of care,
communications among and between
practitioners, appropriate exchange of
information, and quality assessment
activities, will help ensure that the
physician’s decisions relating to
treatment or transfer of a resident to an
acute care facility are made on the basis
of the best information available.
Widely available methodologies and
tools may assist facilities in ensuring
that effective information exchanges
occur. For example, Situation,
Background, Assessment,
Recommendation (SBAR) is a common
methodology for structured
communication. Information and tools
relating to SBAR are widely available,
including but not limited to from
sources such as the Agency for
Healthcare Research and Quality
(www.innovations.ahrq.gov), The Joint
Commission
(www.jointcommission.org), the Institute
for Healthcare Improvement
(www.ihi.org), the INTERACT
(Interventions to Reduce Acute Care
Transfers) project (https://interact2.net),
and others.
We propose to revise the language of
§ 483.10(b)(11)(i) and re-designate it as
new § 483.11(e)(7)(i) to provide that the
facility would be required to notify the
resident representatives, rather than the
current requirement that the facility
notify ‘‘. . . the resident’s legal
representative or an interested family
member . . .’’. The proposed language
allows a guardian or other legal
representative as well as any other
individuals the resident identifies,
including family members, other
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relatives, close personal friends, or any
other persons identified by the resident,
to receive the required notifications and
thus remain informed of important
information about the resident.
We propose to re-designate
§ 483.10(b)(1), which addresses the
facility requirement to provide a notice
of rights and services, as § 483.11(e)(9)(i)
through (iii). We propose one minor
revision for clarity in § 483.11(e)(9)(ii) to
state ‘‘the State-developed notice of
Medicaid rights, if any’’ instead of the
current language ‘‘notice (if any) of the
State developed under 1919(e) of the
Act’’.
We propose to revise § 483.10(b)(5)(i)
and (ii) and re-designate them as
§ 483.11(e)(10). The revised provision
would specify that the facility must
inform each resident, in writing, at the
time of admission to a Medicaidparticipating nursing facility and when
the resident becomes eligible for
Medicaid—(1) Of the items and services
that are included in nursing facility
services under the state plan and for
which the resident may not be charged;
(2) of those items for which the resident
may be charged, and the amount of
charges for those services; and (3)
inform Medicaid-eligible residents
when changes are made to the items and
services in proposed paragraph (e)(11)(i)
of this section.
We propose to revise and re-designate
§ 483.10(b)(6) as new § 483.11(e)(11). In
addition, we propose to add new
paragraphs (i) through (v) to require the
facility to provide notice to residents
when changes are made to the items and
services covered by Medicare and/or
Medicaid or to the amount that the
facility charges for items and services. It
is important that residents remain
informed of these issues in order to
ensure their ability to make informed
decisions, both financial and health-care
related.
To improve clarity, we propose to redesignate § 483.10(b)(7) as new
§ 483.11(e)(12) and revise current
paragraph (b)(7)(iii) to require that the
facility provide the resident with ‘‘a list
of names, addresses (mailing and email),
and telephone numbers of all pertinent
state regulatory and informational
agencies, resident advocacy groups such
as the state survey and certification
agency, the state licensure office, the
state long-term care ombudsman
program, the protection and advocacy
agency, adult protective services, the
state or local contact agencies for
information about returning to the
community and the Medicaid fraud
control unit.’’ Additionally, we propose
to revise current paragraph (b)(7)(iv) to
require that the facility include in the
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written description of legal rights ‘‘a
statement that the resident may file a
complaint with the state survey and
certification agency concerning any
suspected violation of LTC
requirements, including but not limited
to resident abuse, neglect,
misappropriation of resident property in
the facility, non-compliance with the
advance directives requirements, and
requests for information regarding
returning to the community.’’
We propose a new § 483.11(e)(13) that
would establish that the facility must
protect and facilitate a resident’s right to
communicate with individuals and
entities both inside and external to the
facility, including at § 483.11(e)(13)(ii)
reasonable access to the internet, to the
extent it is available to the facility.
Section 483.11(e)(13)((i) would revise
and replace § 483.10(k) and
§ 483.11(e)(13)((iii) would revise and
replace § 483.10(i)(2) with regard to
reasonable access to a telephone,
including TTY and TDD services, and to
stationery, postage, writing implements
and the ability to send mail,
respectively.
We propose a new § 483.11(f) to
include provisions related to privacy
and confidentiality. Proposed
§ 483.11(f)(1) would require that the
facility respect the resident’s right to
personal privacy. Proposed (f)(1)(ii)
would incorporate the definition of
personal privacy currently set out at
§ 483.10(e)(1). We propose to replace the
requirements of existing § 483.10(e)(2)
with new § 483.11(f)(2) which requires
the facility to comply with the
requirements of proposed § 483.10(g)(3).
We propose to redesignate existing
§ 483.10(j)(3) as § 483.11(f)(3) and revise
it to require that the facility allow
representatives of the Office of the State
Long-Term Care Ombudsman to
examine a resident’s medical, social,
and administrative records in
accordance with state law. This is
consistent with the requirements of
section 712(b)(1) of the Older Americans
Act.
We propose a new § 483.11(g) that
would include provisions related to a
safe environment. Specifically, we
propose to re-designate § 483.15(h)(1)
through (7) as § 483.11(g)(1) through (7)
and revise paragraph (g)(1) to include
paragraphs (g)(1)(i) specifying that the
facility must ensure an environment
where care and services can be
delivered safely, and (g)(1)(ii) specifying
that the facility must ensure that the
physical layout of the facility maximizes
independence and does not pose a
safety risk.
We are proposing a new § 483.11(h)
Grievances, which would incorporate
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the facility responsibilities expressed in
existing § 483.10(f) and would also
require that facilities ensure that
residents know how to file grievances.
The proposed provision would also
require that the facility establish a
grievance policy to ensure the prompt
resolution of grievances, and identify a
Grievance Officer. Additionally, the
facility would be required to provide a
copy of this policy upon request, as well
as make information about filing
grievances available to residents.
Furthermore, the facility would be
required to take a number of actions in
response to a grievance, including:
1. Preventing further violations of
resident rights during an investigation,
2. Immediately reporting allegations
of neglect, abuse (including injuries of
unknown source), and/or
misappropriation of resident property,
by anyone furnishing services on behalf
of the facility, to the administrator of the
facility and as required by state law,
3. Ensuring that all written grievance
decisions include the date the grievance
was received, a summary statement of
the resident’s grievance, the steps taken
to investigate the grievance, a summary
of the pertinent findings or conclusions
regarding the resident’s concerns, a
statement as to whether the grievance
was confirmed or not confirmed, any
corrective action taken or to be taken by
the facility as a result of the grievance,
and the date the written decision was
issued,
4. Taking appropriate corrective
action in accordance with state law if
the alleged violation of the residents’
rights is confirmed by the facility or if
an outside entity having jurisdiction
confirms a violation of any of these
residents’ rights within its area of
responsibility; and
5. Maintain evidence demonstrating
the resolution of complaints and
grievances for at least 3 years.
The right to file a grievance is an
important protection for residents and
an important right of residents. The
proposed revisions are intended to
ensure that grievances are taken
seriously and processed appropriately.
Finally, we propose a new § 483.11(i)
which would require that a facility not
prevent or discourage a resident from
communicating with Federal, State, or
local officials, including but not limited
to Federal and State surveyors, other
Federal or State health department
employees, including representatives of
the Office of the State Long-Term Care
Ombudsman and of the protection and
advocacy system. Residents must have
the ability to communicate freely with
representatives of these entities when
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they have concerns about quality or care
and quality of life.
E. Freedom From Abuse, Neglect, and
Exploitation (§ 483.12)
Currently, § 483.13 is titled ‘‘Resident
Behavior and Facility Practices.’’ The
focus of this section is to ensure that
residents of SNFs and NFs are not
subjected to abuse, neglect,
misappropriate of resident property, and
exploitation when they reside in a
facility, to specify the facility
responsibilities to prevent abuse,
neglect and exploitation, and to
establish requirements for the facility
response to allegations that any of these
has occurred. Thus, we propose to redesignate and revise this section as
§ 483.12, ‘‘Freedom from Abuse, Neglect
and Exploitation,’’ to more accurately
reflect the contents and intent. The term
‘‘exploitation’’ was not previously
included in this regulatory provision.
However, in reviewing available
materials related to abuse such as The
Joint Commission standards for
accreditation of long term care facilities
and language relating to
‘‘misappropriation of resident
property,’’ currently defined at
§ 488.301, we believe it is appropriate
and necessary to add this term here as
well to address circumstances that may
not rise to the level of abuse or neglect
but nonetheless would be prohibited.
Therefore, we propose in our discussion
of the definitions section of this
regulation to provide a definition of
‘‘exploitation’’. Although there have
been significant improvements in many
areas of nursing home care, abuse
remains a serious issue. According to
CMS Certification and Survey Provider
Enhanced Reports (CASPER) data, there
were 474 noncompliance deficiency
citations related to freedom from abuse
in Fiscal Year (FY) 2011, and 475
citations in FY 2012, affecting 2.5
percent of nursing home providers. Our
proposed updates and revisions to this
section are intended to both recognize
that abuse continues to occur, and to
provide language that will build on
progress to improve conditions in
nursing homes begun by the nursing
home reforms of the Omnibus Budget
Reconciliation Act of 1987, Pub. L. 100–
203 (OBRA ’87).
Currently, paragraph § 483.13(a)
addresses the use of restraints. We
propose to address restraints in both the
introductory paragraph to proposed
§ 483.12 and in proposed § 483.25(d)(1).
In the introductory paragraph to
proposed § 483.12, we would continue
to prohibit the inappropriate use of
restraints. Restraints can be used
abusively. There may be very limited
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circumstances where restraints would
be appropriate in a nursing facility. We
propose to further address restraints in
proposed section § 483.25(d)(1) on
Quality of Care and Quality of Life. The
use of restraints has fallen significantly
in the last decade and CMS continues to
promote reduction in the use of physical
restraints. (See CMS 2012 Nursing
Home Action Plan; https://www.cms.gov/
Medicare/Provider-Enrollment-andCertification/
CertificationandComplianc/Downloads/
2012-Nursing-Home-Action-Plan.pdf).
We note that many facilities have
achieved a rate of zero percent restraint
use (see https://www.cms.gov/Medicare/
Provider-Enrollment-and-Certification/
QAPI/Downloads/QAPINewsBrief.pdf).
Existing paragraph § 483.13(b) would
also be included in the new
introductory paragraph to revised
§ 483.12. The revised introductory
paragraph would set out the intent of
this section. We propose to re-designate
existing § 483.13(c)(1) as § 483.12(a)(2)
and modify the language to clarify that
a facility must not employ or otherwise
engage individuals who have been
found guilty of abuse, neglect, or
mistreatment of residents by a court of
law; had a finding of abuse, neglect,
mistreatment of resident or
misappropriation of property reported
into a state nurse aide registry, or had
a disciplinary action taken against a
professional license by a state licensure
body as a result of a finding of abuse,
neglect, or mistreatment of residents or
a finding of misappropriation of
property. The proposed revision makes
clear that the facility is responsible for
protecting residents from abuse, neglect
and exploitation by a person providing
services, whether the individual has an
employee relationship with the facility
or is ‘‘otherwise engaged’’ by the
facility—that is, providing services
under a different arrangement, such as
a volunteer or a contractor. Currently,
the regulations require that a facility
must not employ an individual who has
had a finding entered against them into
a state nurse aide registry concerning
abuse, neglect, mistreatment of residents
or misappropriation of property. We
propose to add a new § 483.12(a)(2)(iii)
to expand this employment prohibition
to include licensed professionals who
have had a disciplinary action taken
against them by a state licensure body
as a result of a finding of abuse, neglect,
mistreatment of residents or
misappropriation of resident property.
Although a licensure disciplinary action
would normally prevent a licensed
professional from further practice in the
state of licensure for some specified
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period of time, we believe inclusion in
the federal standards is necessary to
ensure the safety of long term care
facility residents. We believe that
disciplinary action information is
available through state licensing boards
and that it is appropriate to explicitly
hold licensed personnel to the same
standard as nurse aides.
We propose to re-designate existing
§ 483.13(c) as § 483.12(b) and to revise
it to also require that the facility
develop and implement written policies
and procedures that prohibit and
prevent abuse, neglect, exploitation of
residents and misappropriation of
resident property. We propose to add a
new § 483.12 (b)(2) to require that the
facility establish policies and
procedures to investigate any allegations
of abuse, neglect, exploitation, or
misappropriation of property, We also
propose to add a new § 483.12(b)(3) to
require training, including training on
resident’s rights, facility
responsibilities, and recognition and
reporting of abuse neglect and
exploitation, which we would require in
proposed § 483.95. Our proposals
related to training are discussed in
section X, ‘‘Training requirements’’
(§ 483.95) of this preamble. We believe
both the requirements in proposed new
§ 483.12(b)(2) and (b)(3) are necessary to
ensure effective and consistent
investigative processes and to ensure
that direct care/direct access workers
are trained to recognize when treatment
is abusive or constitutes neglect or
exploitation. We are hopeful that
training may reduce the frequency of
these incidents. Finally, we propose a
new § 483.12(b)(5) to require that
facilities establish policies and
procedures to ensure reporting of crimes
in accordance with section 1150B of the
Act. The policies and procedures would
have to include, at a minimum, annual
notification of covered individuals,
posting a conspicuous notice of
employee rights, and prohibiting and
preventing retaliation.
Annual notification of covered
individuals, as defined at sec.
1150B(a)(3), includes notification of that
individual’s obligation, as specified at
1150B(b)(1), to report to the State
Agency and one or more law
enforcement entities for the political
subdivision in which the facility is
located any reasonable suspicion of a
crime against any individual who is a
resident of, or is receiving care from, the
facility. Reporting to the State Agency
fulfills the statutory directive to report
to the Secretary. In accordance with
1150B(b)(2), the reporting required by
1150B(b)(1) must occur not later than 2
hours after forming the suspicion, if the
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events that cause the suspicion result in
serious bodily injury, or not later than
24 hours if the events that cause the
suspicion do not result in serious bodily
injury. A fuller discussion of these
requirements was provided in a June 17,
2011 Survey and Certification Letter to
State Survey Agency Directors and
further addressed through a question
and answers document in January, 2012.
These documents are available at
https://www.cms.gov/Medicare/ProviderEnrollment-and-Certification/
SurveyCertificationGenInfo/Downloads/
SCLetter11_30.pdf . We propose that
enforcement of these requirements
would be based on the terms of that
guidance. We are specifically requesting
comment on these proposed provisions
and our proposed implementation of
Section 1150B of the Act.
We propose to re-designate existing
§ 483.13(c)(1)(iii) as proposed
§ 483.12(a)(3) and revise existing
§ 483.13(c)(2), (3) and (4) as proposed
§ 483.12(c)(1), (2), (3) and (4).
Specifically, we propose to add the term
‘‘exploitation’’ in proposed paragraph
(c)(1) and add adult protective services
where state law provides for jurisdiction
in long-term care facilities to the list of
officials who must be notified in
accordance with state law; otherwise the
language would be unchanged from
§ 483.12(c)(2). We propose to divide
existing § 483.13(c)(3) into two
paragraphs, § 483.12(c)(2) and (3),
making the investigation of alleged
violations distinct from the facility’s
obligation to prevent further abuse of
the allegedly abused resident or other
residents while the investigation is in
progress.
F. Transitions of Care (§ 483.15)
We propose to re-designate current
§ 483.12 ‘‘Admission, transfer, and
discharge rights’’ as new § 483.15, and
revise the general title to ‘‘Transitions of
care’’ in order to reflect current
terminology that applies to all instances
where care of a resident is transitioned
between care settings. Extensive
literature speaks to quality of care
concerns related to the transitions.
In proposed new paragraph (a) we
would begin with requirements for
admissions policies, which would be
moved to the beginning of the section to
reflect chronological order. We propose
a new paragraph (a)(1) to require that
the facility establish an admissions
policy.
Additionally, we would re-designate
current § 483.12(d)(1) as § 483.15(a)(2)
to state that facilities cannot request or
require residents or potential residents
to waive their rights to Medicare or
Medicaid benefits or to any rights
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conferred by applicable state, federal
and local licensing or certification laws.
We propose to add a new paragraph
(a)(2)(iii) to prohibit facilities from
requesting or requiring residents or
potential residents to waive any
potential facility liability for losses of
personal property. We understand that
residents are sometimes asked to waive
facility responsibility for the loss of
their personal property or are unable to
use personal property because it is only
permitted in the facility if safeguarded
by the facility in a manner that makes
the property usually inaccessible to the
resident. These policies effectively take
away the residents’ right to use personal
possessions and relieve facilities from
their responsibility to exercise due care
with respect to residents’ personal
property. We expect this requirement
will encourage facilities to develop
policies and procedures to safeguard
residents’ personal possessions without
effectively prohibiting a resident’s use
of personal possessions. We further
propose to add a new paragraph (a)(6)
to specify that a nursing facility must
disclose and provide to a resident or
potential resident, prior to time of
admission, notice of any special
characteristics or service limitations of
the facility. For example, if a facility has
a religious affiliation that guides its
practices, any resulting special
characteristics, requirements, or
limitations would have to be
communicated to potential residents at
admission. Similarly, if a facility did not
have the capability to care for residents
requiring psychiatric care, potential
residents would have to be advised of
this prior to admission. The potential
resident or resident representative could
then make an informed initial decision
about admission, should the need for
specific types of care or services later
become necessary, the need for an
appropriate transfer will be more
predictable and understandable to the
resident. We believe this type of
disclosure is current standard business
practice, however, in keeping with
proposed provisions related to
specifying reasons for transfer or
discharge as well as to ensure informed
choices on the part of the resident at the
time of admission, we would add this
requirement explicitly.
We also propose to relocate existing
§ 483.10(b)(12) to new § 483.15(a)(7).
This section addresses admission
disclosure requirements for composite
distinct part nursing facility, and is
more appropriately located in the
section on admissions.
We propose to re-designate § 483.12(a)
as proposed § 483.15(b) and address
transfers and discharges.
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§ 483.15(b)(1)(ii)(C) would revise
existing § 483.12(a)(2)(iii) and we would
clarify that a resident could be
discharged when the safety of other
individuals is endangered due to the
clinical or behavioral status of that
resident. In proposed
§ 483.15(b)(1)(ii)(E), we would revise
existing § 483.12(a)(2)(v) and clarify that
provisions for discharge as a result of
non–payment of facility charges would
not apply unless the resident did not
submit the necessary paperwork for
third party payment or until the third
party, including Medicare or Medicaid,
denied the claim and the resident
refused to pay for his or her stay. This
is consistent with existing guidance and
would help to clarify the meaning of
failure to pay. Finally, we propose a
new § 483.15(b)(1)(iii) to specify that the
facility may not transfer or discharge the
resident while the appeal is pending,
pursuant to 42 CFR 431.230 when a
resident exercises his or her right to
appeal a transfer or discharge notice
from the facility pursuant to 42 CFR
431.220(a)(3). ‘‘Discharge/Eviction’’ was
the most frequent nursing facility
complaint category processed by the
Long-Term Care Ombudsman Programs
nationally in FY 2013 (8,478
complaints) and has been the first or
second most frequent complaint
category consistently since 2006.
Involuntary discharges are often
traumatic for residents. Transfer or
discharge from a facility prior to an
appeal determination can result in an
unnecessary transfer out of and back to
a facility.
In the proposed revision to paragraph
§ 483.15(b)(2), we would make a number
of revisions based on the importance of
effective communication between
providers during transitions of care.
First, we propose to clarify that the
transfer or discharge would be
documented in the resident’s clinical
record and that appropriate information
would be communicated to the
receiving setting. While this type of
documentation is presently required for
hospitals with which the facility has a
transfer agreement, such
communication is important regardless
of the setting to which the resident is
being transferred or discharged. In
addition, we propose to require that,
when a facility transfers or discharges a
resident because the transfer or
discharge is necessary for the resident’s
safety and welfare, the facility would
include in its documentation the
specific resident needs that it cannot
meet, facility attempts to meet the
resident needs, and the service(s)
available at the receiving facility that
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will meet the resident’s needs. We
believe this proposal will discourage
facilities from discharging residents
inappropriately. We note that facilities
are obligated under the Americans with
Disabilities Act and the Rehabilitation
Act not to discriminate against residents
based on the severity of their disability.
Discharging or transferring a resident
without first implementing
accommodations to better meet the
resident’s needs may be in conflict with
these laws.
We propose to add a new requirement
at § 483.15(b)(2)(i) that the transferring
facility provide necessary information to
the resident’s receiving provider,
whether it is an acute care hospital, a
LTC hospital, a psychiatric facility,
another LTC facility, a hospice, home
health agency, or another communitybased provider or practitioner. We note
that the exchange of information
‘‘needed for care and treatment of
residents, and when the transferring
facility deems it appropriate, for
determining whether such residents can
be safely and appropriately cared for in
a less expensive setting than either the
facility or the hospital’’ is already
required under § 483.75(n) as a
component of the transfer agreement a
facility must have with one or more
hospitals. However, that provision only
applies to hospitals with which the
facility has a transfer agreement and it
does not require any minimum
standards for the information to be
exchanged. To provide safe, effective
care to residents, we believe it is critical
that timely and accurate clinical
information follow the resident across
care settings and providers. Transitions
of care represent a period of increased
risk for complications and adverse
events for the individual. One way to
reduce this risk is to ensure effective
communication between care providers.
In recognition of this, in August of 2011,
the State of New Jersey mandated the
use of a universal transfer form. Rhode
Island and Massachusetts also require a
universal transfer form and the
American Medical Directors Association
has developed and recommends the use
of a universal transfer form.
Additionally, other tools and
information are available from CMS (see
https://www.medicare.gov/Pubs/pdf/
11376.pdf) and AHRQ (see https://
www.innovations.ahrq.gov/
content.aspx?id=3285) as well as
through a number of professional
organizations, including but not limited
to the National Transitions of Care
Coalition (www.ntocc.org). Examples of
resources include TeamSTEPPS® Long
Term Care Version (https://
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www.ahrq.gov/professionals/education/
curriculum-tools/teamstepps/
longtermcare/
interact2.net/), and the On-Time Quality
Improvement Program (https://
www.ahrq.gov/professionals/systems/
long-term-care/resources/ontime/
qualityimprov/). We expect
that new tools and information will be
developed over time. Electronic health
records could simplify the process of
extracting necessary information when a
resident is transferred from a nursing
home and electronic summary of care
documents provide a standardized way
to exchange critical information
between providers.
As noted earlier, HHS also has a
number of initiatives designed to
encourage and support the adoption of
health information technology and to
promote nationwide health information
exchange to improve health care. While
current Medicare and Medicaid EHR
Incentive programs have focused on
providers other than SNFs and NFs,
certified health IT possesses capabilities
that can assist any health care provider
to improve the quality, safety and
efficiency of the care they deliver. For
more information about how currently
available certified health IT systems can
enable the electronic exchange of a
summary care record, providers should
review ‘‘Certification Guidance for EHR
Technology Developers Serving Health
Care Providers Ineligible for Medicare
and Medicaid EHR Incentive
Payments,’’ which addresses use of the
2014 Edition of ONC certification
criteria (available at https://
www.healthit.gov/sites/default/files/
generalcertexchangeguidance_final_9-913.pdf).
The 2015 Edition of certification
criteria for health IT, published on
March 30, 2015 at 80 FR 16902,
proposes to define a common clinical
data set. As discussed in the draft
Interoperability Roadmap, HHS believes
a core priority for improving health and
health care quality through nationwide
interoperability is the ability to
electronically send, receive, find and
use a common clinical data set. By
aligning the data elements proposed
below with this proposed common
clinical data set, we believe facilities
will be well-positioned to engage in
electronic communication of
information during the transfer process.
In addition, new standards supporting
the exchange of a summary care record
include additional information directly
applicable to SNF and NF settings. The
HL7 Clinical Document Architecture
(CDA) Release 2.0, now identified as the
best available standard for exchange of
a summary care record (https://
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www.healthit.gov/standards-advisory)
and proposed for inclusion in the 2015
Edition of certification criteria for health
IT (80 FR 16804) makes new standards
available for pressure ulcers, functional
and cognitive status, advanced
directives, and other clinical health
information that could be used for
exchange in summary records, as well
as a new dedicated Transfer Summary
document that could be used for
exchange in summary records. These
standards were developed through a
public-private collaboration including
an ONC-sponsored Standards and
Interoperability Longitudinal
Coordination of Care Workgroup and
HL7 (a private sector, American
National Standards Institute (ANSI)accredited standards development
organization) and will support more
robust interoperable health information
exchange across the care continuum,
including with and by nursing homes.
We note that we are not proposing to
require a specific form, format, or
methodology for this communication.
Instead, we propose specific data
elements or a set of information that
must be communicated during the
transfer process. We believe that
existing state-mandated forms would
meet our proposed requirements. We
have reviewed literature related to
transitions of care and re-hospitalization
as well as the available universal
transfer forms and work on the
development of interoperability
standards for EHRs and propose to
require specific information consistent
with our research. This includes
demographic information, including but
not limited to name, sex, date of birth,
race, ethnicity, and preferred language,
resident representative information
including contact information,
advanced directive information, history
of present illness/reason for transfer,
including primary care team contact
information, past medical/surgical
history, including procedures, active
diagnoses/current problem list,
laboratory tests and the results of
pertinent laboratory and other
diagnostic testing, functional status,
psychosocial assessment including
cognitive status, social supports,
behavioral health issues, medications,
allergies including medication allergies,
immunizations, smoking status, vital
signs, unique identifier(s) for a
resident’s implantable device(s), if any,
comprehensive care plan including
health concerns, assessment and plan,
goals, resident preferences, other
interventions, efforts to meet resident
needs, and resident status. We have not
established a time frame for this
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communication, as this may vary based
on the circumstances surrounding the
transfer; however, we would expect
communication to occur shortly before
or as close as possible to the actual time
of transfer and that the facility would
document that communication has
occurred. We understand that limited
information may initially be sent with a
resident in an emergency situation;
however, we would expect that if an
initial communication does not include
all of the required information, a
subsequent communication to fill-out
the missing information would occur in
a timely manner. We are soliciting
comment on both the information
elements we are requiring and the time
frame for transmission of the required
information. While we are not
proposing any specific form, format, or
methodology for the communication of
this information for all facilities, we
strongly believe that those facilities that
are electronically capturing this
information should be doing so using
certified health IT that will enable the
real time electronic exchange with the
receiving provider. By utilizing certified
health IT, facilities can ensure that they
are transmitting interoperable data that
can be used by other settings,
supporting more robust care
coordination and higher quality care for
patients.
In proposed paragraph (b)(3)(i), we
would update the language currently in
§ 483.12(a)(4)(i) to reflect our ‘‘resident
representative’’ language and propose to
require that the facility send a copy of
the notice of transfer or discharge to the
State Long-Term Care Ombudsman with
the resident’s consent. If a resident does
not agree to have the notice sent to the
State Long-Term Care Ombudsman, we
would expect the refusal to be
documented in the resident’s medical
record. The requirement to send this
notice the State Long-Term Care
Ombudsman is another provision
related to concerns about inappropriate
discharges and was suggested by
stakeholders to allow timely assistance
to the resident in cases where the
discharge is involuntary. In proposed
paragraph (b)(3)(ii), we propose a minor
revision to the language currently in
§ 483.12(a)(4)(ii) to clarify that the
facility records the reasons for the
transfer or discharge, in accordance
with proposed § 483.15(b)(2).
In paragraph § 483.15(b)(5)(iii), we
propose to modify language currently in
§ 483.12(a)(6)(iii) by adding the phrase
‘‘expected to be’’ to reflect our
understanding that when a notice of
transfer or discharge is issued 30 days
prior to transfer, the transfer or
discharge destination may subsequently
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change. We also propose in paragraph
(b)(5)(iv) to require that the notice
include the name, address (mailing and
email), and telephone number of the
state entity which receives discharge or
transfer appeal requests; and
information on how to obtain an appeal
form, how to obtain assistance in
completing the form, and how to submit
the appeal request. We also propose to
add a new paragraph § 483.15(b)(6) to
require that when information in the
notice changes, the facility must update
the recipients of the notice as soon as
practicable with the new information to
ensure that residents are aware of and
can respond appropriately to discharge
information. We propose to re-designate
§ 483.12(a)(7) as § 483.15(b)(7) and
revise it to require that the facility
provide to the resident an orientation
regarding his or her transfer or discharge
in a form and manner that the resident
can understand. The facility must also
document this orientation, including the
resident’s understanding of the
orientation (teach back or other
methodology). To do otherwise would
negate the intent of this provision.
Finally, in § 483.15(b)(9), we propose to
clarify that room changes in a composite
distinct part are subject to the
requirements of proposed § 483.10(d)(7).
Some states have requirements for
facilities to reserve a resident’s bed
when the resident is transferred to an
acute care facility. These requirements
and individual facility policies may
vary widely and may impact the
availability of the resident’s original bed
or any bed when the resident is ready
to return to the facility as well as have
payment implications for the resident.
In paragraph § 483.15(c) we propose to
add language to require that the facility
provide information to the resident that
informs the resident of and
distinguishes and explains the
difference between the duration of the
state bed-hold policy, if any, as well as
the reserve bed payment policy in the
state plan, required under 42 CFR
447.40, if any. In § 483.15(c)(1)(iv), we
propose to add a new requirement that
a facility’s notice of its bed-hold policy
and readmission must also include
information on the facility’s policy for
readmission, as required under
proposed § 483.15(c)(3), for a resident
whose hospitalization or therapeutic
leave exceeds the bed-hold period under
the state plan. We are soliciting
comments on state and facility bed-hold
policies and state reserve bed payment
policies, including whether the
proposed notices have adequately
differentiated these. Further, we are
interested in the impact, if any, of
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reserve bed arrangements between some
hospitals and some facilities. Finally,
we propose to redesignate existing
§ 483.12(a)(3) as § 483.15(c)(3) and
revise it to add a new requirement that
a resident who is hospitalized or placed
on therapeutic leave with an
expectation of returning to the facility
must be notified in writing by the
facility when the facility determines
that the resident cannot be readmitted to
the facility, the reason the resident
cannot be readmitted to the facility, and
the appeal and contact information
specified in § 483.15(b)(5)(iv) through
(vii). As noted earlier, discharge/
eviction is the most common category of
complaint processed by the Long-Term
Care Ombudsman Program. Residents
often do not realize that there are
requirements allowing them to return to
a facility after a hospitalization or that
they may have appeal rights. This
provision is intended to ensure that
residents have an opportunity to
exercise an appeal right if they choose
to do so.
G. Resident Assessments (§ 483.20)
Current regulations at § 483.20 require
that a facility must initially and
periodically conduct a comprehensive,
accurate, standardized, reproducible
assessment of each resident’s functional
capacity and sets forth the requirements
a facility must meet to be in compliance.
As part of the proposed restructuring of
subpart B, current § 483.20(k) and
§ 483.20(l), which set forth requirements
for care plans and discharge planning,
would be removed and re-designated to
proposed § 483.21(b) and § 483.21(c),
respectively. Similarly § 483.20(m)
would be re-designated as proposed
§ 483.20(k). The proposed removal and
re-designation of paragraphs (k) and (l)
are discussed below in the section
entitled, ‘‘§ 483.21 Comprehensive
Person-Centered Care Planning.’’
Existing § 483.20(b) sets forth the
information that must be included in a
resident’s comprehensive assessment
using the resident assessment
instrument. Consistent with our goal of
encouraging person-centered care, we
propose to revise this section to clarify
that the assessment is not merely for the
purpose of understanding a resident
needs, but also to understand their
strengths, goals, life history, and
preferences. We also revise the
regulations to specify that CMS (not the
State) prescribes the resident assessment
instrument. At § 483.20(b)(1)(xvi) we
propose to revise the text from
‘‘discharge potential’’ to read,
‘‘discharge planning’’ in an effort to
encourage facilities to move the
discussion of possible discharge away
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from a facility’s judgment and towards
a resident’s preference and expectation.
Existing regulations at § 483.20(e)
require facilities to coordinate
assessments with the PASARR program
under Medicaid in part 483, subpart C
to the maximum extent practicable to
avoid duplicative testing and efforts. It
is our understanding that many facilities
are unclear as to what this provision
requires. Our goal is to clarify for
facilities what it means to coordinate
resident assessments with PASARR.
Therefore, we propose to add new
§ 483.20(e)(1) and § 483.20(e)(2). In new
§ 483.20(e)(1), we propose to clarify that
coordination with PASARR includes
incorporating the recommendations
from the PASARR level II determination
and the PASARR evaluation report into
a resident’s assessment, care planning,
and transitions of care. In new
§ 483.20(e)(2), we propose to clarify that
PASARR coordination also includes
referring all level II residents and all
residents with newly evident or possible
serious mental illness, intellectual
disability, or related conditions for level
II resident review upon a significant
change in status assessment (that is, a
decline or improvement in a resident’s
status). Often facilities overlook the
PASARR recommendations during a
resident’s assessment and the
development of their care plan. The
recommendations should be used as a
tool by facilities to make a complete and
accurate assessment of a resident with
evident or possible mental illness. The
addition of these two requirements
would promote better coordination of a
resident’s assessment with the PASARR,
allowing for a facility to better assess
their residents with mental illness.
As mentioned earlier in this section,
we are proposing to re-designate
existing § 483.20(m) as § 483.20(k). In
addition, we propose to make a few
technical corrections at proposed
§ 483.20(k). First, we propose to redesignate existing § 483.20(k)(2) as
(k)(3), and add a new paragraph (k)(2).
Sections 1919(e)(7)(A)(ii) and (iii) of the
Act provide exceptions to the
preadmission screening for individuals
with mental illness and individuals
with intellectual disability for
admittance into a nursing facility.
Newly proposed § 483.20(k)(2) would
add to the regulation these statutory
exceptions that were inadvertently
omitted when this regulation was
initially written. Second, we propose to
add a new paragraph at § 482.20(k)(4).
Section 1919(e)(7)(B)(iii) of the Act
requires a NF to notify the state mental
health authority or state intellectual
disability authority when there has been
a significant change in the resident’s
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physical or mental condition so that a
resident review can be conducted.
Proposed § 483.20(k)(4) would add to
the regulation this statutory requirement
that was inadvertently omitted. Lastly,
we propose to replace ‘‘mental
retardation’’ with the term ‘‘intellectual
disability’’ throughout § 483.20(k), as
appropriate.
H. Comprehensive Person-Centered Care
Planning (§ 483.21)
In accordance with the proposed
reorganization of part 483, subpart B, we
propose to add a new § 483.21
‘‘Comprehensive Person-Centered Care
Planning’’. This section would retain
certain existing provisions of current
§ 483.20 as well as other additions and
revisions discussed in detail below.
Through the care planning process a
facility should establish and document
the services that the facility will provide
to residents to assist them in attaining
or maintaining their highest quality of
life. Care planning drives the type of
care that a resident receives and is
essentially the framework for the quality
of care that a facility will provide. The
diversity of the nursing home
population can create challenges for
facilities in meeting care planning
requirements, and improper care
planning or the lack of care planning by
a facility can negatively impact the
quality of care that a resident receives
while in a nursing home.
OIG reports reveal some gaps in care
planning within LTC facilities.
According to a July 2012 report,
‘‘Nursing Facility Assessments and Care
Plans for Residents Receiving Atypical
Antipsychotic Drugs’’ ((OEI–07–08–
00151), https://oig.hhs.gov/oei/reports/
oei-07-08-00151.asp), the OIG found
that nearly all records (99 percent)
reviewed in their study failed to meet
one or more Medicare requirements for
beneficiary assessments and/or care
plans. Furthermore, 9 percent of records
contained care plans that were not
developed or updated within the
required 7 days from the completion of
the Minimum Data Set (MDS), while 6
percent of records did not include care
plans at all. The report also found that
less than 5 percent of the records
actually contained care plans that were
developed by the required
interdisciplinary team. Moreover, 91
percent of the records did not contain
evidence that the resident, resident’s
family, or the resident’s legal
representative participated in the care
planning process. Nearly two-thirds of
these records lacked documentation as
to why participation was not
practicable.
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Similarly, a February 2013 OIG report,
‘‘Skilled Nursing Facilities Often Fail to
Meet Care Planning and Discharge
Planning Requirements’’ ((OEI–02–09–
00201), https://oig.hhs.gov/oei/reports/
oei-02-09-00201.asp), studied the extent
to which LTC facilities meet
requirements for care planning. The OIG
report found that for 37 percent of the
stays, facilities did not meet Medicare
requirements for care planning. The
February 2013 OIG report also found
that for 31 percent of nursing home
stays, facilities did not meet
requirements specific to discharge
planning. However, the report noted
that despite these deficiencies, Medicare
paid approximately $4.5 billion for the
stays that did not meet quality of care
requirements and approximately $1.9
billion for those that did not meet the
discharge planning requirements.
Currently, the requirements for care
plans and discharge planning are set out
at § 483.20 along with the requirements
for conducting an assessment of each
resident’s health and completing the
MDS. To emphasize the level of
importance for care planning and to
increase the visibility of the
requirements, we propose to remove the
requirements for care plans from current
§ 483.20(k) and discharge planning in
current § 483.20(l) (collectively referred
to here as care planning) and relocate
them to a new proposed § 483.21,
entitled ‘‘Comprehensive PersonCentered Care Planning.’’ This new
section would contain all of the existing
requirements for care planning. We
believe that relocating the requirements
to a new section dedicated solely to care
planning would emphasize the
importance of care planning as well as
provide clarity to the regulations. In
addition to relocating existing
provisions, we are also adding new
requirements as discussed in detail
below.
Proposed § 483.21(a)
Currently, § 483.20(k)(2)(i) requires
that a comprehensive care plan be
developed for each resident within 7
days after completion of the
comprehensive resident assessment.
Section 1819(b)(3)(C)(i) of the Act
requires that the comprehensive
resident assessment be completed
within 14 days after a resident is
admitted. These timeframes allow a
facility up to 21 days to develop a
comprehensive care plan for a new
resident. While we believe that most
facilities are indeed developing their
care plans much sooner than required,
the February 2013 OIG report reveals
that some facilities are not. During our
dialogue with stakeholders, concerns
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were expressed about the ability of a
facility to delay development of a care
plan for 21 days without consequence to
residents. We recognize that during
these 21 days facilities could use
admission orders to determine a
resident’s care; however, we believe that
there are common health concerns
found in the residents of LTC facilities
that need to be identified and addressed
in a care plan to prevent resident
decline or injury. Some of these
problems include behavioral
intervention in dementia care, dietary
issues, fall risks, supervision, and the
ability to perform activities of daily
living (ADLs). These areas need to be
assessed and issues identified quickly in
order to prevent adverse events such as
injuries, unintended weight loss and
dehydration, and instances of
wandering off. Without a proper interim
care plan within the initial period of
residency, residents could receive poor
quality care simply due to the fact that
staff does not receive the relevant
information they need to be effective
and provide high quality care and
services to the resident. This could also
place residents at a much higher risk of
hospital readmission. Therefore, we are
proposing to add a new § 483.21(a)(1) to
the current care planning regulations
and require that facilities complete a
baseline interim care plan for each
resident upon their admission to the
facility. This baseline interim care plan
would include the necessary
instructions for the proper professional
care and services to meet the immediate
needs of a new resident. This proposal
would increase resident safety and
safeguard against adverse events that are
most likely to occur right after
admission.
We believe that residents are
receiving initial services and care based
on physician’s orders within the first 24
to 48 hours of admission and therefore
propose to require that the proposed
baseline care plan be completed within
48 hours of a resident’s admission. It is
our expectation that facilities would
continuously revise and update this
baseline care plan as needed until the
comprehensive assessment and care
plan could be developed. We believe
that most facilities are assessing
residents as soon as possible and
establishing plans of care earlier than
the regulatory deadline; however this
requirement would eliminate the
possibility that residents could reside in
a facility for 21 days without any care
planning. Also, requiring facilities to
complete this baseline interim care plan
within 48 hours would promote
continuity of care across shift changes
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by improving communication among
nursing home staff during a period
when residents are especially
vulnerable to adverse health events.
At § 483.21(a)(1)(ii), we propose to list
the information that would, at a
minimum, be necessary for inclusion in
a baseline care plan, but would not limit
the contents of the care plan to only this
information. Information such as initial
goals based on admission orders,
physician orders, dietary orders, therapy
services, social services, and PASARR
recommendations as appropriate would
be the type of information that would be
necessary to provide appropriate
immediate care for a resident. However,
since care plans are developed
specifically for each resident, a facility
could decide to include additional
information as appropriate.
Finally, at § 483.21(a)(2), we propose
to allow facilities to complete a
comprehensive care plan instead of
completing both a baseline care plan
and then a comprehensive care plan. In
this circumstance, the comprehensive
care plan would then have to be
completed within 48 hours of admission
and comply with the requirements for a
comprehensive care plan at proposed
§ 483.21(b). We discuss those
requirements below.
Proposed § 483.21(b)
Current regulations at § 483.20(k) set
forth the requirements for developing a
comprehensive care plan. As mentioned
above, we propose to re-designate this
section as a new § 483.21(b). In
addition, we are also proposing
revisions to this section that we believe
would provide clarity, promote resident
safety, and encourage person-centered
care. First, we propose to add a new
§ 483.21(b)(1)(iii), that would require
any specialized services or specialized
rehabilitation services that a nursing
facility provided pursuant to a PASARR
recommendation to be included in the
resident’s care plan. This inclusion
would improve coordination between
the nursing facilities and a resident’s
PASARR. In addition, we propose to
require that if a facility disagrees with
the findings of the PASARR, it must
indicate this disagreement and the
reasons for it in the resident’s medical
record.
We also propose to add a new
§ 483.21(b)(1)(iv) that would require
discharge assessment and planning to be
a part of developing the comprehensive
care plan. We are proposing to require
facilities to assess a resident’s potential
for future discharge, as appropriate, as
early as upon admission, to ensure that
residents are given every opportunity to
attain their highest quality of life. This
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proposal seeks to improve resident
satisfaction and encourage facilities to
operate in a person-centered fashion
that addresses resident choice and
preferences. Upon a resident’s request,
this discharge assessment may include
referral to a community transition
planning agency to explore community
living options, resources, and available
supports and services. We propose to
require at § 483.21(b)(1)(iv) that
facilities document whether a resident’s
desire for information regarding
returning to the community is assessed
and any referrals that are made for this
purpose. Furthermore, we also
acknowledge that residents’ preferences
and goals of care may change
throughout the length of their stay in a
facility, so we also want to emphasize
that there needs to be an ongoing
discussion with the resident or their
representatives of the goals of care.
Also in the spirit of person-centered
care, we are proposing to specify
additional mandatory members of the
interdisciplinary team (IDT). The IDT is
responsible for developing a
comprehensive care plan for each
resident at proposed § 483.21(b)(2)(ii).
Under current § 483.20(k)(2)(ii), the
attending physician, a registered nurse
with responsibility for the resident,
other appropriate staff in disciplines as
determined by the resident’s needs, and
to the extent possible the resident or the
resident’s family/legal representative are
all required to participate in the IDT.
We are proposing to add the term ‘‘other
appropriate staff’’, which should be
determined based on the specific needs
of the resident or at the request of the
resident. For example, a qualified
mental health professional should be
involved when residents are diagnosed
with mental health conditions or
prescribed psychotropic drugs.
Similarly, based on a resident’s needs,
a chaplain or other spiritual care
provider could be deemed appropriate
for inclusion in the development of a
residents care plan. However, we
believe there would be other
appropriate staff in specific disciplines
that all residents need to also be a part
of the IDT. Therefore, we propose to
also explicitly require a NA with
responsibility for the resident, an
appropriate member of the food and
nutrition services staff, and a social
worker to be a part of the IDT. Including
these critical team members in the IDT
and the care planning process would
ensure that the individual needs of a
particular resident are being assessed
and appropriately addressed.
NAs spend much of their time
interacting directly with the residents
providing them day-to-day care. Their
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knowledge of a resident care plan and
medical needs directly relates to how
well they can care for a resident. Dietary
concerns and unplanned weight loss are
major concerns for the LTC population,
especially for the elderly population.
Since nutrition is a fundamental part of
a resident’s overall health and wellbeing, it is important that a member of
the food and nutrition services staff be
knowledgeable of the resident’s needs
and preferences to achieve their
maximum practicable well-being. Social
workers serve as a critical link with
families in many ways, including
arranging post-discharge services and
addressing mental and behavioral health
care needs. The involvement of social
services and food and nutrition services
would also promote and enhance a
resident’s choice regarding their day-today activities and meals as well as
encourage facilities to take a more
comprehensive approach to providing
individualized quality of care and
quality of life specific to each resident.
Additionally, we propose to revise
§ 483.21(b)(2)(ii)(F), to provide that to
the extent practicable, the IDT must
include the participation of the resident
and the resident representatives. We
want to ensure that residents have the
ability to choose who they want to be
a part of making decisions about their
care. This participation can incorporate
many forms of communication such as
conference calls or using electronic
tools for video conferencing. Further, at
§ 483.21(b)(2)(ii)(F) we propose to add
the requirement that an explanation
must be included in a resident’s medical
record if the IDT decides not to include
the resident and/or their resident
representative in the development of the
resident’s care plan or if a resident or
their representative chooses not to
participate. Residents should be
involved in making decisions about
their care and facilities should be held
accountable for their attempts to involve
the resident when it is appropriate and
provide an explanation when they
determine that it is not feasible or
appropriate. We believe the addition of
these requirements would increase
resident choice, but also seek to
improve the communication between
the facilities and the residents regarding
the aspects of a resident’s care, choice,
and the services to be provided by
facility to maintain or improve a
resident’s care.
Lastly, we have added a new
requirement at § 483.21(b)(3)(iii) to
require that the services provided or
arranged by the facility be culturallycompetent and trauma-informed. As
discussed previously, culturallycompetent (including language, culture
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preferences and other cultural
concerns), trauma-informed approaches
that help to minimize triggers and retraumatization, and that address the
unique care needs of Holocaust
survivors and other trauma survivors,
are an important aspect of personcentered care for these individuals.
We note that certified health IT can
support efforts by LTC facilities to
develop robust comprehensive care
plans that can be shared with other
providers across the continuum of care.
We strongly believe that facilities that
use certified health IT applications
should seek to generate comprehensive
care plans using technology solutions,
in order to further improve access and
communication among staff. ONC has
identified the HL7 Clinical Document
Architecture (CDA) Release 2.0:
Consolidated CDA Templates for
clinical notes as the best available
standard for care plans (see the
Interoperability Standards Advisory at
https://www.healthit.gov/standardsadvisory). The dedicated care plan
document contained within this
standard is designed to help providers
reconcile and resolve conflicts between
different plans of care and to help the
care team prioritize goals and
interventions. As part of the 2015
Edition of certification criteria for health
IT, ONC proposed to certify health IT
systems to their ability to generate a
Care Plan document according to this
standard (see 80 FR 16842).
Proposed § 483.21(c)
Current regulations at § 483.20(l) set
forth the requirements for discharge
planning. As mentioned above, we
propose to re-designate this section as a
new § 483.21(c). Transitions between
settings of care are often complex for
residents as well as for LTC facilities
given that each facility differs greatly in
its organization, practices and cultures.
As mentioned earlier, the population
receiving care and service in LTC
facilities is diverse and includes those
who have complex health and
continuing care needs and rely on
various services to help meet these
needs. Furthermore, these individuals
may have increased susceptibility to
infections, malnutrition, dehydration,
comorbidities, or functional
impairments. All of these factors
contribute to a person’s increased
vulnerability to receiving suboptimal
care during a period of transition from
one care setting to another. Older adults
often receive healthcare in multiple
settings thus requiring multiple
transitions of care. For example, an
older adult with an acute or chronic
illness may receive healthcare at an
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inpatient hospital setting, followed by
treatment at a LTC facility, possibly
followed by discharge to their home to
receive services from a visiting nurse or
a primary care physician in an
outpatient setting. The February 2013
OIG report found that for the current
discharge planning requirements
(summary of a resident’s stay and a
post-discharge plan of care), many SNF
stays that did not meet the discharge
planning requirements did not have a
post-discharge plan of care. Results of
the study also indicated that, in some
instances, staff provided only verbal
instructions to the beneficiary and in
one example a resident did not receive
specific instructions about medications.
Another study found that one in five
Medicare beneficiaries are rehospitalized within 30 days, largely a
result of medication errors, resident
confusion about and subsequent failure
to follow up on care instructions and
the management of multiple chronic
conditions (Parry, C., & Coleman, E. A.
(2010). Active Roles for Older Adults in
Navigating Care Transitions: Lessons
Learned from the Care Transitions
Intervention. Open Longevity Science,
43–50).
Relevant literature indicates that
different priorities and organizational
structures result in little coordination
and lack of understanding about what
occurs across settings. (McCloskey R. A
Qualitative Study on the Transfer of
Residents between a Nursing Home and
an Emergency Department. Journal of
the American Geriatrics Society [serial
online]. April 2011; 59(4):717–724.
Available from: Academic Search
Complete, Ipswich, MA. Accessed
November 14, 2012.) For example, staff
in a LTC facility setting may decide that
a resident’s condition requires acute
care services and transfer the resident to
the hospital for an assessment. The
physicians in the hospital setting may
not believe the resident’s condition
warrants acute care and thus may send
the resident back to the nursing home,
or may admit the resident when a
hospital level of care is not indicated.
Proper discharge planning across all
provider settings helps improve the
communication regarding a resident’s
needs and promotes safer care
transitions.
Given the heightened need to ensure
safe transitions of care across all
providers, we are proposing to
strengthen the current LTC
requirements for discharge planning.
These proposals would also support
CMS’ initiative to safely reduce hospital
readmissions and unnecessary
hospitalizations by improving
communication and ensuring that
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residents are being empowered and
educated about their care. Our proposals
also emphasize that discharge planning
should focus on the necessary steps to
achieve discharge consistent with a
resident’s goals and preferences. In
addition, the IMPACT Act amended title
XVIII of the Act by adding Section
1899B to require that post-acute care
(PAC) providers, home health agencies
(HHAs), SNFs, inpatient rehabilitation
facilities (IRFs), and long-term care
hospitals (LTCHs) report standardized
patient assessment data, data on quality
measures, and data on resource use and
other measures. The IMPACT Act also
requires that this data be standardized
and interoperable to allow for the
exchange of data among PAC providers
and other providers. The IMPACT Act
requires the modification of PAC
assessment instruments to allow for the
submission of standardized patient
assessment data and enable comparison
of this assessment data across providers.
Additionally, the IMPACT Act requires
that standardized patient data, quality
measures, and resource use measures
along with patient treatment goals and
preferences be taken into account in
discharge planning.
At § 483.21(c)(1) we propose to
improve the discharge planning for LTC
facilities by adding a requirement that
facilities must develop and implement
an effective discharge planning process.
The facility’s discharge planning
process must ensure that the discharge
goals and needs of each resident are
identified. This process should also
result in the development of a discharge
plan for each resident and any referrals
to local contact agencies or other
appropriate entities, should the resident
have a desire to receive information
about returning to the community. In
addition, we propose to require that the
facility’s discharge planning process
require the regular re-evaluation of
residents to identify changes that
require modification of the discharge
plan. The discharge plan must also be
updated, as needed, to reflect these
changes. We also propose to require that
the IDT responsible for the developing
a resident’s comprehensive care plan be
involved in the ongoing process of
developing the discharge plan.
Furthermore, we propose to require
that the facility consider caregiver/
support person availability, and the
resident’s or caregiver support persons’
capacity and capability to perform the
required care, as part of the
identification of discharge needs. In
order to incorporate residents and their
families in the discharge planning
process, we also propose to require that
the discharge plan address the resident’s
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goals of care and treatment preferences.
Facilities would have to document in
the discharge plan that a resident has
been asked about their interest in
receiving information regarding
returning to the community. If the
resident indicated interest in returning
to the community, the facility must
document any referrals to local contact
agencies or other appropriate entities
made for this purpose and update a
resident’s comprehensive care plan and
discharge plan in response to
information received from such
referrals. Likewise, if discharge to the
community were determined to not be
feasible, the facility would document
who made the determination and why.
As required under section 1899B(i)(1)
of the Act, to help inform the discharge
planning process, we propose to require
LTC facilities to take into account,
consistent with the applicable reporting
provisions, standardized patient
assessment data, quality measures and
resource use measures that pertain to
the IMPACT Act domains, as well as
other relevant measures specified by the
Secretary. For those residents who are
transferred to another LTC facility or
who are discharged to a HHA, IRF, or
LTCH, we propose at § 483.21(c)(1)(viii)
to require that the facility assist
residents and their resident
representatives in selecting a post-acute
care provider by using data that
includes, but is not limited to SNF,
HHA, IRF, or LTCH standardized
patient assessment data, data on quality
measures, and data on resource use to
the extent the data are available.
Further, under the proposed regulation,
the facility would have to ensure that
the post-acute care standardized patient
assessment data, data on quality
measures, and data on resource use are
relevant and applicable to the resident’s
goals of care and treatment preferences.
In order to emphasize resident
preferences, we would expect that the
facility would compile the relevant data
and present it to the resident and their
resident representative in an accessible
and understandable format and with
useful content. For example, the facility
could provide the aforementioned
quality data on other post-acute care
providers that are within the resident’s
desired geographic area. Facilities
would then need to assist residents and
their resident representative as they
seek to understand the data and use it
to help them choose a high quality postacute care provider, or other setting for
discharge, as appropriate.
Finally, at § 483.21(c)(1)(viii), we
propose that facilities must document in
the discharge plan whether a
determination is made by the resident,
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42195
resident representative, or
interdisciplinary team that discharge to
the community is not feasible. At
§ 483.21(c)(1)(ix), we propose to require
that the evaluation of the resident’s
discharge needs and discharge plan
must be documented, completed on a
timely basis based on the resident’s
needs, and included in the clinical
record. The results of the evaluation
must be discussed with the resident or
resident’s representative. Furthermore,
all relevant resident information must
be incorporated into the discharge plan
to facilitate its implementation and to
avoid unnecessary delays in the
resident’s discharge or transfer.
At § 483.21(c)(2), we propose to set
forth the existing requirements for
providing a resident with a discharge
summary when discharge from the
facility is anticipated.
At § 483.21(c)(2)(i) we propose to
revise the current requirements for the
post-discharge plan of care to specify
that a recapitulation of a resident’s stay
would include, but not be limited to,
diagnoses, course of illness/treatment or
therapy, and pertinent lab, radiology,
and consultation results. We also
propose to explicitly include a
requirement for facilities to include
what arrangements have been made
with other providers for the resident’s
follow-up care and any post-discharge
medical and non-medical services as
needed. These arrangements should
include community care options,
resources, and available supports and
services presented and arranged by the
community care provider as needed.
Some local community transition
agencies include Area Agencies on
Aging (AAAs), Aging and Disability
Resource Centers (ADRCs), or Centers
for Independent Living (CILs), which
can provide information and assist the
resident in arranging for available
community supports and services prior
to discharge. Adding this requirement
would hold facilities accountable for
their role in preparing residents for care
transitions from one setting to another
and assist in decreasing a resident’s risk
for complications and hospitalization.
In addition, the discharge planning
process should ensure that residents
receive adequate information that is
understandable and prepares them to be
active partners and advocates for their
healthcare upon discharge. Yet residents
and/or their representatives frequently
are unable to understand their
diagnoses, list their medications and
describe their purpose and side effects,
or explain their follow-up plan of care
instructions, all key factors of a
resident’s healthcare needs. Therefore,
at § 483.21(c)(2)(iii) we propose to add
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a new requirement that would require
facilities to reconcile all pre-discharge
medications both prescribed and nonprescription, with the resident’s post
discharge medications. This medication
reconciliation would be included as part
of the discharge summary. The addition
of this requirement would ensure that
residents avoid unnecessary
medications and prevent drug
interactions. This proposal would also
improve transitions across varying care
settings by avoiding unnecessary
situations, such as placing a resident on
duplicate prescriptions leading to an
adverse event and unnecessary
hospitalization.
Lastly, in keeping with the theme of
resident centered care, we also propose
at § 483.21(c)(2)(iv) to require that the
post-discharge plan be developed along
with the participation of the resident
and, with the resident’s consent, his or
her resident representative.
Furthermore, upon a resident’s request,
facilities should also include the
community transition planning agency
to assist the resident and facility with
housing, personal care assistance,
assistive technology, and other
resources.
We encourage facilities to explore
how the use of certified health IT can
support their efforts to electronically
develop and share standardized
discharge summaries. Information about
how currently available certified health
IT systems can enable the electronic
exchange of a summary care record is
available in ‘‘Certification Guidance for
EHR Technology Developers Serving
Health Care Providers Ineligible for
Medicare and Medicaid EHR Incentive
Payments,’’ which addresses the use of
the 2014 Edition of ONC certification
criteria (available at https://
www.healthit.gov/sites/default/files/
generalcertexchangeguidance_final_9-913.pdf). Facilities may also wish to
review the Discharge Summary
document that is included in the HL7
Clinical Document Architecture (CDA)
Release 2.0, now identified as the best
available standard for the summary care
record (see the Interoperability
Standards Advisory at https://
www.healthit.gov/standards-advisory).
I. Quality of Care and Quality of Life
(§ 483.25)
Current regulations at § 483.25
establish requirements for numerous
aspects of care and special needs of
nursing home residents under the
general heading of ‘‘Quality of Care.’’
Quality of Care and Quality of Life are
two separate and overarching principles
in the delivery of care to residents of
nursing homes. These principles apply
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to every service provided by a SNF or
NF. Sections 1819(b)(1)(A) and
1919(b)(1)(A) of the Act require that a
SNF or NF care for its residents in a
manner and in an environment that will
promote maintenance or enhancement
of the quality of life of each resident.
Services and care must be provided in
accordance with established standards
of practice, in a manner intended to
support achievement of a resident’s
individualized goals for attaining or
maintaining his or her highest
practicable physical, mental, and
psychosocial well-being, as set out in
the plan of care. In addition, services
and care must be provided in a manner
intended to support each resident’s
overall well-being, as perceived by the
resident, including emotional, social
and physical aspects of his or her life.
We propose to comprehensively revise
and re-organize the current § 483.25 to
ensure person-centered, quality care and
quality of life for this vulnerable
population. In this proposed revised
section, we would focus on a limited set
of concerns that do not clearly fit in
other general sections of the regulation
but which are of significant importance
for each resident’s health and safety and
which contribute substantially to their
quality of care, quality of life and
person-centered issues such as dignity,
respect, self-esteem and selfdetermination. These concerns have
both medical and psychosocial aspects
and include activities of daily living
which are those self-care activities that
an individual performs daily, including
everyday routines involving functional
mobility and personal care, such as
bathing, dressing, toileting, and meal
preparation and consumption.
Diminished ability or inability to
perform these activities renders an
individual vulnerable and dependent on
others for assistance.
First, we propose to retitle this section
‘‘Quality of Care and Quality of Life’’,
reflecting the overarching application of
these principles. In our proposed
revised introductory paragraph, we
reiterate the requirement that each
resident must receive and the facility
must provide the necessary care and
services to attain or maintain the highest
practicable physical, mental, and
psychosocial well-being, consistent with
the resident’s comprehensive
assessment and plan of care. We focus
throughout this section, as we have in
other areas, on establishing personcentered requirements that acknowledge
both the resident’s needs and the
resident’s right to make choices.
Second, in § 483.25(a), we propose to
address the residents’ ability to perform
ADLs and establish that, based on the
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comprehensive assessment of a resident
and consistent with the resident’s
needs, choices, and preferences, the
facility must provide the necessary care
and services to maintain or improve, as
practicable, the resident’s abilities to
perform his or her activities of daily
living and to ensure that those abilities
do not diminish unless the diminution
is unavoidable as a result of the
individual’s clinical condition. This
means that a resident is offered the
appropriate treatment and services to
improve or maintain his or her ability to
carry out ADLs and, if a resident is
unable to do so, he or she receives the
necessary care and services from
qualified staff to maintain good
nutrition, functional mobility,
grooming, and personal and oral
hygiene. We propose to divide the
requirements of existing § 483.25(a)(1)
into proposed § 483.25(a) and (b).
Existing (a)(2) and (a)(3) would be redesignated as § 483.25(a)(1) and (a)(2),
respectively. We propose a new
§ 483.25(a)(3) to clarify that, in keeping
with the requirement to provide the
necessary care and services to attain or
maintain the highest practicable
physical, mental, and psychosocial
well-being, a facility must ensure that
appropriate personnel provide basic life
support, including cardiopulmonary
resuscitation (CPR) to a resident
requiring this emergency care prior to
the arrival of emergency medical
personnel and subject to accepted
professional guidelines and the
resident’s advance directives. It has
come to our attention that there are
nursing facilities that have implemented
a facility-wide policy of not initiating
basic life support. They will, instead,
call 911 and wait for the arrival of
emergency personnel, unless the
resident does not want CPR at all. We
believe that the determination to
provide or not provide basic life support
such as CPR should be made on an
individual resident basis rather than as
a facility-wide policy. The
determination should be based on a
resident’s advance directives, the
presence or absence of do-notresuscitate orders, and accepted
professional standards. Further, we
believe that the provision of CPR in
applicable emergency situations and
subject to an individual’s advance
directives is a generally accepted
expectation in healthcare facilities.
In proposed § 483.25(b), we would
establish those activities that we include
as ADLs. These activities are currently
listed in § 483.25(a)(1)(i) through (v). We
propose to update the language of that
list, although the underlying activities
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remain unchanged. We would establish
as ADLs (1) hygiene, such as bathing,
dressing, grooming, and oral care; (2)
mobility, which includes transfers and
ambulation; (3) toileting and use of the
bathroom; (4) dining, including eating
meals and snacks; and (5)
communication, including speech,
language and other functional
communication systems. We note that
communications are not considered an
ADL in standard instruments such as
the Barthel Index of Activities of Daily
Living or the Index of Independence in
Activities of Daily Living (Katz, 1963).
However, we believe that the ability to
communicate is a vital aspect of an
individual’s daily life and a resident’s
ability to do so should continue to be
included in our provisions relating to
ADLs. We also highlight the inclusion of
oral hygiene in this section. In the
elderly population, periodontal disease
has been linked to a wide variety of
systemic diseases, including diabetes,
cardiovascular disease, arthritis,
neurodegenerative diseases, respiratory
diseases, and nutritional deficits. One
study suggests that maintaining optimal
oral health may do more to reduce
healthcare expenditures in an elder’s
remaining lifespan than any other
public health measure. According to a
2000 report by HHS, 23 percent of 65to 74-year olds have severe periodontal
disease. Nursing home residents in
particular are recognized as receiving
inadequate oral care. Even if a resident
enters a nursing facility with good oral
health, that oral health is likely to
decline within 6 months. Thus, we
emphasize here that if a resident is
unable to brush and floss his or her
teeth or otherwise maintain good oral
hygiene, the facility must ensure that he
or she receives the necessary care and
services from qualified staff to maintain
good oral hygiene.
In proposed § 483.25(c), we propose
to relocate the current requirements
related to an activities program as
required in existing § 483.15(f). An
ongoing individualized activities
program that incorporates an
individual’s interests and hobbies can
and should be integral to maintaining
and improving a resident’s physical,
mental, and psychosocial well-being
and his or her independence. Thus, we
propose to revise the language to
include a required consideration of the
comprehensive assessment, care plan
and the preferences of the resident as
well as potential for independence and
ability to interact with the community.
This reflects our focus on personcentered care as well as our recognition
of the development of support programs
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and community resources in some areas
that may allow for resident involvement
or reintegration into the community
setting for some nursing home residents.
We received stakeholder input on the
requirements for the director of a facility
activities program and considered, but
did not modify the requirements for the
director of the activities program.
However, we are soliciting comments on
the current requirements to determine if
they remain appropriate and, if not,
what the evidence is for changing the
current requirements for this position
and what stakeholders would
recommend as minimum requirements
for this position.
We propose a new § 483.25(d),
‘‘Special Care Issues,’’ which we revise,
re-locate, and add requirements for
specific special concerns, including
restraints; bed rails; vision and hearing;
skin integrity; mobility; incontinence;
colostomy, ureterostomy, or ileostomy;
assisted nutrition and hydration;
parenteral fluids, accidents, respiratory
care, prostheses, pain management,
dialysis, and trauma-informed care.
Each of these special concerns is related
to an ADL but has a significant medical
component or is an issue that could
significantly impact a resident’s ability
to perform or engage in ADLs. For
example, there are specific medical
professional standards of practice that
affect when and how tube-feedings are
initiated and performed. At the same
time, the resident’s need for tubefeeding reflects the resident’s
significantly diminished ability to
perform or participate in ADLs related
to eating. Similarly, pain management is
a medical issue, but can significantly
alter a resident’s ability to engage in an
activities program of choice, perform
transfers or ambulate, impairs quality of
life and can contribute to depression. As
many of the concerns in this section
were previously included in § 483.25,
we discuss here only the provisions we
propose to add or modify.
Specifically, we propose to redesignate and revise § 483.13(a),
‘‘Restraints,’’ as § 483.25(d)(1). While we
would prohibit the use of any physical
or chemical restraint not required to
treat the resident’s medical symptoms in
the introductory language to proposed
§ 483.12, in proposed § 483.25(d)(1), we
would require that the facility ensure
that residents are free from restraints
that are imposed for purposes of
discipline or convenience, in addition
to ensuring that residents are free from
restraints not required to treat the
resident’s medical symptoms. In
addition, we would add new
requirements to specify that, if used,
restraints must be the least restrictive
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alternative for the least amount of time.
Further, documentation of ongoing
evaluation of the need for the restraints
is required. As noted in our discussion
above regarding the proposed
requirement ‘‘Freedom from Abuse,
Neglect, and Exploitation’’ (§ 483.12),
there are very limited circumstances
where restraints may be appropriate in
a nursing facility. However, many
facilities have achieved a rate of zero
percent restraint use, and CMS
continues to promote reduction in the
use of physical restraints. We
considered proposing requirements for
the use of restraints and seclusion that
parallel the more extensive
requirements for restraint and seclusion
currently set forth in the Conditions of
Participation for Hospitals at
§ 483.13(e). However, given the progress
towards zero restraint use under
existing guidance and taking into
consideration the different types of care
provided in the two settings, we have
chosen to pursue a less burdensome
approach and codify existing guidance.
In addition, we are proposing
requirements for the use of psychotropic
medications, including the use of PRN
orders, at § 483.45(e), discussed below,
to ensure that these medications are
only used to treat specific conditions
that are diagnosed and documented in
the resident’s clinical record. We
welcome comments on our approach as
well as suggestions for more extensive
requirements.
We propose a new § 483.25(d)(2) to
establish specific requirements when a
facility uses bed rails on a resident’s
bed. Specifically, we propose to require
that the facility ensure correct
installation, use and maintenance of bed
rails, including attempting to use
alternatives prior to installing a side or
bed rail, assessing the resident for risk
of entrapment from bed rails prior to
installation, reviewing the risks and
benefits of bed rails with the resident
and obtaining informed consent prior to
installation, ensuring that the resident’s
size and weight are appropriate for the
bed’s dimensions, and following the
manufacturers’ recommendations and
specifications for installing and
maintaining bed rails. Bed rails can pose
a significant safety risk to residents.
Between January 1, 1985 and January 1,
2013, FDA received 901 incidents of
patients caught, trapped, entangled, or
strangled in hospital beds. The reports
included 531 deaths, 151 nonfatal
injuries, and 220 cases where staff
needed to intervene to prevent injuries.
Most patients were frail, elderly or
confused. Additional information and
resources regarding the use of bed rails
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is available at https://www.fda.gov/
MedicalDevices/
ProductsandMedicalProcedures/
GeneralHospitalDevicesandSupplies/
HospitalBeds/default.htm. We propose
to revise existing language at § 483.25(c)
and § 483.25(k)(7) and re-designate them
under a new § 483.25(d)(4), ‘‘Skin
Integrity.’’ Here, we propose to revise
the language to include a statement that
care must be consistent with
professional standards of practice and to
clarify that foot care includes care to
prevent complications from the
resident’s medical conditions such as
diabetes, peripheral vascular disease, or
immobility, and also includes assistance
in making and keeping necessary
appointments with qualified healthcare
providers such as podiatrists.
In § 483.25(d)(5), we propose to
address mobility both range of motion
and other limitations of mobility. We
propose to retain, unchanged, the
provisions related to range of motion,
but to add a new provision to require
that residents with limited mobility
receive appropriate services and
equipment to maintain or improve
mobility unless reduced mobility is
unavoidable based on the resident’s
clinical condition.
In § 483.25(d)(6), we propose to retain
existing provisions on urinary
incontinence, add a new
§ 483.25(d)(5)(B) to address residents
who are admitted with an indwelling
urinary catheter, and add a new
§ 483.25(d)(6)(iii) to require that
residents with fecal incontinence
receive the appropriate treatment and
services to restore as much normal
bowel function as possible. Fecal or
bowel incontinence affects a substantial
number of nursing home residents.
Urinary and fecal incontinence affect 50
percent or more of nursing home
residents and frequently occur together
because immobility and dementia are
primary risk factors for both conditions
(John F Schnelle, Felix W Leung,
Urinary and fecal incontinence in
nursing homes, Gastroenterology,
Volume 126, Supplement 1, January
2004, Pages S41–S47, ISSN 0016–5085,
10.1053/j.gastro.2003.10.017. (https://
www.sciencedirect.com/science/article/
pii/S0016508503015658)). In an older
study, 20 percent of nursing home study
participants developed fecal
incontinence over a 10 month period
(Chassagne P, Landrin I, Neveu C, et al.
Fecal incontinence in the
institutionalized elderly: incidence, risk
factors, and prognosis. Am J Med
1999;106:185–90.), and a 1998 survey of
18,000 Wisconsin nursing home
residents found a prevalence of up to 50
percent (Nelson RL, Furner S, Jesudason
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V. Fecal incontinence in Wisconsin
nursing homes. Dis Colon Rectum
1998;41:1226–9). Fecal incontinence
may be related to impaired skin
integrity, including pressure ulcers, as
well as depression and anxiety. We
retain, unchanged, colostomy,
ureterostomy, and ileostomy care in
§ 483.25(d)(7).
In § 483.25(d)(8), we propose to
modify existing provisions on
nasogastric tubes to reflect current
clinical practice and to include enteral
fluids. Other methods of providing
assisted nutrition are now common
practice. Therefore, we propose to
include gastrostomy tubes with
nasogastric tubes, both percutaneous
endoscopic gastrostomy and
percutaneous endoscopic jejunostomy.
We also propose to include in this
paragraph requirements regarding both
assisted nutrition and hydration and
specify that the facility must ensure that
the resident maintains acceptable
parameters of nutritional status, such as
usual body weight or desirable body
weight range and protein levels, unless
the resident’s clinical condition
demonstrates that this is not possible
and that the resident receives sufficient
fluid intake to maintain proper
hydration and health. Additionally, we
propose to modify the requirement for a
therapeutic diet to require that the
resident is offered a therapeutic diet
when appropriate, recognizing that the
resident has a right to choose to eat a
therapeutic diet or not. Finally, we
propose to specify that based on the
comprehensive assessment of a resident,
the facility must ensure that a resident
who has been able to eat enough on his
or her own or with assistance is not fed
by enteral methods unless the resident’s
clinical condition demonstrates that
enteral feeding was clinically indicated
and consented to by the resident; and a
resident who is fed by enteral means
receives the appropriate treatment and
services to restore, if possible, oral
eating skills and to prevent
complications of enteral feeding. The
American Geriatric Society (AGS), in
their May 2013 position statement on
feeding tubes in advanced dementia,
states that institutions such as hospitals,
nursing homes and other care settings
should promote choice, endorse shared
and informed decision-making, and
honor patient preferences regarding tube
feeding. The statement further notes that
enteral feeding is not associated with
better outcomes in older adults with
advanced dementia, but is associated
with agitation, increased use of
restraints, and worsening pressure
ulcers and is not recommended for older
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adults with advanced dementia and
recommends careful hand-feeding.
(https://www.americangeriatrics.org/
files/documents/
feeding.tubes.advanced.dementia.pdf).
Our proposed requirements are
consistent with the AGS position
statement.
In § 483.25(d)(9), we propose to
address only parenteral fluids. We
would include enteral fluids in
§ 483.25(d)(8), our proposed provisions
on assisted nutrition and hydration, as
discussed above.
We propose to add a new
§ 483.25(d)(13) to ensure that residents
receive necessary and appropriate pain
management. Pain that impairs function
affects 45 percent to 80 percent of
nursing home residents, with half of
those experiencing daily pain (Davis,
M., & Srivastava, M. (2003).
Demographics, assessment and
management of pain in the elderly.
Drugs & Aging, 20(1), 23–57). Also,
Thomas Cavalieri noted that pain in the
elderly is often unrecognized and
undertreated. He further recognized that
ineffective pain management can have a
significant impact on the quality of life
of older adults, including contributing
to depression, isolation, and loss of
function. (J Am Osteopath Assoc
September 1, 2002 vol. 102 no. 9 481–
485). Further, Cheryl Phillips, MD,
speaking to the United State Senate
Special Committee on Aging on behalf
of the American Geriatrics Society,
reported that pain is common among
nursing home residents and is
undertreated in an estimated 45 percent
to 80 percent of residents with
substantial pain. According to Dr.
Phillips untreated pain is associated
with multiple consequences, including
poor oral intake and weight loss,
inability to sleep, depression, loss of
mobility and increased risk of falls,
increased risk of pressure ulcers,
depression, anxiety, decreased
socialization, sleep disturbance,
increased emergency room transfers and
increased re-hospitalization rates
(Testimony of Cheryl Phillips, MD
before the Special Committee on Aging,
United States Senate, March 24, 2010.
https://www.americangeriatrics.org/files/
documents/Adv_Resources/
AGS.Testimony.Senate.
Aging.Pain.Management.in.
Nursing.Homes.pdf).
More recently, in 2011, the Institute of
Medicine issued a comprehensive report
on pain entitled ‘‘Relieving Pain in
America: A Blueprint for Transforming
Prevention, Care, Education and
Research’’ (https://www.iom.edu/
Reports/2011/Relieving-Pain-inAmerica-A-Blueprint-for-Transforming-
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Prevention-Care-EducationResearch.aspx). This report identifies
pain as a national challenge, affecting
more Americans than heart disease,
diabetes, and cancer combined, and as
a factor that significantly increases the
cost of health care across all settings,
including nursing facilities.
Clearly, adequate pain management is
critical to the health, safety, and quality
of life for nursing home residents.
Therefore, we propose to explicitly
include oversight of pain management
as a special concern. We propose that
the facility, based on the resident’s
comprehensive assessment and choices,
must ensure that residents receive
treatment and care for pain management
in accordance with professional
standards of practice.
We also propose to add a new
§ 483.25(d)(14) to ensure that residents
who require dialysis receive those
services in accordance with professional
standards of practice and the residents
choices.
We further propose to add a new
§ 483.25(d)(15) to ensure that trauma
survivors, including Holocaust
survivors, survivors of abuse, military
veterans with post-traumatic stress
disorder, and survivors of other trauma
receive care that addresses the special
needs of trauma survivors. Specifically,
we propose to require that facilities
ensure that residents who are trauma
survivors receive care and treatment
that is trauma-informed, takes into
consideration the resident’s experiences
and preferences in order to avoid
triggers that may cause retraumatization, and meet professional
standards of practice.
Finally, we propose to revise and
relocate to § 483.45, ‘‘Pharmacy
services’’, the provisions related to
unnecessary drugs, antipsychotic drugs,
medication errors, and influenza and
pneumococcal immunizations. These
provisions are further discussed below
in our section on pharmacy services.
J. Physician Services (§ 483.30)
Under the reorganization discussed
above, requirements regarding physician
services currently located at § 483.40
would be moved to proposed § 483.30.
We would retain the current
requirements but propose a few
additions as discussed below. In our
review of the requirements for LTC
facilities, we have considered what, if
any, minimum health and safety
standards are appropriate and necessary
to ensure that residents of SNFs and
NFs are not unnecessarily hospitalized.
CMS has focused recently on reducing
the number of avoidable
hospitalizations of nursing home
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residents. We believe that many of our
proposals will support this objective.
We propose to revise the introductory
text of new § 483.30 to specify that, in
addition to a physician’s
recommendation that the individual be
admitted to a facility, a physician, a
physician assistant, a nurse practitioner,
or a clinical nurse specialist must
provide orders for the resident’s
immediate care and needs. This is
consistent with the current requirement
at § 483.20(a) that the facility must have
physician’s orders for the resident’s
immediate care and ensure that each
resident receives care for his or her
specific needs until a comprehensive
assessment and care planning can be
completed.
We also propose to add a new
§ 483.30(e) to require that a facility,
prior to an unscheduled transfer of a
resident to a hospital, provide or arrange
for an in-person evaluation of a resident,
to be conducted expeditiously, by a
physician, a physician assistant, nurse
practitioner, or clinical nurse specialist
prior to transferring the resident to a
hospital, unless the transfer is emergent
and obtaining the in-person evaluation
would endanger the health or safety of
the individual or unreasonably delay
the transfer. This requirement, in
concert with proposals to improve
transitions of care, communications
among and between practitioners,
appropriate exchange of information,
and quality assessment activities, will
help ensure that the decision to transfer
a resident to an acute care facility is
made on the basis of a clinical
assessment and the best evidence
available. Physicians are already
required under § 483.12(a)(3) to
document in the medical record when a
resident is discharged or transferred as
a result of the facility’s inability to meet
the needs of the resident. However, an
evaluation of a resident by a physician,
a physician assistant, a nurse
practitioner, or a clinical nurse
specialist prior to a resident’s transfer
may identify options that could allow
for the resident to be treated in place
and avoid an unnecessary
hospitalization. Additionally, in the
event the resident needs to be
transferred, the evaluation would
provide valuable assessment
information for the receiving facility.
At § 483.30(f)(2), we propose to
provide the physician with the
flexibility to delegate to a qualified
dietitian or other clinically qualified
nutrition professional the task of writing
dietary orders, to the extent the dietitian
or other clinically qualified nutrition
professional is permitted to do so under
state law. We believe this flexibility is
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beneficial to both the physician and the
resident and is consistent with the
training and experience of qualified
dietitians and other clinically qualified
nutrition professionals, as discussed
below in section II. P. of this preamble,
‘‘Food and Nutrition Services.’’
Similarly, at § 483.30(f)(3), we
propose to provide the physician with
the flexibility to delegate to a qualified
therapist under proposed § 483.65
below the task of writing therapy orders,
to the extent that the therapist is
permitted to do so under state law. We
believe this flexibility is beneficial to
both the physician and the resident,
allowing the physician to determine
how to best use his or her time and
allowing the resident to have more
frequent adjustments to therapy as his
or her condition or abilities change.
Furthermore, we believe this is
consistent with the training and
experience of qualified therapists acting
in accordance with their state scope of
practice acts. Moreover, we believe
therapists already write therapy orders
that are routinely endorsed by a
physician without change.
K. Nursing Services (§ 483.35)
Under the proposed reorganization,
requirements for nursing services
currently located at § 483.30 would be
located at proposed § 483.35. The
current regulations at § 483.30 address
certain aspects of nursing home staffing
but leave gaps related to a number of
areas such as the competencies of
licensed nurses and the need to take
into account resident acuity. Since the
promulgation of the original regulations,
state requirements and industry
standards, as well as research, literature
and related policy in other healthcare
settings regarding nursing home staffing
have all evolved. Issues such as nursing
home administrator standards,
minimum nurse staffing standards,
requirements related to specialized
personnel such as dietitians,
pharmacists, therapists and
practitioners with behavioral health
and/or geriatric training/experience as
well as utilization of nurse practitioners,
clinical nurse specialists, and physician
assistants have all been raised as
concerns or options to address care and
services provided in the LTC setting.
We are aware of long-standing interest
in increasing the required hours of
nurse staffing per day. We have heard
suggestions that we impose a minimum
number of hours per resident day or
require a RN to be on site 24 hours a day
7 days a week. Existing regulations at
§ 483.30 mirror the statutory language at
sections 1819(b)(4)(C)(i) and
1919(b)(4)(C)(i) of the Act requiring
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(with certain exceptions) an RN
providing services in a facility 8
consecutive hours a day, 7 days a week,
licensed nurses 24 hours a day and
‘‘sufficient staff’’ to meet residents’
needs. We may also waive the nurse
staffing requirements in specific
circumstances.
There is abundant research that
associates increased RN staffing with
improved quality of care. Rather than
specify how many nurses must be on
duty, most focus on the number of hours
of nursing care a resident must receive
to achieve certain quality objectives. A
2001 DHHS Report to Congress provides
substantial information about potential
minimum requirements, although it
stops short of making a
recommendation. A 2011 study by Zhao
and Haley demonstrated that higher RN
staffing hours per resident day was
associated with significantly lower
malpractice paid-losses and higher NA
hours per resident day was found to be
related to higher malpractice paidlosses. At least one study notes that the
relationship is not necessarily linear—
that is, it takes more resources to
achieve a certain level of improvement,
but beyond that the improvement slows.
(Zhang, Unruh, Liu, and Wan, 2006.
‘‘Minimum Nurse Staffing Ratios for
Nursing Homes.’’
CMS’s own study reported that
facilities with staffing levels below 4.1
hours per resident day (HRPD) for long
stay residents may provide care that
results in harm and jeopardy to
residents (Appropriateness of Minimum
Nurse Staffing Ratios in Nursing Homes,
Phase II Final Report, 2001, Abt
Associates). A study by Schnelle and
colleagues (2004) also supports a
threshold level of 4.1 total nursing
hours per resident day to ensure that the
processes of nursing care are adequate
(Nursing Facilities, Staffing, Residents,
and Facility Deficiencies, 2005–2010.
Charlene Harrington, Ph.D.; Helen
Carrillo, M.S.; Megan Dowdell, M.A.;
Paul P. Tang, B.S.; Brandee Woleslagle
Blank, M.A.). A staffing level of 4.1
hours per resident day is the most
common number put forward as a
minimum standard. However, the
conclusions in the 2001 Abt Associates
study previously cited were rejected by
the then Secretary of HHS due to
‘‘serious reservations about the
reliability of staffing data at the nursing
home level.’’ Based on existing data,
according to the Centers for Disease
Control’s National Center for Health
Statistics National Study of Long-Term
Care Providers (2013), the average hours
of nursing care per resident per day for
nursing homes is 3.83 (.52 RN, .85 LPN
or LVN, and 2.46 Aide) plus an
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additional .08 hours of Social Worker
time. This does not include therapist
time, although virtually all nursing
homes (99.3%) offer therapeutic
services and therapeutic services are
critical to helping residents ‘attain or
maintain the highest practicable
physical, mental, and psychosocial
well-being’—in order for a facility to
achieve its statutory mandate that a
nursing facility provide services and
activities to attain or maintain the
highest practicable physical, mental,
and psychosocial well-being of each
resident.’’ (see sections 1819(b)(2)
and1919(b)(2) of the Act). However, as
a result of section 1128I of the Act, as
added by the ACA, CMS is currently
developing systems to collect staffing
information that is auditable back to
payroll data. Once implemented, this
new system is expected to increase
accuracy and timeliness of data. When
this improved staffing data is collected
at the nursing home level, more accurate
and reliable estimates of the care hours
provided by staff categories will be
available, potentially leading to updated
research and reconsideration of HPRD
requirements and recommendations.
An alternative approach to mandating
a specific number of hours per resident
day is to mandate the presence of a
registered nurse in a nursing home for
more hours per day than is currently
required, potentially 24 hours a day 7
days a week, subject to the statutory
waiver. We note that a number of states
already require this. Increased presence
of RNs in nursing facilities would
address several issues. First, greater RN
presence has been associated in research
literature with higher quality of care and
fewer deficiencies. Second, it has been
reported in the literature that LPNs or
LVNs may find themselves practicing
outside of their scope of practice
because, at least in part, there are not
enough RNs providing direct patient
care. Increasing the number of hours a
day that an LTC facility must have RNs
in the nursing home would alleviate this
issue. While imposing a mandate for
more RNs raises concerns about the
adequacy of the supply of registered
nurses, a December 2014 HRSA report
on the future of the nursing workforce
suggests that growth in RN supply will
actually outpace demand in the period
between 2012 and 2025 (U.S.
Department of Health and Human
Services. ‘‘The Future of the Nursing
Workforce: National- and State-Level
Projections, 2012–2025.’’ Health
Resources and Services Administration,
Bureau of Health Workforce, National
Center for Health Workforce Analysis.
(December 2014)). The study notes that
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the national projections mask a
distributional imbalance of RNs at the
state level and that there is considerable
variation in the geographic distribution
of the growth in RN supply. Sixteen
states are projected to have a shortage by
2025, particularly Arizona, Colorado,
and North Carolina (https://
bhpr.hrsa.gov/healthworkforce/
supplydemand/nursing/
workforceprojections/
nursingprojections.pdf). In looking at
the employment of registered nurses in
nursing homes, the BLS reported in its
May 2012 Occupational Employment
Statistics (https://www.bls.gov/oes/2012/
may/oes291141.htm) that 139,440
registered nurses were employed in
nursing care facilities (skilled nursing
facilities); in the May 2014
Occupational Employment Statistics
(https://www.bls.gov/oes/current/
oes291141.htm) that number has risen
to 148,970. At the same time, the
number of nursing homes has decreased
somewhat from 15,844 based on FY
2012 to 15,691 in 2015, based on
CASPER data.
Perhaps somewhat contrary to much
of the discussion and literature, a 2011
review of the literature on nurse staffing
and quality of care raises questions
about the direct cause and effect
relationship between the nursing
workforce and quality of care.
Specifically, the authors conclude that
‘‘A focus on numbers of nurses fails to
address the influence of other staffing
factors (for example, turnover and
agency staff use), training and
experience of staff, and care
organization and management.’’ They
note that the studies they reviewed
presented 42 measures of quality and 52
ways of measuring staffing. They also
note that it is ‘‘difficult to offer
conclusions and recommendations
about nurse staffing based on the
existing research evidence.’’ (Spilsbury,
Hewitt, Stirk and Bowman ‘‘The
relationship between nurse staffing and
quality of care in nursing homes: a
systematic review’’ The International
Journal of Nursing Studies 48(2011)732–
750.) An October 2011 research article
by John R. Bowblis concludes that
minimum direct care staffing
requirements for nursing homes
‘‘change staffing levels and skill mix,
improve certain aspects of quality, but
can lead to use of care practices
associated with lower quality’’ (HSR:
Health Services Research 46:5 (2011)
1945). In short, there is concern that a
facility can have sufficient numbers of
staff, but if those staff do not have the
skills and competencies to do the
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necessary work, quality will not
improve.
While we believe that existing
requirements for sufficient staff need
further clarification, we do not believe
that we have sufficient information at
this time to require a specific number of
staff or hours of nursing care per
resident. Furthermore, we do not
necessarily agree that imposing such a
requirement is the best way to clarify
what is ‘‘sufficient’’ to the exclusion of
other factors that are important in
improving the quality of care for each
resident. The American Nurses
Association (ANA), in its 2012
Principles for Nurse Staffing, describe
appropriate nurse staffing as ‘‘a match of
registered nurse expertise with the
needs of the recipient of nursing care
services in the context of the practice
setting and situation.’’ The ANA further
notes that ‘‘staffing needs must be
determined based on an analysis of
healthcare consumer status (for
example, degree of stability, intensity,
and acuity), and the environment in
which the care is provided. Other
considerations to be included are:
professional characteristics, skill set,
and mix of the staff and previous
staffing patterns that have been shown
to improve outcomes. The International
Council of Nurses (ICN) included
similar considerations in its 2012
statement of principles of safe staffing
levels (https://www.icn.ch/images/
stories/documents/pillars/sew/ICHRN/
Policy_Statements/Policy_statement_
Safe_staffing_levels.pdf). The ICN
policy statement includes as one of its
key principles that ‘‘safe staffing levels
must reflect the skills, experience and
knowledge required to meet patient care
needs, taking acuity levels into
account.’’ A second key principle states
that safe staffing ‘‘involves a range of
factors including (but not limited to) a
sufficient number of staff available, an
appropriate level and mix of skills, a
manageable workload of both teams and
individuals; . . .’’. We agree. We believe
that the focus should be on the skill sets
and specific competencies of assigned
staff to provide the nursing care a
resident needs rather than a static
number of staff or hours of nursing care
that does not consider resident
characteristics such as stability,
intensity and acuity and staffing
abilities including professional
characteristics, skill sets and staff mix.
We are concerned that establishing a
specific number of staff or hours of
nursing care could result in staffing to
that number rather than to the needs of
the resident population. A competencybased staffing approach would require
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the facility to evaluate its population
and its resources in accordance with
proposed § 483.70(e), including the
number and acuity of the residents, the
range of diagnoses and resident needs
and the training, experience, and skill
sets of staff, and base staffing plans and
assignments on these assessments. This
would include, but not be limited to,
allocating the appropriate number of
competent staff to a care situation.
Based on evolving demographic shifts
and staffing patterns, we believe a
competency based approach will help to
maintain flexibility in facility staffing
and capability. Our intent is to require
facilities to make thoughtful, informed
staffing plans and decisions that are
focused on meeting resident needs,
including maintaining or improving
resident function and quality of life. We
maintain that such an approach is
essential to person-centered care. We
considered combining this approach
with a minimum staffing requirement.
Options included establishing minimum
nurse hours per resident day,
establishing minimum nurse to resident
ratios, requiring that an RN be present
in every facility either 24 hours a day
or 16 hours a day, and requiring that an
RN be on-call whenever an RN was not
present in the facility. We also
considered multiple combinations of
these option and note that states have
implemented a variety of these options.
We welcome comment on all of these
options. In particular, we are aware that
the IOM has recommended in several
reports that we require the presence of
at least one RN within every facility at
all times. We specifically invite
comments on the costs of mandating a
24 hour RN presence. We also invite
comment on the benefits of a mandatory
24 hour RN presence, including cost
savings and improved resident
outcomes, as well as any unintended
consequences of implementing this
requirement. We further welcome
evidence of appropriate thresholds for
minimum staffing requirements (for
both nurses and direct care workers)
and evidence of the actual cost of
implementing recommended thresholds,
including taking into account current
staffing levels as well as projected
savings from reduced hospitalizations
and other adverse events.
As noted earlier, current regulations
at § 483.30 mirror the statutory language
at sections 1819(b)(4)(C)(i) and
1919(b)(4)(C)(i) of the Act, requiring
(with certain exceptions) an RN
providing services in a facility 8
consecutive hours a day, 7 days a week,
licensed nurses 24 hours a day current
regulations and requiring the facility to
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have ‘‘sufficient’’ nursing staff. This
standard has been praised by some in
that it provides facilities with flexibility
to determine the level of staffing needed
in order to meet the needs of each
resident, based upon individual
assessments and plans of care. However,
the current standard has been criticized
by others who have found it lacking
sufficient clarity to indicate to facilities
what level of staffing is sufficient to
provide residents with even minimal
standards of care and quality of life. In
this proposed rule, we have proposed an
approach of a facility assessment
process, requiring facilities to determine
adequate staffing based on this
assessment, which includes but is not
limited to the number of residents,
resident acuity, range of diagnoses, and
the content of care plans. (proposed
§§ 483.35 and 483.70). We solicit
comments on whether this proposed
approach can reasonably be expected to
enable facilities to determine and
provide adequate levels of staffing to
meet the needs of each resident.
We recognize that many States have
developed minimum staffing levels of
CNAs in their nursing facility licensure
requirements. States have implemented
a variety of methods to address staffing
levels to best meet resident care and
quality of life needs. Some States have
implemented a CNA hours-per-residentday model (some include part or all of
the hours of licensed nurses into this
calculation). For example, Washington,
DC requires a minimum daily average of
4.1 hours of direct nursing care per
resident per day (with opportunity to
adjust the requirements above or below
this level, as determined by the Director
of Department of Health), an RN on site
24/7, plus additional nursing and
medical staffing requirements. https://
doh.dc.gov/sites/default/files/dc/sites/
doh/publication/attachments/Nursing_
Facility_Regulations_Health_Care_
Facilities_Improvement_2012.pdf.
Some States have implemented a ratio
of numbers of full-time equivalent CNAs
per resident. For example, Maine
requires no fewer than one direct care
provider for every five residents during
the day shift, one per ten in the evening,
and one per fifteen in the night.
Arkansas requires no less than one
direct care provider for every six
residents during the day shift, one per
nine in the evening, and one per
fourteen in the night, plus requirements
for minimum numbers of licensed
nurses per residents per shift. We solicit
comments on whether CMS should
consider adopting one of these or other
approaches in determining adequate
direct care staffing. We invite
information regarding research on these
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approaches which indicate an
association of a particular approach or
approaches and the quality of care and/
or quality of life outcomes experienced
by resident, as well as any efficiencies
that might be realized through such
approaches.
States have found that requirements
for increased staffing levels resulted in
improved resident care outcomes and
decreased deficiencies. For example,
after increasing its nurse staffing levels,
Florida found ‘‘evidence that quality of
care has substantially improved in
Florida nursing homes since the
introduction of increased nurse staffing
levels and other quality standards since
2001. Average deficiencies per facility
have decreased. Importantly, the
citations for the more serious
deficiencies have decreased
dramatically and remain lower than the
national average. Measures of resident
care outcomes have improved in 2007
after the new staffing standards of 2.9
hours per resident day were instituted.’’
Hyer, K. et al, (2009) University of
South Florida, Analyses on Outcomes of
Increased Nurse Staffing Policies in
Florida Nursing Homes: Staffing Levels,
Quality and Costs (2002–2007); i. At this
time, we have deferred deciding on any
potential specific requirement pending
evaluation of additional data that will
be collected on payroll based staffing
data.
We are proposing to revise the section
to incorporate language to require that
nursing service personnel have the
competencies and skill sets necessary to
provide nursing and related services to
assure the safety of residents and help
them to attain or maintain the highest
practicable physical, mental, and
psychosocial well-being. The facility
would have to take into account its
assessment of all residents as well as the
skill-sets of individual staff when
making staffing decisions. We also
propose revisions to improve the logical
order and readability of these regulatory
provisions.
We propose to include in the
introductory language of proposed
§ 483.35 ‘‘Nursing Services’’ the
requirement that, in addition to having
sufficient staff to provide nursing care to
each resident in accordance with his or
her care plan and individual needs, the
facility ensure that staff have
appropriate competencies and skill sets
to assure resident safety. We would also
require that the determination of what is
sufficient staff as well as the
determination of the necessary
competencies and skill sets take into
account the number, acuity and
diagnoses of the facility’s resident
population.
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We propose to clarify at
§ 483.35(a)(1)(ii) that nurse aides are
included in the term ‘‘other nursing
personnel.’’ Currently, a number of
provisions regarding nurse aides are
included in the regulatory provisions
under § 483.75 Administration. Nurse
aides provide much, if not most, of the
direct care provided in nursing facilities
and as a practical matter are managed
within most organizations by the
nursing services department in medical
models of care delivery. We include
nurse aides in proposed § 483.35 in
recognition of this fact and to ensure
clarity of our intent.
We propose to add § 483.35(a)(3) and
(4) to specify that the facility ensure that
licensed nurses have the competencies
and skill sets necessary to care for
residents’ needs, as identified through
resident assessments, and as described
in each resident’s individual plan of
care. We further propose to specify that
caring for a resident’s needs would
include but not be limited to assessing,
evaluating, planning and implementing
resident care plans and responding to
each resident’s needs. This continues
our focus on ensuring that not only are
there a sufficient number of staff in a
facility, but also that staff have the
necessary abilities, knowledge and
competencies to be effective and
efficient in carrying out the work
necessary to meet the needs of each
resident receiving care in the facility.
Consistent with our clarification that
nurse aides are included in the term
‘‘other nursing personnel,’’ we propose
to move most of the provisions relating
to nurse aides previously located in
§ 483.75 to proposed § 483.35.
Specifically, we propose to re-designate
§ 483.75(f) ‘‘Proficiency of Nurse Aides’’
as § 483.35(c). We propose to redesignate § 483.75(e) as § 483.35(d) and
re-title the provision as ‘‘Requirements
for Facility hiring and use of nursing
aides’’ to reflect its contents more
accurately. A proposed revision to the
definition of a nurse aide is included in
our proposed revisions to § 483.5 and is
included in our earlier discussion of
that section. The regulations at
proposed § 483.35(d)(2) are redesignated from § 483.75(e) and address
non-permanent employees Nonpermanent caregivers are expected to
meet competency, knowledge and skill
requirements to the same extent as
permanent personnel. These caregivers
may have less familiarity than
permanent staff with a facility’s
residents and processes. Therefore, this
must be considered when using,
orienting, and assigning non-permanent
staff. We also propose to add the term
‘‘minimum’’ to § 483.35(c)(3) to clarify
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that this paragraph identifies the
minimum requirements for hiring a
nurse aide. Meeting this minimum
standard does not automatically meet
the competency requirement specified
in § 483.35 that would be specific to the
needs of each individual resident.
L. Behavioral Health Services (§ 483.40)
Currently, § 483.25 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, in accordance
with the comprehensive assessment and
plan of care. We propose to add a new
section § 483.40 to address this
requirement as it relates to behavioral
health services.
Serious mental illness and cognitive
and/or functional impairment are strong
predictors of admission into a nursing
home. Although estimates vary, the
industry literature indicates that a large
number of nursing home residents have
a significant mental health disorder. In
2004, over 16 percent of nursing home
residents received a primary diagnosis
of a mental disorder upon admission
(Jones, Figure 7). By the time residents
were interviewed for the National
Nursing Home Survey that percentage
increased to almost 22 percent. The
1999 estimate was about 18 percent. In
addition, nursing homes are caring for a
significant number of patients with
dementia and depression. By 2012, over
48 percent of nursing home residents
had a diagnosis of Alzheimer’s disease
or another dementia and/or depression
(Harris-Kojetin, p. 35, Figure 23).
In a 2003 report, the OIG concluded
that not all residents of LTC facilities
receive the behavioral health services
they need. Additionally, there is
evidence that there is not full
compliance with the requirement to
provide medically-related social
services to attain or maintain the highest
practicable physical, mental and
psychosocial well-being of each resident
(‘‘Psychosocial Services in Skilled
Nursing Facilities,’’ Department of
Health and Human Services, Office of
the Inspector General, OEI–02–01–
00610, March 2003).
Given the prevalence of mental health
disorders and other cognitive
impairments and in order to achieve the
LTC requirements’ goal of the highest
practicable mental and psychosocial
well-being for each resident, it is critical
that LTC facilities ensure that
behavioral health issues are addressed.
Therefore, we propose to add a new
section § 483.40 to include requirements
for both behavioral health services and
for social workers. These provisions
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work in conjunction with other
provisions we propose, including those
related to reducing the inappropriate
use of psychotropic medications.
Currently, sections 1819(b)(7) and
1919(b)(7) of the Act require that a
facility with more than 120 beds employ
at least one social worker on a full-time
basis or assure the provision of social
services. However, all facilities are
required to provide the necessary care
and services to attain or maintain the
highest practicable physical, mental and
psychosocial well-being, in accordance
with the comprehensive assessment and
plan of care. Meeting one requirement
does not negate the need to meet other
requirements. In keeping with our
competency focus, we propose to
include in new § 483.40 requirements to
ensure that there are sufficient direct
care staff with the appropriate
competencies and skills to provide the
necessary care to residents with mental
illness and cognitive impairment. The
needed competencies and skill sets
include knowledge and training,
including non-pharmacologic
interventions, necessary to provide the
care for residents with mental illnesses
and psychosocial disorders. Thus, LTC
facilities would be required to have the
staff, including social workers,
necessary to provide the social services
needed by their residents.
We propose, in § 483.40(a) to require
that the facility have sufficient direct
care staff with the appropriate
competencies and skills sets to provide
nursing and related services to assure
resident safety and attain or maintain
the highest practicable physical, mental,
and psychosocial well-being of each
resident, as determined by resident
assessments and individual plans of
care and considering the number, acuity
and diagnoses of the facility’s resident
population in accordance with the
facility assessment required at proposed
§ 483.70(e). Necessary competencies and
skills include knowledge of and
appropriate training and supervision for
caring for residents with the mental
illness and psychosocial or adjustment
problems as well as residents with a
history of trauma and/or post-traumatic
stress disorder that have been identified
in the facility assessment. Furthermore,
staff must be trained in implementing
non-pharmacological interventions. We
propose to specify in new paragraph (b)
that, based on the comprehensive
assessment of a resident, the facility
must ensure that a resident who
displays or is diagnosed with mental or
psychosocial adjustment difficulty
receives appropriate treatment and
services to correct the assessed problem
or to attain the highest practicable
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mental health and psychosocial wellbeing. In addition, we propose to
specify that a resident whose
assessment does not reveal or who does
not have a diagnosis of a mental illness
or psychosocial adjustment difficulty
will not display a pattern of decreased
social interaction and/or increased
withdrawn, angry, or depressive
behaviors, unless the resident’s clinical
condition demonstrates that the pattern
was unavoidable. Furthermore, if
rehabilitative services such as physical
therapy, speech-language pathology,
occupational therapy, and rehabilitative
services for mental illness and
intellectual disability are required in the
resident’s comprehensive plan of care,
the facility must provide the required
services, including specialized
rehabilitation services as required in
§ 483.45; or obtain the required services
from an outside provider of specialized
rehabilitative services in accordance
with proposed § 483.75(g).
We encourage facilities to take
advantage of the many tools and
resources available to them for free or at
low cost. Facilities may also contact
CMS staff at dnh_behavioralhealth@
cms.hhs.gov, to be put in touch with
state coalition leads and state-level
resources.
M. Pharmacy Services (§ 483.45)
Currently, the LTC requirements
require that each resident’s drug
regimen be reviewed by a pharmacist at
least once a month (§ 483.60(c)). Based
on our experience with LTC facilities,
some pharmacists review the medical
chart for each resident when they
perform the drug regimen review, and
others simply review the medication
administration record (MAR).
We believe that there are specific
circumstances under which the
pharmacist must at least periodically
review the resident’s medical record
concurrently with the drug regimen
review. Those circumstances include
transitions in care, specifically when the
resident is new to the facility or is
returning or being transferred from
another facility. We also believe it is
critical when a resident is on a
psychotropic or antimicrobial
medication. In addition, we propose
specific requirements related to the use
of psychotropic drugs, § 483.45(e), and
antibiotics, § 483.80(a)(2). We believe
having the pharmacist review residents’
medical charts when these medications
are prescribed would not only assist the
pharmacist in detecting irregularities
related to these drugs but also enhance
or contribute to the goal of ensuring that
these medications are used only when
medically appropriate for the resident.
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We also believe that the pharmacist’s
review could contribute to our proposed
requirements for infection control and
antibiotic stewardship. By reviewing the
resident’s medical chart, the pharmacist
could review whether an infection or
communicable disease has been
documented in the chart, whether the
antibiotic is usually prescribed for that
condition, and whether it has been
prescribed for the recommended length
of time. To maximize the effectiveness
of this review, we would recommend
that the pharmacist be familiar with the
facility’s antibiotic use protocols and its
system for monitoring antibiotic use.
Thus, we propose that a pharmacist be
required to review the resident’s
medical record coincident with the drug
regimen review when—(1) the resident
is new to the facility; (2) a prior resident
returns or is transferred from a hospital
or other facility; and (3) during each
monthly drug regimen review when the
resident has been prescribed or is taking
a psychotropic drug, an antibiotic, or
any drug the QAA Committee has
requested be included in the
pharmacist’s monthly drug review. We
are proposing the last criteria to give
each facility’s QAA Committee the
ability to request that certain drugs
receive more scrutiny during the
monthly drug regiment review. For
example, anticoagulants and
antidiabetic medications have been
identified as being related to adverse
events related to medications in SNFs
(Adverse Events in Skilled Nursing
Facilities: National Incidence Among
Medicare Beneficiaries. Office of
Evaluations and Inspections, Report
OEI–06–11–00370. Office of Inspector
General, Department of Health & Human
Services. (2014)). Our proposal would
give the facility’s QAA Committee the
ability to add specific drugs or drug
categories that need additional scrutiny
so that those residents on those drugs
would have their medical record
reviewed by a pharmacist as part of the
monthly drug review. In addition, we
encourage the QAA Committee to
collaborate with the pharmacist to
enhance the committee’s understanding
and oversight of the facility’s
pharmaceutical practices, especially
concerning the use of psychotropic
drugs and its antibiotic stewardship, as
well as their QAPI activities.
The current LTC requirements at
§ 483.25(l)(2) also specifically identify
antipsychotic drugs and provide
specific safeguards for their use. Section
483.25(l)(2)(i) requires that residents
who have not previously been
prescribed antipsychotics not be given
them unless the medication is necessary
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to treat a specific condition as
diagnosed and documented in the
clinical record. Also, § 483.25(l)(2)(ii)
requires that residents taking
antipsychotics should receive gradual
dose reductions, and behavioral
interventions, unless clinically
contraindicated, in an effort to
discontinue use of these drugs. In this
proposed rule, we are moving this
requirement to § 483.45(e).
Antipsychotics are a particular
concern for residents. These drugs have
serious side effects and can be
especially dangerous for the elderly.
Since the LTC requirements became
effective in 1992, there has been a
reduction in the number of
antipsychotics prescribed to residents.
However, we are concerned that as the
use of antipsychotic drugs has
decreased, the use of other psychotropic
medications has increased. Therefore,
we propose to expand the drugs to
which proposed § 483.45(e) applies to
include all psychotropic medications. In
conducting our research into a
definition for psychotropic medications,
we discovered different definitions. We
are proposing to use the definition used
in the November 2001 OIG report,
‘‘Psychotropic Drug Use in Nursing
Homes’’ (OEI–02–00–00490), which is
that they are drugs that affect brain
activities associated with mental
processes and behavior. These drugs
include, but are not limited to, drugs in
the following categories: (1) Antipsychotic, (2) anti-depressant, (3) antianxiety, (4) hypnotic, (5) opioid
analgesic, and (6) any other drug that
results in effects similar to the drugs
listed above. We are proposing the last
category, ‘‘(6) any other drug that results
in effects similar to the drugs listed
above,’’ to address other medications.
We are also specifically soliciting
comments on this definition and the
types of drugs that should be included.
In addition, we are concerned about
the PRN use of psychotropic
medications. A PRN order is often used
to titrate or adjust the dosage of a
psychotropic medication until an
appropriate therapeutic dose is
determined for the resident. However,
we have received reports that some
residents remain on PRN orders for
psychotropic medications for extended
periods of time. Therefore, we are
proposing that LTC facilities ensure that
residents do not receive psychotropic
drugs pursuant to a PRN order unless
that medication is necessary to treat a
diagnosed specific condition that is
documented in the clinical record. In
addition, every PRN order for a
psychotropic drug is limited to 48 hours
and cannot be continued beyond that
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time unless the resident’s primary care
provider, for example, his or her
physician, documents the justification
for this continuation in the resident’s
clinical record. We would also
appreciate comments on the use of PRN
orders for these medications and our
proposal to limit PRN prescriptions for
these drugs to 48 hours unless the
resident’s primary care provider
provides a rationale for the continuation
of the PRN order in the resident’s
clinical record.
The current LTC requirements also
require the pharmacist conducting the
monthly drug regimen review must
report any irregularities to the attending
physician and the director of nursing.
The term ‘‘irregularities’’ is not defined
in the regulation and no examples are
given. We propose to define
‘‘irregularities’’ to include, but not be
limited to, the use of any drug that
meets the criteria set forth in proposed
paragraph (d) for an unnecessary drug.
In addition, we propose to require that
the pharmacist performing the monthly
drug regimen review must report any
‘‘irregularities’’ to the attending
physician and the facility’s medical
director and the director of nursing, and
that these reports must be acted upon
(re-designated in proposed
§ 483.45(c)(4)). However, it does not
indicate how the pharmacist is to notify
these individuals or how to ascertain if
the report was acted upon. Based on our
experience with facilities, this reporting
of irregularities has been communicated
in different ways, including by simply
making a note in the resident’s medical
chart that the drug will be continued as
ordered. We are concerned that the
pharmacist’s report of irregularities may
not be given the appropriate review and
consideration that is merited. Therefore,
we propose that the medical director be
added to the individuals who should be
notified of irregularities in residents’
drug regimens. We also propose that the
pharmacist create a written report that
is dated, and contains, at a minimum,
the resident’s name, the relevant drug,
and the irregularity the pharmacist
noted. We are not proposing the manner
in which this report is developed or
transmitted because we want nursing
homes to have the flexibility to comply
with this proposed requirement in the
most efficient manner considering their
circumstances. For example, for many
nursing homes, the facility may develop
an electronic form that the pharmacist
can fill out on-line as he or she is
performing the reviews and prepopulating the emails to which the form
is to be sent to include, at a minimum,
the attending physician, medical
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director, and director of nursing. Other
nursing homes may need to develop a
paper form and ensure that copies are
transmitted to the appropriate
individuals. To ensure that the reported
irregularities are acted upon, we are also
proposing that the attending physician
must document in the resident’s
medical record that the identified
irregularity has been reviewed and
what, if any, action has been taken to
address it. If there is to be no change in
the medication, the attending physician
should document his or her rationale in
the resident’s medical record.
The current description of
‘‘unnecessary drugs’’ and the specific
requirements for antipsychotic drugs are
set forth in § 483.25(l)(1) and (2),
respectively, under the ‘‘Quality of
Care’’ condition of participation.
Furthermore, the requirements for the
facility to maintain a medication error
rate of no greater than 5 percent and to
keep residents free of any significant
medication errors is set forth in current
§ 483.25(m). After reviewing the existing
provisions, we believe that these
requirements should be relocated from
§ 483.25 ‘‘Quality of Care’’ to proposed
§ 483.45 ‘‘Pharmacy services.’’ All of
these requirements are concerned with
medications and medication errors.
Although medication errors and
unnecessary drugs are clearly part of the
quality of care that residents receive, we
believe it is more appropriate and
logical to relocate these requirements
under the general section at proposed to
§ 483.45, ‘‘Pharmacy Services.’’ This
relocation should make it easier for
individuals to locate the requirements
concerning medications since they will
all be set forth in the pharmacy services
section.
We want to emphasize that the
proposed requirements concerning
psychotropic medications are not
intended to have a chilling effect or in
any manner discourage the prescription
or use of any medication intended for
the benefit of a resident who has been
diagnosed for a specific condition that
requires these medications. Our
proposed requirements are intended to
protect nursing home residents from
drugs that are not being prescribed for
their benefit. Our proposed
requirements for gradual drug
reductions, if not clinically
contraindicated, and for behavioral
interventions are intended to reduce or,
if possible, eliminate the need for these
medications. Likewise, our proposed
requirement for a 48 hour limitation on
PRN orders for psychotropic
medications is intended to safeguard the
resident’s health. We are concerned
about reports that PRN orders for these
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drugs may remain in effect for an
extended time without being reviewed
by the resident’s physician or primary
care provider. These proposed
requirements are completely in
alignment with the concepts and
requirements of person-center care and
the requirement that residents receive
the necessary behavioral health care and
services to attain or maintain the highest
practicable physical, mental, and
psychosocial well-being, in accordance
with the comprehensive assessment and
plan of care (Proposed §§ 483.21 and
483.40). Therefore, we do not believe
these proposed requirements should
discourage the use of psychotropic
medications when these drugs are
required for the resident’s benefit.
N. Laboratory, Radiology, and Other
Diagnostic Services (§ 483.50)
Currently, § 483.75(j) sets forth
requirements regarding laboratory
services and § 483.75(k) sets forth
requirements for radiology and other
diagnostic services that a facility must
provide or obtain to meet the needs of
its residents. These regulations are
currently located in § 483.75
‘‘Administration,’’ which largely focuses
on the manner in which a facility must
operate to provide quality care to its
residents. In an effort to improve the
readability of our regulations and follow
our proposed reorganization of subpart
B, we propose to relocate and redesignate both § 483.75(j) and
§ 483.75(k) to a new proposed § 483.50
entitled, ‘‘Laboratory, Radiology, and
Other Diagnostic Services.’’ This
proposed new section would include all
of the content from current § 483.75(j)
and § 483.75(k) relocated to § 483.50(a)
and § 483.50(b), respectively. We
propose to retain the existing
requirements with some revisions as
discussed in detail below.
Current § 483.75(j)(a)(2)(i) and
§ 485.75(k)(2)(i), require that a facility
must provide or obtain laboratory and
radiology and other diagnostic services
‘‘only when ordered by the attending
physician.’’ We propose to clarify these
requirements by removing the phrase,
‘‘the attending physician’’ and replacing
it with ‘‘a physician, a physician
assistant, nurse practitioner, or clinical
nurse specialist.’’ The revised
requirements would be located at
proposed § 483.50(a)(2)(i) and (b)(2)(i),
respectively. Furthermore, we would
allow for these orders only if the
practitioners are acting in accordance
with state law, including scope of
practice laws and facility policy. We
believe that this proposal reflects
current practice models and recognizes
the importance of non-physician
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practitioners in LTC facilities. These
revisions would also increase access to
care by avoiding possible delays in
treatment of residents as well as
eliminate burden to attending
physicians by clarifying the services
that non-physician practitioners can
provide.
Additionally, current § 483.75(j)(2)(ii)
and (k)(2)(ii) require that facilities
‘‘promptly notify the attending
physician of the findings’’ once
laboratory results have been obtained.
We are sympathetic to stakeholder
concerns regarding the potential for
disruption that notification of attending
physicians for nonemergency results or
findings could cause. Therefore, we are
proposing to allow increased flexibility
under this requirement to provide that
other practitioners have the ability to
receive laboratory and radiology and
other diagnostic results if these
practitioners ordered the tests.
Specifically, we propose to revise
§ 483.50(a)(2)(ii) to permit that the
ordering physician, physician assistant,
nurse practitioner, or clinical nurse
specialist to be notified of laboratory
results. In addition, we propose in
§ 483.50(a)(2)(ii) to clarify that the
laboratory must promptly notify the
ordering professional if results fall
outside of clinical reference or expected
‘‘normal’’ ranges, unless the orders for
the test or the facility’s policies and
procedures require otherwise. While we
want to ensure that the lab notifies the
appropriate professional, we also want
to reduce unnecessary notification of
staff. We believe this revision would
improve the notification process,
therefore saving time and reducing
burden, while still ensuring resident
safety.
We received a comment from
stakeholders requesting that we revise
the regulations to explicitly state that
laboratory and diagnostic services be
provided or obtained from ‘‘a certified
or accredited company.’’ Current
§ 483.75(j)(1)(i) (now re-designated in
proposed § 483.50(a)(1)(i)), provides that
laboratory services provided in a facility
are subject to the requirements set forth
in 42 CFR part 493 under the Clinical
Laboratory Improvement Amendment
(CLIA). Part 493 sets forth the
conditions that all laboratories must
meet to be certified to perform testing
on human specimens. In addition,
current § 483.75(k)(1)(i) specifies that if
a facility provides its own diagnostic
services, the services must meet the
requirements set forth in § 482.26.
Section 482.26 sets forth the conditions
of participation that a hospital must
meet to provide diagnostic radiologic
services including staff qualifications.
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Similarly, current § 483.75(k)(ii)
specifies that if the facility does not
provide its own diagnostic services, it
must have an agreement to obtain the
services from a provider or supplier that
is approved to provide the services
under Medicare. We believe that the
current requirements for laboratory and
diagnostic services to be furnished by
qualified laboratories and facilities are
sufficient, and are proposing to retain it
without change.
O. Dental Services (§ 483.55)
Under the proposed reorganization,
requirements regarding dental services
would remain at § 483.55. Section
1862(a)(12) of the Act states, in part,
that Medicare will not cover dental
services such as the care, treatment,
filling, removal, or replacement of teeth
or structures directly supporting teeth.
State plans vary in their coverage of
dental services. However, both sections
1819(b)(4)(A)(vi) and 1919(b)(4)(A)(vi)
of the Act include requirements related
to the provision of dental services. We
recognize that dental care supports the
overall well-being of all facility
residents. Currently, § 483.55 requires
that facilities assist residents in
obtaining appropriate dental services at
the resident’s expense for SNF residents
and as covered under the state plan for
NF residents.
We propose limited changes to update
and clarify this section. First, we
propose to add a new § 483.55(a)(3) to
clarify that a facility may not charge a
resident for the loss of or damage to
dentures when the loss or damage is the
responsibility of the facility. We
considered, but are not specifying in
this proposed rule, the circumstances
under which a facility is responsible,
believing that facilities already make
this determination, but we do specify
that the determination must be made
pursuant to facility policy. We welcome
comment on this issue. Second, we
propose to re-designate existing
§ 483.55(a)(3) as § 483.55(a)(4) and
revise § 483.55(a)(4) by adding the
phrase ‘‘or if requested’’ to clarify that
if a resident asks for assistance in
scheduling a dental appointment, the
facility would be required to provide the
assistance. Third, we propose to modify
the section by adding language at new
§ 483.55(a)(4)(ii) and § 483.55(a)(5)
regarding transportation and referrals
for dental services. We note that
facilities could comply with these
provisions by referring and transporting
residents to a dental clinic or dental
school rather than a dentist’s office. We
also understand that in some facilities,
dental services are provided in the
facility. In these instances, the facility
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would be in compliance with these
provisions by assisting resident access
to the dental office within the facility.
Finally, we propose to re-designate
§ 483.55(a)(4) as § 483.55(a)(5) and
would require that referral for dental
services occur in 3 business days or less
from the time the loss or damage to
dentures is identified unless the facility
can provide documentation of
extenuating circumstances that resulted
in the delay. We believe that it is
imperative that the loss or damage is
addressed and corrected quickly to
avoid adverse consequences such as
weight loss. We propose to make the
same changes at § 483.55(b)(2) and
§ 483.55(b)(3) to apply to nursing
facilities and add a new § 483.55(b)(4) to
require that facilities assist residents to
apply for reimbursement of dental
services as an incurred medical expense
under the state plan as appropriate.
P. Food and Nutrition Services
(§ 483.60)
Dietary standards for residents of LTC
facilities are critical to both quality of
care and quality of life. An August 2011
report by the Pioneer Network Food and
Dining Clinical Standards Task Force
notes research by Simmons and others
(Simmons SF, Lim B & Schnelle JF.
(2002). Accuracy of Minimum Data Set
in identifying residents at risk for
undernutrition: Oral intake and food
complaints. Journal of the American
Medical Directors’ Association, 3(May/
June):140-145) that 50 to 70 percent of
residents leave 25 percent or more of
their food uneaten at most meals and
that documentation by facility staff on
food consumption is inaccurate. A 2005
position paper by the American Dietetic
Association suggests that malnutrition is
one of the most serious problems in LTC
and is associated with poor outcomes
(https://
www.journals.elsevierhealth.com/
periodicals/yjada/article/S00028223(05)01742-6/fulltext). Malnutrition,
protein-energy under nutrition (PEU),
and dehydration can have a deleterious
cascade effect on residents, resulting in
a downward spiral of declining
physical, mental and psychosocial wellbeing. An earlier (2000) report
sponsored by the Commonwealth Fund
stated that between 35 percent and 85
percent of nursing home residents are
malnourished and between 3 percent
and 50 percent are substandard in
bodyweight (https://www.common
wealthfund.org/∼/media/Files/
Publications/Fund%20Report/2000/Jul/
Malnutrition%20and%20
Dehydration%20in%20Nursing%
20Homes%20%20Key%20Issues%
20in%20Prevention%20and%20
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Treatment/burger_mal_386%20pdf.pdf).
Thus, in considering requirements for
food and nutrition services in facilities,
we seek to establish minimum health
and safety standards that support the
nutritional well-being of all nursing
home residents while respecting each
resident’s right to make informed
choices about his or her care, including
decisions about diet. Given the diversity
of nursing home residents, it may be
challenging for facilities to meet every
resident’s individual preferences every
time; however, we believe by
incorporating a facility assessment,
along with individual assessments,
more can be done to ensure residents
are offered meaningful choices in diets
that are nutritionally adequate and
satisfying to the individual. At the same
time, we do not intend to require a
facility to provide on an ongoing basis
a diet that would be impractical or
financially unreasonable. Therefore, we
propose revisions described below
consistent with our goals to provide
flexibility for the facility while
enhancing resident choice. We believe
that this will lead to overall
improvement in the nutritional status of
nursing home residents.
It is not enough; however, to ensure
that residents have choices in what they
eat. Many nursing home residents have
other barriers to eating, including dental
issues, medical issues, medicationrelated issues, physical limitations and
the need for proper positioning and
assistance at mealtimes. With so many
issues facing nursing home residents,
adequate nutrition requires both an
understanding of the facility’s
population as a whole and an
interdisciplinary approach for each
resident. This includes ensuring that
sufficient staff are available and have
the appropriate skill sets, competencies,
and training to assess and plan an
overall facility dietary program as well
as assess and assist individual residents
at meals and with snacks. Some
individual residents may require
assistance to get to a dining area or to
sit up in a comfortable position
conducive to eating. Other residents
may require the correct application and
set up of assistive devices or may need
an individual to sit with them and
actively assist them throughout the
meal. Thus, our proposed revisions
include person-centered requirements
that are outcome focused and intended
to ensure each resident is provided, in
a dignified manner, the nutritional and
dietary care and services needed to meet
the statutory goal of attaining or
maintaining his or her highest
practicable mental, physical and
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psychosocial well-being. We propose to
revise this section as follows:
We propose to re-designate existing
§ 483.35 ‘‘Dietary Services’’ as new
proposed § 483.60 ‘‘Food and Nutrition
Services’’ and revise the introductory
language to include taking resident
preferences into consideration. We
propose to revise § 483.60(a) to require
that the facility employ sufficient staff
with the appropriate competencies and
skills sets to carry out the functions of
the food and nutrition service, taking
into consideration resident assessments,
individual plans of care and the
number, acuity and diagnoses of the
facility’s resident population.
In proposed § 483.60(a)(1) we would
retain the requirement that a facility
employ a qualified dietitian on a fulltime, part-time or consultant basis and
update the requirements to be
considered a qualified dietitian. The
role of the dietitian is critical in the
delivery of food and nutrition services.
Dietitians are part of the
interdisciplinary team and play a
significant role, working with other
clinicians, to treat wounds, weight-gain
or -loss, protein malnutrition,
dehydration, and nutrition-related
chronic diseases such as diabetes,
congestive heart failure and chronic
obstructive pulmonary disease. The
dietitian is the subject-matter expert for
making person-centered
recommendations to ensure the
nutritional well-being of each resident.
In addition to individual evaluations,
the dietitian plays a vital role in
developing the nursing home’s overall
menus. This means the dietitian must
understand the general and individual
needs of the population of the nursing
home, encompassing not just minimum
nutritional needs, but also diversity and
cultural variety of the residents and
work with the director of food service to
craft menus to serve the facility
population. Finally, the dietitian plays a
role in managing and monitoring the
dietary staff and food quality, including
nutritional standards, food service
standards, and infection control
standards. In order to ensure the highest
level of expertise to meet these
requirements, we are proposing to
require minimum qualifications for
dietitians working in SNFs or NFs. We
propose to require that a qualified
dietitian must either be registered by the
Commission on Dietetic Registration of
the Academy of Nutrition and Dietetics,
or be recognized (licensed or certified)
by the state in which the SNF or NF
operates as a dietitian or clinically
qualified nutrition professionals.
Currently, five states (AZ, CA, CO, NJ,
and VA) do not license or certify
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dietitians. We note that the California
State Personnel Board requires valid
certificate of registration with the
Commission on Dietetic Registration of
the American Dietetic Association to
qualify for state employment in various
dietetic positions. We would allow for
the retention of dietitians hired or
contracted prior to the effective dates of
the revised regulations, for a period of
no longer than 5 years after the effective
date of a finalized requirement. We
propose to change the requirement for
employment of a dietitian on a full-time,
part-time or consultant basis to allow for
employment of other clinically qualified
nutrition professionals who are
recognized (licensed or certified) by the
state in which the SNF or NF operates.
Retaining the option to employ a
dietitian or other clinically qualified
nutrition professional less than full-time
would allow flexibility for small
facilities and alternative care delivery
models. We note that regardless of how
the facility chooses to obtain the
services of a dietitian or other clinically
qualified nutrition professional, the
facility must ensure it achieves the
required outcomes for food and
nutrition services, both in terms of
providing a nourishing, palatable,
balanced diet and in terms of ensuring
that each resident is provided the
necessary services, both assessment and
care delivery, to achieve his or her
highest practicable physical, mental,
and psychosocial well-being.
In re-designated § 483.60(a)(2), we
propose to continue to require that, if a
qualified dietitian or other clinically
qualified nutrition professional is not
employed full-time, the facility must
designate a person to serve as the
director of food and nutrition services
who receives frequently scheduled
consultation from a qualified dietitian.
We do not currently establish any
standards for a director of food and
nutrition services. However, we believe
that this position is responsible for
critical aspects of food and nutrition
services and we believe this individual
should have specialized training to
manage menus, food purchasing, and
food preparation; to be able to apply
nutrition principles, document nutrition
information, ensure food safety and
sanitary procedures, and to manage staff
and work teams. We propose to require
that the director of food and nutrition
services, if hired or designated after the
effective date of these regulations, must
be a certified dietary manager or
certified food service manager as
evidenced by meeting national
certification standards for a certified
dietary manager such as those by the
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Association of Nutrition and
Foodservice Professionals (ANFP), or for
a certified food manager such as those
by the International Food Service
Executives Association or the Food
Management Professional certification
through the National Restaurant
Association. If already serving as a
director of food and nutrition service on
the effective date without one of these
certifications, the individual must
obtain a certification no later than 5
years after the effective date of the rule.
Alternatively, the director of food and
nutrition services may also meet the
proposed requirement through
specialized education or training in food
service management and safety resulting
in an associate’s or higher degree in
hospitality or food service management.
Finally, the director of food and
nutrition services would meet our
proposed requirement if he or she meets
applicable state requirements to be a
food service manager or dietary
manager. We do not suggest that a the
director of food and nutrition services
replaces the specialized expertise of
qualified dietitians or other clinically
qualified nutrition professionals;
however, with their expertise in
managing dietary operations in a
facility, they may provide needed
expertise and assistance in combination
with a qualified dietitian or other
clinically qualified nutrition
professional to achieve the necessary
quality of food and nutrition services for
residents.
In new § 483.60(a)(4), we propose to
require that the facility provide
sufficient support personnel with the
appropriate competencies and skills sets
to carry out the functions of the food
and nutrition service, taking into
consideration resident assessments,
individual plans of care and a facility
assessment that includes the number,
acuity and diagnoses of the facility’s
resident population. The current
regulations require that the facility
employ sufficient support personnel to
carry out the functions of the dietary
service. Our proposed revisions would
clarify that those support personnel
must have the requisite skill sets that
take into account an assessment of the
facility and considering the individual
needs of residents. We believe that most
facilities already meet this requirement;
however, because nutrition and dining
safety are critical to the well-being of
residents, we think it is important to be
more explicit in our expectations. In
particular, we think it is imperative that
facilities consider not just the number of
residents when making staffing
decisions, but the acuity and diagnoses
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of residents in order to provide effective
and appropriate food and nutrition
services. SNF and NF residents have
become sicker and more complex over
time and this must be factored into
staffing decisions, both in terms of how
many staff are present and the skill sets
and competencies the staff need to have.
We propose a new § 483.60(b) to
specify that a member of food and
nutrition services also participate in the
IDT. The registered dietitian or other
clinically qualified nutrition
professional is a critical member of the
IDT; however, in some cases another
member of food and nutrition services
with the appropriate skill sets and
competencies may be an acceptable
alternative. Nutrition is an integral
aspect of a resident’s well-being, thus it
is critical an individual knowledgeable
about the facility capabilities as well as
the resident’s needs and preferences
participate in the interdisciplinary team
in order to ensure that resident can
achieve or maintain his or her
maximum practicable well-being.
In proposed § 483.60(c)(1), we would
change ‘‘Recommended Dietary
Allowances’’ to ‘‘established national
guidelines or industry standards.’’ For
example, United States Department of
Agriculture provides an online,
interactive tool for healthcare
professions to calculate daily nutrient
recommendations for dietary planning
based on the Dietary Reference Intakes
(DRIs) at https://fnic.nal.usda.gov/fnic/
interactiveDRI/. The DRIs are the Food
and Nutrition Board of the Institute of
Medicine’s update to the Recommended
Dietary Allowances, developed in
partnership with Health Canada. Since
1998, the Institute of Medicine has
issued a series of DRIs that offer
quantitative estimates of nutrient
intakes to be used for planning and
assessing diets applicable to healthy
individuals in the United States and
Canada. Additional information on the
DRIs, including access to 14 nutrient
specific reports and several summary
charts, are available in the USDA Food
and Nutrition Information Center at
https://fnic.nal.usda.gov/. We also
propose to add a new § 483.60(c)(4) to
require that menus reflect the religious,
cultural, and ethnic needs of the
residents, as well as input received from
residents or resident groups. While we
do not require that every resident be
afforded every possible choice at any
time, we are cognizant of the
importance of appropriate choice
availability. Utilizing information from
a facility assessment and from residents
and resident groups should assist in
ensuring that appropriate options are
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available to residents under most
circumstances.
In proposed § 483.60(d), we propose
minor revisions to incorporate the
addition of drinks, to clarify that
‘‘proper’’ means both safe and
appetizing, to include consideration of
allergies, intolerances, and preferences
in preparing food, and to ensure that
water and other dietary liquids are
available to residents and provided,
consistent with resident needs and
preferences. We believe it is critical to
specifically include dietary fluids in our
regulations pertaining to food and
nutrition services. Hydration is a critical
aspect of nutrition and elderly people
who do not receive adequate fluids are
more susceptible to urinary tract
infections, pneumonia, decubitus
ulcers, and confusion and
disorientation. Chidester, J.C., and
Spangler, A.A., ‘‘Fluid Intake in the
Institutionalized Elderly,’’ Journal of the
American Dietetic Association 97
(1997):23–30. Orthostasis, confusion
and disorientation, function decline,
recurrent falls, pressure sores, urinary
tract infections, pneumonia, and skin
infections are all common conditions
associated with inadequate fluid intake
in frail, elderly long-term care residents.
Feinsod, F., Levenson, S., Rapp, K.,
Rapp, M., Beechinor, E., & Liebmann, L.
(2004). ‘‘Dehydration in frail, older
residents in long-term care facilities.’’
Journal of The American Medical
Directors Association, 5(2 Suppl), S35–
S41. Available from: MEDLINE with
Full Text, Ipswich, MA. A 1999 study
by Gaspar revealed that only 8 of 99
nursing home residents observed met
their standard water requirement based
on two 24 hour observation periods.
(Gasper, P.M. ‘‘Water Intake of Nursing
Home Residents.’’ Journal of
Gerontologic Nursing. 1999;25(4):22–
29.)
In new § 483.60(e) ‘‘Therapeutic
diets,’’ we propose to retain the
requirement in current § 483.35(e) that
therapeutic diets be prescribed by the
attending physician. However, we
propose to add a new § 483.60(e)(2) to
allow the attending physician to
delegate to a qualified dietitian or other
clinically qualified nutrition
professional the task of prescribing a
resident’s diet, including a therapeutic
diet, to the extent allowed by state law.
While the statute requires physician
supervision of each resident’s nursing
home care, we believe that the
physician can delegate authority to a
dietitian or other clinically qualified
nutrition professional to write dietary
orders, so long as the authority is
consistent with dietitian or other
clinically qualified nutrition
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professional practice allowed under
state law. In this instance, the physician
is responsible for making the decision of
whether or not to delegate this task and
remains responsible for the resident’s
care even if the task is delegated.
Further, if necessary, the physician
would be able to modify a diet order
with a subsequent physician order. We
believe this is consistent with other
tasks that the physician may delegate
and may allow for more efficient use of
physician time and effort and more
frequent assessment and updating of
diet orders by an on-site dietitian or
other clinically qualified nutrition
professional. We believe qualified
dietitians and other clinically qualified
nutrition professional are well qualified
to assess a resident’s nutritional status
and design and implement a nutritional
treatment plan in consultation with the
resident’s interdisciplinary team. In
order for residents to receive timely
nutritional care, the qualified dietitian
or other clinically qualified nutrition
professional must be viewed as an
integral member of the IDT who, as the
team’s clinical nutrition expert, is
responsible for a resident’s nutritional
evaluation and treatment in light of the
resident’s medical diagnosis. Without
allowing for the delegation for writing
diet orders to qualified dietitians or
other clinically qualified nutrition
professionals, nursing homes will not be
able to effectively realize the improved
resident outcomes and overall cost
savings that we believe would be
possible with these changes. However,
we note that because a few states elect
not to use the regulatory term
‘‘registered’’ and choose instead to use
the term ‘‘licensed’’ (or use no
modifying term at all), we are proposing
to use the term ‘‘qualified dietitian.’’
Our intention is to include all qualified
dietitians, regardless of the modifying
term (or lack thereof), as long as each
qualified dietitian meets the
requirements of his or her respective
state laws. We also recognize that there
are other nutrition professionals who
are equally qualified to provide required
services and we are expressly including
these or other clinically qualified
nutrition professionals to the extent
they are authorized under state law.
We propose to modify § 483.35(f) in
re-designated § 483.60(f) regarding
frequency of meals. Specifically, we
propose to modify the requirement that
facilities provide and residents receive 3
meals per day at regular times by adding
language to clarify that meals should be
served at times in accordance with
resident needs, preferences, requests
and the plan of care. We further propose
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to eliminate the requirement that there
be no more than 14 hours between a
substantial evening meal and breakfast
the following day, except when a
substantial bedtime snack is provided,
and focus instead on when residents
prefer to eat and on ensuring that meal
service is provided to meet residents’
clinical and nutritional needs. Rather,
we propose to require instead that the
facility provide suitable, nourishing
alternative meals and snacks for each
resident who want to eat at nontraditional times or outside of the
facility’s scheduled meal service times,
in accordance with their respective plan
of care. By suitable, nourishing
alternative meals, we mean that when a
resident misses a meal or snack, an
alternative of comparable nutritive
value to the missed meal or snack
should be provided. We do not intend
to require a 24-hour-a-day full service
food operation or an on-site chef.
Suitable alternatives may be meals
prepared in advance that can be
appropriately served by appropriately
trained facility staff at non-traditional
times. For example, staff may be trained
to safely re-heat soup and serve a
sandwich as a reasonable alternative for
a resident who prefers to eat a late
supper, so long as it meets the resident’s
nutritional needs, takes into
consideration the resident’s preferences,
and is prepared using safe food
handling techniques.
We propose to re-designate existing
§ 483.35(g) as new § 483.60(g) and revise
it to require that the facility provide not
only adaptive eating equipment and
utensils for residents who need these
devices but also provide the appropriate
staff assistance to ensure that these
residents can use the assistive devices
when consuming meals and snacks.
We propose to re-designate existing
§ 483.35(h) as new § 483.60(h) and
retain, with some revisions, provisions
for paid feeding assistants, as set out in
the 2003 final rule (68 FR 55528). We
believe the use of paid feeding assistants
provides a valuable flexibility to nursing
facilities and can serve to ensure that
residents requiring dining assistance are
able to receive it. In § 483.60(h)(2)(ii),
we propose to eliminate the reference to
the resident call system. Section
483.35(h)(2)(ii) currently requires that,
in an emergency, a paid feeding
assistant must call a supervisory nurse
for help ‘‘on the resident call system.’’
Paid feeding assistants should be able to
call for assistance in whatever manner
is most efficient rather than be limited
to a specific call system. We focus on
the outcome of getting assistance rather
than on the mechanism used to request
it. We also propose to have the IDT
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make the determination if a resident is
appropriate for assistance by a paid
feeding assistant which would be
separate from a charge nurse’s ability
and responsibility to make work
assignments on a more immediate basis
reflecting the current situation.
In proposed § 483.60(i), we clarify in
new § 483.60(i)(1)(i) that facilities may
procure food directly from local
producers—farmers or growers, in
accordance with state and local laws or
regulations. We further propose to
clarify in new § 483.60(i)(1)(ii) that this
provision does not prohibit or prevent
facilities from using produce grown in
facility gardens, subject to compliance
with applicable safe growing and
handling practices, such as using
pesticides in accordance with
manufacturers’ instructions. We note
that facilities are required under
proposed § 483.70(b) and (c) to be in
compliance with applicable federal,
state and local laws, regulations and
codes and professional standards as
well as other HHS regulations. We
believe this includes food service
requirements applicable to facilities and
note that most states and territories have
adopted some version of the FDA model
food code (https://www.fda.gov/Food/
FoodSafety/RetailFoodProtection/
FederalStateCooperativePrograms/
ucm108156.htm). We expect that
facilities comply with these
requirements as required by state law.
Consistent with § 483.70(b), we propose
to specify in § 483.60(i)(2) that facilities
would be required to store, prepare,
distribute, and serve food in accordance
with professional standards for food
service safety. We considered requiring
a Hazard Analysis and Critical Control
Points (HACCP) program in facilities;
however, we are concerned about the
application of this requirement in
innovative and small health care
delivery models. We understand this
may be a requirement under some state
or local laws and solicit comment on
whether or not a HACCP program
should be required in all SNFs and NFs.
We propose to add a new § 483.60(i)(3)
to require a facility to have a policy in
place regarding use and storage of foods
brought to residents by visitors to
ensure safe and sanitary handling. A
resident has the right to make choices,
including the right to decide whether or
not to accept food from family, friends,
or other visitors and guests. However,
the facility has a responsibility to help
family, visitors, and residents
understand safe food handling practices.
If facility staff is assisting with reheating
or other preparation activities for food
brought by visitors, the facility staff
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must use safe food handling practices
and encourage visitors and residents
who are contributing to food
preparation to also use these safe
practices. We believe having a policy in
place to address use and storage of foods
brought to residents will help ensure
consistent application of safe and
sanitary food handling practices by staff
when these foods are present in the
facility.
Q. Specialized Rehabilitative Services
(§ 483.65)
Current regulations at § 483.45 set
forth the services that a facility must
provide if a resident needs specialized
rehabilitative services including, but not
limited to, physical therapy, speechlanguage pathology, occupational
therapy, and mental health
rehabilitative services for mental illness.
Following our proposed reorganization
of part 483 subpart B, we propose to
relocate these existing provisions to
proposed § 483.65 with minor revisions.
Consistent with specialized
rehabilitative services, the need for
respiratory therapy and respiratory
illnesses are very common among older
adults; however, the current regulations
do not discuss respiratory therapy.
According to data collected by the
Centers for Disease Control and
Prevention (CDC), 6.7 percent of nursing
home residents have some form of
disease of the respiratory system at the
time of their admission into a nursing
home (The National Nursing Home
Survey. 2004 overview: National Center
for health Statistics [on-line]. https://
www.cdc.gov/nchs/about/major/nnhsd/
nnhsd.htm. Accessed January 10, 2013).
In addition to the occurrence of
respiratory illnesses at admission,
outbreaks of respiratory tract infections
are also common in LTC facilities
among older adults. In LTC facilities,
rates of pneumonia as high as 42
percent and case-fatality rates exceeding
70 percent have been reported in
outbreaks due to the influenza virus
(Loeb M, McGeer A, McArthur, Peeling
R, Petric M, Simor A. Surveillance for
outbreaks of respiratory tract infections
in nursing homes (cover story). CMAJ:
Canadian Medical Association Journal
[serial online]. April 18,
2000;162(8):1133–1137. Available from:
Health Policy Reference Center,
Ipswich, MA. Accessed January 23,
2013).
Given these statistics and our prior
knowledge about the need for
respiratory related treatment and
therapy in facilities, we propose at redesignated § 483.65(a) to specifically
add respiratory therapy to the list of
specialized rehabilitative services.
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Adding this service to the regulations
would reflect the more current needs of
facility residents. The addition of this
service would also explicitly require
facilities to provide or obtain these
services when necessary and meet the
needs of residents facing respiratory
issues. However, this would not change
coverage policy regarding respiratory
therapy. At § 483.65(a)(2), we propose to
clarify that when it is necessary for
facilities to obtain these services from
an outside source, the provider should
be a certified Medicare and/or Medicaid
provider.
Secondly, we propose to clarify the
meaning of specialized rehabilitative
services in relation to PASARR. Current
requirements do not clarify what
specialized rehabilitative services for
mental illness are and this has led to
confusion among providers, states, and
others. Therefore, to eliminate
confusion and provide clarification, we
propose to add in § 483.65 a cross
reference to the PASARR regulations at
§ 483.120(c) which define the mental
health or intellectual disability services
a nursing facility must provide to all
residents who need these services. In
addition, we would correct a
typographical error deleting the
redundant ‘‘mental health’’ before
‘‘rehabilitative services for mental
illness and intellectual disability’’.
R. Outpatient Rehabilitative Services
(§ 483.67)
We propose to add a new § 483.67
‘‘Outpatient Rehabilitative Services’’ to
address facilities that choose to provide
outpatient rehabilitative therapy
services to individuals that do not
reside in the facility. Currently, the
provision of outpatient rehabilitative
services for non-residents is not
addressed by the requirements for LTC
care facilities. We note that § 483.65
‘‘Specialized Rehabilitative Services’’
sets forth the requirements that a facility
must meet when providing
rehabilitative therapy services to
residents who reside in their facility.
We understand that some, and possible
many, facilities provide rehabilitative
services on an outpatient basis and that
these services may be paid for under
Medicare Part B (see section 1861(p) of
the Act, implementing regulations at 42
CFR 410.60(b), and the Medicare Benefit
Policy Manual, Pub. 100–02, Chapter
15, § 220.1.4.) Therefore, we believe it is
necessary to ensure that services meet
health and safety standards. We propose
to require facilities that provide
outpatient rehabilitative therapy
services to meet requirements similar to
those already established for hospitals.
Specifically, we propose to require in
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new § 483.67 that if the facility provides
outpatient rehabilitation, physical
therapy, occupational therapy,
audiology, or speech-language
pathology services, the services must
meet the needs of the patients in
accordance with acceptable standards of
practice and the facility must meet
certain requirements. The requirements
include at proposed § 483.67(a) that the
organization of the service must be
appropriate to the scope of the services
offered. In proposed § 483.67(b), we are
proposing to require that the facility
assign one or more individuals to be
responsible for outpatient rehabilitative
services and that the individual
responsible for the outpatient
rehabilitative services must have the
necessary knowledge, experience, and
capabilities to properly supervise and
administer the services. We also
propose to require that the facility must
have appropriate professional and
nonprofessional personnel available at
each location where outpatient services
are offered. In addition, we propose to
require that physical therapy,
occupational therapy, speech-language
pathology or audiology services, if
provided, must be provided by qualified
physical therapists, physical therapist
assistants, occupational therapists,
occupational therapy assistants, speechlanguage pathologists, or audiologists as
defined in part 484 of this chapter. In
proposed § 483.68(c) we would require
that services must only be provided
under the orders of a qualified and
licensed practitioner who is responsible
for the care of the patient, acting within
his or her scope of practice under state
law and that all rehabilitation services
orders and progress notes must be
documented in the patient’s clinical
record in accordance with the
requirements at § 483.70(i). Finally, we
propose to require that the provision of
care and the personnel qualifications
must be in accordance with national
acceptable standards of practice. We
believe the addition of these provisions
is necessary to ensure that outpatient
rehabilitative services provided by
facilities meet health and safety
standards.
S. Administration (§ 483.70)
We propose to re-designate current
§ 483.75 ‘‘Administration’’ as § 483.70.
In paragraph (c), we propose to replace
the term ‘‘handicap’’ with the term
‘‘disability’’and to add a reference to the
HIPAA Privacy, Security, and Breach
Notification Rules, 45 CFR parts 160
and 164. In addition, we would clarify
that violations of other HHS regulations,
as determined by the agency or entity
with enforcement authority for those
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regulations, may result in a finding by
CMS of non-compliance with the
requirements of § 483.70(c). In proposed
§ 483.70(d)(2)(i) we would delete the
phrase ‘‘where licensing is required’’
since all states participating in the
Medicaid program are required to
license nursing home administrators
under section 1908 of the Act. We
propose to add a new § 483.70(d)(2)(iii)
to specify that the nursing home
administrator would report to and be
accountable to the governing body. We
are concerned that the governing body
can appoint the nursing home
administrator but is not, on an ongoing
basis, required to remain cognizant of
the operations and management of the
facility. Given that the governing body
is responsible for implementing the
management and operations of the
facility, we believe it is important to
ensure that it remains informed and
knowledgeable regarding those issues.
We also propose to add a new
§ 483.70(d)(3) to specify that the
governing body is responsible and
accountable for the QAPI program, in
accordance with proposed § 483.75(f).
We propose to re-designate and revise
existing § 483.75(e) and (f), provisions
regarding nurse aides, to our proposed
section on Nursing Services at § 483.35
or our proposed new section on
Training at § 483.95. We refer readers to
see the separate discussions under those
sections.
We propose to create new section
§ 483.50 ‘‘Laboratory, radiology, and
other diagnostic services’’ and relocate
and revise existing paragraphs,
§ 483.75(j) laboratory services and
§ 483.75(k) radiology and other
diagnostic services, to the new section.
Please see our separate discussions of
the new section.
We are proposing a new § 483.70(e)
which would establish a new
requirement for an annual facility
assessment. This new requirement
would be a central feature of our
revisions to subpart B and is intended
to be used by the facility for multiple
purposes, including but not limited to
activities such as determining staffing
requirements, establishing a QAPI
program, and conducting emergency
preparedness planning. This is similar
to existing common business practices
for strategic planning and capital budget
planning and we believe that facilities
will find this assessment useful beyond
what is required to meet our
requirements. This facility-wide
assessment would determine what
resources a facility would need to care
for its residents competently during
both day-to-day operations and
emergencies. This assessment would
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have to be facility and communitybased, utilizing an all-hazards approach.
The facility would have to review and
update the assessment as necessary, but
at least annually and whenever there
was, or the facility planned for, any
change that would require a substantial
modification to any part of the
assessment. We propose to require that
the facility assessment address or
include:
• The facility’s resident population,
including the number of residents, the
facility’s resident capacity, the care
required by the resident population
considering the types of diseases,
conditions, physical and cognitive
disabilities, overall acuity that are
present within that population.
• The staff competencies that are
necessary to provide the level and types
of care needed for the resident
population.
• The physical environment,
equipment, and services that are
necessary to care for this population.
• Any ethnic, cultural, or religious
factors that may potentially affect the
care provided by the facility, including,
but not limited to, activities and food
and nutrition services.
• The facility’s resources, including
but not limited to buildings and other
physical structures and vehicles;
medical and non-medical equipment.
• The services provided, such as
physical therapy, pharmacy, and
specific rehabilitation therapies.
• Personnel, including managers,
employed and contracted staff, and
volunteers, as well as their education
and/or training and any competencies
related to resident care.
• Contracts, memorandums of
understanding, or other agreements with
third parties to provide services or
equipment to the facility both during
normal operations and emergencies.
• Health information technology
resources, such as systems for
electronically managing patient medical
records and electronically sharing
information with other organizations.
In conducting the facility assessment,
we did not propose that the facility
include any input from either the
resident or any other individuals who
have a personal interest in the resident.
We believe the facility should have the
flexibility to determine when and from
whom a facility would seek input and
how to incorporate that information into
their assessment. However, we
encourage facilities to determine when
it would be appropriate to seek input
from the resident, the resident’s
representative or any of the resident’s
family or friends and consider that
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information in formulating their
assessment.
We propose to retain the provisions in
existing § 483.75(g), (h) and (i)
unchanged and re-designate them as
proposed § 483.70 (f), (g), and (h). We
propose to re-designate existing
§ 483.75(l) as proposed § 483.70(i) and
to amend it to better conform to the
requirements of the HIPAA Privacy,
Security, and Breach Notification rules
at 45 CFR parts 160 and 164. We also
propose minor revisions in it to clarify
that the clinical record must contain the
resident’s comprehensive plan of care
and physician’s and other licensed
professional’s progress notes. It is
important that the clinical record reflect
the services provided across disciplines
to ensure information is readily
available when needed and to facilitate
communication among the
interdisciplinary team. Existing
paragraph (m) would be removed and
revised pursuant to a separate proposed
rule, ‘‘Medicare and Medicaid Programs:
Emergency Preparedness Requirements
for Medicare and Medicaid Participating
Providers and Suppliers’’ (78 FR 79081,
December 27, 2013).
In proposed § 483.70(j), ‘‘Transfer
Agreement, ’’we propose to modify the
current language at § 483.75(n) to allow
a practitioner other than the attending
physician to determine that a hospital
transfer is medically appropriate in an
emergency situation and consistent with
state law and facility policy. We believe
this is both appropriate and necessary to
promote prompt treatment and protect
resident safety. We further propose to
specify here that the information
exchange required by existing paragraph
§ 483.75(n)(ii) be modified to require
that the exchanged information include,
at a minimum, the information we
propose to require under new paragraph
§ 483.15(b)(2)(iii)(B). As discussed
earlier, the effective exchange of
information can reduce the risk inherent
to transitions of care and promote
improved resident outcomes.
We propose to incorporate existing
§ 483.75(o), assessment and quality
assurance, into proposed § 483.75(c).
New § 483.75 will also include
requirements established under section
6102 of the Affordable Care Act for a
QAPI program. We refer readers to the
separate discussion on QAPI, in Section
II.S. of this proposed rule.
Provisions on Disclosure of
Ownership, Facility ClosureAdministrator, Facility Closure, and
Hospice services are re-designated as
paragraphs § 483.75(k), (l), (m), and (o)
respectively, and the cross-reference in
proposed (m) updated, but otherwise
unchanged. We propose to address
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training of paid feeding assistants in our
proposed new § 483.95—Training
requirements.
We propose in § 483.70(n) to require
facilities that ask residents to accept
binding arbitration to resolve disputes
between the facility and the resident to
meet certain criteria. Alternative dispute
resolution (ADR), including binding
arbitration, has become increasingly
popular in recent years. However,
unlike other forms of ADR, binding
arbitration requires that both parties
waive the right to any type of judicial
review or relief. While this can be a
valid agreement when entered into by
individuals with equal bargaining
power, we are concerned that the
facilities’ superior bargaining power
could result in a resident feeling
coerced into signing the agreement.
Also, if the agreement is not explained
to the resident, he or she may be
waiving an important right, the right to
judicial relief, without fully
understanding what he or she is
waiving. Also, the increasing prevalence
of these agreements could be
detrimental to residents’ health and
safety and may create barriers for
surveyors and other responsible parties
to obtain information related to serious
quality of care issues. This results not
only from the residents’ waiver of
judicial review, but also from the
possible inclusion of confidentiality
clauses that prohibit the resident and
others from discussing any incidents
with individuals outside the facility,
such as surveyors and representatives of
the Office of the State Long-Term Care
Ombudsman.
We propose that the facility be
required to explain the agreement to the
resident in a form, manner and language
that he or she understands and have the
resident acknowledge that he or she
understands the agreement. The
agreement must not contain any
language that prohibits or discourages
the resident or any other person from
communicating with federal, state, or
local officials, including, but not limited
to, federal and state surveyors, other
federal or state health department
employees, or representatives of the
Office of the State Long-Term Care
Ombudsman, regarding any matter,
whether or not subject to arbitration or
any other type of judicial or regulatory
action, in accordance with proposed
§ 483.11(i). The explanation must state,
at a minimum, that the resident is
waiving his or her right to judicial relief
for any potential cause of action covered
by the agreement. The agreement must
be entered into by the resident
voluntarily and provide for the selection
of a neutral arbitrator and a venue
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convenient to both parties, the resident
and the facility. An agreement will not
be considered to have been entered into
voluntarily by the resident if the facility
makes it a condition of admission,
readmission, or the continuation of his
or her residence at the facility. Thus, we
believe that any agreement for binding
arbitration should not be contained
within any other agreement or
paperwork addressing any other issues.
It should be a separate agreement in
which the resident must make an
affirmative choice to either accept or
reject binding arbitration for disputes
between the resident and the facility.
Finally, in order to address concerns
about conflict of interest when the
resident has a guardian that is affiliated
with the facility, we propose to specify
that the guardians or representatives
cannot consent to an agreement for
binding arbitration on the resident’s
behalf unless that individual is allowed
to do so under state law, all of the other
requirements in this section is met, and
the individual has no interest in the
facility. We are also aware that there are
concerns that these agreements should
be prohibited in the case of nursing
home residents. Therefore, we are also
soliciting comments on whether binding
arbitration agreements should be
prohibited.
We propose to relocate the
requirement for and qualifications of a
social worker from the current
§ 483.15(g)(3) to proposed § 483.70(p).
In addition, there is a list of human
services fields from which a bachelors
degree could provide the minimum
educational requirement for a social
worker. We propose to add
‘‘gerontology’’ to that list of human
services fields. We would also welcome
comments related to qualifications for
the social worker, especially whether
state licensure should remain the
threshold requirement or if additional
requirements are appropriate.
Finally, in our proposed rule
‘‘Medicare and Medicaid Programs;
Prospective Payment System and
Consolidated Billing for Skilled Nursing
Facilities (SNFs) for FY 2016, SNF
Value-Based Purchasing Program, SNF
Quality Reporting Program, and Staffing
Data Collection’’ (CMS–1622–P) (80 FR
22044), published on April 20, 2015, at
§ 483.75(u), we proposed to require that
facilities submit staffing information
based on payroll data in a uniform
format. Section 6106 of the Affordable
Care Act of 2010 (Pub. L. 111–148,
March 23, 2010) added a new section
1128I to the Act that requires a facility
to electronically submit to the Secretary
direct care staffing information,
including information for agency and
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contract staff, based on payroll and
other verifiable and auditable data in a
uniform format according to
specifications established by the
Secretary. In this proposed regulation,
we are proposing to redesignate
§ 483.75(u) (as set out in the April 20,
2015 proposed rule at 80 FR 22044) to
§ 483.70(q).
T. Quality Assurance and Performance
Improvement (QAPI) (§ 483.75)
Section 6102 of the Affordable Care
Act amended the Act by adding new
section 1128I. Subsection (c) of section
1128I of the Act requires that the
Secretary establish and implement a
QAPI program requirement for SNFs
and NFs, including those that are part
of a multi-unit chain of facilities. Under
the QAPI provision, the Secretary must
establish standards relating to facilities’
QAPI program and provide technical
assistance to facilities on the
development of best practices in order
to meet these standards. No later than 1
year after the date on which the
regulations are promulgated, a facility
must submit to the Secretary a plan for
the facility to meet these standards and
implement the best practices, including
a description of how it would
coordinate the implementation of the
plan with quality assessment and
assurance activities currently conducted
under sections 1819(b)(1)(B) and
1919(b)(1)(B) of the Act. This proposed
rule would establish these
programmatic standards.
Current regulations at § 483.75(o)
require a facility to maintain a quality
assessment and assurance (QAA)
committee, consisting of the director of
nursing services, a physician designated
by the facility, and at least three other
members of the facility staff. The QAA
committee must meet at least quarterly
and identify quality deficiencies and
develop and implement plans of action
to correct the deficiencies. The facility
is only required to disclose records of
the QAA committee if the disclosure is
related to the compliance of the
committee with the regulatory
requirements. While our proposal
retains the existing QAA requirements
at § 483.75(o), these requirements alone
do not conform to the current health
care industry standards that proactively
design quality improvement into each
program at the outset, monitor data
(indicators, measures and reports of
staff/residents/families), determine root
causes of problems, design and use
performance improvement projects
(PIPs) to promote continuous
improvement, develop and implement
plans that effect system improvement,
and monitor the success of this
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systematic approach to improving
quality. The focus of a QAPI approach
is to optimize quality improvement
activities and programs
comprehensively and proactively, even
in areas where no specific deficiencies
are noted. The QAPI program should
include standards for quality assurance,
active feedback systems to monitor
performance, and continuous efforts to
optimize program design through
quality improvement activities and
proactive strategies. The QAPI
requirements we propose would not
replace the QAA committee
requirements but would enhance and be
coordinated with these requirements.
The QAPI program utilizes objective
data to study and continually make
improvements to all aspects of an
organization’s operations and services.
It enables facilities to take a systematic
approach to reviewing its operating
systems and processes of care and
identifying and implementing
opportunities for improvement. QAPI
has significant potential to be an
efficient and effective method for
improving the quality of care and
performance of health care providers.
In 2001, the Institute of Medicine
released a pivotal report, ‘‘Crossing the
Quality Chasm’’ in which it stated that
‘‘the American healthcare delivery
system is in need of fundamental
change’’ and recognized that ‘‘quality
problems are everywhere affecting many
patients (https://www.iom.edu/Reports/
2001/Crossing-the-Quality-Chasm-ANew-Health-System-for-the-21stCentury.aspx). In a 2004 educational
publication co-sponsored by the Office
of Inspector General (OIG) of the U.S.
Department of Health and Human
Services and the American Health
Lawyers Association (AHLA),
‘‘Corporate Responsibility and Health
Care Quality: A Resource for Health
Care Boards of Directors, (https://
oig.hhs.gov/fraud/docs/
complianceguidance/
CorporateResponsibilityFinal%209-407.pdf), the authors discuss the IOM
report and state that the oversight of
quality and patient safety is becoming
clearly recognized as a core fiduciary
responsibility of health care
organizations. They further note that
promoting quality of care and
preserving patient safety are at the core
of the health care industry and the
reputation of each health care
organization and suggest that
‘‘contemporary health care quality,
patient safety and cost efficiency
initiatives provide an opportunity for
health care organizations to make a
positive difference to society while
promoting their missions and enhancing
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their financial success.’’ Therefore,
pursuant to the requirements of the
Affordable Care Act and as discussed in
detail below, we are proposing to add a
new § 483.75 entitled, ‘‘Quality
Assurance and Performance
Improvement.’’
At proposed § 483.75(a), we would
require that a facility develop,
implement, and maintain an effective,
comprehensive, data-driven QAPI
program, reflected in its QAPI plan, that
focuses on systems of care, outcomes
and services for residents and staff. The
QAPI program would be designed to
monitor and evaluate performance of all
services and programs of the facility,
including services provided under
contract or arrangement. We propose
that the facility’s governing body, or
designated persons functioning as a
governing body, ensure that the QAPI
program is defined, implemented, and
maintained and addresses identified
priorities. As discussed above, facilities
are required to submit the QAPI plan to
the Secretary. Therefore, we propose in
new § 483.75(a)(1) that the facility
would maintain documentation and
demonstrate evidence of its QAPI
program. This includes but is not
limited to the QAPI plan. We propose in
new § 483.75(a)(2) that the facility must
submit the QAPI plan to the State
Agency or federal surveyor, as the agent
of the Secretary, at the first annual
recertification survey that occurs at least
1 year after the effective date of these
regulations. In addition, we propose in
new § 483.75(a)(3), based on the
Secretary’s authority at sections
1819(d)(4)(B) and 1919(d)(4)(B) of the
Act to establish other requirements
relating to the health and safety of
residents, to require that the facility
present the QAPI plan to the State
Agency surveyor at each annual
recertification survey and upon request
to the State Agency or federal surveyor
at any other survey and to CMS upon
request. In addition, we propose in new
§ 483.75(a)(4), to require the facility to
present its documentation and evidence
of an ongoing QAPI program upon
request of a State Agency, federal
surveyor, or CMS. The State Agency,
pursuant to its agreement with the
Secretary under section 1864 (a) of the
Act, will consider such plan in making
its certification recommendation and
providing evidence to the CMS Regional
Office for a compliance determination.
We propose this recurring requirement
to ensure that the QAPI program is
ongoing and that the facility meets the
standards established in this section.
At § 483.75(b), we establish
requirements for the design and scope of
the QAPI program. We propose to
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require that the facility design its QAPI
program to be ongoing, comprehensive
and address the full range of care and
services provided by the facility. When
implemented, the QAPI program would
be required to address all systems of
care and management practices and
would always include clinical care,
quality of life, and resident choice. It
would have to utilize the best available
evidence to define and measure
indicators of quality and facility goals
that reflect processes of care and facility
operations that have been shown to be
predictive of desired outcomes for
residents of a facility and reflect the
complexities, unique care, and services
that the facility provides.
We propose in new § 483.75(c) to
establish requirements for QAPI
program feedback, data systems and
monitoring. We propose at new
§ 483.75(c)(1) that, as part of its QAPI
process, the facility would have to
maintain effective systems to obtain and
use feedback and input from direct care/
direct access workers, other staff, and
residents, resident representatives and
families to identify opportunities for
improvement. In new § 483.75(c)(2), we
propose to require that the systems,
governed by appropriate policies and
procedures, also include how the
facility would identify, collect, and use
data from all departments, including
how the information would be used to
identify high risk, high volume or
problem-prone areas. In new
§ 483.75(c)(3), we would require that the
policies and procedures include a
description of the methodology and
frequency for developing, monitoring,
and evaluating performance indicators.
Finally, in new § 483.75(c)(4), we
propose to require that the system,
policies and procedures include the
process for identification, reporting,
analysis, and prevention of adverse
events and potential adverse events or
near misses. This would include
methods by which the facility would
obtain information on adverse events
and potential adverse events from
residents, family and direct care/direct
access staff, and how the facility would
address and investigate the adverse
event or potential adverse event and
provide feedback to those same
individuals. Adverse events remain a
serious problem in LTC facilities. A
recent OIG report estimated that 22
percent of Medicare beneficiaries
experienced adverse events during a
skilled nursing facility stay. Many of
those adverse events were preventable.
(Adverse Events in Skilled Nursing
Facilities: National Incidence Among
Medicare Beneficiaries. Office of
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Evaluations and Inspections, Report
OEI–06–11–00370. Office of Inspector
General, Department of Health & Human
Services. (2014)). According to the
World Health Organization (WHO), an
adverse event is an injury related to
medical management, in contrast to
complications of disease. Medical
management includes all aspects of
care, including diagnosis and treatment,
failure to diagnose or treat, and the
systems and equipment used to deliver
care. Adverse events may be preventable
or non-preventable. A near miss is a
serious error or mishap that has the
potential to cause an adverse event but
fails to do so because of chance or
because it is intercepted; it is also called
a potential adverse event. (WHO Draft
Guidelines for Ad verse Event Reporting
and Learning Systems. 2005 https://
www.who.int/patientsafety/events/05/
Reporting_Guidelines.pdf). Examples of
situations that would qualify as an
adverse event for a facility include, but
are not limited to, medication errors,
resident injury due to falls, resident
injury due to abuse or neglect by caregivers or other residents, failure to
identify acute change in condition,
pressure ulcers due to inappropriate
care and the spread of disease due to
errors in infection prevention and
control. Near misses in any of these
situations would be considered
potential adverse events. As discussed
in section II.B. of this preamble, we
propose to define an adverse event as an
untoward, undesirable, and usually
unanticipated event that cause death or
serious injury, or the risk thereof,
consistent with the definition currently
established at 42 CFR 482.70 and
already in use for transplant centers.
However, we are aware that there are
other definitions and welcome
comments on this definition.
We propose to establish a new
§ 483.75(d) to address QAPI program
systematic analysis and action. We
propose in § 483.75(d)(1) to require that
the facility take actions aimed at
performance improvement and, after
implementing those actions, to measure
the success of those actions and to track
performance to ensure that the
improvements are sustained. We further
propose to require in § 483.75(d)(2), that
the facility develop policies describing
how they would use a systematic
approach (such as, root cause analysis,
reverse tracer methodology, and health
care failure and effects analysis, for
example) to determine underlying
causes of problems impacting larger
systems. These policies would address
the development of corrective actions
that would be designed to affect change
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at the systems level, and how the
facility would monitor the effectiveness
of its performance improvement
activities to ensure that improvements
were sustained.
In § 483.75(e), we propose to establish
requirements for program activities.
Specifically, we would require at new
§ 483.75(e)(1) through(3) that the facility
establish priorities for performance
improvement activities that focus on
patient safety; coordination of care;
autonomy; choice; and high risk, high
volume, and/or problem-prone areas
identified as a result of the facility
assessment as specified in § 483.70(e).
We propose to require that performance
improvement activities track medical
errors and adverse resident events,
analyze their causes, and implement
preventative actions and mechanisms
that include feedback and learning
throughout the facility. Finally, QAPI
program activities would be required to
include Performance Improvement
Projects (PIPs). Under our proposal, the
facility would be required to conduct
distinct performance improvement
projects. The number and frequency of
improvement projects conducted by the
facility would have to reflect the scope
and complexity of the facility’s services
and available resources. We propose
that each facility would be required to
implement at least one project annually
that focused on a high risk or problem
prone area identified through the
required data collection and analysis.
We considered not establishing a
minimum requirement or establishing a
requirement based on facility size and
welcome comment on whether or not
there should be a specific number of
PIPS and what that number should be.
We also considered establishing
mandatory PIPs and requiring facilities
to implement at least one PIP selected
from the mandatory PIPs. We solicit
comment on establishing mandatory
PIPS, specifically regarding the
feasibility for and impact on facilities.
Finally, in new § 483.75(f), we
propose to require that the facility
ensure, through the governing body or
executive leadership, that an ongoing
QAPI program is defined, implemented,
and sustained during transitions in
leadership and staffing and that the
QAPI program is adequately resourced,
including ensuring staff time,
equipment, and technical training as
needed. Furthermore, the governing
body or executive leadership would
have to ensure that the QAPI program
identified and prioritized problems and
opportunities based on performance
indicator data; resident and staff input
that reflected organizational processes,
functions, and services provided to
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residents; that corrective actions
addressed gaps in systems, and were
evaluated for effectiveness; and that
clear expectations were set around
safety, quality, rights, choice, and
respect.
These proposed requirements for the
QAPI program are an outgrowth of the
QAPI demonstration project conducted
by CMS working with stakeholders,
providers and experts. Our proposed
requirements directly reflect five
elements that were identified through
this process as critical to the success of
a QAPI program. We discuss this project
below under ‘‘Technical Assistance for
facilities.’’
We propose to re-designate
§ 483.75(o) as § 483.75(g). In
§ 483.75(g)(1) we propose to revise the
language to clarify that the QAA
committee membership requirements
are a minimum requirement. Facilities
may, at their discretion, include
additional individuals on their QAA
committee. For example, some facilities
may wish to include a pharmacist on
the QAA committee to coordinate QAPI
activities related to reducing the
inappropriate use of psychotropic
medications. The QAA committee may
also benefit from including individuals
such as a resident council president, the
director of social services or the
activities director. We also propose to
add the requirement that the Infection
Control and Prevention Officer (ICPO)
participate in the quality assessment
and assurance committee. We consider
the ICPO’s coordination with the quality
assurance committee and with QAPI
activities important to the success of the
infection control and prevention
program and discuss the need for this
further in our section on infection
control.
In § 483.75(g)(2), we propose to
specify that the quality assessment and
assurance committee report to the
facility’s governing body, or designated
persons functioning as a governing
body, regarding its activities, including
implementation of the QAPI program
required under new § 483.75(a) through
(f). We further propose to specify that
the committee coordinate and evaluate
activities under the QAPI program,
including performance improvement
projects, and that the committee review
and analyze data collected under the
QAPI program as well as data from
pharmacists resulting from monthly
drug regimen reviews and the resulting
reports as specified in § 483.45(c)(4).
Section 6102(c)(1) of the Affordable
Care Act specifically requires that the
implementation of the QAPI plan be
coordinated with the quality assessment
and assurance activities conducted
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under sections 1819(b)(1)(B) and
1919(b)(1)(B) of the Act. As there is
significant overlap in the expectations
for the QAPI program and the quality
assessment and assurance committee,
we believe that the existing committee
is the appropriate resource to coordinate
the QAPI program.
We propose to add a new § 483.75(h)
to address disclosure of information. We
propose to re-designate existing
§ 483.75(o)(3) as § 483.75(h)(1) and add
a new § 483.75(h)(2) to clarify that
facilities, in order to demonstrate
compliance with the requirements of
this section, may be required to disclose
or provide access to certain QAPI
information. Specifically, we would
require, to the extent necessary to
demonstrate compliance with the
requirements of this section, access to
systems and reports demonstrating
systematic identification, reporting,
investigation, analysis, and prevention
of adverse events; documentation
demonstrating the development,
implementation, and evaluation of
corrective actions or process
improvement activities; and other
documentation considered necessary by
a state or federal surveyor in assessing
compliance. We further propose to redesignate § 483.75(o)(4) as § 483.75(i).
In sum, we believe these proposed
requirements would ensure that
facilities establish and implement QAPI
plans that result in continuous quality
improvement throughout the facility
and enhanced quality of care, quality of
life and resident and staff satisfaction,
while providing facilities with the
flexibility to design, monitor, and
maintain QAPI approaches best suited
to the type and complexity of services
they provide and the needs of their
residents.
Technical Assistance for Facilities
In addition to establishing the
standards for a QAPI program in this
proposed rule, we would provide
technical assistance to nursing homes
on the development of best practices
relating to QAPI. Since 2011, we have
worked with stakeholders, providers
and experts to develop tools, resources
and technical assistance to implement a
QAPI program. A demonstration project
tested implementation strategies and
effectiveness of QAPI tools, resources
and technical assistance. Through this
process, five critical elements, which
are reflected in our proposed
requirements, have been identified for a
successful QAPI program. The five
elements are as follows:
• Design and Scope.
• Governance and Leadership.
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• Feedback, Data Systems and
Monitoring.
• Performance Improvement Projects.
• Systematic Analysis and Systemic
Action.
QAPI materials developed through
this process are available at no cost to
all facilities at https://www.cms.gov/
Medicare/Provider-Enrollment-andCertification/
SurveyCertificationGenInfo/QAPI.html.
In addition, facilities may choose from
a wide variety of existing professionally
recognized quality assurance and
performance improvement resources.
We discuss a non-exhaustive list of
some of these resources below.
Under the direction of CMS, the
Medicare Quality Improvement
Organization (QIO) Program
(www.cms.hhs.gov/
QualityImprovementOrgs) consists of a
national network of 53 QIOs—one in
each state, plus the District of Columbia,
Puerto Rico, and the Virgin Islands.
QIOs work with beneficiaries,
healthcare providers, consumers and
stakeholder to achieve national
priorities focused on three broad aims
of—(1) better care; (2) improved health;
and (3) lower costs. QIOs work with
nursing homes (among other providers)
to focus on a number of quality
improvement measures, such as
decreasing healthcare associated
conditions, providing direct technical
assistance and engaging with nursing
homes and other long term care
providers participating in the National
Nursing Home Quality Care
Collaborative.
Advancing Excellence in America’s
Nursing Homes (https://
www.nhqualitycampaign.org) is a
national campaign to encourage, assist
and empower nursing homes to improve
the quality of care and life for residents.
It is composed of LTC providers,
medical professionals, consumers,
employees, and is an ongoing, coalitionbased campaign focused on
improvements in care and services for
the elderly, chronically ill and disabled,
as well as those recuperating in a
nursing home environment. The
mission of the Advancing Excellence in
America’s Nursing Homes Campaign is
to help nursing homes achieve
excellence in the quality of care and
quality of life for the more than 1.5
million residents in America’s nursing
homes by improving clinical and
organizational outcomes, among other
goals. The Campaign works to achieve
its mission by providing free practical
and evidence-based resources to support
quality improvement efforts in
America’s nursing homes.
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The State Medicaid Agencies (SMAs)
and HHS’s Administration for
Community Living (ACL) provide
online information resources for
community care and transition
programs, options, supports and
services, community care transition
planning entities, and contacts and
links: www.medicaid.gov; www.mfptac.com; and www.acl.gov. Finally, CMS
provides links to resources in its
existing Interpretive Guidelines that
provide information on how to develop
and enhance quality improvement
programs.
U. Infection Control (§ 483.80)
Healthcare-associated infections
(HAIs) often result in considerable
suffering for residents in LTC facilities
as well as increased costs for the
healthcare system. Although estimates
vary widely, there are between 1.6 and
3.8 million HAIs in nursing homes
every year. Annually, these infections
result in an estimated 150,000
hospitalizations, 388,000 deaths, and
between $673 million to $2 billion
dollars in additional healthcare costs
(Castle, et al. Nursing home deficiency
citations for infection control, American
Journal of Infection Control, May 2011;
39, 4). Individuals receiving care in a
nursing home may have increased
susceptibility to infections as a result of
malnutrition, dehydration,
comorbidities, or functional
impairments, such as urinary and fecal
incontinence, or medications that
diminish immunity, or immobility. In
addition, residents may have a higher
risk of exposure to infectious agents in
the facility due to socialization among
residents, staff, and visitors. The
National Action Plan to Prevent Health
Care Associated Infections includes a
chapter focused on long term care
settings that pertains to nursing
facilities: https://www.hhs.gov/ash/
initiatives/hai/actionplan/hai-actionplan-ltcf.pdf. According to the Plan, the
most common HAIs in nursing facilities
are urinary tract infections, lower
respiratory tract infections, skin and soft
tissue infections, and gastroenteritis.
Since 1992, our requirements for LTC
facilities currently set out at § 483.65
have required these facilities to
establish and maintain infection control
programs designed to provide a safe,
sanitary, and comfortable environment
and to help prevent the development
and transmission of disease and
infection. The program must investigate,
control, and prevent infections in the
facility; issue and maintain protocols to
guide decisions about what procedures,
such as isolation, should be applied to
an individual resident, and maintain a
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record of incidents and corrective
actions related to infections. Under
§ 483.65(b)(1), when the infection
control protocol recommends that a
resident be isolated to prevent the
spread of infection, the facility must
isolate the resident. Under § 483.65(b)(2)
of our regulations, the facility must
prohibit employees with a
communicable disease or infected skin
lesions from direct contact with
residents or their food if direct contact
will transmit the disease. Under
§ 483.65(b)(3), the facility must require
staff to wash their hands after each
direct resident contact. Section
483.65(c) requires LTC facilities to
handle, store, process, and transport
linens so as to prevent the spread of
infection.
Each of these requirements remains
important; however, as a result of
advances in the study and practice of
infection prevention and control and
given the impact of HAIs, we find that
the current requirements for infection
control in our requirements warrant
updating and strengthening. In
developing our proposals, we reviewed
the existing requirements for SNFs and
NFs, as well as the current requirements
for other Medicare providers and
suppliers related to infection control.
We also reviewed available research and
literature related to infection prevention
and control in nursing homes and
published infection control guidelines
for long term care facilities from the
Society for Healthcare Epidemiology of
America (SHEA) and the Association for
Professionals in Infection Control
(APIC) (Smith, P.W., et al., SHEA/APIC
Guideline: Infection Prevention and
Control in the Long-Term Care Facility,
Infection Control and Hospital
Epidemiology, Vol. 29, No. 9
(September 2008), pp. 785–814).
We especially want to emphasize the
importance of infection prevention and
surveillance. As discussed below, we
propose that each facility’s infection
prevention and control program (IPCP)
include an antibiotic stewardship
program, which includes antibiotic use
protocols and antibiotic monitoring.
Antibiotic resistance has emerged as a
national healthcare concern and even
the appropriate use of antibiotics can
contribute to antibiotic resistance.
Nursing homes are the next frontier
where new antibiotic resistant
organisms may emerge and flourish.
Organisms such as Clostridium difficile
(C-diff) and methicillin-resistant
Staphylococcus aureus (MRSA) are
known concerns. Nursing homes need
to have the tools to participate in
surveillance, learn and use infection
control and containment practices, and
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adopt a proactive approach to
preventing spread while being good
stewards of antibiotics to preserve
effectiveness of the agents we have
today. While avoiding the inappropriate
use of antibiotics is critical, one of the
best mechanisms to combat the rise in
antibiotic resistance is to prevent
infections and, when they do occur,
prevent the spread of the infection to
others (Spellberg, Brad, et al., The
Future of Antibiotics and Resistance,
The New England Journal of Medicine,
368:4 (January 24, 2013), pp. 299–302).
In addition, the Centers for Disease
Control and Prevention (CDC) has
identified four core actions to prevent
antibiotic resistance (Frieden, Tom, et
al., Antibiotic Resistance Threats in the
United States, 2013, Centers for Disease
Control and Prevention (2013)). Those
four core actions are preventing
infections and the spread of those
infections, tracking or monitoring,
improving antibiotic prescribing and
stewardship, and developing new
medications and tests. The first three
actions are within the control of the
nursing home. Thus, we propose to
require that the IPCP incorporate
preventing and controlling infections
and communicable diseases, and an
antibiotic stewardship program, which
includes both antibiotic use protocols
and a system to monitor antibiotic use.
We believe these requirements will
improve antibiotic use by ensuring that
the residents who require antibiotics are
prescribed the appropriate antibiotics
for the medically necessary time. This
should reduce unnecessary antibiotic
use and the risk to residents from being
prescribed an unnecessary antibiotic or
an inappropriate antibiotic for an
inappropriate time. The surveillance
and prevention aspects of the LTC
facilities’ IPCP are crucial to the health
of the residents, as well as for
individuals who work or visit the
facility.
Based on our research, we propose to
revise the regulatory description of the
infection control program to: include
infection prevention, identification,
surveillance, and antibiotic
stewardship; require each facility to
periodically review and update its
program; require performance of an
analysis of their resident population and
facility; designate an infection
prevention and control officer(s) (IPCO);
integrate the IPCO with the facility’s
quality assurance and performance
improvement (QAPI) program; establish
written policies and procedures for the
IPCP; and provide the IPCO and facility
staff with education or training related
to the IPCP.
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Specifically, as part of our overall
reorganization of these regulations to
improve clarity, we propose to redesignate the provisions under existing
§ 483.65 as § 483.80. We propose to
modify the introductory language to
include infection prevention as well as
control and to clarify that the program
must help prevent the development and
transmission of communicable diseases
as well as infections. We propose to
revise paragraph (a) to read ‘‘Infection
prevention and control program’’ and
add new § 483.80(a)(1), (2) and (3) to
specify the elements of the IPCP. We
propose to require that the program
must follow accepted national
standards, be based upon the facility
assessment conducted according to
proposed § 483.70(e) and include, at a
minimum, a system for preventing,
identifying, reporting, investigating, and
controlling infections and
communicable diseases for all residents,
staff, volunteers, visitors, and other
individuals providing services under a
contractual arrangement. We would
require the facility to have written
standards, policies, and procedures for
the IPCP, including but not limited to,
a system of surveillance designed to
identify possible communicable disease
or infections before it can spread to
other persons in the facility; reporting
requirements for possible incidents of
communicable disease or infections;
standard and transmission-based
precautions to be followed to prevent
spread of infections; circumstances in
which generally, isolation should be
used for a resident; the circumstances
under which the facility must prohibit
employees with a communicable
disease or infected skin lesions from
direct contact with residents or their
food, if the contact is likely to transmit
the disease; and the hand hygiene
procedures to be followed by all staff as
indicated by accepted professional
practice. The facility would be required
to train staff related to the IPCP as
specified below in proposed § 483.95.
We are not proposing specific
requirements for the standard and
transmission-based precautions to be
followed to prevent the spread of
infections and isolation. Medical
science and our knowledge of infectious
agents are constantly improving. In
addition, we can expect that new
infectious agents will be identified in
the future. Facilities need the flexibility
to determine the appropriate care for
their residents who have infectious
agents, including whether isolation is
appropriate and the circumstances of
that isolation.
Antibiotics are one of the most
frequently prescribed medications in
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nursing homes. Antibiotics may account
for approximately 40 percent of the
drugs given in nursing homes (NAP, p.
216). It has been estimated that between
25 and 75 percent of antibiotic
prescriptions in nursing homes may be
inappropriate. This extensive use of
antibiotics results in the risk of not only
adverse drug reactions, but also the
development of antibiotic-resistant or
even multidrug resistant organisms
(MDROs). Thus, the inappropriate use of
antibiotics poses a significant risk to the
resident population (Smith, 2008). In
order to effectively address the problem
of healthcare-associated infections, a
LTC facility must have an effective IPCP
that includes antibiotic stewardship.
Therefore, we are proposing that the
facility’s IPCP must also include an
antibiotic stewardship program that
includes antibiotic use protocols and
systems for monitoring antibiotic use
and recording incidents identified
under the facility’s IPCP and the
corrective actions taken by the facility.
We further propose to add a new
paragraph (b) to require that the facility
designate an IPCO who is responsible
for the IPCP and who has received
specialized training in infection
prevention and control. While all staff
members should be responsible for
infection prevention and control, we
agree with the SHEA/APIC guidelines
that establish that an effective IPCP
should have a designated IPCO for
whom implementation and management
of the IPCP is a major responsibility. We
understand that infection control is
often assigned to a nurse who may have
other administrative or patient care
responsibilities. We want to allow
sufficient flexibility for facilities to
determine the qualifications of and the
time needed for an IPCO to devote to the
IPCP based on the facility assessment
but also ensure that an IPCO has the
time and other resources necessary to
properly develop, implement, monitor
and maintain the IPCP for the facility.
Thus we require that the IPCP be a
major responsibility for the individual
assigned as the facility’s IPCO. In
addition, while nurses and other
healthcare professionals may be likely
candidates for the IPCO role, many of
these professionals may have only
received training in basic infection
control practices in their core
professional preparation for licensure.
The responsibility and necessary
knowledge for an IPCP likely goes well
beyond basic infection control training.
Therefore, we propose to require that
the IPCO be a healthcare professional
with specialized training in infection
prevention and control beyond their
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initial professional degree. Considering
the diverse nature of the resident
population and of the healthcare
delivery model, the qualifications,
training, and time needed by an IPCO at
each facility would vary widely, thus
we are not at this time proposing more
specific requirements. We do, however,
solicit comment on the issue of IPCO
qualifications as well as the
requirements for an effective IPCP.
In new § 483.80(c), we propose to
require that the IPCO be a member of
the facility’s Quality Assessment and
Assurance (QAA) committee. While the
literature suggests and we agree that an
infection control committee is a good
idea, we are also mindful that many
nursing homes have limited staff and
that requiring an infection control
committee could be overly burdensome,
especially for small facilities. We
believe that requiring that the IPCO
work with the facility’s QAA committee,
which is responsible for implementing
the facility’s QAPI plan, as well as
coordinating and evaluating activities
under the QAPI plan, as discussed in
section II.S. of this preamble, would
achieve many of the same benefits. Thus
we do not propose to require that a
facility have an infection control
committee, only that the IPCO be a
member of the facility’s QAA committee
to ensure that the IPCO is an active
participant in the facility’s QAPI plan.
If a facility does have an infection
control committee, we would still
expect the IPCO to be a member of the
QAA committee.
We are also proposing to eliminate the
exception that is currently located at
§ 483.25(v), which provides that, based
on an assessment and practitioner
recommendation, a second
pneumococcal immunization could be
given after 5 years following the first
pneumococcal immunization, unless
medically contraindicated or the
resident or the resident’s legal
representative refuses the second
immunization. We are proposing to
remove this exception because it is no
longer the standard of care.
We also propose to add a new
§ 483.80(f) to require that the facility
review its IPCP annually and update the
program as necessary. Due to changes in
the issues and practice of infection
prevention and control and changes in
the facility itself, an annual update is
important to ensuring the effectiveness
of the IPCP.
We are proposing to relocate the
requirements for influenza and
pneumococcal immunizations from the
current § 483.25(n) to § 483.80(d). The
language in § 483.80(d) is identical to
the current § 483.25(n), except that we
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propose using the term ‘‘resident
representative’’ instead of ‘‘legal
representative.’’ We believe this is a
broader term and encompasses
individuals whom the resident has
personally identified as their
representative. A more detailed
discussion of this change is set forth in
Section II. ‘‘Provisions of the Proposed
Rule’’, B. Definitions.
Finally, we propose moving the
requirement concerning linens from the
current § 483.65(c) to the proposed
§ 483.80(e). Otherwise, the language is
identical.
V. Compliance and Ethics Program
(§ 483.85)
As noted previously, section 6102 of
the Affordable Care Act amended the
Act by adding new section 1128I.
Subsection 1128I(b) requires the
operating organizations for SNFs and
NFs to have in operation a compliance
and ethics program that is effective in
preventing and detecting criminal, civil,
and administrative violations under the
Act and in promoting quality of care
consistent with regulations developed
by the Secretary. The current
regulations governing SNFs and NFs at
§ 483.75(b) require these facilities to be
‘‘in compliance with all applicable
Federal, State, and local laws,
regulations, and codes, and with
accepted professional standards and
principles that apply to professionals
providing services in such a facility.’’ In
addition, according to § 483.75(c), SNFs
and NFs must be in compliance with
‘‘the applicable provisions of other HHS
regulations, including but not limited to
those pertaining to . . . fraud and abuse
(42 CFR part 455).’’ However, the
current regulations do not require that
SNFs and NFs have in place compliance
and ethics programs as required by the
Affordable Care Act.
In this proposed rule, we seek to
address how nursing facilities can best
establish internal controls, prevent
fraudulent activities, and promote
quality of care through these elements
as implementing written procedures and
standards of conduct, designating a
compliance officer, and other specific
requirements. This proposed rule would
require SNFs, NFs, and duallyparticipating SNF/NFs to have in place
an effective compliance and ethics
program that would require facilities to
use internal controls to more efficiently
monitor adherence to applicable
statutes, regulations, and program
requirements to deter, reduce, and
detect violations and promote quality of
care for nursing home residents. SNFs
and NFs must meet the requirements in
part 483 to participate in the Medicare
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and Medicaid programs and therefore,
we are proposing that the requirements
for effective compliance and ethics
programs as set forth in section 1128I of
the Act be incorporated into the SNF
and NF Requirements in Part 483.
Specifically, we are proposing to add a
new § 483.85 entitled, ‘‘Compliance and
ethics program’’.
Prior OIG Guidance
The DHHS Office of the Inspector
General (OIG) has issued several
industry-specific guidance documents
on compliance. In the March 16, 2000,
Federal Register (65 FR 14289), the OIG
published its ‘‘Final Compliance
Program Guidance for Nursing
Facilities’’ (herein after referred to as the
2000 OIG Guidance). In this guidance,
the OIG uses the term ‘‘nursing facility’’
to include SNFs and NFs that meet the
requirements of sections 1819 and 1919
of the Act, respectively. The OIG
guidance was intended to assist SNFs
and NFs in the development of
comprehensive compliance programs
that would promote facilities’ adherence
to applicable statutes and regulations in
the federal health care programs, as well
as meet private insurance program
requirements. It indicated that the
guidance was voluntary for nursing
homes and did not establish any
mandatory requirements. The OIG also
noted that compliance programs
promote a nursing home’s goals of
providing quality care to its residents
and enhancing operation functions, as
well as strengthen the government’s
efforts in preventing and reducing fraud
and abuse. The 2000 OIG Guidance
listed the following seven basic
elements that, at a minimum, should be
included in any effective
comprehensive compliance program:
• The development and distribution
of written standards of conduct, as well
as written policies, procedures and
protocols that promote the nursing
facility’s commitment to compliance
(for example, including adherence to the
compliance program as an element in
evaluating managers and employees)
and address specific areas of potential
fraud and abuse, such as claims
development and submission processes,
quality of care issues, and financial
arrangements with physicians and
outside contractors.
• The designation of a compliance
officer and other appropriate bodies (for
example, a corporate compliance
committee) charged with the
responsibility for developing, operating
and monitoring the compliance
program. The officers and committees,
report directly to the owner(s),
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governing body, and or chief executive
officers.
• The development and
implementation of regular, effective
education and training programs for all
affected employees.
• The creation and maintenance of an
effective line of communication
between the compliance officer and all
employees, including a process, such as
a hotline or other reporting system, to
receive complaints, and the adoption of
procedures to protect the anonymity of
complainants and protect whistleblowers from retaliation.
• The use of audits and other risk
evaluation techniques to monitor
compliance, identify problem areas, and
assist in the reduction of identified
problems.
• The development of policies and
procedures addressing the nonemployment or retention of excluded
individuals or entities and the
enforcement of appropriate disciplinary
action against employees or contractors
who have violated corporate or
compliance policies and procedures,
applicable statutes, regulations, or
federal, state, or private payer health
care program requirements.
• The development of policies and
procedures with respect to the
investigation of identified systemic
problems, which include direction
regarding the prompt and proper
response to detected offenses, such as
the initiation of appropriate corrective
action, repayments, and preventive
measures (see 65 FR 14291).
In the September 30, 2008 Federal
Register (73 FR 56832), the OIG
published additional guidance entitled,
‘‘OIG Supplemental Compliance
Program Guidance for Nursing
Facilities’’ (hereinafter referred to as the
‘‘2008 OIG Guidance’’). In this
supplemental guidance, the OIG again
indicated that the guidance was only a
recommendation and provided
voluntary guidelines to assist SNFs and
NFs. It noted that facilities should
regularly conduct periodic reviews of
the implementation and execution of
their compliance programs, such as on
an annual basis (73 FR 56848). It also
reiterated that the basic elements of a
compliance program include all of the
following:
• Designation of a compliance officer
and compliance committee.
• Development of compliance
policies and procedures, including
standards of conduct.
• Development of open lines of
communication.
• Appropriate training and teaching.
• Internal monitoring and auditing.
• Response to detected deficiencies.
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• Enforcement of disciplinary
standards.
Although the basic elements of an
effective compliance program listed in
the 2008 OIG guidance are more
concise, they appear to be essentially
the same as those provided in the
original 2000 OIG guidance to which the
supplemental guidance directs facilities
to review for further details on the
elements.
Comments Solicited in the September
23, 2010 Proposed Rule
Section 6401(a)(3) of the Affordable
Care Act, as amended by subsection
1304(1) of HCERA, established a new
paragraph 1866(j)(8) of the Act. This
paragraph requires that all providers of
medical or other items or services or
suppliers shall, as a condition of
enrollment in Medicare, Medicaid, or
the Children’s Health Insurance
Program (CHIP), establish a compliance
program that contains core elements to
be established by ‘‘the Secretary in
consultation with the Inspector General
[of DHHS].’’ SNFs and NFs are subject
to the compliance program requirements
under both section 6102 and section
6401(a) of the Affordable Care Act since
section 6401(a) of the Affordable Care
Act applies to all providers and
suppliers enrolling into the Medicare
and Medicaid programs, and CHIP.
In order to consider the view of the
industry stakeholders, on September 23,
2010, we published a proposed rule
entitled, ‘‘Medicare, Medicaid, and
Children’s Health Insurance Programs;
Additional Screening Requirements,
Application Fees, Temporary
Enrollment Moratoria, Payment
Suspensions and Compliance Plans for
Providers and Suppliers,’’ in the
Federal Register (75 FR 58204). In
section II.E. of that proposed rule, we
solicited public comments on
compliance program requirements that
are required by both sections 6102 and
6401(a) of the Affordable Care Act. We
listed the seven basic elements of an
effective compliance and ethics program
that were taken from Chapter 8 of the
U.S. Federal Sentencing Guidelines
Manual (75 FR 58228) and specifically
sought comments on those elements.
Some of the commenters were
supportive of using those elements as a
basis for the core elements of any
required compliance program for
Medicare, Medicaid, and CHIP. In
addition, a few commenters from the
healthcare industry indicated that they
had already incorporated at least some
of those elements into their existing
compliance programs. Only one of those
commenters appeared to be from the
nursing home industry. Some
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commenters expressed concerns about,
among other things, the use of those
elements, how compliance would be
evaluated, and how long they would be
given to get their compliance and ethics
programs in compliance with our
requirements.
The 2010 proposed rule was
published as a final rule with comment
period in the February 2, 2011 Federal
Register (76 FR 5862). In that final rule
with a comment period, we stated that
we did not intend to finalize any of the
compliance and ethics plan
requirements of sections 6102 and
7401(a) of the Affordable Care Act in
that final rule at that time. Rather, we
intended to propose both compliance
plan requirements in future rulemaking
(76 FR 5942). This proposed rule only
implements section 6102 of the
Affordable Care Act, which applies only
to SNFs and NFs. The requirements
under section 6401(a) of the Affordable
Care Act, which apply to all providers
and suppliers including SNFs and NFs,
will be addressed in separate
rulemaking at a later time. We will
consider this proposed and subsequent
final rule as we are developing the rule
for section 6401(a) of the Affordable
Care Act to ensure consistency.
We would like to express our
appreciation to all of the individuals
and groups that submitted comments in
response to our solicitation, which
greatly assisted us in developing this
proposed rule regarding the
requirements of section 6102 of the
Affordable Care Act. In addition to
reviewing the public comments
received, we have met with and will
continue to work with the OIG to
discuss the statutory provisions for
sections 6102 and 6401(a) of the
Affordable Care Act and the lessons the
OIG has learned about establishing
effective and comprehensive
compliance programs in general.
Proposed § 483.85(a) and § 483.85(b)
At proposed § 483.85(a), we would
define the terms ‘‘compliance and ethics
program,’’ ‘‘high-level personnel’’, and
‘‘operating organization.’’ We are
proposing to define ‘‘compliance and
ethics program’’ to mean with respect to
a facility, a program of the operating
organization that has been reasonably
designed, implemented, and enforced so
that it is effective in preventing and
detecting criminal, civil, and
administrative violations under the Act,
and in promoting quality of care; and
includes, at a minimum, the required
components specified in proposed
§ 483.85(c). We are proposing to define
‘‘high-level personnel’’ as individuals
who have substantial control over the
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operating organization or who have a
substantial role in the making of policy
within the operating organization. The
individuals considered ‘‘high-level
personnel’’ will differ according to each
operating organization’s structure.
However, some examples include, but
are not limited to, the following: (1) A
director; (2) an executive officer; (3) an
individual in charge of a major business
or functional unit; and (4) an individual
with a substantial ownership interest as
defined in section 1124(a)(3) of the Act
in the operating organization.
We do not propose using the term
‘‘managing employee’’ that is contained
in the current nursing home
requirements. Section 1126(b) of the Act
defines a managing employee as, ‘‘with
respect to an entity, an individual,
including a general manager, business
manager, administrator, and director
who exercises operational or managerial
control over the entity, or who directly
or indirectly conducts the day-to-day
operations of the entity.’’ In describing
the required components for the
compliance and ethics program in
section 1128I(b)(4) of the Act, the
Congress specifically used the term
‘‘high-level personnel.’’ The term ‘‘highlevel personnel’’ was also used in the
September 23, 2010 proposed rule that
solicited comments on, among other
things, the compliance and ethics
program requirements that are required
by section 6102 of the Affordable Care
Act. While the definition of ‘‘managing
employee’’ refers to an individual with
either operational or managerial control
over the entity or who directly or
indirectly conducts the day-to-day
operations of the entity, the proposed
definition of ‘‘high-level personnel’’
includes the term ‘‘substantial’’ and
adds someone who has ‘‘a substantial
role in the making of policy within the
operating organization.’’ We believe the
differences in these two terms clearly
convey our intention that only
individuals who exercise the greatest
control over the operating organization
are to have the overall responsibility
and oversee its compliance and ethics
program. Therefore, we propose to
retain the terminology used in the
Affordable Care Act and the former
proposed rule.
We are also proposing to define
‘‘operating organization’’ to mean the
individual(s) or entity that operates a
facility. Section 1128I(b)(1) of the Act
defines an ‘‘operating organization’’ as
‘‘the entity that operates the facility.’’
Although many nursing homes are part
of corporate chains, there are still some
nursing homes that are owned by an
individual or a small group of
individuals. Therefore, we added
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‘‘individual(s)’’ to the definition to make
it clear that all nursing homes,
regardless of their legal structure, are
required to comply with these
requirements.
In § 483.85(b), we propose that the
operating organization for each facility
must have in operation a compliance
and ethics program (as defined in
proposed § 483.85(a)) that meets the
requirements of this section beginning
on the date that is one year after the
rule’s effective date.
Proposed § 483.85(c)
In § 483.85(c), we propose that the
operating organization for each facility
be required to develop, implement, and
maintain an effective compliance and
ethics program that contains, at a
minimum, several components, which
we discuss below.
The operating organization would
have to establish written compliance
and ethics standards, policies, and
procedures to follow that are reasonably
capable of reducing the prospect of
criminal, civil, and administrative
violations under the Act and which
include, but are not limited to, the
designation of an appropriate
compliance and ethics program contact
to which individuals may report
suspected violations, as well as an
alternate method of reporting suspected
violations anonymously without fear of
retribution; and disciplinary standards
that set out the consequences for
committing violations for the operating
organization’s entire staff; individuals
providing services under a contractual
arrangement; and volunteers, consistent
with the volunteers’ expected roles
(proposed § 483.85(c)(1)).
We expect that each operating
organization would establish its own
written compliance and ethics
standards, policies, and procedures. We
also expect that each operating
organization’s standards, policies, and
procedures would include, among other
things, financial disclosure obligations,
conflicts of interest standards, and
requirements for promptly reporting any
abuse or neglect of a resident.
Additionally, within their program,
each operating organizations should
designate an appropriate compliance
and ethics program contact to which
individuals may report suspected
violations, as well as an alternate
method of reporting suspected
violations anonymously without fear of
retribution; and establish disciplinary
standards so that the operating
organization’s entire staff, individuals
providing services under a contractual
arrangement, and volunteers, consistent
with the volunteers’ expected roles, are
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clearly aware of the consequences of
program violations. We also expect that
these disciplinary standards would
promote consistent enforcement of the
operating organization’s program
through disciplinary mechanisms, as
required in proposed § 483.85(c)(7). We
acknowledge that there may be
instances when an individual who
chooses to report a suspected violation
anonymously may subsequently be
subject to discipline for not reporting
the suspected violation. Each operating
organization should be aware of this
possibility and address how it would be
handled in their program.
The operating organization would
assign specific individuals within the
high-level personnel of the operating
organization with the overall
responsibility to oversee compliance
with the operating organization’s
compliance and ethics program’s
standards, policies, and procedures,
such as, but not limited to, the chief
executive officer (CEO), members of the
board of directors, or directors of major
divisions in the operating organization
(proposed § 483.85(c)(2)).
The program would include
provisions ensuring that the specific
individuals designated with oversight
responsibility in proposed § 483.85(c)(2)
have sufficient resources and authority
to assure compliance with these
standards, policies, and procedures
(proposed § 483.85(c)(3)). The resources
devoted should include both human
and financial resources.
The operating organization would be
required to use due care not to delegate
discretionary authority to individuals
whom the operating organization knew,
or should have known through the
exercise of due diligence, had a
propensity to engage in criminal, civil,
or administrative violations under the
Act. (Proposed § 483.85(c)(4)). ‘‘Due
care’’ generally means the care that a
reasonable person would use under the
same or similar circumstances (see, e.g.,
https://thelawdictionary.org/due-care/
(accessed on April 17, 2015)). While the
degree of due care would vary
depending upon the circumstances, we
would expect that the operating
organization would apply the degree of
scrutiny commensurate with the level of
discretion being delegated to the
individual. For example, the level of
scrutiny applied to the compliance
officer should be much higher than the
level given to an employee who has
minimal discretionary authority over
the residents’ activities.
The operating organization would be
required to effectively communicate the
standards, policies, and procedures in
the operating organization’s compliance
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and ethics program to the operating
organization’s entire staff including
individuals providing services under a
contractual arrangement, and
volunteers, consistent with the
volunteers’ expected roles.
Requirements would include, but not be
limited to, mandatory participation in
training or orientation programs, and/or
dissemination of information that
explained in a practical manner what
was required under the program
(proposed § 483.85(c)(5)).
The compliance program would need
to ensure that reasonable steps were
being taken to achieve compliance with
the program’s standards, policies, and
procedures, such as utilizing monitoring
and auditing systems reasonably
designed to detect criminal, civil, and
administrative violations under the
Social Security Act by any of the
operating organization’s staff,
individuals providing services under a
contractual arrangement, or volunteers,
having in place and publicizing a
reporting system whereby any of these
individuals could report violations by
others anonymously within the
operating organization without fear of
retaliation, and having a process for
ensuring the integrity of any reported
data (proposed § 483.85(c)(6)).
The operating organization would be
required to enforce consistently the
operating organization’s standards,
policies, and procedures through
appropriate disciplinary mechanisms,
including, as appropriate, discipline of
individuals responsible for the failure to
detect and report a violation to the
appropriate party identified in the
operating organization’s compliance and
ethics program. An operating
organization would be required to
consistently enforce its standards and
procedures through appropriate
disciplinary mechanisms (proposed
§ 483.85(c)(7)).
After an operating organization
detected a violation, it would have to
ensure that all reasonable steps
identified in its program were taken to
respond appropriately to the violation
and, to prevent further similar
violations, including any necessary
modification to the operating
organization’s program to prevent and
detect criminal, civil, and
administrative violations under the Act
(proposed § 483.85(c)(8)).
The ‘‘reasonable steps’’ that should be
taken when a violation is detected
should be clearly identified in the
operating organization’s program. We
expect that the steps would differ
depending upon the size of the
operating organization, the position of
the individual reporting the violation,
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and possibly the type of violation. For
example, an operating organization’s
program may state that a staff member
should immediately notify their
immediate superior when he or she
detects a violation. However, if it is the
immediate superior or the operating
organization’s management whom the
staff member believes is committing the
violation, the staff member should have
an alternative process to report the
violation, such as, the Office of the State
Long-Term Care Ombudsman or other
appropriate agency or law enforcement
authority. In addition, the operating
organization’s program should include
those steps that are necessary to comply
with any mandatory reporting
requirements, such as those concerning
suspected resident neglect or abuse.
Under those circumstances, reporting to
an immediate supervisor or manager
may not be sufficient and the program
should clearly indicate how any
suspected neglect or abuse is to be
reported. We also expect that ethics
compliance would be a strong
component of each operating
organization’s program.
In sections 1128I(b)(3)(F) and (G) of
the Act, which correspond to proposed
§ 483.85(c)(7) and (8), the term
‘‘offense,’’ is used instead of
‘‘violation.’’ We believe that the terms
are used interchangeably. We have used
‘‘violations’’ throughout the proposed
regulatory text. The eight previously
described components would be
mandatory for all of the SNF and NF
operating organizations’ compliance and
ethics programs.
Proposed § 483.85(d)
In proposed § 483.85(d), we would
require operating organizations that
operate five or more facilities to
designate a compliance officer, and
require that such individuals be
designated as high-level personnel of
the operating organizations with the
overall responsibility to oversee the
compliance and ethics program. In
addition, the designated compliance
officer should report directly to the
governing body for the operating
organization. We believe this is
necessary to ensure that the compliance
officer is not unduly influenced by other
managers or executive officers, such as
the general counsel, chief financial
officer or chief operating officer. Thus,
we are proposing the compliance officer
should not be subordinate to the general
counsel, chief financial officer or the
chief operating officer. We considered
requiring all operating organizations to
designate a compliance officer.
However, some smaller operating
organizations may not have the staff to
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have one individual to whom the
compliance and ethics program could be
a major responsibility. However, it is
very important that there be an
individual that staff, as well as others,
may contact for questions or concerns
and to whom they could report
suspected violations. Therefore, we are
proposing that all operating
organizations designate a compliance
and ethics program contact. We
welcome comments on this issue.
In § 483.85(d), in addition to all of the
other requirements in proposed
§ 483.85(a), (b), and (c), we propose that
operating organizations that operate five
or more facilities must also include, at
a minimum, the following components
in their compliance and ethics program:
• A mandatory annual training
program on the operating organization’s
compliance and ethics program
(§ 483.85(d)(1)).
• A designated compliance officer for
whom the operating organization’s
compliance and ethics program is a
major responsibility (§ 483.85(d)(2)).
• Designated compliance liaisons
located at each of the operating
organization’s facilities (§ 483.95(d)(3)).
The compliance officer should be
among those individuals designated as
high-level personnel of the operating
organization with the overall
responsibility to oversee the operating
organization’s compliance and ethics
program as required by proposed
§ 483.85(c)(2). We also believe that the
compliance officer must have the
authority to raise compliance and ethics
issues directly with the Board of
Directors, President, CEO, and General
Counsel or their equivalents in the
operating organization. We have not
defined ‘‘major responsibility’’ in this
rule because we believe that operating
organizations must have flexibility in
designating their compliance officers.
The category of ‘‘five or more operating
organizations’’ encompasses small
chains of facilities with as few as five
nursing homes up to very large nursing
home chains with hundreds of nursing
homes. For some operating
organizations to have an effective
compliance and ethics program, they
will need a compliance officer who can
devote all of her or his time to the
program. However, some operating
organizations will have the resources to
have a dedicated individual whose sole
responsibility is the compliance and
ethics program and others will not. For
operating organizations that have
insufficient resources to appoint a
compliance officer whose sole
responsibility is the operating
organization’s program, we would
expect that the operating organization
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would ensure that the assigned
compliance officer has sufficient time
and other resources to fulfill all of his
or her responsibilities under the
operating organization’s compliance and
ethics program.
In selecting their designated
compliance officers, we also expect that
operating organizations would consider
potential conflicts of interest. For
example, if the compliance officer was
also the director of accounting, he or she
might have a conflict of interest if there
were an allegation of deliberate billing
errors. In addition, if the compliance
officer was also related to other highlevel personnel in the operating
organization, staff members might be
hesitant to report certain violations that
might involve the compliance officer’s
family members. Therefore, we expect
that operating organizations would take
appropriate action concerning any
actual or potential conflicts of interest
when selecting their compliance
officers. In addition, we believe that the
compliance officer should report
directly to the governing body.
The facility would be required to
designate compliance liaisons at each of
the operating organization’s facilities
(proposed § 483.85(d)(3)). We have not
provided a specific definition for a
‘‘designated compliance liaison’’ in this
rule. We believe that operating
organizations need to have flexibility in
defining these positions and their
responsibilities. We would expect that
operating organizations would develop
a description for these positions and the
duties and responsibilities these
individuals would have in the operating
organization’s compliance and ethics
program. At a minimum, these liaisons
should be responsible for assisting the
compliance officer with his or her
duties under the operating
organization’s program at their
individual facilities.
In addition to the additional elements
for operating organizations that operate
five or more facilities, as set out
previously in proposed paragraph (d),
we also anticipate that their programs
would be more formal. However, the
formality of these programs will be
addressed in other guidance, including
the interpretative guidelines, which will
be developed to provide more
instruction on how this rule should be
implemented after it is finalized.
We welcome comments on the
proposed additional requirements for
operating organizations with five or
more facilities and how to address the
formalizing of these programs. In
addition to the auditing and monitoring
systems described in proposed
§ 483.85(c), we also considered
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requiring periodic external audits
specifically focusing on financial
records and quality of care issues. We
would welcome comments on a
requirement for these types of audits or
any other additional requirements for
operating organizations that operate five
or more facilities.
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Proposed § 483.85(e)
Lastly, at § 483.85(e), we propose that
the operating organization for each
facility must review its compliance and
ethics program annually, and revise its
program, as needed to reflect changes in
all applicable laws or regulations and
within its organization and facilities to
improve its performance in deterring,
reducing, and detecting criminal, civil,
and administrative violations under the
Act and in promoting quality of care.
Laws, regulations, and administrative
requirements are subject to change.
Without an annual review, an operating
organization’s compliance and ethics
program could easily become out of
date. As an operating organization
becomes aware of changes in these
requirements, it should modify its
program to ensure it is current with
these requirements. Importantly, the
operating organization’s performance in
prior years should also be used to
improve its program. In addition, as an
operating organization revises its
program, it should ensure that those
changes are communicated to all of the
individuals identified in proposed
§ 483.85(c)(5).
In proposed § 483.85(a), we use the
term ‘‘reasonable’’ or ‘‘reasonably’’ in
the definition of a compliance and
ethics program and in three of the
proposed required components of the
program in proposed § 483.85(c)(1), (6)
and (8). These terms are used in the
Affordable Care Act legislation. We
would appreciate comments on how to
evaluate the reasonableness of the
design, implementation, and
enforcement of an operating
organization’s compliance and ethics
program and how to determine the
reasonableness of the steps an operating
organization has taken to achieve
compliance with its standards and the
steps an operating organization should
take in response to offenses and prevent
similar occurrences.
W. Physical Environment (§ 483.90)
The physical environment of a
nursing facility is integral to the
resident’s health and safety. Therefore,
the facility must be designed,
constructed, equipped, and maintained
to protect the health and safety of
residents, personnel and the public.
Many of these provisions relate to Life
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Safety Code (LSC) requirements. We
have recently published a proposed rule
which would adopt many provisions of
the 2012 LSC ‘‘Medicare and Medicaid
Programs; Fire Safety Requirements for
Certain Health Care Facilities,’’ 79 FR
21552, April 16, 2014. Those
requirements have been or are being
addressed in separate rule-making and
we are not proposing any substantial
changes or revisions. As part of our
comprehensive review and
restructuring, we propose to redesignate the existing provisions of
§ 483.70 as new § 483.90; however, the
language in existing § 483.70(a) ‘‘Life
safety from fire’’ and § 483.70(b)
‘‘Emergency power’’ would be
unchanged, including new provisions
related to the requirement that long term
care facilities have automatic sprinkler
systems added by the final rule
‘‘Medicare and Medicaid Programs;
Regulatory Provisions to Promote
Program Efficiency, Transparency, and
Burden Reduction, Part II’’ published in
the Federal Register on May 12, 2014
(79 FR 27106). In new § 483.90(c)
‘‘Space and equipment’’, we propose to
add the resident’s individual
assessment, including preferences and
choices, as an element to consider in
addition to the resident’s plan of care
when considering the space and
equipment requirements of the facility.
While this assessment is considered in
developing the resident’s plan of care,
we believe including it separately for
consideration will help avoid any gaps
in the facility’s ability to provide
required services based on space and
equipment needs and help ensure
person-centeredness. We propose to
eliminate the word ‘‘essential’’ from
new § 483.90(c)(2) (re-designated from
§ 483.70(c)(2)), as we believe that all
equipment the resident may be exposed
to, whether it is deemed essential or not,
must be maintained in safe operating
condition in order to ensure resident
safety. In addition, we propose to add a
new § 483.90(c)(3) to specifically require
that facilities conduct regular
inspections of all bed frames,
mattresses, and bed rails and to ensure
that bed rails are compatible with the
bed frame and mattress. As noted
earlier, bed rails can pose a significant
entrapment hazard, so ensuring that
they are used safely warrants explicit
reference here.
Currently, in existing § 483.70(d), the
regulations allow for bedrooms that
accommodate up to four residents. We
believe that this number of residents per
room is inconsistent with current
common practice, is not personcentered nor supportive of achieving the
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42221
resident’s highest practicable mental,
physical and psychosocial well-being
and is not an environment that
promotes maintenance or enhancement
of each resident’s quality of life.
Therefore, we propose to require in new
§ 483.90(d)(1)(i) that, bedrooms in
facilities accommodate not more than
two residents unless the facility is
currently certified to participate in
Medicare and/or Medicaid or has
received approval of construction or
reconstruction plans by state and local
authorities prior to the effective date of
this regulation. Reconstruction means
that the facility undergoes
reconfiguration of the space such that
the space is not permitted to be
occupied, or the entire building or an
entire occupancy within the building,
such as a wing of the building, is
modified. We believe that semi-private
rooms are far more supportive of
privacy and dignity. While a facility is
not a permanent home for all of its
residents, this provision is particularly
critical for those residents whose only
home is the nursing facility. We
considered, but did not propose to
require private rooms. We note that
many states have physical environment
requirements that exceed our
requirements. These requirements vary
widely, but many include a requirement
for no more than two beds per resident
room or establish a minimum
percentage of rooms that must be private
or semi-private. Proposed § 483.90(d)
also would require that the bed size and
height be not only convenient for the
resident’s needs, but also safe. The Food
and Drug Administration (FDA) reports
that between Jan 1, 1985 and January 1,
2013, it received 901 incidents of
patients caught, trapped, entangled, or
strangled in hospital beds. Most patients
were frail, elderly or confused. (see
https://www.fda.gov/medicaldevices/
productsandmedicalprocedures/
generalhospitaldevicesandsupplies/
hospitalbeds/default.htm). Therefore,
we believe that bed safety should be an
explicit consideration for facilities.
Guidance for facilities as well as other
information related to bed safety is
available from FDA, which issued, on
March 10, 2006, its ‘‘Hospital Bed
System Dimensional and Assessment
Guidance to Reduce Entrapment.’’
(https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/ucm072662.htm).
Section 483.70(e) currently requires that
each bedroom be equipped with or
located near toilet and bathing facilities.
We propose in new § 483.90(e) to add
the requirement that, for facilities that
receive approval of construction or
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reconstruction plans by State and local
authorities or are newly certified to
participate in Medicare and/or Medicaid
after the effective date of this rule, each
resident room must have its own
bathroom equipped with at least a toilet,
sink and shower. In addition, we
propose that if a facility undergoes
reconstruction, each resident room in
the reconstructed space must have its
own bathroom equipped with at least a
toilet, sink and shower. Reconstruction
means that the facility undergoes
reconfiguration of the space such that
the space is not permitted to be
occupied, or the entire building or an
entire occupancy within the building,
such as a wing of the building, is
modified. We understand that this is
common in new construction, and we
believe it is important to ensure that
residents can achieve their highest
practicable mental, physical and
psychosocial well-being and maintain
self-respect and dignity. Further, we
expect that this will ease care delivery.
Ensuring facilities in each room may
minimize staff time and effort to assist
residents to and from the bathroom,
reduce the likelihood of avoidable
incontinence episodes, and enhance the
facility’s ability to effectively implement
toileting protocols for residents who are
good candidates for these interventions.
Proposed § 483.90(f), re-designated
from § 483.70(f), requires a resident call
system. The intent of this provision is
to ensure that a resident can easily call
for assistance in his or her room or
bathroom. This is a critical safety issue.
The existing language refers to a
‘‘nurse’s station.’’ This language may, in
many cases, be outdated. Therefore, we
propose to require that the facility must
be adequately equipped to allow
residents to call for staff assistance
through a communication system which
relays the call directly to a staff member
or to a centralized staff work area from
the resident’s bedside, toilet and bathing
facilities. This provides flexibility that
will be supportive of innovation in care
delivery and still provide the elements
necessary for resident needs and safety.
Proposed § 483.90(g), re-designated
from § 483.70(g) addresses dining and
activity rooms and includes a
requirement to designate non-smoking
areas. We propose to eliminate the
language ‘‘with non-smoking areas
identified’’, as it is inconsistent with
current practice. Many, if not all, states
have specific requirements related to the
permissibility of smoking in healthcare
facilities and related issues. In current
practice, facilities are likely to be nonsmoking facilities or may have
designated smoking areas. Therefore, we
propose to add a new paragraph (h)(5)
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to new § 483.90(h) that would require
facilities to establish policies, in
accordance with applicable federal,
state and local laws and regulations,
regarding smoking, including tobacco
cessation, smoking areas and safety,
including but not limited to nonsmoking residents. The inclusion of a
tobacco cessation policy is consistent
with the recommendations of the U.S.
Preventive Services Task Force (https://
www.uspreventiveservicestaskforce.org/
Page/Document/UpdateSummaryDraft/
tobacco-use-in-adults-and-pregnantwomen-counseling-andinterventions1?ds=1&s=Smoking) as
well as the National Strategy for Quality
Improvement in Health Care (https://
www.ahrq.gov/workingforquality/
about.htm). Smoking cessation, even
among older, frail adults, produces
significant health and quality of life
benefits (Cataldo, JK. J Gerontol Nurs,
2007 Aug; 33(8):32–41). While we
would expect that, when appropriate,
tobacco cessation would be a matter to
be discussed between a resident and his
or her primary care provider and to be
addressed in a resident’s care plan,
based on the individual’s preferences
and goals of care, we believe that
including the overarching policy within
the facility policy related to smoking
would be beneficial.
X. Training Requirements (§ 483.95)
We are proposing to add a new
§ 483.95 to subpart B that would set
forth training requirements. We propose
that a facility must develop, implement,
and maintain an effective training
program for all new and existing staff;
individuals providing services under a
contractual arrangement; and
volunteers, consistent with their
expected roles. We also propose that a
facility be required to determine the
amount and types of training necessary
based on a facility assessment as
specified at § 483.70(e). We encourage
facilities to take advantage of the many
free or low cost resources available to
them. Various resources and training
materials are available at https://
www.nhqualitycampaign.org.
Communication Training
We propose at § 483.95(a) to include
effective communications as a required
training topic for direct care personnel.
Effective communication has been
identified as important in reducing
unnecessary hospitalizations as well as
for improving a nursing home resident’s
overall quality of life and quality of
care. Breakdowns in communications
are a known contributor to adverse
events of all types. CMS noted in its
2012 Nursing Home Action Plan that
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critical information often is not
communicated from one set of providers
to another during a care transition.
According to the Agency for Health
Research and Quality, detecting and
promptly reporting changes in a nursing
home resident’s condition are critical
for ensuring the resident’s well-being
and safety. These changes may represent
a patient safety problem, and they can
be a signal that the resident is at
increased risk for falling, medication
errors, and other complications.
Training all nursing home staff,
particularly direct care staff, to be on the
lookout for changes in a resident’s
condition and to effectively
communicate those changes is one tool
LTC facilities can employ to improve
patient safety, create a more personcentered environment, and reduce the
number of adverse events or other
resident complications. AHRQ offers
training materials to train front line
personnel in nursing homes in effective
communications (Improving Patient
Safety in Long-Term Care Facilities:
Training Modules. AHRQ Publication
No. 12–0001. July 2012. Agency for
Healthcare Research and Quality,
Rockville, MD. https://www.ahrq.gov/
qual/ptsafetyltc/). AHRQ’s
TeamSTEPPS® Long Term Care Version
is a training program to enhance
communication for front line staff in
nursing homes. (https://www.ahrq.gov/
professionals/education/curriculumtools/teamstepps/longtermcare).
AHRQ’s On-Time Pressure Ulcer
Prevention program provides training
for nursing homes with an EHR to use
the EHR to improve communications of
changes in residents’ pressure ulcer risk
factors to help staff intervene earlier.
(www.ahrq.gov/professionals/systems/
long-term-care/resources/on-time/
qualityimprov/). An
evaluation of nursing homes in New
York State showed a reduction of 59%
in the incidence of pressure ulcers that
integrated 3 EHR pressure ulcer risk
reports into day-to-day workflow.
(Olsho, L., Spector, W., Williams, C. et
al. Evaluation of AHRQ’s On-Time
Pressure Ulcer Prevention Program: A
Facilitator-assisted Clinical Decision
Support Intervention for Nursing
Homes. Medical Care 2014
Mar;52(3):258–66.) In an analysis of
interviews of direct care workers,
communication and teamwork were also
identified as important in delirium
prevention and appropriate
management (Peacock, R., Hopton, A.,
Featherstone, I., & Edwards, J. (2012).
Care home staff can detect the difference
between delirium, dementia and
depression. Nursing Older People, 24(1),
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26–30.) Finally, enhanced
communication skills can have a
positive impact on job satisfaction and
turnover, factors that can also impact
resident care (Rubin, G., Balaji, R. V., &
Barcikowski, R. (2009). Barriers to
nurse/nursing aide communication: the
search for collegiality in a southeast
Ohio nursing home. Journal of Nursing
Management, 17(7), 822–832.
doi:10.1111/j.1365–2834.2008.00913.x)
We are not proposing to require a
specific amount of time, specific
communications topics, or specific
training mechanisms to meet this
requirement. While we believe
communications training is vital, we
also believe that each facility should
have the flexibility to determine, based
on its internal facility assessment and
competencies and skill sets needed for
employees, how to structure training to
meet its specific needs. We also
recognize that training needs are likely
to change over time. The specific
communications training may even vary
within the facility, based on its aspects
of care and service. We also note that
states may have their own requirements,
at the facility or professional levels that
already require training. We have,
therefore, only proposed this as a
training topic that must be incorporated
into a facility’s ongoing training
expectations for all employees. We
welcome comments on whether or not
more specific requirements are
necessary.
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Resident’s Rights Training
We propose at § 483.95(b) to require
that facilities train staff members on the
rights of the resident and the
responsibilities of a LTC facility to
properly care for its residents as set
forth at § 483.10 and § 483.11,
respectively. We believe that it is
necessary to ensure that direct care
workers are trained to recognize when
treatment is abusive or constitutes
neglect or exploitation. We also believe
that training in these areas is likely to
reduce incidents. In addition, the
effective training of staff on the
requirements for participation is likely
to have a positive effect on the operation
of a facility.
Abuse, Neglect, and Exploitation
Training
At § 483.95(c) we propose to require
that a facility provide training to its staff
on the freedom from abuse, neglect, and
exploitation requirements found in
§ 483.12. We propose to specify that
facilities must provide training to their
staff that at a minimum educates staff on
activities that constitute abuse, neglect,
exploitation, and misappropriation of
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resident property and procedures for
reporting incidents of abuse, neglect,
exploitation, or the misappropriation of
resident property. We believe that in
order for staff to be proactive and
prevent these types of incidents, they
must first be educated on what they are
and how to report them. We believe that
requiring this training would not only
educate a facilities staff, but would also
improve operations and increase the
level of accountability for staff
members.
Quality Assurance and Performance
Improvement Training
At § 485.95(d), we propose to require
that a facility must provide mandatory
QAPI training to its staff. This training
would outline the elements and goals of
the facility’s QAPI program. All facility
staff should be aware of what a QAPI
program entails and how the facility
intends to implement and monitor their
program. Given that a facility’s QAPI
program is meant to encompass input
from facility staff, it is imperative that
staff members are adequately trained on
the elements of the facility’s QAPI
program.
Infection Control Training
As discussed earlier, HAIs result in
considerable suffering to nursing home
residents and considerable costs to the
healthcare system. Therefore, at
§ 483.95(e) we propose to require LTC
facilities to include staff training as part
of their efforts to prevent and control
infection. It would be the facility’s
responsibility to ensure that their staff
was effectively educated on the facility’s
infection control policies and
procedures.
Compliance and Ethics Training
At § 483.95(f)(1), we propose that the
operating organization for each facility
must include as part of their compliance
and ethics program training for staff that
outlines the standards, policies, and
procedures. We do not specify how a
facility should develop this training;
however the training must explain in a
practical manner the requirements
under the compliance and ethics
program. In addition, at § 483.95(f)(2)
we propose to require that if the
operating organization operates five or
more facilities, it must include
mandatory training annually.
Required In-Service Training for Nurse
Aides
The Need for Nurse Aide Training in
Dementia Management
Dementia among nursing home
residents is prevalent and increasing.
According to the Certification and
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Survey Provider Enhanced Reports
(CASPER) data, in June 2009, 47 percent
of all nursing home residents had a
diagnosis of Alzheimer’s or other
dementia in their nursing home record.
The Alzheimer’s Association noted in a
report entitled, ‘‘2010-Alzheimer’s
Disease Facts and Figures,’’ at https://
www.alz.org/documents_custom/report_
alzfactsfigures2010.pdf that the number
of Americans surviving into their 80s
and 90s and beyond is expected to grow
dramatically due to advances in
medicine and medical technology, as
well as social and environmental
conditions. Since the incidence and
prevalence of Alzheimer’s disease and
other dementias increase with age, the
number of people with these conditions
will also grow rapidly. The Alzheimer’s
Association also noted in the report that
two-thirds of those dying with dementia
die in nursing homes, compared with 20
percent of cancer patients and 28
percent of residents dying from all other
conditions in nursing homes.
According to the OIG in a 2002 report
entitled, ‘‘Nurse Aide Training,’’ (OEI–
05–01–00030), 63 percent of the nursing
home supervisors interviewed said that
training has not kept pace with the care
demands imposed by current resident
diagnoses. Many of these supervisors
pointed out that they are seeing more
combative and violent residents. Many
supervisors and nurse aides stated that
nurse aides need more training in caring
for residents with behavioral and
cognitive disorders, such as Alzheimer’s
disease. Also, six state Nurse Aide
Training Competency Evaluation
Program (NATCEP) directors
specifically emphasized the need for
more training in caring for residents
with cognitive disorders.
According to a September, 2008
report prepared for CMS entitled,
‘‘Improving Nurse Aide Training,’’ by
Abt Associates, Inc. (Contract #500–95–
0062/TO#3), studies have shown that
educational programs are more likely to
be successful when the education is
ongoing. Students are also more
receptive to new information that is
relevant to their current work
environment, rather than information
that is presented during the initial
training. This report suggests that
ongoing training in dementia
management and abuse prevention, in
addition to the already-required initial
training, would be valuable.
Based on the information included in
these reports, we believe that ongoing
training in dementia management and
abuse prevention for NAs is necessary
and could enhance the overall quality of
care that residents receive in LTC
facilities.
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The Need for Nurse Aide Training in
Abuse Prevention
Based on CASPER data for 2007–
2009, nursing homes received 3,124
citations for abuse and mistreatment of
residents. In 2003, State Long-Term Care
Ombudsman programs nationally
investigated 20,673 complaints of abuse,
gross neglect, and exploitation on behalf
of nursing home and board and care
residents. Among the types of abuse
categories, physical abuse was the most
common type reported.
A GAO report entitled, ‘‘More Can Be
Done to Protect Residents from Abuse,’’
((GAO–02–312) March 1,2002 https://
www.gao.gov/newitems/do2312.pdf)
revealed that experts who have
conducted studies on the issue of
physical and sexual abuse of nursing
home residents have reported that abuse
is a serious problem with potentially
devastating consequences. Nursing
home residents have suffered serious
injuries or, in some cases, have died as
a result of abuse.
A report by the National Association
of State Units on Aging, published in
2005, entitled, ‘‘Nursing Home Abuse
Risk Prevention Profile and Checklist’’
concluded that understaffing and
inadequate training of NAs are major
causes of abuse, especially for
individuals with dementia.
The Center for Advocacy Rights and
Interests (CARIE) reports on their Web
site (https://www.carie.org/programsservices/for-provider-professionals/
abuse-prevention/) the results of a
research study conducted by Beth
Hudson Keller, Director of Education
and Training at the Philadelphia CARIE,
and Dr. Karl Pillemer, Associate
Professor at Cornell University, on
nursing home abuse. The research
showed that nursing assistants in 10
Philadelphia-area nursing homes selfreported abusive behaviors over a onemonth period. During this period,
• 51 percent reported yelling at a
resident in anger;
• 23 percent insulted or swore at a
resident;
• 8 percent threatened to hit or throw
something at a resident;
• 17 percent excessively restrained a
resident;
• 2 percent had slapped a resident;
and
• 1 percent had kicked or hit a
resident with a fist
CARIE believes that training helps to
increase staff awareness of abuse and
neglect and potentially abusive
situations. In addition, training equips
workers with appropriate conflict
intervention strategies and reduces
incidents of abuse and neglect in LTC
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settings, thus improving the quality of
life for residents.
According to the National Center on
Elder Abuse (NCEA), training can,
among other things, enable NAs to build
confidence and develop skills in
defusing volatile situations, alert them
to the penalties for abuse, and help NAs
cope with the stresses that are
associated with care giving. Also, as
stated above, the 2008 Abt Report
suggested that ongoing NA training in
abuse prevention should result in fewer
instances of resident abuse.
Section 6121 of the Affordable Care
Act added sections 1819(f)(2)(A)(i)(1)
and 1919(f)(2)(A)(i)(1) of the Act. These
sections require all NAs to receive ongoing training in both dementia
management and patient abuse
prevention training, ‘‘if the Secretary
determines appropriate.’’ While all NAs
currently receive initial training by the
states in dementia management and
abuse prevention, the regulation does
not require that training be provided by
LTC facilities to all NAs during their
annual 12 hours of in-service training.
However, since NAs are the primary
caregivers in LTC facilities, we believe
ongoing training of NAs is critical to
prevent abuse of patients and to ensure
NAs can provide appropriate care for
residents particularly those individuals
suffering from dementia. As discussed
previously, various studies and reports
have indicated that these areas need
improvement.
We are proposing to amend the LTC
requirements by requiring the current
mandatory on-going training
requirements for NAs include dementia
management and resident abuse
training. LTC facilities are required at
existing § 483.75(e)(8) to complete a
performance review of every NA at least
once every 12 months, and facilities
must provide regular in-service
education based on the outcome of these
reviews. The in-service training must be
sufficient to ensure the continuing
competence of NAs, and must be no less
than 12 hours per year. The training
must address areas of weakness, as
determined in the NA’s performance
reviews and may address the special
needs of residents as determined by the
facility staff. The existing requirement at
§ 483.75(e)(8)(iii) requires NAs that
provide services to individuals with
cognitive impairments to receive inservice training to address the care of
the cognitively impaired.
We propose to relocate these training
requirements for CNAs at § 483.75(e)(8)
to proposed § 483.95(g). Specifically, we
propose to re-designate existing
§ 483.75(e)(8)(i), (ii), and (iii) to
§ 483.95(g)(1), (3), and (4), respectively.
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At § 483.95(g)(2), we propose to add the
new requirement that the 12 hours of
annual in-service training for NAs must
include dementia management and
abuse prevention training. Also, at
newly redesignated § 483.95(g)(3), we
propose to add to the existing
requirement that the in-service training
address areas of weakness as
determined by a facility’s assessment at
§ 483.70(e). We note that states have the
option of requiring additional hours of
in-service training, as they deem
appropriate. According to the 2008 Abt
report, ‘‘Improving Nurse Aide
Training’’, with regard to ongoing
training, only four states required more
than 12 annual in-service hours. Florida
required 18 hours and Alaska,
California, and Oklahoma required 24
hours.
Since we are proposing that these four
additional topics be addressed within
the current in-service training
requirement, we would like to solicit
comments on whether it would be
beneficial to require additional ongoing
hours to accommodate this training. As
discussed in the 2008 report by the Abt
Associates, ‘‘Improving Nurse Aide
Training,’’ based on analyses of surveys
of NAs, NATCEP directors, and nursing
home administrators, the report
concluded, that there was no evidence
that additional hours resulted in better
quality care or outcomes for residents.
The report also concluded that simply
adding more training hours without
evaluating the efficacy of the training
would yield very little return on
investment. Therefore, we are
requesting public comment, including
the results of any additional studies that
would support an increase in the
required hours for in-service training
above the currently required 12 hours.
Training for Feeding Assistants
Current regulations at § 483.75(q)
require facilities to only employ as a
paid feeding assistant those individuals
who have successfully completed a state
approved training program, as specified
in § 483.160. We propose to relocate this
provision without change to proposed
§ 483.95(h).
Behavioral Health Training
We propose at § 483.95(i) to require
that facilities provide behavioral health
training to its entire staff, based on the
facility assessment at § 483.70(e). As
required at § 483.70(e), the facility
would be responsible for using their
facility assessment to determine the
behavioral health related needs of their
residents. Then the facility would
ensure that their staff is provided with
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behavioral health training that correlates
with the needs of their residents.
III. Long-Term Care Facilities
Crosswalk
The table below shows the crossreferences between the current sections
to the proposed. We also note that we
42225
have made conforming changes that
would revise any cross-references to
part 483 in title 42 that would change
due to the reorganization of subpart B in
this proposed rule.
TABLE A—TITLE 42 CROSS-REFERENCES TO PART 483 SUBPART B
Existing CFR Section
Title
Action
§ 483.1 ...........................................
Revised .........................................
§ 483.1.
Re-designated ..............................
§ 483.5 in alphabetical order.
Re-designated & revised ..............
Re-designated ..............................
§ 483.5 in alphabetical order.
§ 483.5 in alphabetical order.
§ 483.10 .........................................
§ 483.10(a)(1) ................................
§ 483.10(a)(2) ................................
§ 483.10 (a)(3) ...............................
§ 483.10 (a)(4) ...............................
§ 483.10 (b)(1) ...............................
§ 483.10(b)(2) ................................
§ 483.10(b)(3) ................................
§ 483.10 (b)(4) ...............................
§ 483.10(b)(5) ................................
§ 483.10 (b)(6) ...............................
§ 483.10(b)(7) ................................
§ 483.10(b)(8) ................................
§ 483.10(b)(9) ................................
§ 483.10(b)(10) ..............................
§ 483.10(b)(11) ..............................
§ 483.10(b)(12) ..............................
§ 483.10(c)(1) ................................
§ 483.10(c)(2) ................................
§ 483.10(c)(3) ................................
§ 483.10(c)(4) ................................
§ 483.10(c)(5) ................................
§ 483.10(c)(6) ................................
§ 483.10(c)(7) ................................
§ 483.10(c)(8) ................................
§ 483.10(d) ....................................
§ 483.10(d)(1) ................................
§ 483.10(d)(2) ................................
§ 483.10(d)(3) ................................
§ 483.10(e) ....................................
§ 483.10(e)(1) ................................
§ 483.10(e)(2) ................................
§ 483.10(e)(3) ................................
§ 483.10(e)(3)(i) .............................
§ 483.10(e)(3)(ii) ............................
§ 483.10(f) .....................................
§ 483.10(f)(1) .................................
§ 483.10(f)(2) .................................
§ 483.10(g) ....................................
§ 483.10(g)(1) ................................
§ 483.10(g)(2) ................................
§ 483.10(h) ....................................
§ 483.10(h)(1) ................................
§ 483.10(h)(2) ................................
§ 483.10(h)(2)(i)–(iv) ......................
§ 483.10(i) .....................................
§ 483.10(i)(1) .................................
§ 483.10(i)(2) .................................
Basis and Scope ..........................
(a)
(a) Facility defined ........................
(b) Distinct part.
(c) Composite distinct part.
(d) Common area .........................
(e) Fully sprinklered ......................
(f) Major modification.
Resident rights ..............................
(a) Exercise of rights ....................
(a) Exercise of rights ....................
.......................................................
.......................................................
(b) Notice of rights and services ..
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(c) Protection of resident funds ....
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(d) Free choice .............................
.......................................................
.......................................................
.......................................................
(e) Privacy and confidentiality ......
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(f) Grievances ...............................
.......................................................
.......................................................
(g) Examination of survey results
.......................................................
.......................................................
(h) Work ........................................
.......................................................
.......................................................
.......................................................
(i) Mail ...........................................
.......................................................
.......................................................
Revised .........................................
No change ....................................
Revised .........................................
Re-designated and revised ..........
Re-designated and revised ..........
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Revised .........................................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
Re-designated ..............................
Re-designated ..............................
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
§ 483.10(j)(1) .................................
§ 483.10(j)(1)(i)–(vi) .......................
§ 483.10(j)(1)(vii) ...........................
§ 483.10(j)(1)(viii) ..........................
§ 483.10(j)(2) .................................
§ 483.10(j)(3) .................................
§ 483.10(k) ....................................
§ 483.10(l) .....................................
(j) Access and visitation rights .....
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(k) Telephone ...............................
(l) Personal property .....................
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
§ 483.10.
§ 483.10(a)(2).
§ 483.10(a)(2).
§ 483.10(a)(4).
§ 483.10(a)(3).
§ 483.11(e)(9).
§ 483.10(f)(3).
§ 483.10(b)(1).
§ 483.10(b)(4).
§ 483.11(e)(10).
483.11(e)(11).
483.11(e)(12).
§ 483.11(e)(5)(i)–(v).
§ 483.11(c)(1).
§ 483.11(e)(6).
§ 483.11(e)(7).
§ 483.11(e)(8).
§ 483.10(e)(9), § 483.11(d)(5).
§ 483.11(d)(5)(i).
§ 483.11(d)(5)(ii).
§ 483.11(d)(5)(iii).
§ 483.11(d)(5)(iv).
§ 483.11(d)(5)(v).
§ 483.11(d)(5)(vi).
§ 483.11(d)(6).
§ 483.10(c).
§ 483.10(c).
§ 483.10(b).
§ 483.10(a)(4)(iv), § 483.10(b)(5).
§ 483.10(g).
§ 483.10(g)(2).
§ 483.10(g)(4).
§ 483.10(g)(4).
§ 483.10(g)(4).
§ 483.10(g)(4).
§ 483.10(j).
§ 483.10(j)(1).
§ 483.10(j)(2).
§ 483.10(f)(4).
§ 483.10(f)(4)(i), § 483.11(e)(3).
§ 483.10(f)(4)(ii).
§ 483.10(e)(8).
§ 483.10(e)(8).
§ 483.10(e)(8), § 483.11(d)(4).
§ 483.11(d)(4)(i)–(iv).
§ 483.10(g)(1) & (h)(3).
§ 483.10(g)(1), § 483.11(f)(1)(i).
§ 483.10(h)(3)(ii),
§ 483.11(e)(14)(iii).
§ 483.10(e)(3), § 483.11(d)(1).
§ 483.11(d)(1)(i)(A)–(F).
§ 483.11(d)(1)(ii).
§ 483.11(d)(1)(iii).
§ 483.11(d)(1)(iv).
§ 483.11(f)(3).
§ 483.10(h)(1).
§ 483.10(d)(2).
§ 483.5(a)–(c) ................................
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§ 483.5 (d) .....................................
§ 483.5(e) ......................................
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& revised ..............
& revised ..............
& revised ..............
& revised ..............
..............................
& revised ..............
& revised ..............
& revised ..............
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TABLE A—TITLE 42 CROSS-REFERENCES TO PART 483 SUBPART B—Continued
Existing CFR Section
Title
§ 483.10(m) ...................................
§ 483.10(n) ....................................
§ 483.10(o)(1)–(2) .........................
§ 483.12(a) ....................................
(m) Married couples .....................
(n) Self-Administration of Drugs ...
(o) Refusal of certain transfers .....
Admission, transfer and discharge
rights (a) Transfer and discharge.
(1) Definition: ................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(b) Notice of bed-hold policy and
readmission.
.......................................................
.......................................................
.......................................................
(c) Equal access to quality care ...
.......................................................
.......................................................
(d) Admissions policy ...................
.......................................................
.......................................................
.......................................................
Resident behavior and facility
practices. (a) Restraints.
(b) Abuse ......................................
(c) Staff treatment of residents .....
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
Quality of life .................................
(a) Dignity .....................................
(b) Self-determination and participation.
.......................................................
.......................................................
.......................................................
(c) Participation in resident and
family groups groups.
.......................................................
.......................................................
.......................................................
(d) Participation in other activities
(e) Accommodation of needs .......
.......................................................
.......................................................
(f) Activities ...................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(g) Social Services .......................
.......................................................
(3) Qualifications of social worker
(h) Environment ............................
.......................................................
.......................................................
§ 483.12(a)(1) ................................
§ 483.12(a)(2) ................................
§ 483.12(a)(2)(i)–(vi) ......................
§ 483.12(a)(3) ................................
§ 483.12(a)(3)(i) .............................
§ 483.12(a)(3)(ii) ............................
§ 483.12(a)(4)(i)–(iii) ......................
§ 483.12(a)(5)(i) .............................
§ 483.12(a)(5)(ii)(A)–(E) ................
§ 483.12(a)(6)(i)–(vii) .....................
§ 483.12(a)(7) ................................
§ 483.12(a)(8) ................................
§ 483.12(a)(9) ................................
§ 483.12(b)(1)(i)–(ii) .......................
§ 483.12(b)(2) ................................
§ 483.12(b)(3)(i)–(ii) .......................
§ 483.12(b)(4) ................................
§ 483.12(c)(1) ................................
§ 483.12(c)(2) ................................
§ 483.12(c)(3) ................................
§ 483.12(d)(1) (i)–(ii) .....................
§ 483.12(d)(2) ................................
§ 483.12(d)(3) (i)–(ii) .....................
§ 483.12(d)(4) ................................
§ 483.13(a) ....................................
§ 483.13(b) ....................................
§ 483.13(c) ....................................
§ 483.13(c)(1) ................................
§ 483.13(c)(1)(i) .............................
§ 483.13(c)(1)(ii) ............................
§ 483.13(c)(1)(ii)(A) .......................
§ 483.13(c)(1)(ii)(B) .......................
§ 483.13(c)(1)(iii) ...........................
§ 483.13(c)(2) ................................
§ 483.13(c)(3) ................................
§ 483.13(c)(4) ................................
§ 483.15 .........................................
§ 483.15(a) ....................................
§ 483.15(b) ....................................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.15(b)(1)
§ 483.15(b)(2)
§ 483.15(b)(3)
§ 483.15(c)(1)
................................
................................
................................
................................
§ 483.15(c)(2) ................................
§ 483.15(c)(3) ................................
§ 483.15(c)(4)–(6) ..........................
§ 483.15(d) ....................................
§ 483.15(e) ....................................
§ 483.15(e)(1) ................................
§ 483.15(e)(2) ................................
§ 483.15(f)(1) .................................
§ 483.15(f)(2) .................................
§ 483.15(f)(2)(i) ..............................
§ 483.15(f)(2)(i)(A) .........................
§ 483.15(f)(2)(i)(B) .........................
§ 483.15 (f)(2)(ii)–(iv) .....................
§ 483.15(g)(1) ................................
§ 483.15(g)(2) ................................
§ 483.15(g)(3)(i)–(ii) .......................
§ 483.15(h) ....................................
§ 483.15(h)(1) ................................
§ 483.15(h)(2) ................................
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Re-designated
Re-designated
Re-designated
Re-designated
..............................
& revised ..............
& revised ..............
& revised ..............
§ 483.10(d)(4).
§ 483.10(b)(6).
§ 483.10(d)(7)(i)–(ii), 483.11(d)(8).
§ 483.15(b).
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
..............................
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
§ 483.5.
§ 483.15(b)(1)(ii).
§ 483.15(b)(1)(ii)(A)–(F).
§ 483.15(b)(2).
§ 483.15(b)(2)(ii)(A).
§ 483.15(b)(2)(ii)(B).
§ 483.15(b)(3)(i)–(iii).
§ 483.15(b)(4).
§ 483.15(b)(4)(ii)(A)–(E).
§ 483.15(b)(5)(i)–(vii).
§ 483.15(b)(7).
§ 483.15(b)(8).
§ 483.15(b)(9).
§ 483.15(c)(1)(i)–(iii).
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
& revised ..............
..............................
& revised ..............
& revised ..............
& revised ..............
..............................
& revised ..............
& revised ..............
..............................
..............................
& revised ..............
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
& revised ..............
& revised ..............
..............................
..............................
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
§ 483.15(c)(2).
§ 483.15(c)(3)(i)–(ii).
§ 483.15(c)(4).
§ 483.15(b)(1)(i)(A).
§ 483.15(b)(1)(i)(B).
§ 483.15(b)(1)(i)(C).
S483.15(a)(2)(i)–(ii).
S483.15(a)(3).
S483.15(a)(4)(i)–(ii).
§ 483.15(a)(5).
§ 483.10(d)(1),
§ 483.12,
§ 483.25(d)(1).
§ 483.12.
§ 483.12(b).
§ 483.12(a).
§ 483.12(a)(1).
§ 483.12(a)(2).
§ 483.12(a)(2)(i).
§ 483.12(a)(2)(ii).
§ 483.12(a)(3).
§ 483.12(c)(1).
§ 483.12(c)(2)–(3).
§ 483.12(c)(4).
§ 483.11.
§ 483.11.
§ 483.10(e), § 483.11(d).
Re-designated
Re-designated
Re-designated
Re-designated
& revised ..............
& revised ..............
..............................
& revised ..............
§ 483.10(e)(1).
§ 483.10(e)(2).
§ 483.10(e)(10).
§ 483.10(e)(4).
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
Re-designated& revised ...............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
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§ 483.10(e)(5)–(6).
§ 483.11(d)(3).
§ 483.11(d)(3)(i)–(iii).
§ 483.10(e)(7).
§ 483.10(d).
§ 483.10(d)(3).
§ 483.10(d)(6).
§ 483.25(c)(1).
§ 483.25(c)(2).
§ 483.25(c)(2).
§ 483.25(c)(2)(i).
§ 483.25(c)(2)(ii)(A).
§ 483.25(c)(2)(ii)(B)–(D).
§ 483.40(d).
§ 483.70(p).
§ 483.70(p)(1)–(2).
§ 483.11(g).
§ 483.11(g)(1).
§ 483.11(g)(2).
16JYP2
Federal Register / Vol. 80, No. 136 / Thursday, July 16, 2015 / Proposed Rules
TABLE A—TITLE 42 CROSS-REFERENCES TO PART 483 SUBPART B—Continued
Existing CFR Section
Title
Action
§ 483.15(h)(3) ................................
§ 483.15(h)(4) ................................
§ 483.15(h)(5) ................................
§ 483.15(h)(6) ................................
§ 483.15(h)(7) ................................
§ 483.20 .........................................
§ 483.20(a) ....................................
§ 483.20(b) ....................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
Resident Assessment ...................
(a) Admission orders ....................
(b)
Comprehensive
assessments—(1) Resident assessment instrument.
(c) Quarterly review assessment ..
(d) Use.
(e) Coordination ............................
(f) Automated data processing requirement.
(g) Accuracy of assessments.
(h) Coordination.
(i) Certification.
(j) Penalty for falsification .............
(k) Comprehensive care plans .....
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(l) Discharge summary .................
.......................................................
.......................................................
.......................................................
(m) Preadmission screening for
mentally ill individuals and individuals with mental retardation.
.......................................................
(2) Definition For purposes of this
section—.
Quality of care ..............................
(a) Activities of daily living ............
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(b) Vision and hearing ..................
.......................................................
.......................................................
(c) Pressure sores ........................
.......................................................
.......................................................
(d) Urinary Incontinence ...............
.......................................................
.......................................................
(e) Range of motion .....................
.......................................................
.......................................................
(f) Mental and Psychosocial functioning.
.......................................................
.......................................................
(g) Naso-gastric tubes ..................
.......................................................
.......................................................
(h) Accidents .................................
.......................................................
.......................................................
(i) Nutrition ....................................
.......................................................
.......................................................
(j) Hydration ..................................
(k) Special needs ..........................
Re-designated ..............................
Re-designated & revised ..............
Re-designated ..............................
Re-designated ..............................
Re-designated ..............................
No change ....................................
No change ....................................
Revised .........................................
§ 483.11(g)(3).
§ 483.11(g)(4).
§ 483.11(g)(5).
§ 483.11(g)(6).
§ 483.11(g)(7).
§ 483.20.
§ 483.20(a).
§ 483.20(b).
No change ....................................
§ 483.20(c)–(d).
Revised .........................................
§ 483.20(e).
No change ....................................
Re-designated & revised ..............
Re-designated ..............................
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
§ 483.20(f)–(j).
§ 483.21(b)(1).
§ 483.21(b)(2).
§ 483.21(b)(2)(i).
§ 483.21(b)(2)(ii)(A)–(G).
§ 483.21(b)(2)(iii).
§ 483.21(b)(3)(i)–(ii).
§ 483.21(c)(2).
§ 483.21(c)(2)(i).
§ 483.21(c)(2)(ii).
§ 483.21(c)(2)(iv).
§ 483.20(k)(1).
Re-designated ..............................
Re-designated & revised ..............
§ 483.20(k)(1)(i)–(ii).
§ 483.20(k)(3)(i)–(ii).
Revised .........................................
Re-designated & revised ..............
Re-designated and revised ..........
Re-designated and revised ..........
Re-designated and revised ..........
Re-designated and revised ..........
Re-designated and revised ..........
Re-designated and revised ..........
Re-designated and revised ..........
Re-designated ..............................
Re-designated ..............................
Re-designated ..............................
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Re-designated ..............................
Re-designated & revised ..............
Re-designated ..............................
Re-designated ..............................
Re-designated & revised ..............
§ 483.25.
§ 483.25(a).
§ 483.25(a),(b).
§ 483.25(b)(1).
§ 483.25(b)(2).
§ 483.25(b)(3).
§ 483.25(b)(4).
§ 483.25(b)(5).
§ 483.25(a)(1).
§ 483.25(a)(2).
§ 483.25(d)(3).
§ 483.25(d)(3)(i).
§ 483.25(d)(3)(ii).
§ 483.25(d)(4)(i).
§ 483.25(d)(4)(i)(A).
§ 483.25(d)(4)(i)(B).
§ 483.25(d)(6)(ii).
§ 483.25(d)(6)(ii)(A).
§ 483.25(d)(6)(i)(C).
§ 483.25(d)(5).
§ 483.25(d)(5)(i).
§ 483.25(d)(5)(ii).
§ 483.40(b).
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
§ 483.40(b)(1).
§ 483.40(b)(2).
§ 483.25(d)(8)(iv).
§ 483.25(d)(8)(iv).
§ 483.25(d)(8)(v).
§ 483.25(d)(10).
§ 483.25(d)(10)(i).
§ 483.25(d)(10)(ii).
§ 483.25(d)(8).
§ 483.25(d)(8)(i).
§ 483.25(d)(8)(iii).
§ 483.25(d)(8)(ii).
§ 483.25(d).
§ 483.20(c)–(d) ..............................
§ 483.20(e) ....................................
§ 483.20(f)–(j) ................................
§ 483.20(k)(1) ................................
§ 483.20(k)(2) ................................
§ 483.20(k)(2)(i) .............................
§ 483.20(k)(2)(ii) ............................
§ 483.20(k)(2)(iii) ...........................
§ 483.20(k)(3)(i)–(ii) .......................
§ 483.20(l) .....................................
§ 483.20(l)(1) .................................
§ 483.20(l)(2) .................................
§ 483.20(l)(3) .................................
§ 483.20(m) ...................................
§ 483.20(m)(1)(i)–(ii) ......................
§ 483.20(m)(2)(i)–(ii) ......................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.25 .........................................
§ 483.25(a) ....................................
§ 483.25(a)(1) ................................
§ 483.25(a)(1)(i) .............................
§ 483.25(a)(1)(ii) ............................
§ 483.25(a)(1)(iii) ...........................
§ 483.25(a)(1)(iv) ...........................
§ 483.25(a)(1)(v) ............................
§ 483.25(a)(2) ................................
§ 483.25(a)(3) ................................
§ 483.25(b) ....................................
§ 483.25(b)(1) ................................
§ 483.25(b)(2) ................................
§ 483.25(c) ....................................
§ 483.25(c)(1) ................................
§ 483.25(c)(2) ................................
§ 483.25(d) ....................................
§ 483.25(d)(1) ................................
§ 483.25(d)(2) ................................
§ 483.25(e) ....................................
§ 483.25(e)(1) ................................
§ 483.25(e)(2) ................................
§ 483.25(f) .....................................
§ 483.25(f)(1) .................................
§ 483.25(f)(2) .................................
§ 483.25(g) ....................................
§ 483.25(g)(1) ................................
§ 483.25(g)(2) ................................
§ 483.25(h) ....................................
§ 483.25(h)(1) ................................
§ 483.25(h)(2) ................................
§ 483.25(i) .....................................
§ 483.25(i)(1) .................................
§ 483.25(i)(2) .................................
§ 483.25(j) .....................................
§ 483.25(k) ....................................
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& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
..............................
..............................
..............................
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
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16JYP2
42227
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TABLE A—TITLE 42 CROSS-REFERENCES TO PART 483 SUBPART B—Continued
Existing CFR Section
Title
Action
§ 483.25(k)(1) ................................
§ 483.25(k)(2) ................................
§ 483.25(k)(3) ................................
(1) Injections; ................................
(2) Parenteral and enteral fluids; ..
(3) Colostomy, ureterostomy, or ileostomy care;.
(4) Tracheostomy care; ................
(5) Tracheal suctioning; ................
(6) Respiratory care; .....................
(7) Foot care; and .........................
(8) Prostheses. .............................
(l) Unnecessary drugs ..................
.......................................................
(2) Antipsychotic Drugs ................
(m) Medication Errors ...................
(n) Influenza and pneumococcal
immunizations.
.......................................................
(2) Pneumococcal disease ...........
.......................................................
Exception ......................................
Nursing services ...........................
(a) Sufficient staff .........................
.......................................................
.......................................................
(b) Registered nurse .....................
.......................................................
.......................................................
(c) Nursing facilities: Waiver of requirement to provide licensed
nurses on a 24-hour basis.
.......................................................
.......................................................
.......................................................
(d) SNFs: Waiver of the requirement to provide services of a
registered nurse for more than
40 hours a week.
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(e) Nurse staffing information .......
.......................................................
.......................................................
.......................................................
Dietary services ............................
(a) Staffing ....................................
.......................................................
.......................................................
(b) Sufficient staff .........................
(c) Menus and nutritional adequacy.
.......................................................
(d) Food ........................................
.......................................................
.......................................................
.......................................................
.......................................................
(e) Therapeutic diets ....................
(f) Frequency of meals .................
.......................................................
.......................................................
.......................................................
(g) Assistive devices .....................
(h) Paid feeding assistants ...........
.......................................................
.......................................................
.......................................................
.......................................................
Deleted.
Re-designated & revised ..............
Re-designated ..............................
§ 483.25(d)(9).
§ 483.25(d)(7).
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
& revised ..............
& revised ..............
& revised ..............
& revised ..............
..............................
..............................
..............................
& revised ..............
& revised ..............
..............................
§ 483.25(d)(11).
§ 483.25(d)(11).
§ 483.25(d)(11).
§ 483.25(d)(4)(ii).
§ 483.25(d)(12).
§ 483.45(d).
§ 483.45(d)(1)–(6).
§ 483.45(e)(1)–(2).
§ 483.45(f)(1)–(2).
§ 483.80(d)(1).
Re-designated
Re-designated
Re-designated
Deleted.
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
& revised ..............
..............................
& revised ..............
§ 483.80(d)(1)(i)–(iv).
§ 483.80(d)(2).
§ 483.80(d)(2)(i)–(iv).
& revised ..............
..............................
& revised ..............
..............................
..............................
..............................
..............................
..............................
§ 483.35.
§ 483.35(a).
§ 483.35(a)(1)(ii).
§ 483.35(a)(2).
§ 483.35(b)(1).
§ 483.35(b)(2).
§ 483.35(b)(3).
§ 483.35(e).
Re-designated
Re-designated
Re-designated
Re-designated
..............................
& revised ..............
& revised ..............
..............................
§ 483.35(e)(1)–(5).
§ 483.35(e)(6).
§ 483.35(e)(7).
§ 483.35(f)(1).
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
..............................
..............................
..............................
..............................
..............................
& revised ..............
& revised ..............
..............................
..............................
..............................
..............................
..............................
& revised ..............
& revised ..............
& revised ..............
& revised ..............
& revised ..............
..............................
§ 483.35(f)(1)(i).
§ 483.35(f)(1)(ii).
§ 483.35(f)(1)(iii).
§ 483.35(f)(1)(iii)(A).
§ 483.35(f)(1)(iii)(B).
§ 483.35(f)(1)(iv).
§ 483.35(f)(1)(v).
§ 483.35(f)(2).
§ 483.35(g)(1)(i)–(iv).
§ 483.35(g)(2)(i)–(ii).
§ 483.35(g)(3).
§ 483.35(g)(4).
§ 483.60.
§ 483.60(a)(1).
§ 483.60(a)(2).
§ 483.60(a)(1)(i)–(iii).
§ 483.60(a)(3).
§ 483.60(c).
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Deleted.
Re-designated
Deleted.
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
& revised ..............
..............................
..............................
& revised ..............
..............................
& revised ..............
& revised ..............
& revised ..............
§ 483.60(c)(1)–(3).
§ 483.60(d).
§ 483.60(d)(1).
§ 483.60(d)(2).
§ 483.60(d)(3).
§ 483.60(d)(5).
§ 483.60(e).
§ 483.60(f)(1).
..............................
§ 483.60(f)(3).
& revised ..............
..............................
..............................
..............................
& revised ..............
& revised ..............
§ 483.60(g).
§ 483.60(h)(1).
§ 483.60(h)(1)(i)–(ii).
§ 483.60(h)(2)(i).
§ 483.60(h)(2)(ii).
§ 483.60(h)(3)(i)–(ii).
§ 483.25(k)(4) ................................
§ 483.25(k)(5) ................................
§ 483.25(k)(6) ................................
§ 483.25(k)(7) ................................
§ 483.25(k)(8) ................................
§ 483.25(l) .....................................
§ 483.25(l)(1)(i)–(vi) .......................
§ 483.25(l)(2)(i)–(ii) ........................
§ 483.25(m)(1)–(2) ........................
§ 483.25(n) ....................................
§ 483.25(n)(1)(i)–(iv) ......................
§ 483.25(n)(2) ................................
§ 483.25(n)(2)(i)–(iv) ......................
§ 483.25(n)(2)(v) ............................
§ 483.30 .........................................
§ 483.30(a) ....................................
§ 483.30(a)(1)(ii) ............................
§ 483.30(a)(2) ................................
§ 483.30(b)(1) ................................
§ 483.30(b)(2) ................................
§ 483.30(b)(3) ................................
§ 483.30(c) ....................................
§ 483.30(c)(1)–(5) ..........................
§ 483.30(c)(6) ................................
§ 483.30(c)(7) ................................
§ 483.30(d)(1) ................................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.30(d)(1)(i) .............................
§ 483.30(d)(1)(ii) ............................
§ 483.30(d)(1)(iii) ...........................
§ 483.30(d)(1)(iii)(A) ......................
§ 483.30(d)(1)(iii)(B) ......................
§ 483.30(d)(1)(iv) ...........................
§ 483.30(d)(1)(v) ............................
§ 483.30(d)(2) ................................
§ 483.30(e)(1)(i)–(iv) ......................
§ 483.30(e)(2)(i)–(ii) .......................
§ 483.30(e)(3) ................................
§ 483.30(e)(4) ................................
§ 483.35 .........................................
§ 483.35(a) ....................................
§ 483.35(a)(1) ................................
§ 483.35(a)(2) ................................
§ 483.35(b) ....................................
§ 483.35(c) ....................................
§ 483.35(c)(1)–(3) ..........................
§ 483.35(d) ....................................
§ 483.35(d)(1) ................................
§ 483.35(d)(2) ................................
§ 483.35(d)(3) ................................
§ 483.35(d)(4) ................................
§ 483.35(e) ....................................
§ 483.35(f)(1) .................................
§ 483.35(f)(2) .................................
§ 483.35(f)(3) .................................
§ 483.35(f)(4) .................................
§ 483.35(g) ....................................
§ 483.35(h)(1) ................................
§ 483.35(h)(1)(i)–(ii) .......................
§ 483.35(h)(2)(i) .............................
§ 483.35 (h)(2)(ii) ...........................
§ 483.35(h)(3)(i)–(ii) .......................
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16JYP2
Federal Register / Vol. 80, No. 136 / Thursday, July 16, 2015 / Proposed Rules
TABLE A—TITLE 42 CROSS-REFERENCES TO PART 483 SUBPART B—Continued
Existing CFR Section
Title
§ 483.35(h)(3)(iii) ...........................
§ 483.35(i) .....................................
§ 483.35(i)(1) .................................
§ 483.35(i)(2) .................................
§ 483.35(i)(3) .................................
§ 483.40 .........................................
§ 483.40(a) ....................................
§ 483.40(a)(1)–(2) .........................
§ 483.40(b) ....................................
§ 483.40(b)(1) ................................
§ 483.40(b)(2) ................................
§ 483.40(b)(3) ................................
§ 483.40(c)(1)–(4) ..........................
§ 483.40(d) ....................................
.......................................................
(i) Sanitary conditions ...................
.......................................................
.......................................................
.......................................................
Physician services ........................
(a) Physician supervision .............
.......................................................
(b) Physician visits ........................
.......................................................
.......................................................
.......................................................
(c) Frequency of physician visits ..
(d) Availability of physicians for
emergency care.
(e) Physician delegation of tasks
in SNFs.
.......................................................
.......................................................
(f) Performance of physician tasks
in NFs.
Specialized rehabilitative services
(a) Provision of services ...............
.......................................................
(b) Qualifications ...........................
Dental services .............................
(a) Skilled nursing facilities ...........
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(b) Nursing facilities ......................
.......................................................
.......................................................
.......................................................
.......................................................
Pharmacy services .......................
(a) Procedures ..............................
(b) Service consultation ................
.......................................................
(c) Drug regimen review ...............
.......................................................
(d) Labeling of drugs and
biologicals.
(e) Storage of drugs and
biologicals.
Infection control ............................
(a) Infection control program ........
(b) Preventing spread of infection
.......................................................
.......................................................
(c) Linens ......................................
Physical environment ...................
(a) Life safety from fire .................
(b) Emergency power ...................
(c) Space and equipment .............
(d) Resident rooms .......................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(e) Toilet facilities .........................
(f) Resident call system ................
(f) Resident call system. ...............
(g) Dining and resident activities ..
.......................................................
.......................................................
§ 483.40(e)(1) ................................
§ 483.40(e)(1)(i)–(iii) ......................
§ 483.40(e)(2) ................................
§ 483.40(f) .....................................
§ 483.45 .........................................
§ 483.45(a)(1)–(2) .........................
§ 483.45(b) ....................................
§ 483.55 .........................................
§ 483.55(a)(1) ................................
§ 483.55(a)(2) ................................
§ 483.55(a)(3) ................................
§ 483.55(a)(3)(i) .............................
§ 483.55(a)(3)(ii) ............................
§ 483.55(a)(4) ................................
§ 483.55(b) ....................................
§ 483.55(b)(1)(i)–(ii) .......................
§ 483.55(b)(2) ................................
§ 483.55(b)(2)(i)–(ii) .......................
§ 483.55(b)(3) ................................
§ 483.60 .........................................
§ 483.60(a) ....................................
§ 483.60(b) ....................................
§ 483.60(b)(1)–(3) .........................
§ 483.60(c)(1) ................................
§ 483.60(c)(2) ................................
§ 483.60(d) ....................................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.60(e)(1)–(2) .........................
§ 483.65 .........................................
§ 483.65(a)(1)–(3) .........................
§ 483.65(b)(1) ................................
§ 483.65(b)(2) ................................
§ 483.65(b)(3) ................................
§ 483.65(c) ....................................
§ 483.70 .........................................
§ 483.70(a)(1)–(8) .........................
§ 483.70(b)(1)–(2) .........................
§ 483.70(c)(1)–(2) ..........................
§ 483.70(d) ....................................
§ 483.70(d)(1) ................................
§ 483.70(d)(1)(i) .............................
§ 483.70(d)(1)(ii)–(vii) ....................
§ 483.70(d)(2) ................................
§ 483.70(d)(2)(i) .............................
§ 483.70(d)(2)(ii)–(iv) .....................
§ 483.70(d)(3)(i)–(ii) .......................
§ 483.70(e) ....................................
§ 483.70(f)(1) .................................
§ 483.70(f)(2) .................................
§ 483.70(g)(1)) ...............................
§ 483.70(g)(2) ................................
§ 483.70(g)(3)–(4) .........................
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Re-designated
Re-designated
Re-designated
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Re-designated
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New CFR section
& revised ..............
& revised ..............
& revised ..............
& revised ..............
..............................
& revised ..............
..............................
..............................
..............................
..............................
..............................
& revised ..............
..............................
..............................
§ 483.60(h)(3)(iii).
§ 483.60(i).
§ 483.60(i)(1).
§ 483.60(i)(2).
§ 483.60(i)(4).
§ 483.30.
§ 483.30(a).
§ 483.30(a)(1)–(2).
§ 483.30(b).
§ 483.30(b)(1).
§ 483.30(b)(2).
§ 483.30(b)(3).
§ 483.30(c)(1)–(4).
§ 483.30(d).
Re-designated ..............................
§ 483.30(f)(1).
Re-designated ..............................
Re-designated ..............................
Re-designated ..............................
§ 483.30(f)(1)(i)–(iii).
§ 483.30(f)(4).
§ 483.30(g).
Re-designated & revised ..............
§ 483.65(a).
Re-designated & revised ..............
Re-designated ..............................
No change ....................................
Re-designated ..............................
Re-designated ..............................
Re-designated ..............................
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Re-designated& revised ...............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Re-designated ..............................
Re-designated ..............................
Re-designated ..............................
Re-designated & revised ..............
Re-designated ..............................
§ 483.65(a)(1)–(2).
§ 483.65(b).
§ 483.55.
§ 483.55(a)(1).
§ 483.55(a)(2).
§ 483.55(a)(4).
§ 483.55(a)(4)(i).
§ 483.55(a)(4)(ii).
§ 483.55(a)(5).
§ 483.55(b).
§ 483.55(b)(1)(i)–(ii).
§ 483.55(b).
§ 483.55(b)(2)(i)–(ii).
§ 483.55(b)(3).
§ 483.45.
§ 483.45(a).
§ 483.45(b).
§ 483.45(b)(1)–(3).
§ 483.45(c)(1).
§ 483.45(c)(4).
§ 483.45(g).
Re-designated ..............................
§ 483.45(h)(1)–(2).
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
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Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
§ 483.80.
§ 483.80(a)(1)–(3).
§ 483.80(a)(2)(iv).
§ 483.80(a)(2)(v).
§ 483.80(a)(2)(vi).
§ 483.80(e).
§ 483.90.
§ 483.90(a)(1)–(8).
§ 483.90(b)(1)–(2).
§ 483.90(c)(1)–(2).
§ 483.90(d).
§ 483.90(d)(1).
§ 483.90(d)(1)(i).
§ 483.90(d)(1)(ii)–(vii).
§ 483.90(d)(2).
§ 483.90(d)(2)(i).
§ 483.90(d)(2)(ii)–(iv).
§ 483.90(d)(3)(i)–(ii).
§ 483.90(e).
§ 483.90(f)(1).
§ 483.90(f)(2).
§ 483.90(g)(1).
§ 483.90(g)(2).
§ 483.90(g)(3)–(4).
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& revised ..............
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& revised ..............
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& revised ..............
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Federal Register / Vol. 80, No. 136 / Thursday, July 16, 2015 / Proposed Rules
TABLE A—TITLE 42 CROSS-REFERENCES TO PART 483 SUBPART B—Continued
Existing CFR Section
Title
Action
§ 483.70(h)(1)–(4) .........................
(h) Other environmental conditions.
Administration ...............................
(a) Licensure .................................
(b) Compliance with Federal,
State, and local laws and professional standards.
(c) Relationship to other HHS regulations.
(d) Governing body .......................
.......................................................
(e) Required training of nursing
aides.
(1) Definitions. Licensed health
professional.
Nurse aide ....................................
(2) General rule ............................
(3) Non-permanent employees .....
(4) Competency ............................
(5) Registry verification .................
(6) Multi-State registry verification
(7) Required retraining .................
(8) Regular in-service education ..
(f) Proficiency of Nurse aides .......
(g) Staff qualifications ...................
.......................................................
(h) Use of outside resources ........
.......................................................
(i) Medical director ........................
.......................................................
(j) Laboratory services ..................
.......................................................
.......................................................
(k) Radiology and other diagnostic
services.
.......................................................
.......................................................
(l) Clinical records .........................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
.......................................................
(m) Disaster and emergency preparedness.
Re-designated ..............................
§ 483.90(h)(1)–(4).
Re-designated ..............................
Re-designated ..............................
Re-designated ..............................
§ 483.70.
§ 483.70(a).
§ 483.70(b).
Re-designated & revised ..............
§ 483.70(c).
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
§ 483.70(d)(1).
§ 483.70(d)(2)(i)–(ii).
483.95(g).
Re-designated & revised ..............
483.5.
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
483.5.
§ 483.35(d)(1)(i)–(ii).
§ 483.35(d)(2).
§ 483.35(d)(3)(i)–(iii).
§ 483.35(d)(4)(i)–(ii).
§ 483.35(d)(5).
§ 483.35(d)(6).
§ 483.35(d)(7), § 483.95(g).
§ 483.35(c).
§ 483.70(f)(1).
§ 483.70(f)(2).
§ 483.70(g)(1).
§ 483.70(g)(2)(i)–(ii).
§ 483.70(h)(1).
§ 483.70(h)(2)(i)–(ii).
§ 483.50(a)(1)(i)–(iv).
§ 483.50(a)(2).
§ 483.50(a)(2)(i)–(iv).
§ 483.50(b).
§ 483.75 .........................................
§ 483.75(a) ....................................
§ 483.75(b) ....................................
§ 483.75(c) ....................................
§ 483.75(d)(1) ................................
§ 483.75(d)(2)(i)–(ii) .......................
§ 483.75(e) ....................................
§ 483.75(e)(1) ................................
§ 483.75(e)(1) ................................
§ 483.75(e)(2)(i)–(ii) .......................
§ 483.75(e)(3) ................................
§ 483.75(e)(4)(i)–(iii) ......................
§ 483.75(e)(5)(i)–(ii) .......................
§ 483.75(e)(6) ................................
§ 483.75(e)(7) ................................
§ 483.75(e)(8)(i)–(iii) ......................
§ 483.75(f) .....................................
§ 483.75(g)(1) ................................
§ 483.75(g)(2) ................................
§ 483.75(h)(1) ................................
§ 483.75(h)(2)(i)–(ii) .......................
§ 483.75(i)(1) .................................
§ 483.75(i)(2)(i–ii) ..........................
§ 483.75(j)(1)(i)–(iv) .......................
§ 483.75(j)(2) .................................
§ 483.75(j)(2)(i)–(iv) .......................
§ 483.75(k) ....................................
§ 483.75(k)(1) ................................
§ 483.75(k)(2) ................................
§ 483.75(l)(1) .................................
§ 483.75(l)(1)(i)–(iv) .......................
§ 483.75(l)(2) .................................
§ 483.75(l)(2)(i) ..............................
§ 483.75(l)(2)(ii) .............................
§ 483.75(l)(2)(iii) ............................
§ 483.75(l)(3) .................................
§ 483.75(l)(4)(i)–(iv) .......................
§ 483.75(l)(5)(i)–(v) ........................
§ 483.75(m)(1) ...............................
.......................................................
§ 483.75(n)(1)(i)–(ii) .......................
§ 483.75(n)(2) ................................
§ 483.75(o)(1)(i)–(iii) ......................
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.75(m)(2) ...............................
(n) Transfer agreement ................
.......................................................
(o) Quality assessment and assurance.
.......................................................
.......................................................
.......................................................
(p) Disclosure of ownership ..........
.......................................................
.......................................................
(q) Required training of feeding
assistants.
(r) Facility closure-Administrator ...
(s) Facility closure ........................
§ 483.75(o)(2)(i)–(ii) .......................
§ 483.75(o)(3) ................................
§ 483.75(o)(4) ................................
§ 483.75(p)(1) ................................
§ 483.75(p)(2)(i)–(iv) ......................
§ 483.75(p)(3) ................................
§ 483.75(q) ....................................
§ 483.75(r)(1)–(3) ..........................
§ 483.75(s) ....................................
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& revised ..............
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& revised ..............
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..............................
..............................
..............................
& Revised .............
..............................
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated ..............................
Re-designated ..............................
Re-designated ..............................
Re-designated & revised ..............
Re-designated & revised ..............
Re-designated & revised ..............
See Proposed Rule: Emergency
Preparedness Requirements for
Medicare and Medicaid Participating Providers and Suppliers
(78 FR 79081, December 27,
2013).
See Proposed Rule: Emergency
Preparedness Requirements for
Medicare and Medicaid Participating Providers and Suppliers
(78 FR 79081, December 27,
2013).
Re-designated & revised ..............
Re-designated ..............................
Re-designated & revised ..............
§ 483.50(b)(1).
§ 483.50(b)(2).
§ 483.70(i)(1).
§ 483.70(i)(1)(i)–(iv).
§ 483.70(i)(4).
§ 483.70(i)(4)(i).
§ 483.70(i)(4)(ii).
§ 483.70(i)(4)(iii).
§ 483.70(i)(3).
§ 483.70(i)(2).
§ 483.70(i)(5)(i)–(v).
See 78 FR 79081.
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
Re-designated
§ 483.75(g)(2)(i)–(iii).
§ 483.75(h)(1).
§ 483.75(i).
§ 483.70(k)(1).
§ 483.70(k)(2)(i)–(iv).
§ 483.70(k)(3).
§ 483.95(h).
& revised ..............
& revised ..............
..............................
..............................
..............................
..............................
& revised ..............
Re-designated ..............................
Re-designated & revised ..............
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See 78 FR 79081.
§ 483.70(j)(1)(i)–(ii).
§ 483.70(j)(2).
§ 483.75(g)(1)(i)–(iv).
§ 483.70(l)(1)–(3).
§ 483.70(m).
16JYP2
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42231
TABLE A—TITLE 42 CROSS-REFERENCES TO PART 483 SUBPART B—Continued
Existing CFR Section
Title
Action
§ 483.75(t) .....................................
(t)Hospice services .......................
Re-designated ..............................
IV. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995, we are required to provide 60day notice in the Federal Register and
solicit public comment before a
collection of information (COI)
requirement is submitted to the Office of
Management and Budget (OMB) for
review and approval. In order to fairly
evaluate whether an information
collection should be approved by OMB,
section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we
solicit comment on the following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
We are soliciting public comment on
each of these issues for the following
sections of this document that contain
information collection requirements
(ICRs).
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Omnibus Budget Reconciliation Act of
1987 Waiver
Ordinarily, we would be required to
estimate the public reporting burden for
information collection requirements for
these regulations in accordance with
chapter 35 of title 44, United States
Code. However, sections 4204(b) and
4214(d) of Omnibus Budget
Reconciliation Act of 1987, Public Law
100–203 (OBRA ’87) provide for a
waiver of Paperwork Reduction Act
(PRA) requirements for these
regulations. We believe that this waiver
still applies to those revisions and
updates we made to existing
requirements in part 483 subpart B.
However, we provide burden estimates
for the new information collection
requirements proposed in this rule,
specifically those requirements
implemented as a result of the
Affordable Care Act.
Sources of Data Used in Estimates of
Burden Hours and Cost Estimates
We obtained the data used in this
discussion on the number of the various
Medicare and Medicaid nursing
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facilities from Medicare’s Certification
and Survey Provider Enhanced
Reporting (CASPER) as of April 1, 2015.
We have not included data for nursing
facilities that are not Medicare and/or
Medicaid certified. According to our
CASPER database, there are 15,691
SNFs and NFs participating in the
Medicare and Medicaid programs. Since
the individual States periodically
update the CASPER system, the number
of SNFs and NFs may vary depending
upon the date of the report. Thus, while
this number is accurate as of the date of
the report, the actual number of
facilities may be different as of the date
of this proposed rule’s publication.
Unless otherwise indicated, we
obtained all salary information for the
different positions identified in the
following assessments from the US
Bureau of Labor Statistics at https://
www.bls.gov/oes. We used the data from
this Web site because it identifies many
different healthcare industry
occupations and specialties and updates
that data monthly. We calculated the
estimated hourly rates based upon the
national median salary for that
particular position, including fringe
benefits and overhead worth 48 percent
of the base salary. Where we were able
to identify positions linked to specific
positions, we used that compensation
information. However, in some
instances, we used a general position
description or we used information for
comparable positions. For example, we
were not able to locate specific
information for nursing home
administrators and directors of nursing,
so we used the average hourly wage for
a medical and health services manager
for these positions. We welcome any
comments on the accuracy of our
compensation estimates.
In estimating the burden associated
with this proposed rule, we also took
into consideration the many free or low
cost resources nursing facilities have
available to them. Following is a nonexhaustive list of some of the available
resources:
• https://www.nhqualitycampaign.org
• https://www.ascp.com
• https://www.amda.com
• https://www.ahcancal.org
• https://www.leadingage.org
• https://www.americangeriatrics.org
• https://www.ntocc.org
We will discuss the burden for each
provision included in this proposed rule
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New CFR section
§ 483.70(o)
in the order in which they appear in the
CFR.
A. ICRs Regarding Quality Assurance
and Performance Improvement
(§ 483.75)
Each facility is currently required to
maintain a QAA committee consisting
of the director of nursing services, a
physician designated by the facility and
at least three other members of the
facility’s staff. The committee must meet
at least quarterly to identify issues with
respect to which quality assessment and
assurance activities are necessary. The
committee is required to develop and
implement appropriate plans of action
to correct identified quality deficiencies.
Based on our experience with facilities’
compliance with QAA requirements, we
anticipate that they already have some
of the resources needed to develop and
implement a proactive QAPI program.
In addition, some ICRs will be met
through the technical assistance
provided to facilities by CMS on the
development of best practices, as
required by the Affordable Care Act.
We propose at § 483.75 that a facility
have a QAPI program. The burden
associated with these proposed
requirements would be the time and
effort necessary to develop, implement,
and maintain a comprehensive, datadriven QAPI program designed to
monitor and evaluate the ongoing
performance of the facility. The facility
would have to establish a program to
address the key components of the
proposed standards (program measures,
program scope, and program activities).
The existing regulations require that
QAA committees identify and correct
specific deficiencies. We believe
facilities would use some of the
resources they have to comply with the
QAA requirements (such as collecting
data), in the development of a QAPIbased, proactive approach to assessing
services they provide (including those
services furnished under contract or
arrangement) and to improve the quality
of care and quality of life provided to
their residents.
Since the existing Interpretative
Guidelines for facilities to comply with
the Medicare regulations provide
information on how to conduct quality
improvement programs, we anticipate
that some facilities are already utilizing
the QAPI model. We also anticipate that
facilities would use their existing
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Federal Register / Vol. 80, No. 136 / Thursday, July 16, 2015 / Proposed Rules
resources to meet the requirements in
this proposed rule. To the extent that
facilities are utilizing a QAPI quality
model and are proactively collecting
data, evaluating their performance, and
making and monitoring program
improvements, they would be better
prepared to comply with the QAPI
requirements. However, for the purpose
of this burden analysis, we assume that
all facilities would need to develop a
QAPI program.
Based on our experience with other
Medicare providers that have developed
QAPI programs, we estimate that, on
average, it would take 56 hours for the
facility to develop and document a
comprehensive, data-driven QAPI
program designed to monitor and
evaluate performance of all services and
programs of the facility, including
services provided under contract or
arrangement.
We estimate that the facility
administrator/coordinator would be
largely responsible for developing the
overall QAPI program and would spend
approximately 30 hours on this activity;
the director of nursing and a registered
nurse would each spend approximately
10 hours each to review and provide
input on clinical services activities; a
physician would spend approximately 4
hours to review the program plan and
provide medical direction and input;
and one office assistant would spend
approximately 2 hours to prepare and
distribute draft and final program plans.
We estimate that this would require a
total of 878,696 burden hours for all
15,691 facilities (56 hours × 15,691
facilities) to develop a QAPI program.
We estimate that the cost for the
administrator/coordinator would be
$2,400 ($80 × 30 hours). We estimate the
cost for the director of nursing would be
$800 ($80 × 10 hours). We estimate that
the cost for an RN would be $580 ($58
per hour × 10 hours). We estimate that
the cost for the physician would be $688
($172 × 4 hours). We estimate that the
cost for an office assistant would be $58
($29 × 2 hours). The estimated one-time
cost for each facility would total $4,526.
The total one-time cost for all 15,691
facilities would be $71,017,466.
We anticipate that the ongoing,
annual burden for each facility to collect
and analyze data for QAPI activities
would be 20 hours. We anticipate that
to document the improvement activities
would require 20 hours. We estimate the
total annual burden hours for all
facilities would be 627,640 (40 hours ×
15,691 facilities). We anticipate that the
staff time would be distributed as
follows:
Administrator/Coordinator to collect
and analyze data: 10 hours × $80 an
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hour = $800; to implement and
document improvement projects: 4
hours × $80 = $320. (Total cost of
$1,120)
Director of Nursing: 4 hours to collect
and analyze data × $80 an hour = $320;
to implement and document
improvement projects: 10 hours × $80
an hour = $800. (Total cost of $1,120)
RN: 4 hours to collect and analyze
data and 6 hours to implement and
document improvement projects; 10
hours × $58 an hour = $580.
Physician: 1 hour to analyze data ×
$172 an hour = $172
Office Assistant: 1 hour collect and
analyze data × $29 an hour = $29
We estimate that the annual cost for
each facility would be $3,021. The total
annual cost for all facilities would be
$47,402,511 ($3,021 × 15,691).
B. ICRs Regarding Compliance and
Ethics Program (§ 483.85)
Proposed § 483.85 would require the
operating organization for each SNF and
NF to have in operation a compliance
and ethics program that would be
effective in preventing and detecting
criminal, civil, and administrative
violations under the Act and promoting
quality of care no later than 1 year after
the effective date of the final rule. Each
compliance and ethics program must
contain at least the eight required
elements in proposed § 483.85(c). The
operating organization for each facility
must also review its compliance and
ethics program annually, and revise its
program, as needed. Furthermore,
proposed § 483.85(d) has additional
requirements for operating organizations
that operate five or more facilities.
For the purpose of determining a
burden for this proposed rule, we have
estimated a burden based on the number
of SNF and NF operating organizations.
Once this rule is finalized and becomes
effective, it would be enforced through
the survey process. We expect that the
operating organization would develop
the compliance and ethics program in
collaboration with staff at their facilities
and then share the implementation of
the program with its operating facilities.
Since it would be the individual
facilities that would be surveyed and
not the operating organization,
operating organizations would need to
ensure that the appropriate
documentation is available at all of their
individual facilities in order to
demonstrate compliance with all of the
relevant requirements in this proposed
rule. Therefore, the burden we have
assessed for the operating organization
would encompass their working with
staff at their individual facilities.
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The current regulations for SNFs and
NFs do not contain any requirements for
a compliance and ethics program.
However, SNFs and NFs, as well as all
other health care facilities, must comply
with all applicable statutes, regulations,
and other mandatory guidance or face
criminal, civil, or administrative
sanctions. In addition, as discussed
previously, the OIG had issued
voluntary guidance about compliance
and ethics programs for SNFs and NFs
in 2000 and 2008. We also believe that
it is standard practice for SNFs and NFs
to have high-level personnel, such as
the administrator, director of nursing, or
the facilities director be responsible for
ensuring that the facility is in
compliance with all of the applicable
federal, state, and local laws. We believe
that many, if not all, of the operating
organizations for SNFs and NFs already
have some type of compliance program
in operation. Furthermore, since many
of the proposed required components
for the compliance and ethics programs
are very similar to many of the listed
elements for the programs in the OIG’s
voluntary guidance documents
published in 2000 and 2008, we believe
the compliance and ethics programs that
are already being used by many nursing
homes include many, if not all, of the
components proposed in this rule.
However, since adherence to the OIG’s
guidance was voluntary and did not
impose mandatory obligations, we also
believe that some of these existing
programs may not have all, or perhaps
any, of the required components or may
not be documented or included in the
facility’s standards, policies, or
procedures. Therefore, we believe that
all of the operating organizations for the
SNFs and NFs would need to review
their current programs and possibly
revise or, in some cases, develop new
sections for their programs in order to
comply with the requirements in this
proposed rule.
According to the Medicare Provider
Enrollment, Chain, and Ownership
System (PECOS) as of March 2015, there
are 9,023 SNFs and NFs that are part of
a multi-facility operating organization
(an operating organization with 2 or
more facilities). Furthermore based on
PECOS data, for purposes of this
regulation, we estimate that there are
7,445 total operating organizations (387
operating organizations with 5 or more
facilities, 437 operating organizations
with 2 to 4 facilities, and 6,621
operating organizations with single
facilities). Based on our experience with
SNFs and NFs, we expect that the
administrator and the director of
nursing would primarily be involved in
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developing the operating organization’s
compliance and ethics program. Thus,
in determining the burden for all of the
requirements in proposed § 483.85,
except for § 483.85(d), we will analyze
the burden based on an administrator
and the director of nursing performing
the necessary tasks and activities. If the
operating organization has a designated
compliance officer, we expect that he or
she would take the lead in developing
the entire program with the assistance of
the administrator and the director of
nursing as needed or when required.
Since we have estimated that the
compliance officer and the director of
nursing would receive about the same
amount of compensation, $80 an hour,
and that the necessary activities would
require about the same numbers of
hours, we believe our estimates would
be about the same regardless of whether
these tasks and activities were
performed by the administrator and the
director of nursing or by the compliance
officer with the assistance of the
administrator and the director of
nursing.
As described previously, nursing
homes must already ‘‘be in compliance
with all applicable Federal, State, and
local laws, regulations, and codes, and
with accepted professional standards
and principles that apply to
professionals providing services in such
a facility’’ (proposed § 483.85(b)). Thus,
we expect that nursing homes are
already performing many of the tasks
and activities necessary to a compliance
program and spending hours of their
time on compliance issues, especially
the nursing homes in multi-facility
operating organizations. However, we
are not certain that most nursing homes
have formal programs that comply with
the requirements in this proposed rule.
Thus, we believe that nursing homes
would sustain a burden associated with
the requirement to develop a program
that complied with this proposed rule
from the resources needed for each
facility to review, revise, and, if needed,
develop new sections for the operating
organization’s compliance and ethics
program.
We estimate that complying with this
requirement would require 10 burden
hours from the administrator and 10
burden hours from the director of
nursing for a total of 20 burden hours
from these individuals at an estimated
cost of $1,600 (20 hours × $80 hourly
wage). In addition, since we are
proposing that compliance and ethics
programs should now be mandatory, we
expect that facilities would have an
attorney review their programs to ensure
they are in compliance with the
requirements in this rule. The cost of
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having an attorney review the operating
organization’s program will vary
depending on whether the operating
organization has in-house counsel or
has to hire an attorney at a law firm. For
the purposes of determining the burden,
we will assume that each operating
organization has in-house counsel. We
expect that an attorney would need to
review the facility’s compliance and
ethics program, make recommendations,
and approve the final program. We
estimate this would require 4 burden
hours at an estimated cost of $492 ($123
hourly wage × 4 hours).
Based on this data, we estimate it
would require a total of 24 burden hours
(10 hours for an administrator + 10
hours for the director of nursing + 4
hours for an attorney) for each operating
organization to develop a compliance
and ethics program that complied with
the requirements in this proposed rule
at a cost of $2,092 ($1,600 for the
administrator and director of nursing +
$492 for an attorney). Therefore, we
estimate it would require 178,680
annual burden hours (24 burden hours
for each operating organization × 7,445
operating organizations) at a cost of
$15,574,940 ($2,092 for each operating
organization × 7,445 operating
organizations) for all facilities to comply
with this requirement.
Each operating organization would
also need to develop the policies and
procedures necessary to implement the
operating organization’s compliance and
ethics program. The burden associated
with this requirement would be the
resources needed to review and revise
any existing policies and procedures
and, if needed, develop new policies
and procedures. Based on our
experience with SNFs and NFs, we
expect that the administrator, director of
nursing, or perhaps both of these
individuals would develop these
policies and procedures. We estimate
that it would require 10 burden hours
for each operating organization to
comply with this requirement at a cost
of $800 ($80 hourly wage for a health
services manager × 10 hours). Therefore,
we estimate that for all 7,445 operating
organizations to comply with this
requirement, it would require 74,450
burden hours (10 burden hours for each
operating organization × 7,445 operating
organizations) at a cost of $5,956,000
($800 per operating organization × 7,445
operating organizations).
In addition to developing the
compliance and ethics program, each
operating organization would be
required to develop training materials
and/or other publications to disseminate
information about the program to its
entire staff, individuals providing
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services under a contractual
arrangement, and volunteers, consistent
with their expected roles. As stated
previously, we believe that nursing
homes are already performing many of
the tasks necessary for a compliance
program and spending many hours on
compliance issues. Thus, we expect that
many operating organizations already
have some of the materials and/or other
publications that would be needed to
comply with this requirement. The
burden associated with this requirement
would be the resources needed to
review and revise any existing materials
and, if needed, develop new materials to
comply with this requirement. Based on
our experience with operating
organizations, we expect that the
compliance liaison (nursing staffs)
would be involved in these activities.
We believe that the compliance
liaison would need 8 hours to develop
these materials. Thus, we estimate it
would require 8 burden hours for each
operating organization to comply with
this requirement at a cost of $464 ($58
hourly wage × 8 hours). Therefore,
based on the previous estimate, for all
7,445 operating organizations to comply
with this requirement it would require
59,560 burden hours (8 hours × 7,445
operating organizations) at a cost of
$3,454,480 ($464 per operating
organization × 7,445 operating
organizations).
We also propose in § 483.85(e) that
the operating organization for each
facility must review its compliance and
ethics program annually, and revise its
program, as needed. Thus, after nursing
homes develop their compliance and
ethics programs, these facilities would
need to review and revise their
programs, as needed, in the subsequent
years. Based on our experience with
other healthcare facilities, we expect
that most facilities are already
periodically reviewing their programs,
policies, and procedures. However,
since an effective compliance and ethics
program requires that a facility stay upto-date with all SNF and NF
requirements to reduce the prospect of
criminal, civil, and administrative
violations and promote quality of care,
we believe that the facility would
require more time to review this
program as compared to its other
programs, policies, and procedures that
it must periodically review. In addition,
since it is common for there to be
changes in laws, regulations, and other
requirements, we expect that most SNFs
and NFs would need to make at least
some revisions annually. Even if there
are no changes in the applicable laws,
regulations, or other requirements, SNFs
and NFs may need to make changes in
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their training materials or other
publications.
We expect that the administrator or
the director of nursing, or perhaps both,
would be responsible for reviewing this
program annually to ensure it was upto-date and in compliance with all of
the relevant federal and state laws,
regulations, and other guidance. We
expect that to comply with this
requirement would require 5 hours from
the administrator and 5 hours from the
director of nursing for 10 burden hours
at a cost of $800 ($80 hourly wage for
administrator and director of nursing ×
10 hours). Therefore, based on the
previous estimate, for all 7,445 facilities
to comply with this requirement would
require 74,450 burden hours (10 hours
× 7,445 operating organizations) at a
cost of $5,956,000 ($800 per facility ×
7,445 operating organizations).
Based upon the previous estimates,
for the first year that this requirement is
in effect, it would require 42 burden
hours (24 hours for developing the
program + 10 hours for developing
policies and procedures + 8 hours for
developing training materials,
publication or both) at a cost of $3,356
($2,092 for developing the program +
$800 for developing policies and
procedures + $464 for developing
training materials, publication or both)
for each operating organization to
comply with this requirement. Based on
the estimates shown previously in this
section, for all 7,445 operating
organizations to comply with these
requirements it would require 312,690
burden hours (42 hours per operating
organization × 7,445 operating
organizations) at an estimated cost of
$24,985,420 ($3,356 per operating
organization × 7,445 operating
organizations). For all subsequent years,
prevention training to all NAs, each
facility would need to review their
training procedures and materials to
ensure that they are complying with the
new requirements. For example,
facilities may currently provide the inservice training (as identified from the
performance review) utilizing an
individual, targeted approach. In this
proposed rule, all NAs would be
required to receive this training
annually, and the facility would need to
evaluate whether another format might
be more appropriate.
Since we are not proposing to
increase the time needed to provide this
training, we are not adding additional
burden for the staff to train the NAs,
since the existing requirements for
facilities require them to provide inservice training to all NAs at least once
every 12 months. We estimate that the
burden associated with complying with
this requirement would be a one-time
burden due to the resources required to
review and, if necessary, modify the
existing training materials to apply to all
NAs, regardless of identified
performance weaknesses. We expect
that these activities would require the
involvement of a RN or a LPN. Based on
our experience with facilities, we
anticipate that it would take each
facility 4 hours to review and modify
their existing training materials. Based
on an hourly rate of $58 for an RN that
includes fringe benefits, we estimate
that this would require 62,764 burden
hours (4 hours × 15,691 facilities) at a
cost of $3,640,312 ($232 per facility ×
15,691 facilities).
Table 1 below summarizes the
estimated annual reporting and
recordkeeping burdens for this proposed
rule.
we estimate to comply with the
information collection would annually
require 10 burden hours at a cost of
$800. For all 7,445 operating
organizations, it would require 74,450
(10 hours × 7,445 facilities) burden
hours at an estimated cost of $5,956,000
($800 per operating organization × 7,445
operating organizations).
C. ICRs Regarding Training
Requirements (§ 483.95)
Each facility is already required to
complete a performance review of every
NA at least once every 12 months, and
must provide in-service education based
on the outcome of these reviews. The
proposed requirement at § 483.95(f)(1)
would require a facility to include
dementia management and abuse
prevention in their regular in-service
education for all NAs.
Section § 483.75(e)(8)(iii) of the
current regulations already requires that
NAs who provide services to
individuals with cognitive impairments
receive in-service training to address the
care of the cognitively impaired. Based
on the existing requirements, facilities
already conduct training for some NAs
on caring for residents who are
cognitively impaired. Additionally, the
current requirement at § 483.75(e)(8)(ii)
states that NAs must receive in-service
training that addresses areas of
weakness as determined in their
performance reviews and may address
the special needs of residents, as
determined by the facility staff. Thus
NAs receive annual training in dementia
management and abuse prevention only
if the training is indicated by their
performance reviews.
Because this proposed rule would
specifically require facilities to provide
dementia management and abuse
TABLE 1—ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDENS
Total annual
burden
(hours)
Hourly labor
cost of
reporting
($)
OMB Control
No.
Number of
respondents
§ 483.75(a) ..............
§ 483.75(b)(2) ..........
§ 483.85(b) ..............
§ 483.85(c) ...............
§ 483.85(d)(1) ..........
§ 483.85(e) ..............
§ 483.95 ...................
0938—New
0938—New
0938—New
0938—New
0938—New
0938—New
0938—New
15,691
15,691
7,445
7,445
7,445
7,445
15,691
15,691
15,691
7,445
7,445
7,445
7,445
15,691
56
40
24
10
8
10
4
878,696
627,640
178,680
74,450
59,560
74,450
62,764
**
**
**
**
**
**
**
Totals ...............
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Number of
responses
Burden per
response
(hours)
Regulation section(s)
......................
23,136
76,853
......................
1,956,240
......................
Total labor
cost of
reporting
($)
Total capital/
maintenance
costs
($)
Total cost
($)
71,017,466
47,402,511
15,574,940
5,956,000
3,454,480
5,956,000
3,640,312
0
0
0
0
0
0
0
71,017,466
47,402,511
15,574,940
5,956,000
3,454,480
5,956,000
3,640,312
......................
......................
106,001,709
** The hourly labor wages are discussed in detail earlier in this section.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated
column from Table 1.
If you comment on these information
collection and recordkeeping
requirements, please submit your
comments electronically as specified in
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the ADDRESSES section of this proposed
rule.
Comments must be received on or by
September 14, 2015.
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V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
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able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
VI. Regulatory Impact Analysis (RIA)
A. Introduction
We have examined the impacts of this
rule as required by Executive Order
12866 on Regulatory Planning and
Review (September 30, 1993), Executive
Order 13563 on Improving Regulation
and Regulatory Review (January 18,
2011), the Regulatory Flexibility Act
(RFA) (September 19, 1980, Pub. L. 96–
354), section 1102(b) of the Social
Security Act, section 202 of the
Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999) and the Congressional
Review Act (5 U.S.C. 804(2).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). Section 3(f) of Executive Order
12866 defines a ‘‘significant regulatory
action’’ as an action that is likely to
result in a rule: (1) Having an annual
effect on the economy of $100 million
or more in any 1 year, or adversely and
materially affecting a sector of the
economy, productivity, competition,
jobs, the environment, public health or
safety, or state, local or tribal
governments or communities (also
referred to as ‘‘economically
significant’’); (2) creating a serious
inconsistency or otherwise interfering
with an action taken or planned by
another agency; (3) materially altering
the budgetary impacts of entitlement
grants, user fees, or loan programs or the
rights and obligations of recipients
thereof; or (4) raising novel legal or
policy issues arising out of legal
mandates, the President’s priorities, or
the principles set forth in the Executive
Order.
A regulatory impact analysis (RIA)
must be prepared for major rules with
economically significant effects ($100
million or more in any 1 year). We
estimate that this rulemaking is
‘‘economically significant’’ as measured
by the $100 million threshold, and
hence also a major rule under the
Congressional Review Act. We estimate
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the total projected cost of this rule
would be $729,495,614 million in the
first year. This results in an estimated
first-year cost of approximately $ 46,491
per facility and a subsequent-year cost
of $40,685 per facility on 15,691 LTC
facilities. Accordingly, we have
prepared a Regulatory Impact Analysis
that to the best of our ability presents
the costs and benefits of the rulemaking.
B. Statement of Need
CMS had not comprehensively
reviewed the entire set of requirements
for participation it imposes on LTC
facilities in many years. CMS staff as
well as stakeholders identified
problematic requirements over the
years. Accordingly, we decided to
conduct a review of the requirements in
an effort to improve the quality of life,
care, and services in facilities, optimize
resident safety, reflect current
professional standards, and improve the
logical flow of the regulations. Based on
our analysis, we decided to pursue
those regulatory revisions that would
reflect the advances that have been
made in healthcare delivery and that
would improve resident safety.
C. Anticipated Impacts on SNFs and
NFs
There are about 15,691 SNFs and NFs
that are certified by Medicare and
Medicaid. We use these figures to
estimate the potential impacts of the
proposed rule. In addition, we have
used the same data source for the RIA
that we used to develop the PRA burden
estimates. As stated in the COI section,
we obtained all salary information from
the May 2014 National Occupational
Employment and Wage Estimates,
United States by the BLS at https://
www.bls.gov/oes/current/oes_nat.htm
and all salary estimates include benefits
and overhead package worth 48 percent
of the base salary. The analysis below
overlaps with the COI section for some
requirements and much of the economic
impact of the rule would be due to the
cost for facilities to comply with the
information collection requirements.
The COI section contains more technical
and legal detail, therefore readers may
wish to consult both sections on some
topics.
This proposed rule would require
facilities to review their current
practices and make changes to be in
compliance with the health and safety
standards as set forth in this proposed
rule. Many of the proposals in this rule
are current and standard medical or
business practices and as a result do not
pose an additional burden or new cost
to facilities. We have made several
assumptions and estimates in order to
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42235
assess the time that it would take for a
facility to comply with the proposed
provisions and the associated costs of
compliance.
Resident Rights § 483.10
Notification of Changes to Care Plan
(§ 483.10(b)(5)(F))
As noted above, current requirements
already require that a resident, to the
extent practicable, participate in the
development of his or her care plan and
be informed of the need to significantly
alter treatment. We believe that the
involvement and notification would
include an opportunity to see the care
plan. Periodic review after development
of the care plan is also already required.
However, we propose a new right for the
resident, the right to sign the care plan.
The intent is to ensure that the resident,
to the extent practicable and consistent
with the resident’s choices,
demonstrates his or her participation in
and review of his or her care planning
and that participation is evident to caregivers, surveyors, and other interested
parties. We estimate that it should take
a caregiver, probably a nurse, no more
than an additional 2 minutes per
resident, to obtain a resident signature.
We estimate that this may occur up to
four times per year per resident. Based
on an estimated 1,382,201 residents per
year, the resulting burden would be
$9,620,119 for all nursing homes. ($58
hourly wage for a nurse × .03 hour per
occurrence × 1,382,201 residents × 4
occurrences per year = $9,620,119).
Notification of a Need To Select a New
Physician (§ 483.10(c)(3) and
§ 483.11(c)(2))
The facility would have to inform the
resident if the facility determines that
the physician chosen by the resident is
unable or unwilling to comply with
regulatory requirements, discuss
alternatives, and honor the resident’s
preferences. Under current
requirements, the facility must already
ensure that the resident is informed of
the name, specialty, and way of
contacting the physician responsible for
his or her care. We have no basis upon
which we can quantify how often this
occurs or how often a facility would
need to obtain an alternate provider. We
believe that these conversations will be
accomplished, and in most cases
already occur, in the course of routine
communication between a resident and
caregivers. Thus, we do not believe this
creates any new burden.
If a resident requests an item or
service for which the facility will
charge, the facility must inform the
resident both orally and in writing of
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the charge. This requirement is
modified to specify orally and in
writing; the previous requirement was
just ‘to inform.’ We expect that
‘‘informing’ has typically been
accomplished orally; therefore the
burden would be in providing the
written information at the time the oral
information is given. We anticipate that
this written information would most
often be in the form of a list of standard
charges for frequently requested items
and the cost would be the cost of
photocopying or printing the list. In
infrequent cases, an individualized cost
page may be needed. We estimate that
a facility would spend no more than $50
per year on average to print the notices.
We estimate the cost of a notice to be
$0.10/page (based on the per page
photocopying cost established at 45 CFR
5.43(c) for FOIA requests) with no more
than 500 notices required per facility
per year for a total estimated cost of
$784,550 ($50 printing cost × 15,691
facilities) annually for all facilities.
Internet Access (§ 483.10(h)(2))
Proposed 483.10(h)(2) proposes to
require that a resident has the right to
reasonable access and privacy for
electronic communications such as
email and video communications and
internet research. This requirement is
proposed in a way that the facility is not
required to provide internet access to
any greater extent than the facility
already has internet access (that is, a
facility that has no internet access due
to logistical deterrents is not required to
overcome those obstacles based on this
requirement) and the facility is allowed
to transfer any additional expense to the
resident if any additional expense is
incurred. The facility is not obligated to
provide each resident an individual
means of access (that is, a personal
computer or tablet). A community
computer with associated rules for
sharing, such as is commonly done in
public libraries, may be an appropriate
model. While we allow the facility to
pass additional costs to the resident, we
anticipate that some facilities may incur
an initial hardware cost that is not
attributable to an individual resident. In
addition, we expect there will be
minimal ongoing maintenance/
replacement costs for the shared
devices. Finally, we do not believe this
will add to the supervision burden for
facility staff, as appropriate resident
supervision is already required, but it
may require a Director of Nursing (DON)
or Nursing Home Administrator (NHA)
to establish rules for use. We estimate
this would require quarter of an hour of
DON or NHA time to develop in those
facilities that do not already have a
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policy established. We believe that up to
ten percent of facilities will need to
develop an internet policy in the first
year, at a total cost of $31,382 (($80
hourly wage for a DON or NHA × .25
hours) × (0.10 × 15,691 facilities) =
$31,382).
Facility Obligations (§ 483.11)
Mutually Agreeable Facility
Representative (§ 483.11(d)(3)(iii))
Facilities are currently required to
provide a facility representative to
participate in resident and family
groups. Any added burden is in
establishing an individual who is
mutually agreed to. We believe it is
most likely that the DON will select a
representative and obtain group
agreement by providing a name or
names to the group and the group will
respond. We estimate that this should
generally consume no more than an
additional 15 minutes of the DONs time
in most cases. We believe some, and
perhaps many, facilities already have
such mutually agreed upon
representatives; however, for estimation
purposes, we estimate an additional 15
minutes of DON time at a cost of $80 per
hour for 15,691 facilities, resulting in a
total cost of $313,820.
Visitation Related Notices
(§ 483.11(d)(2))
We believe that—(1) these notices are
periodically reviewed and updated as a
standard business practice, (2) the DON
and Nursing Home Administrator will
develop the associated policy, and (3)
visitation is already addressed in the
notice of rights and services. While we
believe that the notice of rights and
services is or should be periodically
reviewed by each nursing facility as a
standard practice, we expect that the
notice will need to be updated on a onetime basis specifically to include the
new visitation policy. We estimate that
an office clerk will require no more than
30 minutes to update the notice and that
will cost each facility approximately
$14.50 ($29 hourly wage for an office
clerk × .5 hour = $14.50) or a total of
$227,520 for all facilities ($10.50 ×
15,691 = $227,520).
Posting of Contact Information
(§ 483.11(e)(5))
The facility must post a list of names
and contact information. This
information must already be gathered
for the notice of legal rights, so the new
burden is limited to the posting. This
means printing out and placing the
notice in an appropriate location and/or
on an accessible Web site and perhaps
updating the information annually.
Based on other current requirements,
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the location for this information should
already be identified and an office clerk
should be able to update, print and post
a listing in 10 minutes. We estimate this
will cost each facility approximately
$4.93 or a total of $77,357 for all
facilities. ($29 hourly wage for an office
clerk × .17 of an hour × 15,691 facilities
= $77,357).
Medicaid Eligibility (§ 483.11(e)(11)(i))
The facility must provide notice to
each Medicaid-eligible resident, in
writing, at the time of admission and
when the resident becomes eligible for
Medicaid. This means some residents
will require a second notice. As the
notice is already required once, the
burden is in providing the notice an
additional time. We anticipate that this
will affect only a subset of residents
(those eligible but not yet receiving
Medicaid) and that the notice will be
unchanged from the admission notice.
Thus the burden is in identifying
eligible residents and delivering the
second notice. We anticipate that this
will require a social worker no more
than 3 minutes per eligible resident.
Based on a data analysis by AHCA,
approximately 64 percent of nursing
home residents are already Medicaid
recipients (that is, Medicaid is the payor
of record); 14 percent are covered by
Medicare and 22 percent have another
payor. Of those, only the 36 percent
who are not receiving Medicaid may
require the second notice of Medicaid
eligibility. We assume that a portion of
those will require ongoing care and
become eligible for Medicaid. We also
assume that some of those residents will
apply for Medicaid at or shortly after
admission or as a result of the first
notice and not require the second
notice. For burden calculation purposes,
we estimate that 20 percent of nursing
home residents (slightly more than half
of those not already receiving Medicaid)
will require a second notice of Medicaid
eligibility. The per facility cost will vary
significantly according to facility size
and resident mix and will be about
$2.20 per resident who requires
notification, or $608,168 for all such
residents across all 15,691 facilities.
(($44 hourly wage for social worker ×
.05 of an hour) × (.20 estimate percent
of all nursing home residents who will
require a second notice × 1,382,201
nursing home residents) = $608,168).
Update the Description of Legal Rights
(§ 483.11(e)(13))
Our proposed changes will require
that facilities review and possibly
update their description of legal rights
to include additional names and contact
information as well as some additional
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language to meet the requirements of the
revised regulatory language. Collecting
and verifying some of this information
may require some additional research.
We anticipate that a social worker
would need 45 minutes to review
information and conduct the necessary
research and an office clerk would need
an additional 15 minutes to update the
notice. The cost per facility is estimated
at $30 per facility or a total of $631,563
for all facilities. (($44 hourly wage for a
social worker × .75 of an hour) + ($29
hourly wage for an office clerk × .25 of
an hour) × 15,691 facilities = $631,563).
Grievances (§ 483.11(h)(1))
A facility must make information
regarding the grievance process and
how to file a grievance available to
residents. We believe this information is
already included in the notice of legal
rights, but it may need reviewed and
updated. It would take an office clerk
approximately 10 minutes to review and
update the notice. This would cost each
facility $4.93 or a total of $77,357 for all
facilities. ($29 hourly wage for an office
clerk × .17 of an hour × 15,691 facilities
= $77,357).
Transitions of Care (§ 483.15)
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Notice of Transfer (§ 483.15(b)(4))
The notice is already created for the
resident; this requirement poses an
additional burden of printing a copy of
the notice and sending it to the Office
of the State Long-Term Care
Ombudsman or, if a secure means of
electronic transmission is available,
sending a notice electronically. We
estimate the burden of this requirement
to be $.10 per notice to make a copy,
and $.58 for a single pre-stamped first
class envelope (USPS retail) plus 5
minutes for an office clerk to address
and mail the notice. This will apply
primarily to residents who are
involuntarily discharged from the
facility and does not include residents
who request the transfer or who are
transferred on an emergency basis to an
acute care facility. We estimate this
notice may need to be sent to the Office
of the State Long-Term Care
Ombudsman for one third of all nursing
home residents, resulting in a cost of
$1,243,981 for all facilities. The perfacility cost will vary significantly
according to facility size and number of
transfers out of each facility. (($.10 +
$.58 + ($29 hourly wage for an office
clerk × .08 of an hour)) × (.3 percentage
of nursing home residents for whom a
copy of a transfer notice needs sent to
the Office of the State Long-Term Care
Ombudsman × 1,382,201 nursing home
residents) = $1,243,981).
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Update Transfer Notices (§ 483.15(b)(7))
The proposed requirement requires
the facility to update transfer notices if
information in the notice changes and to
provide the updated information to the
resident. We believe that the updates
already occur informally and estimate
that updating the notice and providing
it to the resident will require a social
worker an additional 5 minutes per
notice. As discussed above, this
requirement will apply primarily to
residents who are involuntarily
discharged from the facility and does
not include resident who request the
transfer or who are transferred on an
emergency basis to an acute care
facility. We estimate this notice may
need to be updated once for up to one
third of nursing home residents who are
transferred. The resulting cost is
$1,459,604 for all facilities. (($44 hourly
wage for a social worker × .08 of an
hour) × (.3 percent of nursing facility
residents × 1,382,201 nursing facility
residents) = $1,459,604). The per-facility
cost will vary significantly according to
facility size and number of transfers out
of each facility.
We believe the DON or administrator
would perform a comprehensive review
of all required notices after all the
cumulative changes noted above are
made and that this cumulative review
would require approximately 30
minutes at a cost of $40 per facility or
$627,640 for all facilities ($80 hourly
wage for a NHA or DON × .5 of an hour
× 15,691 facilities = $627,640).
Comprehensive Resident Centered Care
Planning (§ 483.21)
Additional Members of the IDT
(§ 483.21(b)(2)(ii))
We would require that a NA, member
of nutrition services, and social worker
participate on the IDT. We believe that
this requirement would add to the
current duties of each of these staff
members and therefore would be a new
economic cost to each facility.
Communications about the status of a
resident are a part of standard job
duties. We envision that these staff
members are already regularly
discussing resident’s needs and their
plans of care. When assessing the
amount of burden associated with this
requirement, we believe that this
requirement would only produce an
incremental increase in the staff time
necessary to participate on the IDT. In
addition, we do not specify the type of
communication the IDT must use. IDT
members may use electronic
communication as well as informal
discussions to participate in IDT
meetings. We estimate that participation
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42237
on the IDT would add an additional one
hour of staff time to the duties of a NA,
member of food services, and social
worker. While we do not require that a
dietitian participate on the IDT, for
purposes of estimating the cost we use
the salary of a dietitian to represent the
participation of a member of food
services. We estimate that this
requirement would cost $97,911,840
($120 hourly wage ($23 NA hourly wage
+$53 dietitian hourly wage +$44 social
worker hourly wage = $120) × 52 hours
(1hour per week × 52 weeks) × 15,691
facilities).
Discharge Planning (§ 483.21(c)(1)(vii))
We would require that, for residents
who are transferred to another SNF or
who are discharged to a HHA, IRF, or
LTCH, facilities assist residents and
their resident representatives in
selecting a post-acute care provider by
using data that includes, but is not
limited to SNF, HHA, IRF, or LTCH
standardized patient assessment data,
data on quality measures, and data on
resource use. The facility also must
ensure that the post-acute care
standardized patient assessment data,
data on quality measures, and data on
resource use is relevant and applicable
to the resident’s goals of care and
treatment preferences. We believe that a
social worker would be responsible for
compiling the standardized data,
reviewing the resident’s preferences/
goals, and pulling data that applies to
these preferences/goals. We estimate
that it would take a social worker
approximately one hour of staff time to
compile and review the data in order to
align the data with each resident’s
preferences/goals. This staff time would
only be required for those residents who
are transferred to another SNF or
discharged from the nursing home. We
are unable to determine the average
number of residents who are transferred
to another SNF or discharged from a
nursing home annually. We believe that
a conservative estimate would be that if
there are an estimated 1,382,201
residents per year in nursing homes,
possibly a third of these residents are
discharged or transferred to another
SNF on an annual basis. Therefore, we
estimate that this requirement would
cost $20,272,252 ($44 social worker
hourly wage × 1 hour staff time ×
460,733 residents discharged or
transferred to another SNF annually).
Physician Services (§ 483.30)
Practitioner Evaluation of a Resident
(§ 483.30(e))
We believe that a physician, NP, CNS
or PA often evaluate in person a
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resident prior to hospital transfer unless
a delay in transfer places the resident at
risk. However, we also believe that there
are instances when an evaluation does
not occur and could prevent an
avoidable hospital transfer. We estimate
that it will require a physician, NP,
CNS, or PA 30 minutes to evaluate a
resident prior to transfer. For purposes
of estimating this cost we will use the
hourly wage of a physician. Research
shows that more than 15 percent of
long-term nursing home residents are
hospitalized in any given 6 month
period and approximately 40 percent of
nursing home to hospital transfers are
considered inappropriate (David C.
Grabowski, A. James O’Malley and
Nancy R. Barhydt, The Costs And
Potential Savings Associated With
Nursing Home Hospitalizations, Health
Affairs, 26, no.6 (2007):1753–1761). If
we use 30 percent to estimate the
number of in-person evaluations
required per year (15 percent per 6
months), the resulting calculation
provides a lower bound estimate of
$35,660,786 (($172 hourly wage for a
physician × .5 of an hour) × (30 percent
of facility residents who require an inperson evaluation prior to transfer ×
1,382,201 facility residents) =
$35,660,786).1
Nursing Services (§ 483.35)
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Competency Requirements (§ 483.35,
§ 483.60)
Our focus on competency
requirements requires identification of
and documentation of training,
certification, and similar records in an
existing personnel file or training record
for direct care personnel. This
specifically includes nursing services
and food and nutrition services but may
apply to any direct care provider. Initial
competency requirements would be
identified via facility assessment with
documentation of individual
accomplishments managed by an
administrative position, likely an office
clerk, as an addition to existing
documentation. We estimate the
incremental burden of adding the
additional information to existing files
(paper or electronic) at 8 hours per year
per facility, or $232. The cost for all
facilities is estimated at $3,640,312. ($29
office clerk hourly wage × 8 hours per
facility × 15,691 facilities = $3,640,312)
1 We refer to this estimate as a lower bound
because the input that is available—residents who
are hospitalized—may be lower (due to repeat
admissions) than the input that would be most
appropriate for this calculation—the number of
hospitalizations.
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Food and Nutrition (§ 483.60)
Requirements for Food Service Directors
(§ 483.60(a)(2))
The proposed provision establishes
requirements for directors of food and
nutrition services hired after the
effective date of these requirements or,
for current directors of food and
nutrition services, within 5 years of the
effective date of these requirements. We
would require that the director of food
and nutrition services be certified as a
certified dietary manager, certified food
service manager or similar national
certification for food service
management and safety from a national
certifying body; or has an associate’s or
higher degree in food service
management or hospitality from an
accredited institution of higher learning,
or meets established state requirements.
Many states already establish additional
staff qualifications for food service
directors and we expect that most
facilities already hire food service
directors that meet the proposed
requirements. We anticipate that some
hiring officials may spend some
additional time recruiting appropriate
candidates for the food service manager
position and verifying credentials,
although we believe this is a small
percentage of facilities. When necessary,
we estimate this will require an extra
hour of the NHA’s time. The burden is
imposed only on those facilities needing
to hire a food service manager after the
effective date of the regulation. We
anticipate that this will affect less than
10 percent of all facilities during the
five-year time horizon we are analyzing
in this regulatory impact analysis. The
cost per affected facility is
approximately $80 and the total cost for
all affected facilities is estimated to be
$125,528. (($80 NHA hourly wage × 1
hour) × (.1 percentage of affected
facilities × 15,691 facilities) = $125,528).
Menu Options (§ 483.60(c))
We expect that our proposed
requirement for menus to reflect the
cultural and ethnic needs of residents
would require that menus be updated by
a qualified dietitian or other clinically
qualified nutrition professional in the
course of routine reviews and updates.
Additional time would include the
dietitian or other clinically qualified
nutrition professional reviewing the
facility assessment for pertinent factors
and reviewing and updating the menus.
We anticipate this would require 1 to 4
hours, on average 2 hours, depending on
the size of the facility and complexity of
resident needs. While we believe that
some facilities already meet this
requirement, for estimation purposes,
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we multiply the $53 hourly wage of a
qualified dietitian or other clinically
qualified nutrition professional for 2
hours for 15,691 facilities, for a total
cost of $1,663,246.
Facility Assessment (§ 483.70(e))
The proposed provision establishes
requirements for each LTC facility to
conduct and document a facility-wide
assessment to determine what resources
are necessary to care for its residents
competently during both day-to-day
operations and emergencies. LTC
facilities must already determine and
plan for what staffing they will need, as
well as the other resources that will be
required to care for their residents and
operate their facilities. Thus, we believe
that conducting and documenting a
facility assessment is a standard
business practice and will not include a
burden for this requirement in the
impact analysis.
QAPI (§ 483.75)
We have proposed to require that each
facility develop a QAPI program. In
addition to the QAPI requirement
related ICR costs discussed in the COI
section, we expect that facilities would
incur additional costs that would be
dependent upon the projects they
selected for their quality improvement
activities. In turn, the projects would be
dependent upon resident needs, and the
type, complexity, and quality of services
already provided by the facility.
Facilities would have the flexibility to
determine their quality performance
improvement activities based on their
assessment of needs of their residents
and their prioritized performance
improvement projects. For example, a
facility that chose, as one of its projects,
to improve residents’ nutritional status
and satisfaction with the facility’s food
services could incur costs for higher
quality, more palatable food. A facility
that chose, as one of its projects, to
improve nurse aides’ interactions with
residents suffering from dementia could
incur costs for nurse aide training and/
or additional nurse aide staffing. A
facility that chose, as one of its projects,
to improve residents’ psychosocial wellbeing could incur costs for conversion
of double rooms to single rooms, and
additional social worker, and/or
increased social activities for residents.
Because the number, degree, and costs
of these activities are difficult, if not
impossible, to quantify, we have
calculated only the cost of the QAPI
ICRs ($118,419,977 upfront) that would
be associated with the QAPI
requirements (discussed in the COI
section of the preamble). However, we
encourage the public to comment on the
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potential costs for facilities of their
quality improvement projects. We
estimate that the ongoing annual cost for
each facility to comply with the QAPI
requirements would be $3,021 for each
facility and for all facilities would be
$47,402,511 ($3,021 × 15,691). (This
discussion is detailed in the COI
section.)
Infection Control (§ 483.80)
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Infection Prevention and Control Officer
(§ 483.80(b))
Facilities and their staffs are currently
required to have an infection control
program (§ 483.65). In this rule, we are
proposing that each facility must also
designate one individual as the
infection prevention and control officer
(IPCO) for whom the infection
prevention and control program (IPCP)
is a major responsibility. The IPCO
would be responsible for assessing the
current program, making any changes to
the IPCP necessary to comply with the
program’s requirements, and
implementing and managing the IPCP.
This individual would also be required
to be a member of the facility’s QAA
committee. The percentage of the RN
FTE that would be required at each
facility will vary greatly. We believe that
each facility would have to determine
the appropriate percentage based upon
it facility assessment, especially its
assessment of the acuity of its resident
population. A facility with a generally
healthy population of elderly
individuals would likely require many
fewer hours than a facility with a large
percentage of subacute residents or
residents that are on ventilators. For the
purposes of determining an estimate, we
believe that the average facility would
designate a registered nurse (RN) to be
the IPCO and that individual would
need to commit about 15 percent of a
full time equivalent position (FTE) to
his or her responsibilities under the
IPCP. We estimate that this would
require 15 percent of one RN FTE for
each of the 15,691 facilities for a total
cost of $283,944,336 (15% of an RN FTE
× $58 average hourly wage for an RN ×
2,080 hours (40 hours a week × 52
weeks = 2,080 hours) × 15,691 facilities
= $283,944,336). We request comment
on the time and other costs that would
be associated with rule-induced
improvements in infection control
procedures if any, put into practice by
facility personnel other than the IPCO.
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Compliance and Ethics Program
(§ 483.85)
Compliance Officer and Compliance
Liaison Activities (§ 483.85)
We propose to require facilities to
develop a compliance and ethics
program. As discussed in the COI
section, we estimate the ICR burden
associated with developing this program
to be $24,985,420. We estimate that in
carrying out this program the
compliance officer (similar to an
administrator) in each of the 387
organizations operating 5 or more
facilities would commit 30 percent of an
full time equivalent (FTE) in the
compliance program operation, for a
total cost of $19,319,040 (30% of FTE ×
2080 × $80 × 387). We also estimate that
in carrying out this program the
compliance liaison (nursing staffs) in
each of 7,879 facilities would commit 10
percent of an FTE, at a total cost of
$95,052,256 (10% of FTE × 2080 × $58
× 7879).
Annual Review of Program (483.85(e))
As detailed in the COI section, we
propose to require each facility to
review their compliance and ethics
program annually. Therefore, for
subsequent years we estimate to comply
with the ICR requirement to review and,
if necessary, revise the operating
organization’s program annually would
cost an estimated $5,956,000.
Physical Environment (§ 483.90)
Resident Rooms (§ 483.90(d)(1)(i))
For facilities that receive approval of
construction or reconstruction plans by
State and local authorities or are newly
certified or undergoing reconstruction,
we would require that resident rooms
accommodate no more than two
residents. A review of CASPER data on
the number of new providers per fiscal
year from 2008 to 2013 reveals an
annually declining number of new
facilities, down from 225 new providers
in 2008 to 172 in 2012, with only 144
new providers as of August 2013. Of
those, the majority were for-profit
facilities of 99 beds or less. We further
note the overall number of facilities has
also declined slightly (by less than 2
percent) but steadily over the same
period. A number of states already have
requirements similar to those proposed
and represent an average of 7 percent of
new providers for the years we
reviewed. Therefore, we expect that
these requirements will affect fewer
than 140 facilities annually. We do not
have statistics on the number of
providers per year who undertake
reconstruction. Although we know that
semi-private rooms will increase
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42239
constructions costs, we were unable to
find data regarding the incremental
increased cost to the facility of semiprivate rooms versus configurations that
accommodate up to four residents. We
welcome data on this issue and on the
question of whether this provision of
the rule creates an incentive for
facilities to avoid or delay otherwise
beneficial renovations.
Toilet Facilities (§ 483.90(e))
For resident rooms newly constructed
or undergoing reconstruction, we would
require that each room have its own
bathroom equipped with at least a toilet,
sink and shower. A review of CASPER
data on the number of new providers
per fiscal year from 2008 to 2013 reveals
an annually declining number of new
facilities, down from 225 new providers
in 2008 to 172 in 2012, with only 144
new providers as of August 2013. Of
those, the majority were for-profit
facilities of 99 beds or less. We further
note the overall number of facilities has
also declined slightly (by less than 2
percent) but steadily over the same
period. In addition, several states
require direct access and limit the
number of rooms or residents who may
be served by a toilet, lavatory (sink),
and/or shower or bath. Given the
decline in new facilities and the impact
of state regulation, we estimate that this
provision will impact fewer than 150
providers per year. We do not have
statistics on the number of providers per
year who undertake reconstruction.
Although we are aware that ensuring
each resident bedroom has an adjacent
bathroom may increase construction
costs, we were unable to find data
regarding neither the number of
facilities that do not currently have
bathrooms adjacent to each resident
room nor the incremental cost of adding
bathrooms adjacent to each resident
room in new or reconstruction. We
welcome data on this issue and on the
question of whether this provision of
the rule creates an incentive for
facilities to avoid or delay otherwise
beneficial renovations.
Training Requirements (§ 483.95)
General Training Topics (§ 483.95a)
We are proposing that facilities
develop and/or update training
materials to include topics on
communication, resident rights, facility
obligations, abuse, neglect, exploitation,
infection control, and its QAPI program.
We would require that these training
topics be provided for all new and
existing staff; individuals providing
services under a contractual
arrangement; and volunteers, consistent
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with their expected roles and that they
be able to demonstrate competency in
these topic areas. We would also expect
each facility to keep a record of these
trainings. To reduce regulatory burden
and create a reasonable requirement we
have not specified the amount or types
of training that a facility must provide.
There are various free online training
tools and resources that facilities can
use to assist them in complying with
this requirement. For example, the
Agency for Healthcare Research and
Quality (AHRQ) released a set of
training modules to help educate
nursing home staff on key patient safety
concepts to improve the safety of
nursing home residents (https://
www.ahrq.gov/professionals/systems/
long-term-care/resources/facilities/
ptsafety/). In addition to the web based
materials, instructor and student
handbooks can be sent to facilities at no
additional cost. Therefore, we believe
that the cost associated with this
requirement would be limited to the
staff time required to review and update
their current training materials.
Based on our experience with
facilities, we expect that all facilities
have some type of training program.
However, we expect that each facility
would need to compare their training
programs to their facilities assessments
as required at proposed § 483.70(e) and
ensure they cover the above training
topics. We expect that complying with
this requirement would require the
involvement of a RN and the infection
control and prevention officer (ICPO).
We expect that a RN would spend more
time reviewing, revising and/or
developing new sections for the training
program. The ICPO would need to
weigh in on the infection control
training related topics. We estimate that
it would require 8 (6 for the RN ($58/
hr) and 2 for the ICPO ($58/hr)) burden
hours for each facility to develop a
training program at a cost of $464. Thus,
for all facilities to comply, it would cost
an estimated $7,280,624 ($464 estimated
cost for each facility × 15,691 facilities).
We believe that the training would be
considered part of regular on-ongoing
training for the staff of each facility.
Compliance and Ethics Program
Training (§ 483.95(f))
We require that SNF and NF operating
organizations include as part of their
compliance and ethics program an
effective way to communicate their
program’s standards, policies, and
procedures. We believe that all
operating organizations would need to
develop training materials and/or other
publications to comply with the training
requirement. Our rule proposes, higher
standards for organizations operating 5
or more facilities, therefore for the
purposes of the RIA our cost estimates
differentiate by organization size. We
estimate that training staff in
organizations operating 1 to 4 facilities
would mainly require the duties of a RN
at a cost of $900,740 for all 7,765
facilities (6,621 single facilities
operating organizations + 1,144 facilities
in operating organizations with 2 to 4
facilities = 7,765 facilities) × 2 hours ×
$58 average hourly wage for a RN =
$900,740). For the training in operating
organizations with 1 to 4 facilities, we
expect that operating organizations
would be able to minimize these
training costs by including the training
on their compliance and ethics program
with any current trainings or in-services
that they already conduct for their staff.
In addition, these facilities could also
include this information in publication,
print or electronic, that are available to
their staff.
We estimate that training staff in
organizations operating 5 or more
facilities would require 2 hours of time
of a compliance officer (similar to an
administrator) conducting the training
at the organizational level (387
organizations) at a cost of $61,920 (387
× 2 × $80 = $61,920) and 2 hours of time
of a compliance liaison (similar to an
RN) at the facility level (7,879 facilities
× 2 × $58 = $913,964), for a total cost
of $975,884 ($61,920 + $913,964 =
$975,884).
included in the current mandatory ongoing training requirements for nurse
aides. Facilities would have the
flexibility to determine the length of the
training and the format of the training.
Since we have not increased the
minimum hours for training, we
anticipate that facilitates would
maximize their on-going training efforts
to improve outcomes through a more
efficient training program by modifying
their current training program to ensure
that all NAs receive annual training in
dementia management and abuse
prevention. In addition, we believe that
the majority of facilities would need to
acquire training materials to either
update or supplement what they are
currently using to train NAs. There are
numerous online tools available to
facilities at no cost. For the sole purpose
of complying with section 6121 of the
Affordable Care Act and ensuring that
nurse aides receive regular training on
caring for residents with dementia and
on preventing abuse. CMS has
published an online hand in hand tool
kit that provides a detailed training
series for nursing homes on dementia
education and abuse prevention (https://
www.cms-handinhandtoolkit.info/).
CMS, supported by a team of training
developers and subject matter experts,
created this training to address the need
for nurse aides’ annual in-service
training on these important topics. The
mission of the hand in hand training is
to provide nursing homes with a highquality training program that
emphasizes person-centered care in the
care of persons with dementia and the
prevention of abuse. Given the
availability of these materials, we have
not assessed a cost burden associated
with acquiring training materials for this
requirement, however, as discussed in
the COI section, we estimate that it
would cost facilities an estimated
$3,640,312 to review and update their
current in-service training material.
Dementia Management and Abuse
Prevention Training § 483.95(g)
This proposed rule would implement
section 6121 of the Affordable Care Act
which requires dementia management
and abuse prevention training to be
D. Summary of Impacts
Table 2 below presents a summary of
the section by section estimated costs to
comply with the requirements of this
proposed rule.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
TABLE 2—SECTION BY SECTION SUMMARY OF ESTIMATED COST FROM ICR AND RIA TO COMPLY WITH THE
REQUIREMENTS CONTAINED IN THIS PROPOSED RULE
Regulatory area
Section
Resident Rights .........................................................................................................
Facility Obligations .....................................................................................................
Transitions of Care ....................................................................................................
Comprehensive Resident Centered Care Planning ..................................................
Physician Services .....................................................................................................
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First year total
cost
483.10
483.11
483.15
483.21
483.30
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$10,436,051
1,935,785
3,331,225
118,184,092
35,660,786
16JYP2
Total cost in year
2 and thereafter
$10,436,051
999,345
3,331,225
118,184,092
35,660,786
Federal Register / Vol. 80, No. 136 / Thursday, July 16, 2015 / Proposed Rules
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TABLE 2—SECTION BY SECTION SUMMARY OF ESTIMATED COST FROM ICR AND RIA TO COMPLY WITH THE
REQUIREMENTS CONTAINED IN THIS PROPOSED RULE—Continued
Regulatory area
First year total
cost
Section
Total cost in year
2 and thereafter
Nursing Services ........................................................................................................
Food and Nutrition Services ......................................................................................
QAPI ..........................................................................................................................
Infection Control .........................................................................................................
Compliance and Ethics Program ...............................................................................
Training ......................................................................................................................
General Training Topics ............................................................................................
Compliance and Ethics Training ................................................................................
Dementia Management and Abuse Training .............................................................
483.35
483.60
483.75
483.80
483.85
483.95
483.95(a)
483.95(f)
483.95(g)
3,640,312
1,788,774
118,419,977
283,944,336
139,356,716
3,640,312
1,663,246
47,402,511
283,944,336
120,327,296
7,280,624
1,876,624
3,640,312
7,280,624
1,876,624
3,640,312
Total ....................................................................................................................
..............................
729,495,614
638,386,760
E. Alternatives Considered
The requirements for long-term care
facilities have not been
comprehensively updated in many
years. The effective and efficient
delivery of health care services has
changed substantially in that time. We
believe the changes we have proposed
are necessary to ensure the requirements
are consistent with current standards of
practice and continue to meet statutory
obligations and ensure that residents
receive care that maintains or enhances
each resident’s quality of life and attains
or maintains the resident’s highest
practicable physical, mental, and
psychosocial well-being. Below we
discuss the alternatives that we
considered when developing this
proposed rule.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
1. Scope of Proposed Revisions
We considered only proposing those
requirements that are required by
statute. Specifically, the Affordable Care
Act included provisions regarding
dementia and abuse training, QAPI
program, and compliance and ethics
program, and the IMPACT Act requires
that we issue regulations regarding
discharge planning. Taking this
approach would be less burdensome on
the LTC community overall. However
despite the many changes in the
delivery of health care services, the
requirements for LTC care facilities have
not been comprehensively updated in
many years. Our proposed revisions
address several issues, such as
avoidable hospitalizations, staffing
concerns, infection control, and
behavioral health. In addition, we
believed that it was necessary to
modernize the regulations to reflect
advances such as electronic
communications and health information
technology. Overall, we believe that a
general reorganization and
comprehensive revision would ensure
the requirements are consistent with
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current standards of practice and
continue to meet statutory obligations,
while also assisting individuals who are
less familiar with these regulations to
find information within the
requirements. We believe the changes
we have proposed are necessary to
ensure that residents receive care that
maintains or enhances each resident’s
quality of life and attains or maintains
the resident’s highest practicable
physical, mental, and psychosocial
well-being. Therefore, we determined it
would be most effective to make
comprehensive changes at this time.
2. Psychotropic Drugs
We considered not proposing to revise
the existing requirements that apply to
antipsychotic drugs to psychotropic
drugs. This approach would be less
burdensome for nursing homes.
However, we are concerned that the
current requirements are insufficient to
protect the health and safety of nursing
home residents. We learned that while
some residents are being taken off of
anti-psychotics, they are then prescribed
other medications that are continuing to
affect their mental processes and
behavior. We are also concerned that
drugs, other than anti-psychotics, that
affect mental processes or behavior can
be prescribed in ways that benefit of the
staff and not necessarily the resident’s
health. In addition, in cases where
medication is originally prescribed for
the resident’s benefit, we are concerned
that the resident could remain on these
types of medications even after nonpharmacological interventions or
gradual reductions in the medication
could have either eliminated the reason
for the medication or at least reduced
the amount of medication required by
the resident. Thus, we believe that all
psychotropic medications should be
subject to the proposed requirements to
protect the health and safety of nursing
home residents.
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We also considered various
definitions for psychotropic drugs. The
definition would determine the types of
medications that specific requirements
in this proposed rule would apply to
and the burden they would place on the
LTC facilities and health care providers.
After reviewing different definitions, we
are proposing to define a psychotropic
drug as any drug that affects brain
activities associated with mental
processes and behavior. We have
included a list of drug categories that
are typically considered psychotropic
drugs in the literature, that is, antipsychotic, anti-depressant, anti-anxiety,
hypnotic, and opioid analgesics. We
have also included any other drugs that
have effects similar to those drugs in
these categories. We believe that this
provision is necessary so that drugs
used for ‘‘off-label’’ use would be
subject to the regulatory requirements.
We acknowledge that this is a broad
definition and may result in additional
burden for the facilities. However, we
also believe this definition encompasses
all of the drugs that could be used to
control a resident’s mental processes
and behavior. We are specifically
requesting comments on the scope of
our proposal.
3. Binding Arbitration
We considered not proposing any
requirements concerning binding
arbitration agreements. Taking this
approach would certainly be less
burdensome to the facilities. However,
stakeholders raised specific concerns
about nursing homes either requiring or
pressuring nursing home residents to
sign these agreements and, therefore,
waiving the right to pursue resolution of
a dispute with the nursing home in
court. We share the stakeholders’
concern that some nursing homes may
be requiring residents to sign
agreements for binding arbitration as a
requirement for admission into the
facility. In addition, if the nursing home
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is not requiring the agreement as a
condition of admission, some facilities
may be requesting the resident to sign
the agreement without fully explaining
the rights the resident is waiving and
the consequences of that waiver. We
believe that nursing home residents
need to be fully aware of the right they
are waiving (the right to seek relief in a
court for a dispute between the resident
and the facility) if a nursing home
requests they sign an agreement for
binding arbitration. Thus, we have
proposed specific requirements if a
nursing home chooses to request that a
resident sign an agreement for binding
arbitration. These requirements include,
among other things, that the nursing
home must explain the agreement to the
resident in a form and manner that he
or she understands, and that the
resident acknowledge that they
understand the agreement. We have also
proposed specific requirements for the
agreement, including that admission to
the facility cannot be contingent upon
the resident signing the agreement, the
agreement must be entered into
voluntarily, and the arbitration must be
conducted by a neutral arbitrator in a
venue convenient to both parties. In
addition, we have also proposed that the
agreement not contain any language that
prohibits or discourages the resident or
anyone else from communicating with
Federal, State, or local officials,
including but not limited to surveyors,
health department employees, and
representatives of the Office of the State
Long-Term Care Ombudsman. We
believe this requirement is essential so
that residents and others who have
knowledge of their care are not
discouraged from speaking with
surveyors and others from whom the
resident can seek assistance. In
addition, another individual can sign
the agreement for the resident only if
allowed by state law and the individual
has no interest in the facility. Thus, we
believe these comprehensive
requirements are needed so that
residents understand the right they are
waiving by signing an agreement for
binding arbitration and that the
arbitration will be conducted in a
neutral and fair manner.
We also considered prohibiting
binding arbitration agreements. This
would be more burdensome to the LTC
facilities. However, it would remove the
choice to agree to binding arbitration
from the resident. Alternative dispute
resolution, which includes arbitration,
is favored by the courts and provides
both parties, the resident and the
nursing home, with advantages.
Arbitration can result in disputes being
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resolved faster and in a less burdensome
manner for both parties. There have also
been court decisions that have upheld
these agreements in cases involving
nursing home residents. However, we
are concerned that despite the
protections we have proposed in this
rule, some nursing home residents and
potential residents may feel pressured to
sign these agreements. For example, in
cases where a potential resident or their
family have the time to do research and
visit multiple homes, a resident may
feel he or she can more easily refuse to
sign an agreement for binding
arbitration. However, if the resident is
hospitalized and needs to locate a
facility quickly, they may feel more
pressure to accept such an agreement.
Thus, we have also requested comments
on whether agreements for binding
arbitration should be prohibited.
4. In-Person Physician Evaluation
Before Transfer
We considered not proposing to
require an in-person evaluation of a
resident prior to an unscheduled, nonemergency transfer of a resident to a
hospital. However, in concert with
improved communication requirements,
an evaluation of a resident by a
physician, a physician assistant, a nurse
practitioner, or a clinical nurse
specialist prior to a resident’s transfer
may identify options that could allow
some residents to be treated in place
and avoid unnecessary hospitalizations.
5. Additional Changes
We also considered proposing
additional changes. In some cases, we
determined that an issue was not
adequately developed for us to make an
evidenced-based proposal. In several of
these cases, we have specifically
solicited comments so that we are better
informed. For example, we considered
requiring all facilities to implement a
hazard analysis and critical control
point program for food and nutrition
services, but instead chose to request
comments so that we better understand
the potential benefits and impact,
particularly on small facilities. We may
consider these topics in future rulemaking.
We also considered more prescriptive
changes in several areas. Throughout
this rule, we focused on supporting
person-centered approaches and
innovative care delivery models. This
requires that we allow flexibility in the
regulatory language. Where possible, we
chose a more flexible option to ensure
that proposed regulatory requirements
could be accommodated across the
spectrum of facility sizes and resident
populations. This particularly applied
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in our consideration of options to
address nurse staffing. In that area, we
specifically considered establishing
minimum nurse hours per resident day,
establishing minimum nurse to resident
ratios, requiring that an RN be present
in every facility either 24 hours a day
or 16 hours a day, and requiring that an
RN be on-call whenever an RN is not
present in the facility instead of or in
addition to imposing a competencybased staffing requirement that takes
into consideration the acuity, diagnoses,
and number of residents in the facility.
All of the options not chosen had high
associated burdens, with options for RN
staffing changes ranging from in excess
of $1,000,000,000 to over
$5,000,000,000 total to implement
across likely affected facilities, based on
the current statutory minimum staffing
requirements. Earlier in this preamble,
we specifically invited comments on the
costs of mandating a 24 hour RN
presence, the benefits of a mandatory 24
hour RN presence, including cost
savings and improved resident
outcomes, as well as any unintended
consequences of implementing this
requirement. We will reconsider these
options in light of future research,
recommendations, and the availability
of more valid and reliable payroll-based
staffing data.
We also considered adding more
requirements to the qualifications for a
social worker in § 483.70(p). We
considered requiring a masters of social
work (MSW) for the social worker. We
also considered requiring that the social
worker also have a certification related
to clinical work or gerontology. We did
not propose these requirements because
we are concerned that increasing the
qualifications for social workers in
nursing homes may result in access
issues. We have received input that
some nursing homes already have
difficulty in hiring qualified social
workers. We would welcome comments
related to qualification for the social
worker, especially whether state
licensure should remain the threshold
requirement or if additional
requirements are appropriate.
F. Benefits of Proposed Rule
This proposed rule would implement
comprehensive changes intended to
update the current requirements for
long-term care facilities and create new
efficiencies and flexibilities for
facilities. In addition, these changes will
support improved resident quality of
life and quality of care. Quality of life
in particular can be difficult to translate
into dollars saved. However, there is a
body of evidence suggesting the factors
that improve quality of life may also
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increase the rate of improvement in
quality and can have positive business
benefits for facilities. Many of the
quality of life improvements we propose
are grounded in the concepts of personcentered care and culture change. These
changes not only result in improved
quality of life for the resident, they can
result in improvements in the
caregiver’s quality of work life and in
savings to the facility. Savings can be
accrued through reduced turnover,
decreased use of agency labor and
decreased worker compensation costs.
Although these savings are difficult to
quantify, we believe that they must be
lower in magnitude than the costs borne
by facilities; otherwise, facilities would
change their policies even in the
absence of this rulemaking.
In addition to proposing changes that
are likely to have long-term positive
impacts on quality of life and quality of
care, we have proposed several changes
that may mitigate the costs associated
with implementing some of our
proposed requirements. For example,
including the use of electronic health
records in these regulations may reduce
the burden on facilities when providing
a resident with a copy of his or her
clinical record. We believe that the
option to provide an electronic copy of
the record may reduce the amount of
time a staff person is taken away from
other duties to copy the medical
records. We do not have data on how
many medical records requests are made
each year, nor do we have empirical
data on the time difference, thus we
have no way to estimate the magnitude
of these savings. However, to
understand the possible magnitude of
the savings, let us assume that 2 percent
of residents request their record each
year (27,644). We further assume that,
on average, it takes an office clerk 15
minutes to make a page by page copy of
a medical record. If twenty-five percent
of residents (6,911) requesting a copy of
their medical record accept an
electronic copy in lieu of a paper record
or if the paper copy can be printed from
an electronic record rather than copied
page by page and it takes an office clerk
5 minutes to make an electronic copy,
the facility saves 10 minutes of clerk
time per record. The annual savings
would be $24,189. We believe this is
likely a conservative estimate.
Another area that may produce
substantial savings is our proposal to
allow physicians to delegate to a
qualified dietitian or other clinically
qualified nutrition professional the task
of prescribing diet, including
therapeutic diets, to the extent allowed
by state law. We further believe that
dietitians or other clinically qualified
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nutrition professional are already
performing resident dietary assessments
and making dietary recommendations to
the physician who then evaluates the
recommendations and writes orders to
implement them. We do not currently
have data to estimate the savings that
this could produce in SNFs and NFs.
However, we believe that it will allow
for better use of both physician and
dietitian time.
We also propose to allow physicians
to delegate to qualified therapists the
task of prescribing physical,
occupational, speech language, or
respiratory therapies, but as with
dietitians, we have no empirical
evidence with which to quantify a cost
savings. Again, however, we believe that
this allows better use of both physician
and therapist time.
With respect to dental services, we
propose to modify the language relating
to dental services to remove references
to a dentist’s office and replace these
references to ‘dental services location.’
This more explicitly accommodates
options for dental care such as dental
schools or provision of dental hygiene
services on site at a facility. Based on
the literature we reviewed, improved
dental health as a result of improved
access to dental care is highly likely to
result in improved health and wellbeing of facility residents, including
potentially fewer hospitalizations and
less unanticipated weight loss. We have
no definitive data on the direct
reduction in hospitalizations and other
complications stemming from or
exacerbated by poor dental care and
poor dental hygiene, but given the
relationship of poor dental care and
poor dental hygiene to other illnesses,
savings are quite possible. Furthermore,
reducing the number of hospitalization
through these preventative actions
would also reduce our estimated burden
for requiring practitioner evaluation of a
resident prior to a hospital transfer.
Finally, improved dental care and oral
hygiene would likely result in improved
quality of life. However, we have no
basis on which to calculate these
savings and therefore do not quantify
them.
We have also made a number of
changes in the area of food and nutrition
services. These changes are expected to
have multiple impacts, ranging from the
improved nutritional status of residents
to reduced food waste by the facility, to
reductions in the incidence of foodborne illness. In FY 2012, there were
over 9,000 deficiency citations
associated with food and nutrition
services. The most commonly cited
deficiency in this grouping was, by far,
associated with food sanitation. Out of
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42243
6,828 surveys, there were 5,490 citations
for deficiencies in food procurement,
storage, preparation, and servicesanitary, affecting 31.80 percent of
providers. Proposed improvements in
food and nutrition services have the
potential to improve resident quality of
life. They may also result in a reduced
incidence of food-borne illness, which
could result in substantial savings. We
invite comment, data and analysis on
this issue, including the related
question of whether the activities for
which costs were estimated in the cost
section, above, are sufficient to generate
the benefits discussed here.2
We are concurrently proposing to
strengthen requirements related to
infection control. While a reduction in
the incidence of healthcare associated
infections would likely impact
hospitalization of residents, as
discussed below, it will also impact the
care required for residents who remain
in the facility. An effective infection
prevention and control program can,
among other benefits, identify infections
early and prevent their spread. Several
illness-causing organisms are of
particular concern in nursing homes.
For example, Norovirus may cause
illness following a very low infection
dose. The illness is characterized by
nausea, sudden onset of projectile
vomiting (particularly in children),
watery, non-bloody diarrhea, abdominal
cramping, chills, body aches and
fatigue. Dehydration is a common
complication, especially in the elderly.
The illness usually lasts two to three
days. Outbreaks can impact residents
and/or staff and cause significant
inconvenience and cost. (Overview of
the management of norovirus outbreaks
in hospitals and nursing homes,
compiled by the Wisconsin Division of
Public Health, Bureau of Communicable
Diseases, Communicable Disease
Epidemiology Section, February 2004.
Retrieved from https://
www.publichealthmdc.com/
environmental/food/documents/
ManagementofNorovirus
InfectionOutbreaksinHospitalsand
2 It is logical to assume that the requirement for
nursing, food service and other competency either
necessitates hiring more competent staff who
command a higher wage—the cost of which would
be included in the cost section—or the competency
provision is essentially unnecessary because staff
are already competent—in which case, there would
be no benefits to facilities or their residents. As
regards the menu options provision, the cost section
mentions two hours of effort per facility. It might
be plausible that a two-hour review would be
sufficient to confirm that there is nothing in need
of revision (in which case there are no benefits).
However, if a review uncovers that there is
potential for benefits due to menu revisions, then
there will be further costs, such as training for food
service workers or higher costs of raw ingredients.
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NursingHomes.pdf). These illnesses can
result in higher acuity of residents and
increased care needs as well as
increased use of either overtime or
temporary staff to replace ill staff.
Improved prevention, detection, and
mitigation of illnesses can result in
substantial savings to a facility.
Unfortunately, specific rates of infection
and the associated cost to treat residents
or to replace absent staff have not been
clearly quantified in available literature
or data. We invite comment, data and
analysis on this issue, including on the
question of how actions of a facility’s
infection prevention and control officer
affect the practices of other facility
personnel, and whether such effects are
sufficient to yield infection control
benefits.
We note that we made several changes
that target reducing avoidable or
unnecessary hospitalizations. We make
proposals regarding improved
communication of critical information,
in-person evaluation or residents prior
to transfer, competency-based care
assignments, training, and systemic
quality improvement. We believe that
even a small reduction in the number of
unnecessary hospitalizations could
result in substantial savings, however,
we have not quantified potential
savings.
Currently, the regulations require that
the nurse’s station be equipped to
receive resident calls. Our proposal to
require a communications system that
allows residents to call for assistance
through a communications system that
relays the call directly to a staff person
or centralized staff area from each
bedside and from toilet and bathing
facilities provides added flexibility and
efficiency. Eliminating the requirement
for a ‘‘nurses’ station’’ better
accommodates a decentralized care
model, better reflects current practice,
and may improve response times.
However, we have no basis upon which
to calculate specific cost savings that
this flexibility would provide.
This does not take into account dollar
amounts from improved resident quality
of life or improved staff work life.
Reduced costs from improved staff
satisfaction resulting in reduced
turnover, decreased use of agency labor
and decreased worker compensation
costs could be substantial. The cost of
turnover among nurse aides was
estimated at $2,500 per occurrence in
2008 (Frampton, Susan, et al. ‘‘Making
the Case for Change’’ Long-Term Care
Improvement Guide 2010, retrieved
from https://
www.residentcenteredcare.org/Pages/
About%20the%20guide.html).
According to 2014 BLS statistics, there
are over 1.4 million nurse aides
employed in the United States; over
616,000 are employed in nursing
facilities. AHCA reported in 2010 that
the national turnover rate for certified
nurse assistants (nurse aides) was 43
percent.
According to the American Nurses
Association, the cost of recruiting and
replacing an RN is 1.1 to 1.6 times an
annual nurse’s salary (https://
www.nursingworld.org/
SafeStaffingFactsheet.aspx). According
to a 2009 survey by the American
Health Care Association (https://
www.ahcancal.org/research_data/
staffing/Documents/staffsurvey_2009_
full_report.pdf), the turnover rate for
staff RNs was 46.7 percent and for
administrative RNs was 36.3 percent.
2014 BLS data shows that over 140,000
RNs are employed in nursing care
facilities at an annual mean wage of
$62,440. Additional savings would
accrue as a result of reduced turnover of
other personnel such as licensed
practical or vocational nurses, reduced
use of agency staff and decreased
worker compensation costs. One 2012
study found that over 60 percent of all
nurse aides working in the United States
reported being injured once in the study
year. Further, the report found that
certain workers were more likely to
have a workplace injury, including
those who were new, changed jobs more
frequently, reported poor job
preparation, and who had inadequate
time to provide personal care.
Khatutsky, G., Wiener, J. M., Anderson,
W. L., & Porell, F.W. (2012). Workrelated injuries among certified nursing
assistants working in U.S. nursing
homes. RTI Press publication No. RR–
0017–1204. Research Triangle Park, NC:
RTI Press. Retrieved from www.rti.org/
rtipress). Some of our proposals, such as
nurse aide training and competency
requirements, would address some of
these issues. However, the savings are
not easily estimated. Cumulative,
modest impacts from proposed changes
could result in savings, in addition to
the improvements in quality of life for
residents. In addition to the more
specific requests related to food service
and infection control, we invite general
comment, data and analysis on whether
the actions whose costs are estimated
elsewhere in the regulatory impact
analysis are sufficient to yield the
benefits discussed in this section.
G. Cost to the Federal Government
If these requirements are finalized,
CMS will update the interpretive
guidance, update the survey process,
and make IT systems changes. In order
to implement these new standards, we
anticipate initial federal start-up costs
between $15 to20 million. Once
implemented, improved surveys to
review the new requirements will
require an estimated $15 to20 million
annually in federal costs. CMS will
continue to examine and seeks comment
on the potential impacts to both
Medicare and Medicaid.
H. Accounting Statement
As required by OMB Circular A–4
(available at https://
www.whitehouse.gov/omb/circular/
a004/a-4.pdf), we have prepared an
accounting statement.
TABLE 3—ACCOUNTING STATEMENT
Units
Category
Estimates
Year dollar
Discount rate
Period
covered
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Benefits
Qualitative ........................................................................................................
Improve in quality of life and quality of care
Costs
Annualized Monetized ($million/year) ..............................................................
Qualitative ........................................................................................................
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659
658
2015
2015
7%
3%
2016–2020
2016–2020
Unquantified possible cost associated with the toilet requirement
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42245
Regulatory Flexibility Act (RFA)
Federalism
42 CFR Part 447
The RFA requires agencies to analyze
options for regulatory relief of small
entities, if a rule has a significant impact
on a substantial number of small
entities. For purposes of the RFA, we
estimate that most nursing homes are
small entities as that term is used in the
RFA (include small businesses,
nonprofit organizations, and small
governmental jurisdictions). The great
majority of nursing and residential care
facilities are small entities; either by
being nonprofit organizations or by
meeting the Small Business
Administration’s (SBA) definition of a
small business having revenues of less
than $25.5 million in any 1 year (see the
SBA’s Web site at https://www.sba.gov/
content/small-business-size-standards).
Therefore, the Secretary has determined
that this proposed rule will have a
significant economic impact on a
substantial number of small entities.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis if a rule may have a
significant impact on the operations of
a substantial number of small rural
hospitals. This analysis must conform to
the provisions of section 603 of the
RFA. For purposes of section 1102(b) of
the Act, we define a small rural hospital
as a hospital that is located outside of
a metropolitan statistical area and has
fewer than 100 beds. This proposed rule
pertains solely to SNFs and NFs.
Therefore, the Secretary has determined
that this proposed rule will not have a
significant impact on the operations of
a substantial number of small rural
hospitals.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on state and local
governments, preempts state law, or
otherwise has Federalism implications.
We have determined that this proposed
rule does not contain policies that have
substantial direct effects on the states,
on the relationship between the
National Government and the states, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly, we
have concluded that the rule does not
contain policies that have Federalism
implications as defined in the Executive
Order 13132 and, consequently, a
Federalism summary impact statement
is not required.
Accounting, Administrative practice
and procedure, Drugs, Grant programshealth, Health facilities, Health
professions, Medicaid, Reporting and
recordkeeping requirements, Rural
areas.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Unfunded Mandates Reform Act
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending in any 1 year of $100
million in 1995 dollars, updated
annually for inflation. In 2014, that is
approximately $141 million. This
proposed rule contains mandates that
would impose a one-time net cost of
approximately $766,822,783 (after
including savings of $24,189). Thus, we
have assessed the various costs and
benefits of this proposed rule. This
proposed rule would not mandate any
new requirements for state, local or
tribal governments. For the private
sector facilities, the regulatory impact
section, together with the remainder of
the preamble, constitutes the analysis
required under UMRA.
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Congressional Review Act
This proposed regulation is subject to
the Congressional Review Act
provisions of the Small Business
Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.) and has been
transmitted to the Congress and the
Comptroller General for review.
I. Conclusion
The proposed requirements in this
proposed rule would update the existing
requirements for long-term care
facilities to reflect current standards of
practice. In addition, proposed changes
would provide added flexibility to
providers, potentially improve
efficiency and effectiveness, potentially
enhance resident quality of care and
quality of life, and potentially improve
clinical outcomes. The analysis above,
together with the remainder of this
preamble, provides a Regulatory Impact
Analysis.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
List of Subjects
42 CFR Part 405
Administrative practice and
procedure, Health facilities, Health
professions, Kidney diseases, Medical
devices, Medicare, Reporting and
recordkeeping requirements, Rural
areas, X-rays.
Fmt 4701
42 CFR Part 483
Grant programs-health, Health
facilities, Health professions, Health
records, Medicaid, Medicare, Nursing
homes, Nutrition, Reporting and
recordkeeping requirements, Safety.
42 CFR Part 485
Grant programs-health, Health
facilities, Medicaid, Medicare,
Reporting and recordkeeping
requirements.
42 CFR Part 488
Administrative practice and
procedure, Health facilities, Medicare,
Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services proposes to amend
42 CFR chapter IV as set forth below:
PART 405—FEDERAL HEALTH
INSURANCE FOR THE AGED AND
DISABLED
1. The authority citation for part 405
continues to read as follows:
■
Authority: Secs. 205(a), 1102, 1861,
1862(a), 1869, 1871, 1874, 1881, and 1886(k)
of the Social Security Act (42 U.S.C. 405(a),
1302, 1395x, 1395y(a), 1395ff, 1395hh,
1395kk, 1395rr and 1395ww(k)), and sec. 353
of the Public Health Service Act (42 U.S.C.
263a).
§ 405.926
[Amended]
2. In § 405.926, amend paragraph (f)
by removing the reference ‘‘§ 483.12’’
and add in its place, the reference
‘‘§§ 483.5(n) and 483.15’’.
■
PART 431—STATE ORGANIZATION
AND GENERAL ADMINISTRATION
3. The authority citation for part 431
continues to read as follows:
■
Authority: Sec. 1102 of the Social Security
Act, (42 U.S.C. 1302).
[Amended]
4. In § 431.206, amend paragraph
(c)(3) by removing the reference
‘‘§ 483.12’’ and adding in its place the
reference ‘‘§ 483.15’’.
■
Grant programs-health, Health
facilities, Medicaid, Privacy, Reporting
and recordkeeping requirements.
Frm 00079
Grant programs-health, Hospitals,
Medicaid, Medicare, Reporting and
recordkeeping requirements.
§ 431.206
42 CFR Part 431
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Sfmt 4702
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Federal Register / Vol. 80, No. 136 / Thursday, July 16, 2015 / Proposed Rules
[Amended]
PART 447—PAYMENTS FOR
SERVICES
6. The authority citation for part 447
continues to read as follows:
■
Authority: Sec. 1102 of the Social Security
Act (42 U.S.C. 1302).
§ 447.253
[Amended]
7. In § 447.253, amend paragraph
(b)(1)(iii)(B) by removing the reference
‘‘§ 483.30(c)’’ and adding in its place the
reference ‘‘§ 483.35(e)’’.
■
PART 482—CONDITIONS OF
PARTICIPATION FOR HOSPITALS
8. The authority citation for part 482
continues to read as follows:
■
Authority: Secs. 1102, 1871 and 1881 of
the Social Security Act (42 U.S.C. 1302,
1395hh, and 1395rr), unless otherwise noted.
9. In § 482.58, paragraphs (b)(1)
through (8) are revised and paragraph
(b)(9) is added to read as follows:
■
§ 482.58 Special requirements for hospital
providers of long-term care services
(‘‘swing-beds’’).
*
*
*
*
(b) * * *
(1) Resident rights (§ 483.10(a)(4)(iv),
(b), (c), (d)(1), (d)(3), (e)(8), (g), and
(h)(3)).
(2) Facility responsibilities
(§ 483.11(d)(1)(i), (d)(1)(iii), (d)(4),
(e)(11), (e)(12), (e)(14)(iii), and (f)(1)(i)).
(3) Transitions of care (§ 483.5(n),
§ 483.15(b)(1), (b)(2), (b)(3)(i)
through(iii), (b)(4), (b)(5)(i) through (vii),
and (b)(7)).
(4) Freedom from abuse, neglect and
exploitation (§ 483.12).
(5) Patient activities (§ 483.25(c)).
(6) Social services (§ 483.40(d) and
§ 483.75(p)).
(7) Discharge planning (§ 483.20(e)).
(8) Specialized rehabilitative services
(§ 483.65).
(9) Dental services (§ 483.55).
tkelley on DSK3SPTVN1PROD with PROPOSALS2
*
PART 483—REQUIREMENTS FOR
STATES AND LONG TERM CARE
FACILITIES
10. The authority citation for part 483
continues to read as follows:
■
Authority: Secs. 1102, 1128I and 1871 of
the Social Security Act (42 U.S.C. 1302,
1320a–7j, and 1395hh.
VerDate Sep<11>2014
18:07 Jul 15, 2015
11. Section 483.1 is amended by
revising paragraphs (a)(1) introductory
text, (a)(3), and (b) and adding
paragraphs (a)(4) and (a)(5) to read as
follows:
■
5. In § 431.213, amend paragraph (h)
by removing reference ‘‘§ 483.12
(a)(5)(ii)’’ and adding in its place the
reference ‘‘§ 483.15(b)(4)(ii) and (b)(8)’’
and by removing the reference ‘‘§ 483.12
(a)(5)(i)’’ and adding in its place the
reference ‘‘§ 483.15(b)(4)(i) of this
chapter’’.
■
Jkt 235001
§ 483.1
Basis and scope.
(a) * * *
(1) Sections 1819(a), (b), (c), (d), and
(f) of the Act provide that—
*
*
*
*
*
(3) Sections 1919(a), (b), (c), (d), and
(f) of the Act provide that nursing
facilities participating in Medicaid must
meet certain specific requirements.
(4) Sections 1128I(b) and (c) require
that—
(i) Skilled nursing facilities or nursing
facility have in operation a compliance
and ethics program that is effective in
preventing and detecting criminal, civil,
and administrative violations.
(ii) The Secretary establish and
implement a quality assurance and
performance improvement program for
facilities, including multi-unit chains of
facilities.
(5) Section 1150B establishes
requirements for reporting to law
enforcement crimes occurring in
federally funded LTC facilities.
(b) Scope. The provisions of this part
contain the requirements that an
institution must meet in order to qualify
to participate as a Skilled Nursing
Facility in the Medicare program, and as
a nursing facility in the Medicaid
program. They serve as the basis for
survey activities for the purpose of
determining whether a facility meets the
requirements for participation in
Medicare and Medicaid.
■ 12. Section 483.5 is amended by—
■ a. Removing the paragraph
designations for paragraphs (a), (b), (c),
(d), (e), and (f) and placing the
definitions in alphabetical order.
■ b. Adding introductory text.
■ c. Revising the definition of ‘‘common
area’’.
■ d. Amending the definition of
‘‘composite distinct part’’ by adding
paragraph (2)(v).
■ e. Amending the definition of
‘‘Facility’’ by removing the italicized
word ‘‘defined’’.
■ f. Adding the new definitions of
‘‘abuse’’, ‘‘adverse event’’,
‘‘exploitation’’, ‘‘licensed health
professional’’, ‘‘misappropriation of
resident property’’, ‘‘neglect’’, ‘‘nurse
aide’’, ‘‘person-centered care’’, ‘‘resident
representative’’, ‘‘sexual abuse’’, and
‘‘transfer and discharge’’ in alphabetical
order.
The revisions and additions read as
follows:
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§ 483.5
Definitions.
As used in this subpart, the following
definitions apply:
Abuse. Abuse is the willful infliction
of injury, unreasonable confinement,
intimidation, or punishment with
resulting physical harm, pain or mental
anguish. Abuse also includes the
deprivation by an individual, including
a caretaker, of goods or services that are
necessary to attain or maintain physical,
mental, and psychosocial well-being.
This presumes that instances of abuse of
all residents, irrespective of any mental
or physical condition, cause physical
harm, pain or mental anguish. It
includes verbal abuse, sexual abuse,
physical abuse, and mental abuse
including abuse facilitated or enabled
through the use of technology. Willful,
as used in this definition of abuse,
means the individual must have acted
deliberately, not that the individual
must have intended to inflict injury or
harm.
Adverse event. An adverse event is an
untoward, undesirable, and usually
unanticipated event that causes death or
serious injury, or the risk thereof.
Common area. Common areas are
areas in the facility where residents may
gather together with other residents,
visitors, and staff or engage in
individual pursuits, apart from their
residential rooms. This includes but is
not limited to living rooms, dining
rooms, activity rooms, outdoor areas,
and meeting rooms where residents are
located on a regular basis.
Composite distinct part. * * *
(2) * * *
(v) Use of composite distinct parts to
segregate residents by payment source
or on a basis other than care needs is
prohibited.
*
*
*
*
*
Exploitation. Means the unfair
treatment or use of a resident or the
taking of a selfish or unfair advantage of
a resident for personal gain, through
manipulation, intimidation, threats, or
coercion.
*
*
*
*
*
Licensed health professional. A
licensed health professional is a
physician; physician assistant; nurse
practitioner; physical, speech, or
occupational therapist; physical or
occupational therapy assistant;
registered professional nurse; licensed
practical nurse; or licensed or certified
social worker.
*
*
*
*
*
Misappropriation of resident property
means the deliberate misplacement,
exploitation, or wrongful, temporary, or
permanent use of a resident’s belongings
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or money without the resident’s
consent.
Neglect is the failure of the facility, its
employees or service providers to
provide goods and services to a resident
that are necessary to avoid physical
harm, pain, mental anguish or mental
illness.
Nurse aide. A nurse aide is 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 § 488.301 of this chapter.
Person-centered care. For purposes of
this subpart, person-centered care
means to focus on the resident as the
locus of control and support the
resident in making their own choices
and having control over their daily
lives.
Resident representative. For purposes
of this subpart, the term resident
representative means an individual of
the resident’s choice who has access to
information and participates in
healthcare discussions or a personal
representative with legal standing, such
as a power of attorney, legal guardian,
or health care surrogate appointed or
designated in accordance with state law.
If selected as the resident representative,
the same-sex spouse of a resident must
be afforded treatment equal to that
afforded to an opposite-sex spouse if the
marriage was valid in the jurisdiction in
which it was celebrated.
Sexual abuse is non-consensual
sexual contact of any type with a
resident.
Transfer and discharge includes
movement of a resident to a bed outside
of the certified facility whether that bed
is in the same physical plant or not.
Transfer and discharge does not refer to
movement of a resident to a bed within
the same certified facility.
■ 13. Section 483.10 is revised to read
as follows:
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.10
Resident rights.
The resident has a right to a dignified
existence, self-determination, and
communication with and access to
persons and services inside and outside
the facility, including those specified in
this section.
(a) Exercise of rights. (1) The resident
has the right to exercise his or her rights
as a resident of the facility and as a
citizen or resident of the United States.
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(2) The resident has the right to be
free of interference, coercion,
discrimination, and reprisal from the
facility in exercising his or her rights
and to be supported by the facility in
the exercise of his or her rights as
required under this subpart.
(3) A resident has the right to
designate a representative, in
accordance with State law.
(i) The resident representative has the
right to exercise the resident’s rights to
the extent those rights are delegated to
the resident representative.
(ii) The resident retains the right to
exercise those rights not delegated to a
resident representative, including the
right to revoke a delegation of rights,
except as limited by State law.
(4) In the case of a resident adjudged
incompetent under the laws of a State
by a court of competent jurisdiction, the
rights of the resident devolve to and are
exercised by the resident representative
appointed under State law to act on the
resident’s behalf.
(i) The resident may exercise his or
her rights to the extent not prohibited by
court order.
(ii) The court-appointed resident
representative exercises the resident’s
rights to the extent judged necessary by
a court of competent jurisdiction, in
accordance with State law.
(iii) The resident’s wishes and
preferences must be considered in the
exercise of rights by the representative.
(iv) To the extent practicable, the
resident must be provided with
opportunities to participate in the care
planning process.
(5) In the case of a resident who has
not been adjudged incompetent by the
state court, any legal surrogate
designated in accordance with state law
may exercise the resident’s rights to the
extent provided by state law. The samesex spouse of a resident must be
afforded treatment equal to that afforded
to an opposite-sex spouse if the
marriage was valid in the jurisdiction in
which it was celebrated.
(b) Planning and implementing care.
The resident has the right to be
informed of, and participate in, his or
her treatment, including:
(1) The right to be fully informed in
language that he or she can understand
of his or her total health status,
including but not limited to, his or her
medical condition.
(2) The right to be informed, in
advance, of the care to be furnished and
the disciplines that will furnish care.
(3) The right to be informed in
advance of the risks and benefits of
proposed care, of treatment and
treatment alternatives or treatment
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42247
options and to choose the alternative or
option he or she prefers.
(4) The right to request, refuse, and/
or discontinue treatment, to participate
in or refuse to participate in
experimental research, and to formulate
an advance directive as specified in
§ 483.11(e)(6).
(5) The right to participate in the
development and implementation of his
or her person-centered plan of care,
including but not limited to:
(i) The right to participate in the
planning process, including the right to
identify individuals or roles to be
included in the planning process, the
right to request meetings and the right
to request revisions to the personcentered plan of care.
(ii) The right to participate in
establishing the expected goals and
outcomes of care, the type, amount,
frequency, and duration of care, and any
other factors related to the effectiveness
of the plan of care.
(iii) The right to be informed, in
advance, of changes to the plan of care.
(iv) The right to receive the services
and/or items included in the plan of
care.
(v) The right to see the care plan,
including the right to sign after changes
to the plan of care.
(6) The right to self-administer
medications if the interdisciplinary
team has determined that this practice
is clinically appropriate in accordance
with § 483.11(b)(2).
(7) Nothing in this paragraph should
be construed as the right of the resident
to receive the provision of medical
treatment or medical services deemed
medically unnecessary or inappropriate.
(c) Choice of attending physician. The
resident has the right to choose his or
her attending physician.
(1) The physician must be licensed to
practice, and
(2) The physician must meet the
professional credentialing requirements
of the facility.
(3) If the physician chosen by the
resident refuses to or does not meet
requirements specified in this part, the
facility may seek alternate physician
participation as specified in § 483.11(c)
to assure provision of appropriate and
adequate care and treatment.
(d) Respect and dignity. The resident
has a right to be treated with respect and
dignity, including:
(1) The right to be free from any
physical or chemical restraints imposed
for purposes of discipline or
convenience, and not required to treat
the resident’s medical symptoms.
(2) The right to retain and use
personal possessions, including
furnishings, and clothing, as space
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permits, unless to do so would infringe
upon the rights or health and safety of
other residents.
(3) The right to reside and receive
services in the facility with reasonable
accommodation of resident needs and
preferences except when to do so would
endanger the health or safety of the
resident or other residents.
(4) The right to share a room with his
or her spouse when married residents
live in the same facility and both
spouses consent to the arrangement.
(5) The right to share a room with his
or her roommate of choice when
practicable, when both residents live in
the same facility and both residents
consent to the arrangement.
(6) The right to receive notice before
the resident’s room or roommate in the
facility is changed.
(7) The right to refuse to transfer to
another room in the facility, if the
purpose of the transfer is to relocate:
(i) A resident of a SNF from the
distinct part of the institution that is a
SNF to a part of the institution that is
not a SNF, or
(ii) A resident of a NF from the
distinct part of the institution that is a
NF to a distinct part of the institution
that is a SNF.
(8) A resident’s exercise of the right to
refuse transfer does not affect the
resident’s eligibility or entitlement to
Medicare or Medicaid benefits.
(e) Self-determination. The resident
has the right to self-determination,
including but not limited to the right
to—
(1) Choose activities, schedules
(including sleeping and waking times),
health care and providers of health care
services consistent with his or her
interests, assessments, and plan of care;
(2) Interact with members of the
community and participate in
community activities both inside and
outside the facility;
(3) Receive visitors of his or her
choosing at the time of his or her
choosing, subject to the resident’s right
to deny visitation, and in a manner that
does not impose on the rights of another
resident, including the individuals
specified in § 483.11(d);
(4) Organize and participate in
resident groups in the facility;
(5) Participate in family groups;
(6) Have family member(s) or other
resident representative(s) meet in the
facility with the families or resident
representative(s) of other residents in
the facility;
(7) Participate in other activities,
including social, religious, and
community activities that do not
interfere with the rights of other
residents in the facility;
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(8) Choose to or refuse to perform
services for the facility subject to the
facility requirements in § 483.11(d)(4);
(9) Manage his or her financial affairs.
This includes the right to know, in
advance, what charges a facility may
impose against a resident’s personal
funds as specified in § 483.11(d)(6)(ii);
(10) Make choices about aspects of his
or her life in the facility that are
significant to the resident.
(f) Access to information. (1) The
resident has the right to be informed of
his or her rights and of all rules and
regulations governing resident conduct
and responsibilities during his or her
stay in the facility.
(2) The resident has the right to
receive notices verbally (meaning
spoken) and in writing (including
Braille) in a format and a language he or
she understands, including
(i) Required notices as specified in
§ 483.11(e);
(ii) Information and contact
information for State and local advocacy
organizations, including but not limited
to the State Long-Term Care
Ombudsman program (established
under section 712 of the Older
Americans Act of 1965, as amended
2006 (42 U.S.C. 3001 et seq) and the
protection and advocacy system (as
designated by the state, and as
established under the Developmental
Disabilities Assistance and Bill of Rights
Act of 2000 (42 U.S.C. 15001 et seq.);
(iii) Information regarding Medicare
and Medicaid eligibility and coverage;
(iv) Contact information for the Aging
and Disability Resource Center
(established under Section
202(a)(20)(B)(iii) of the Older Americans
Act); or other No Wrong Door Program
(v) Contact information for the
Medicaid fraud control unit; and
(vi) Information and contact
information for filing grievances or
complaints about abuse, neglect,
misappropriation of resident property in
the facility, and non-compliance with
§ 489.102 of this chapter.
(3) The resident has the right to access
medical records pertaining to him or
herself,—
(i) Upon an oral or written request, in
the form and format requested by the
individual, if it is readily producible in
such form and format (including in an
electronic form or format when such
medical records are maintained
electronically); or, if not, in a readable
hard copy form or such other form and
format as agreed to by the facility and
the individual, including current
medical records, within 24 hours
(excluding weekends and holidays); and
(ii) After receipt of his or her medical
records for inspection, to purchase, a
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copy of the medical records or any
portions thereof (including in an
electronic form or format when such
medical records are maintained
electronically) upon request and 2
working days advance notice to the
facility. The facility may impose a
reasonable, cost-based fee on the
provision of copies, provided that the
fee includes only the cost of:
(A) Labor for copying the medical
records requested by the individual,
whether in paper or electronic form;
(B) Supplies for creating the paper
copy or electronic media if the
individual requests that the electronic
copy be provided on portable media;
and
(C) Postage, when the individual has
requested the copy be mailed.
(4) The resident has the right to—
(i) Examine the results of the most
recent survey of the facility conducted
by Federal or State surveyors and any
plan of correction in effect with respect
to the facility; and
(ii) Receive information from agencies
acting as client advocates, and be
afforded the opportunity to contact
these agencies.
(g) Privacy and confidentiality. The
resident has a right to personal privacy
and confidentiality of his or her
personal and medical records.
(1) This includes the right to privacy
in his or her verbal (that is, spoken),
written, and electronic communications,
including the right to send and
promptly receive unopened mail and
other letters, packages and other
materials delivered to the facility for the
resident, including those delivered
through a means other than a postal
service.
(2) Personal privacy includes
accommodations, medical treatment,
written and telephone communications,
personal care, visits, and meetings of
family and resident groups, but this
does not require the facility to provide
a private room for each resident;
(3) The resident has a right to a secure
and confidential medical record.
(4) The resident has the right to refuse
the release of personal and medical
records except as provided at
§ 483.70(i)(2) or other applicable federal
or state laws.
(h) Communication. (1) The resident
has the right to have reasonable access
to the use of a telephone, including TTY
and TDD services, and a place in the
facility where calls can be made without
being overheard. This includes the right
to retain and use a cellular phone at the
resident’s own expense.
(2) The resident has the right to have
reasonable access to and privacy in their
use of electronic communications such
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as email and video communications and
for internet research.
(i) If the access is available to the
facility.
(ii) At the resident’s expense, if any
additional expense is incurred by the
facility to provide such access to the
resident.
(3) The resident has the right to send
and receive mail, and to receive letters,
packages and other materials delivered
to the facility for the resident through a
means other than a postal service,
including the right to:
(i) Privacy of such communications
consistent with paragraph (g)(1) of this
section; and
(ii) Access to stationery, postage, and
writing implements at the resident’s
own expense.
(i) Safe environment. The resident has
a right to a safe, clean, comfortable and
homelike environment in accordance
with § 483.11(g), including but not
limited to receiving treatment and
supports for daily living safely.
(j) Grievances. (1) The resident has the
right to voice grievances to the facility
or other agency or entity that hears
grievances without discrimination or
reprisal and without fear of
discrimination or reprisal. Such
grievances include those with respect to
care and treatment which has been
furnished as well as that which has not
been furnished.
(2) The resident has the right to
prompt efforts by the facility to resolve
grievances in accordance with
§ 483.11(h).
■ 14. Section 483.11 is added to subpart
B to read as follows:
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.11
Facility responsibilities.
A facility must treat each resident
with respect and dignity and care for
each resident in a manner and in an
environment that promotes maintenance
or enhancement of his or her quality of
life, recognizing each resident’s
individuality. The facility must protect
and promote the rights of the resident as
specified in § 483.10, including, but not
limited to the following obligations:
(a) Exercise of rights. (1) The facility
must ensure that the resident can
exercise his or her rights without
interference, coercion, discrimination,
or reprisal from the facility.
(2) The facility must provide equal
access to quality care regardless of
diagnosis, severity of condition, or
payment source. A facility must
establish and maintain identical policies
and practices regarding transfer,
discharge, and the provision of services
under the State plan for all residents
regardless of payment source.
(3) The facility must treat the
decisions of a resident representative as
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the decisions of the resident to the
extent required by the court or delegated
by the resident, in accordance with
applicable law.
(4) The facility shall not extend the
resident representative the right to make
decisions on behalf of the resident
beyond the extent required by the court
or delegated by the resident, in
accordance with applicable law.
(5) If the facility has reason to believe
that a resident representative is making
decisions or taking actions that are not
in the best interests of a resident, the
facility may report such concerns as
permitted and shall report such
concerns when and in the manner
required under State law.
(b) Planning and implementing care.
(1) The facility shall inform the resident
of the right to participate in his or her
treatment and shall support the resident
in this right, consistent with § 483.10(b).
The planning process must:
(i) Facilitate the inclusion of the
resident or resident representative.
(ii) Include an assessment of the
resident’s strengths and needs.
(iii) Incorporate the resident’s
personal and cultural preferences in
developing goals of care.
(2) The interdisciplinary team, as
defined by § 483.21(b)(2)(ii), is
responsible for determining if resident
self-administration of medications is
clinically appropriate.
(c) Attending physician. (1) The
facility must ensure that each resident
remains informed of the name,
specialty, and way of contacting the
physician and other primary care
professionals responsible for his or her
care.
(2) The facility must inform the
resident if the facility determines that
the physician chosen by the resident is
unable or unwilling to meet
requirements specified in this part and
the facility seeks alternate physician
participation to assure provision of
appropriate and adequate care and
treatment. The facility must discuss the
alternative physician participation with
the resident and honor the resident’s
preferences, if any, among options.
(3) If the resident subsequently selects
another attending physician who meets
the requirements specified in this part,
the facility must honor that choice.
(d) Self-determination. The facility
must promote and facilitate resident
self-determination through support of
resident choice as specified in
§ 483.10(e) and as follows:
(1) The facility must:
(i) Provide immediate access to any
resident by:
(A) Any representative of the
Secretary,
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(B) Any representative of the State,
(C) Any representative of the Office of
the State long term care ombudsman,
(established under section 712 of the
Older Americans Act of 1965, as
amended 2006 (42 U.S.C. 3001 et seq.);
(D) The resident’s individual
physician,
(E) Any representative of the
protection and advocacy systems, as
designated by the state, and as
established under the Developmental
Disabilities Assistance and Bill of Rights
Act of 2000 (42 U.S.C. 15001 et seq.),
(F) Any representative of the agency
responsible for the protection and
advocacy system for individuals with
mental illness (established under the
Protection and Advocacy for Mentally
Ill Individuals Act of 2000 (42 U.S.C.
10802); and
(G) The resident representative.
(ii) Provide immediate access to a
resident by immediate family and other
relatives of the resident, subject to the
resident’s right to deny or withdraw
consent at any time;
(iii) Provide immediate access to a
resident by others who are visiting with
the consent of the resident, subject to
reasonable clinical and safety
restrictions and the resident’s right to
deny or withdraw consent at any time;
(iv) Provide reasonable access to a
resident by any entity or individual that
provides health, social, legal, or other
services to the resident, subject to the
resident’s right to deny or withdraw
consent at any time; and
(2) The facility must have written
policies and procedures regarding the
visitation rights of residents, including
those setting forth any clinically
necessary or reasonable restriction or
limitation or safety restriction or
limitation that the facility may need to
place on such rights and the reasons for
the clinical or safety restriction or
limitation. A facility must meet the
following requirements:
(i) Inform each resident (or resident
representative, where appropriate) of his
or her visitation rights, including any
clinical or safety restriction or limitation
on such rights, when he or she is
informed of his or her other rights under
this section.
(ii) Inform each resident of the right,
subject to his or her consent, to receive
the visitors whom he or she designates,
including, but not limited to, a spouse
(including a same-sex spouse), a
domestic partner (including a same-sex
domestic partner), another family
member, or a friend, and his or her right
to withdraw or deny such consent at
any time.
(iii) Not restrict, limit, or otherwise
deny visitation privileges on the basis of
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race, color, national origin, religion, sex,
gender identity, sexual orientation, or
disability.
(iv) Ensure that all visitors enjoy full
and equal visitation privileges
consistent with resident preferences.
(3) The facility must provide a
resident or family group, if one exists,
with private space; and
(i) Staff or visitors may attend
meetings only at the group’s invitation;
(ii) The facility must provide a
designated staff person who is approved
by the resident or family group and the
facility and who is responsible for
providing assistance and responding to
written requests that result from group
meetings;
(iii) The facility must consider the
views of a resident or family group and
act upon the grievances and
recommendations of such groups
concerning issues of resident care and
life in the facility.
(A) This should not be construed to
mean that the facility must implement
as recommended every request of the
resident or family group.
(B) The facility must be able to
demonstrate their response and
rationale for such response.
(4) The facility must not require a
resident to perform services for the
facility. The resident may perform
services for the facility, if he or she
chooses, when—
(i) The facility has documented the
resident’s need or desire for work in the
plan of care;
(ii) The plan specifies the nature of
the services performed and whether the
services are voluntary or paid;
(iii) Compensation for paid services is
at or above prevailing rates; and
(iv) The resident agrees to the work
arrangement described in the plan of
care.
(5) The facility must not require
residents to deposit their personal funds
with the facility. If a resident chooses to
deposit personal funds with the facility,
the facility must adhere to the following
requirements.
(i) Management of personal funds.
Upon written authorization of a
resident, the facility must hold,
safeguard, manage, and account for the
personal funds of the resident deposited
with the facility, as specified in this
section.
(ii) Deposit of funds.
(A) In general:
(1) Except as set out in paragraph
(d)(5)(ii)(B)(1) of this section, the facility
must deposit any residents’ personal
funds in excess of $100 in an interest
bearing account (or accounts) that is
separate from any of the facility’s
operating accounts, and that credits all
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interest earned on resident’s funds to
that account. (In pooled accounts, there
must be a separate accounting for each
resident’s share.)
(2) The facility must maintain a
resident’s personal funds that do not
exceed $100 in a non-interest bearing
account, interest-bearing account, or
petty cash fund.
(B) Residents whose care is funded by
Medicaid:
(1) The facility must deposit the
residents’ personal funds in excess of
$50 in an interest bearing account (or
accounts) that is separate from any of
the facility’s operating accounts, and
that credits all interest earned on
resident’s funds to that account. (In
pooled accounts, there must be a
separate accounting for each resident’s
share.)
(2) The facility must maintain
personal funds that do not exceed $50
in a non-interest bearing account,
interest-bearing account, or petty cash
fund.
(iii) Accounting and records. (A) The
facility must establish and maintain a
system that assures a full and complete
and separate accounting, according to
generally accepted accounting
principles, of each resident’s personal
funds entrusted to the facility on the
resident’s behalf. (B) The system must
preclude any commingling of resident
funds with facility funds or with the
funds of any person other than another
resident.
(C) The individual financial record
must be available to the resident
through quarterly statements and upon
request.
(iv) Notice of certain balances. The
facility must notify each resident that
receives Medicaid benefits—
(A) When the amount in the resident’s
account reaches $200 less than the SSI
resource limit for one person, specified
in section 1611(a)(3)(B) of the Act; and
(B) That, if the amount in the account,
in addition to the value of the resident’s
other nonexempt resources, reaches the
SSI resource limit for one person, the
resident may lose eligibility for
Medicaid or SSI.
(v) Conveyance upon discharge,
eviction, or death. Upon the discharge,
eviction, or death of a resident with a
personal fund deposited with the
facility, the facility must convey within
30 days the resident’s funds, and a final
accounting of those funds, to the
resident, or in the case of death, the
individual or probate jurisdiction
administering the resident’s estate, in
accordance with State law.
(vi) Assurance of financial security.
The facility must purchase a surety
bond, or otherwise provide assurance
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satisfactory to the Secretary, to assure
the security of all personal funds of
residents deposited with the facility.
(6) The facility must not impose a
charge against the personal funds of a
resident for any item or service for
which payment is made under Medicaid
or Medicare (except for applicable
deductible and coinsurance amounts).
The facility may charge the resident for
requested services that are more
expensive than or in excess of covered
services in accordance with § 489.32 of
this chapter. (This does not affect the
prohibition on facility charges for items
and services for which Medicaid has
paid. See § 447.15 of this chapter, which
limits participation in the Medicaid
program to providers who accept, as
payment in full, Medicaid payment plus
any deductible, coinsurance, or
copayment required by the plan to be
paid by the individual.)
(i) Services included in Medicare or
Medicaid payment. During the course of
a covered Medicare or Medicaid stay,
facilities may not charge a resident for
the following categories of items and
services:
(A) Nursing services as required at
§ 483.35.
(B) Food and Nutrition services as
required at § 483.60.
(C) An activities program as required
at § 483.25(c).
(D) Room/bed maintenance services.
(E) Routine personal hygiene items
and services as required to meet the
needs of residents, including, but not
limited to, hair hygiene supplies, comb,
brush, bath soap, disinfecting soaps or
specialized cleansing agents when
indicated to treat special skin problems
or to fight infection, razor, shaving
cream, toothbrush, toothpaste, denture
adhesive, denture cleaner, dental floss,
moisturizing lotion, tissues, cotton balls,
cotton swabs, deodorant, incontinence
care and supplies, sanitary napkins and
related supplies, towels, washcloths,
hospital gowns, over the counter drugs,
hair and nail hygiene services, bathing
assistance, and basic personal laundry.
(F) Medically-related social services
as required at § 483.40(d).
(G) Hospice services elected by the
resident and paid for under the
Medicare Hospice Benefit or paid for by
Medicaid under a state plan.
(ii) Items and services that may be
charged to residents’ funds. Listed
below in paragraphs (d)(6)(ii)(A)
through (L) of this section are general
categories and examples of items and
services that the facility may charge to
residents’ funds if they are requested by
a resident, if they are not required to
achieve the goals stated in the resident’s
care plan, if the facility informs the
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resident that there will be a charge, and
if payment is not made by Medicare or
Medicaid:
(A) Telephone, including a cellular
phone.
(B) Television/radio, personal
computer or other electronic device for
personal use.
(C) Personal comfort items, including
smoking materials, notions and
novelties, and confections.
(D) Cosmetic and grooming items and
services in excess of those for which
payment is made under Medicaid or
Medicare.
(E) Personal clothing.
(F) Personal reading matter.
(G) Gifts purchased on behalf of a
resident.
(H) Flowers and plants.
(I) Cost to participate in social events
and entertainment outside the scope of
the activities program, provided under
§ 483.25(c).
(J) Noncovered special care services
such as privately hired nurses or aides.
(K) Private room, except when
therapeutically required (for example,
isolation for infection control).
(L) Except as provided below,
specially prepared or alternative food
requested instead of the food and meals
generally prepared by the facility, as
required by § 483.60.
(1) The facility may not charge for
special foods and meals, including
medically prescribed dietary
supplements, ordered by the resident’s
health care provider, as these are
included per § 483.60.
(2) In accordance with § 483.60(c)
through (f), when preparing foods and
meals, a facility must take into
consideration residents’ needs and
preferences and the overall cultural and
religious make-up of the facility’s
population.
(iii) Requests for items and services.
(A) The facility can only charge a
resident for any noncovered item or
service if such item or service is
specifically requested by the resident.
(B) The facility must not require a
resident to request any item or service
as a condition of admission or
continued stay.
(C) The facility must inform, orally
and in writing, the resident requesting
an item or service for which a charge
will be made that there will be a charge
for the item or service and what the
charge will be.
(e) Information and communication.
(1) With the exception of information
described in paragraph (e)(2) of this
section, the facility must ensure that
information is provided to each resident
in a form and manner the resident can
access and understand, including in an
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alternative format or in a language that
the resident can understand. Summaries
that translate information described in
paragraph (e)(2) of this section may be
made available to the patient at their
request and expense in accordance with
applicable law.
(2) The facility must:
(i) Provide the resident with access to
medical records pertaining to him or
herself, upon an oral or written request,
in the form and format requested by the
individual, if it is readily producible in
such form and format (including in an
electronic form or format when such
medical records are maintained
electronically); or, if not, in a readable
hard copy form or such other form and
format as agreed to by the facility and
the individual, within 24 hours
(excluding weekends and holidays); and
(ii) Allow the resident to purchase,
after receipt of his or her medical
records for inspection, a copy of the
medical records or any portions thereof
(including in an electronic form or
format when such medical records are
maintained electronically) upon request
and 2 working days advance notice to
the facility.
(iii) The facility may impose a
reasonable, cost-based fee, provided that
the fee includes only the cost of:
(A) Labor for copying the medical
records requested by the individual,
whether in paper or electronic form;
(B) Supplies for creating the paper
copy or electronic media if the
individual requests that the electronic
copy be provided on portable media;
and
(C) Postage, when the individual has
requested the copy be mailed.
(3) The facility must make reports
with respect to any surveys,
certifications, and complaint
investigations conducted by Federal or
State surveyors during the 3 preceding
years available for any individual to
review upon request and any plan of
correction in effect with respect to the
facility available for examination in a
place readily accessible to and in a form
understandable by residents, and must
post a notice of its availability.
(4) The facility must post, in a form
and manner accessible and
understandable to residents, resident
representatives and support person:
(i) A list of names, addresses (mailing
and email), and telephone numbers of
all pertinent State agencies and
advocacy groups, such as the State
survey and certification agency, the
State licensure office, adult protective
services where state law provides for
jurisdiction in long-term care facilities,
the Office of the State Long-Term Care
Ombudsman program, the protection
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42251
and advocacy network, home and
community based service programs, and
the Medicaid fraud control unit; and
(ii) A statement that the resident may
file a complaint with the State survey
and certification agency concerning
resident abuse, neglect,
misappropriation of resident property in
the facility, and non-compliance with
the requirements specified in 42 CFR
part 489 subpart I (Advance Directives).
(5) The facility must comply with the
requirements specified in 42 CFR part
489, subpart I (Advance Directives).
(i) These requirements include
provisions to inform and provide
written information to all adult
residents concerning the right to accept
or refuse medical or surgical treatment
and, at the resident’s option, formulate
an advance directive.
(ii) This includes a written
description of the facility’s policies to
implement advance directives and
applicable State law.
(iii) Facilities are permitted to
contract with other entities to furnish
this information but are still legally
responsible for ensuring that the
requirements of this section are met.
(iv) If an adult individual is
incapacitated at the time of admission
and is unable to receive information or
articulate whether or not he or she has
executed an advance directive, the
facility may give advance directive
information to the individual’s resident
representative in accordance with State
law.
(v) The facility is not relieved of its
obligation to provide this information to
the individual once he or she is able to
receive such information. Follow-up
procedures must be in place to provide
the information to the individual
directly at the appropriate time.
(6) The facility must display in the
facility written information, and provide
to residents and applicants for
admission, oral and written information
about how to apply for and use
Medicare and Medicaid benefits, and
how to receive refunds for previous
payments covered by such benefits.
(7) Notification of changes. (i) A
facility must immediately inform the
resident; consult with the resident’s
physician; and notify the resident
representative(s) when there is—
(A) An accident involving the resident
which results in injury and has the
potential for requiring physician
intervention;
(B) A significant change in the
resident’s physical, mental, or
psychosocial status (that is, a
deterioration in health, mental, or
psychosocial status in either life-
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threatening conditions or clinical
complications);
(C) A need to alter treatment
significantly (that is, a need to
discontinue an existing form of
treatment due to adverse consequences,
or to commence a new form of
treatment); or
(D) A decision to transfer or discharge
the resident from the facility as
specified in § 483.15(b)(1)(ii).
(ii) When making notification under
paragraph (e)(7)(i) of this section, the
facility must ensure that all pertinent
information specified in § 483.15(b)(2) is
available and provided upon request to
the physician.
(iii) The facility must also promptly
notify the resident and the resident
representative, if any, when there is—
(A) A change in room or roommate
assignment as specified in
§ 483.10(d)(6); or
(B) A change in resident rights under
Federal or State law or regulations as
specified in paragraph (e)(10) of this
section.
(iv) The facility must record and
periodically update the address (mailing
and email) and phone number of the
resident representative(s).
(8) Admission to a composite distinct
part. A facility that is a composite
distinct part (as defined in § 483.5 must
disclose in its admission agreement its
physical configuration, including the
various locations that comprise the
composite distinct part, and must
specify the policies that apply to room
changes between its different locations
under § 483.15(b)(9).
(9) The facility must provide a notice
of rights and services to the resident
prior to or upon admission and during
the resident’s stay.
(i) The facility must inform the
resident both orally and in writing in a
language that the resident understands
of his or her rights and all rules and
regulations governing resident conduct
and responsibilities during the stay in
the facility.
(ii) The facility must also provide the
resident with the State-developed notice
of Medicaid rights and obligations, if
any.
(iii) Receipt of such information, and
any amendments to it, must be
acknowledged in writing;
(10) The facility must:
(i) Inform each Medicaid-eligible
resident, in writing, at the time of
admission to the nursing facility and
when the resident becomes eligible for
Medicaid of—
(A) The items and services that are
included in nursing facility services
under the State plan and for which the
resident may not be charged;
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(B) Those other items and services
that the facility offers and for which the
resident may be charged, and the
amount of charges for those services;
and
(ii) Inform each Medicaid-eligible
resident when changes are made to the
items and services specified in
paragraphs (e)(10)(i)(A) and (B) of this
section.
(11) The facility must inform each
resident before, or at the time of
admission, and periodically during the
resident’s stay, of services available in
the facility and of charges for those
services, including any charges for
services not covered under Medicare/
Medicaid or by the facility’s per diem
rate.
(i) Where changes in coverage are
made to items and services covered by
Medicare and/or by the Medicaid State
plan, the facility must provide notice to
residents of the change as soon as is
reasonably possible;
(ii) Where changes are made to
charges for other items and services that
the facility offers, the facility must
inform the resident in writing at least 60
days prior to implementation of the
change.
(iii) If a resident dies or is
hospitalized or is transferred and does
not return to the facility, the facility
must refund to the resident, resident
representative, or estate, as applicable,
any deposit or charges already paid, less
the facility’s per diem rate, for the days
the resident actually resided or reserved
or retained a bed in the facility,
regardless of any minimum stay or
discharge notice requirements.
(iv) The facility must refund to the
resident or resident representative any
and all refunds due the resident within
thirty days from the resident’s date of
discharge from the facility.
(v) Where the facility requires the
execution of an admission contract by or
on behalf of an individual seeking
admission to the facility, the terms of
the contract must not conflict with the
requirements of these regulations.
(12) The facility must furnish to each
resident a written description of legal
rights which includes—
(i) A description of the manner of
protecting personal funds, under
paragraph (d)(5) of this section;
(ii) A description of the requirements
and procedures for establishing
eligibility for Medicaid, including the
right to request an assessment of
resources under section 1924(c) of the
Social Security Act.
(iii) A list of names, addresses
(mailing and email), and telephone
numbers of all pertinent State regulatory
and informational agencies, resident
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advocacy groups such as the State
survey and certification agency, the
State licensure office, the State LongTerm Care Ombudsman program, the
protection and advocacy agency, adult
protective services where state law
provides for jurisdiction in long-term
care facilities, the local contact agency
for information about returning to the
community and the Medicaid fraud
control unit; and
(iv) A statement that the resident may
file a complaint with the State survey
and certification agency concerning any
suspected violation of state or federal
nursing facility regulations, including
but not limited to resident abuse,
neglect, misappropriation of resident
property in the facility, non-compliance
with the advance directives
requirements and requests for
information regarding returning to the
community.
(13) The facility must protect and
facilitate that resident’s right to
communicate with individuals and
entities within and external to the
facility, consistent with § 483.10(h),
including reasonable access to:
(i) A telephone, including TTY and
TDD services;
(ii) The internet, to the extent
available to the facility; and
(iii) Stationery, postage, writing
implements and the ability to send mail.
(f) Privacy and confidentiality. (1) The
facility must respect the resident’s right
to personal privacy, including privacy
in his or her verbal (meaning spoken),
written and electronic communications.
(i) This includes ensuring that a
resident can send and promptly receive
mail that is unopened; as well as
receive, unopened, letters, packages and
other materials delivered to the facility
for the resident through a means other
than a postal service.
(ii) Personal privacy includes
accommodations, medical treatment,
written and telephone communications,
personal care, visits, and meetings of
family and resident groups, but this
does not require the facility to provide
a private room for each resident;
(2) The facility must comply with the
residents’ rights in § 483.10(g)(3)
regarding his or her medical records.
(3) The facility must allow
representatives of the Office of the State
Long-Term Care Ombudsman to
examine a resident’s medical, social,
and administrative records in
accordance with State law.
(g) Safe environment. The facility
must provide:
(1) A safe, clean, comfortable, and
homelike environment, allowing the
resident to use his or her personal
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belongings to the extent possible. This
includes ensuring:
(i) That the resident can receive care
and services safely.
(ii) That the physical layout of the
facility maximizes independence and
does not pose a safety risk.
(2) Housekeeping and maintenance
services necessary to maintain a
sanitary, orderly, and comfortable
interior;
(3) Clean bed and bath linens that are
in good condition;
(4) Private closet space in each
resident room, as specified in
§ 483.90(d)(2)(iv);
(5) Adequate and comfortable lighting
levels in all areas;
(6) Comfortable and safe temperature
levels. Facilities initially certified after
October 1, 1990 must maintain a
temperature range of 71–81 °F; and
(7) For the maintenance of
comfortable sound levels.
(h) Grievances. (1) The facility must
make information on how to file a
grievance or complaint available to the
resident, including the information
required under paragraph (f)(2) of this
section.
(2) The facility must make prompt
efforts to resolve grievances the resident
may have, including those with respect
to the behavior of other residents.
(3) The facility must establish a
grievance policy to ensure the prompt
resolution of all grievances regarding
the residents’ rights contained in
§ 483.10. Upon request, the provider
must give a copy of the grievance policy
to the resident. The grievance policy
must include:
(i) Notifying resident individually or
through postings in prominent locations
throughout the facility of the right to file
grievances verbally (meaning spoken) or
in writing; the right to file grievances
anonymously; the contact information
of the grievance official with whom a
grievance can be filed, that is, his or her
name, business address (mailing and
email) and business phone number; a
reasonable expected time frame for
completing the review of the grievance;
the right to obtain a written decision
regarding his or her grievance; and the
contact information of independent
entities with whom grievances may be
filed, that is, the pertinent State agency,
Quality Improvement Organization,
State Survey Agency and State LongTerm Care Ombudsman program or
protection and advocacy system;
(ii) Identifying a Grievance Official
who is responsible for overseeing the
grievance process, receiving and
tracking grievances through their
conclusion; leading any necessary
investigations by the facility;
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maintaining the confidentiality of all
information associated with grievances,
for example, the identity of the resident
for those grievances submitted
anonymously; issuing written grievance
decisions to the resident; and
coordinating with State and Federal
agencies as necessary in light of specific
allegations;
(iii) As necessary, taking immediate
action to prevent further potential
violations of any resident right while
the alleged violation is being
investigated;
(iv) Immediately reporting all alleged
violations involving neglect, abuse,
including injuries of unknown source,
and/or misappropriation of resident
property, by anyone furnishing services
on behalf of the provider, to the
administrator of the provider; and as
required by State law;
(v) Ensuring that all written grievance
decisions include the date the grievance
was received, a summary statement of
the resident’s grievance, the steps taken
to investigate the grievance, a summary
of the pertinent findings or conclusions
regarding the resident’s concern(s), a
statement as to whether the grievance
was confirmed or not confirmed, any
corrective action taken or to be taken by
the facility as a result of the grievance,
and the date the written decision was
issued;
(vi) Taking appropriate corrective
action in accordance with State law if
the alleged violation of the residents’
rights is confirmed by the facility or if
an outside entity having jurisdiction,
such as the State survey and
certification agency, Quality
Improvement Organization, or local law
enforcement agency confirms a violation
of any of these residents’ rights within
its area of responsibility; and
(vii) Maintaining evidence
demonstrating the results of all
grievances for a period of no less than
three years from the issuance of the
grievance decision.
(i) Contact with external entities. A
facility must not prohibit or in any way
discourage a resident from
communicating with Federal, State, or
local officials, including, but not limited
to, Federal and State surveyors, other
Federal or State health department
employees, including representatives of
the Office of the State Long-Term Care
Ombudsman and of the protection and
advocacy system, regarding any matter,
whether or not subject to arbitration or
any other type of judicial or regulatory
action.
■ 15. Section 483.12 is revised to read
as follows:
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§ 483.12 Freedom from abuse, neglect,
and exploitation.
The resident has the right to be free
from abuse, neglect, misappropriation of
resident property, and exploitation as
defined in this subpart. This includes
but is not limited to freedom from
corporal punishment, involuntary
seclusion and any physical or chemical
restraint not required to treat the
resident’s medical symptoms.
(a) The facility must—
(1) Not use verbal, mental, sexual, or
physical abuse, corporal punishment, or
involuntary seclusion;
(2) Not employ or otherwise engage
individuals who—
(i) Have been found guilty of abuse,
neglect, misappropriation of property,
or mistreatment by a court of law;
(ii) Have had a finding entered into
the State nurse aide registry concerning
abuse, neglect, mistreatment of residents
or misappropriation of their property; or
(iii) Have had a disciplinary action
taken against a professional license by a
state licensure body as a result of a
finding of abuse, neglect, mistreatment
of residents or misappropriation of
resident property.
(3) Report to the State nurse aide
registry or licensing authorities any
knowledge it has of actions by a court
of law against an employee, which
would indicate unfitness for service as
a nurse aide or other facility staff.
(b) The facility must develop and
implement written policies and
procedures that:
(1) Prohibit and prevent abuse,
neglect, and exploitation of residents
and misappropriation of resident
property,
(2) Establish policies and procedures
to investigate any such allegations, and
(3) Include training as required at
paragraph § 483.95.
(4) Establish coordination with the
QAPI program required under § 483.75.
(5) Ensure reporting of crimes
occurring in federally-funded long-term
care facilities in accordance with
section 1150B of the Social Security
Act. The policies and procedures must
include but are not limited to the
following elements.
(i) Annually notifying covered
individuals, as defined at section
1150B(a)(3) of the Act, of that
individual’s obligation to comply with
the following reporting requirements.
(A) Each covered individual shall
report to the State Agency and one or
more law enforcement entities for the
political subdivision in which the
facility is located any reasonable
suspicion of a crime against any
individual who is a resident of, or is
receiving care from, the facility.
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(B) Each covered individual shall
report not later than 2 hours after
forming the suspicion, if the events that
cause the suspicion result in serious
bodily injury, or not later than 24 hours
if the events that cause the suspicion do
not result in serious bodily injury.
(ii) Posting a conspicuous notice of
employee rights, as defined at section
1150B(d)(3) of the Act.
(iii) Prohibiting and preventing
retaliation, as defined at section
1150B(d)(1) and (2) of the Act.
(c) In response to allegations of abuse,
neglect, exploitation, or mistreatment,
the facility must:
(1) Ensure that all alleged violations
involving abuse, neglect, exploitation or
mistreatment, including injuries of
unknown source and misappropriation
of resident property, are reported
immediately to the administrator of the
facility and to other officials (including
to the State survey and certification
agency and adult protective services
where state law provides for jurisdiction
in long-term care facilities) in
accordance with State law through
established procedures.
(2) Have evidence that all alleged
violations are thoroughly investigated.
(3) Prevent further potential abuse,
neglect, exploitation, or mistreatment
while the investigation is in progress.
(4) Report the results of all
investigations to the administrator or his
resident representative and to other
officials in accordance with State law
(including to the State survey and
certification agency) within 5 working
days of the incident, and if the alleged
violation is verified appropriate
corrective action must be taken.
§ 483.13
[Removed]
16. Remove § 483.13.
17. Section 483.15 is revised to read
as follows:
■
■
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.15
Transitions of care.
Transitions of care include
admissions to and discharges or
transfers to or from a SNF or NF. This
section also addresses bed-hold policies
and therapeutic leave.
(a) Admissions policy. (1) The facility
must establish and implement an
admissions policy.
(2) The facility must—
(i) Not request or require residents or
potential residents to waive their rights
as set forth in this subpart and in
applicable State, Federal or local
licensing or certification laws, including
but not limited to their rights to
Medicare or Medicaid; and
(ii) Not request or require oral or
written assurance that residents or
potential residents are not eligible for,
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or will not apply for, Medicare or
Medicaid benefits.
(iii) Not request or require residents or
potential residents to waive potential
facility liability for losses of personal
property
(3) The facility must not request or
require a third party guarantee of
payment to the facility as a condition of
admission or expedited admission, or
continued stay in the facility. However,
the facility may request and require a
resident representative who has legal
access to a resident’s income or
resources available to pay for facility
care to sign a contract, without
incurring personal financial liability, to
provide facility payment from the
resident’s income or resources.
(4) In the case of a person eligible for
Medicaid, a nursing facility must not
charge, solicit, accept, or receive, in
addition to any amount otherwise
required to be paid under the State plan,
any gift, money, donation, or other
consideration as a precondition of
admission, expedited admission or
continued stay in the facility.
However,—
(i) A nursing facility may charge a
resident who is eligible for Medicaid for
items and services the resident has
requested and received, and that are not
specified in the State plan as included
in the term ‘‘nursing facility services’’ so
long as the facility gives proper notice
of the availability and cost of these
services to residents and does not
condition the resident’s admission or
continued stay on the request for and
receipt of such additional services; and
(ii) A nursing facility may solicit,
accept, or receive a charitable, religious,
or philanthropic contribution from an
organization or from a person unrelated
to a Medicaid eligible resident or
potential resident, but only to the extent
that the contribution is not a condition
of admission, expedited admission, or
continued stay in the facility for a
Medicaid eligible resident.
(5) States or political subdivisions
may apply stricter admissions standards
under State or local laws than are
specified in this section, to prohibit
discrimination against individuals
entitled to Medicaid.
(6) A nursing facility must disclose
and provide to a resident or potential
resident, at or prior to time of
admission, notice of special
characteristics or service limitations of
the facility.
(7) A nursing facility that is a
composite distinct part as defined in
§ 483.5(c) must disclose in its admission
agreement its physical configuration,
including the various locations that
comprise the composite distinct part,
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and must specify the policies that apply
to room changes between its different
locations under paragraph (b)(10) of this
section.
(b) Transfer and discharge—(1)
Facility requirements—(i) Equal access
to quality care. (A) A facility must
establish, maintain and implement
identical policies and practices
regarding transfer, discharge, and the
provision of services for all individuals
regardless of source of payment;
(B) The facility may charge any
amount for services furnished to nonMedicaid residents unless otherwise
limited by state law and consistent with
the notice requirement in
§ 483.11(e)(11)(i) and (e)(12) describing
the charges; and
(C) The State is not required to offer
additional services on behalf of a
resident other than services provided in
the State plan.
(ii) The facility must permit each
resident to remain in the facility, and
not transfer or discharge the resident
from the facility unless—
(A) The transfer or discharge is
necessary for the resident’s welfare and
the resident’s needs cannot be met in
the facility;
(B) The transfer or discharge is
appropriate because the resident’s
health has improved sufficiently so the
resident no longer needs the services
provided by the facility;
(C) The safety of individuals in the
facility is endangered due to the clinical
or behavioral status of the resident;
(D) The health of individuals in the
facility would otherwise be endangered;
(E) The resident has failed, after
reasonable and appropriate notice, to
pay for (or to have paid under Medicare
or Medicaid) a stay at the facility. Nonpayment does not apply unless the
resident does not submit the necessary
paperwork for third party payment or
until the third party, including
Medicare or Medicaid, denies the claim
and the resident refuses to pay for his
or her stay. For a resident who becomes
eligible for Medicaid after admission to
a facility, the facility may charge a
resident only allowable charges under
Medicaid; or
(F) The facility ceases to operate.
(iii) The facility may not transfer or
discharge the resident while the appeal
is pending, pursuant to § 431.230 of this
chapter, when a resident exercises his or
her right to appeal a transfer or
discharge notice from the facility
pursuant to § 431.220(a)(3) of this
chapter.
(2) Documentation. When the facility
transfers or discharges a resident under
any of the circumstances specified in
paragraphs (b)(1)(i)(A) through (F) of
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this section, the facility must ensure
that the transfer or discharge is
documented in the resident’s clinical
record and appropriate information is
communicated to the receiving health
care institution or provider.
(i) Documentation in the resident’s
clinical record must include:
(A) The basis for the transfer per
paragraph (b)(1)(ii).
(B) In the case of paragraph
(b)(1)(ii)(A) of this section, the specific
resident need(s) that cannot be met,
facility attempts to meet the resident
needs, and the service available at the
receiving facility to meet the need(s).
(ii) The documentation must be made
by—
(A) The resident’s physician when
transfer or discharge is necessary under
paragraph (b)(1)(i)(A) or (B) of this
section; and
(B) A physician when transfer or
discharge is necessary under paragraph
(b)(1)(i)(C) or (D) of this section.
(iii) Information provided to the
receiving provider must include a
minimum of the following:
(A) Demographic information
including but not limited to name, sex,
date of birth, race, ethnicity, and
preferred language.
(B) Resident representative
information including contact
information.
(C) Advance Directive information.
(D) History of present illness/reason
for transfer including primary care team
contact information.
(E) Past medical/surgical history,
including procedures.
(F) Active diagnoses/Current problem
list and status.
(G) Laboratory tests and the results of
pertinent laboratory and other
diagnostic testing.
(H) Functional status.
(I) Psychosocial assessment, including
cognitive status.
(J) Social Supports
(K) Behavioral Health Issues
(L) Medications.
(M) Allergies, including medication
allergies.
(N) Immunizations.
(O) Smoking status.
(P) Vital signs.
(Q) Unique device identifier(s) for a
patient’s implantable device(s), if any.
(R) Comprehensive Care plan goals,
including health concerns, assessment
and plan, resident preferences,
interventions, including efforts to meet
resident needs, and resident status.
(iv) This requirement may be satisfied
by the discharge summary providing it
meets the requirements of § 483.21(c)
and includes at a minimum the
information specified in paragraph
(b)(2)(iii) of this section.
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(3) Notice before transfer. Before a
facility transfers or discharges a
resident, the facility must—
(i) Notify the resident and the
resident’s representative(s) of the
transfer or discharge and the reasons for
the move in writing and in a language
and manner they understand. Subject to
the resident’s agreement, the facility
must send a copy of the notice to a
representative of the Office of the State
Long-Term Care Ombudsman.
(ii) Record the reasons for the transfer
or discharge in the resident’s clinical
record in accordance with paragraph
(b)(2) of this section; and
(iii) Include in the notice the items
described in paragraph (b)(5) of this
section.
(4) Timing of the notice. (i) Except as
specified in paragraphs (b)(4)(ii) and
(b)(8) of this section, the notice of
transfer or discharge required under this
section must be made by the facility at
least 30 days before the resident is
transferred or discharged.
(ii) Notice must be made as soon as
practicable before transfer or discharge
when—
(A) The safety of individuals in the
facility would be endangered under
paragraph (b)(1)(ii)(C) of this section;
(B) The health of individuals in the
facility would be endangered, under
paragraph (b)(1)(ii)(D) of this section;
(C) The resident’s health improves
sufficiently to allow a more immediate
transfer or discharge, under paragraph
(b)(1)(ii)(B) of this section;
(D) An immediate transfer or
discharge is required by the resident’s
urgent medical needs, under paragraph
(b)(1)(ii)(A) of this section; or
(E) A resident has not resided in the
facility for 30 days.
(5) Contents of the notice. The written
notice specified in paragraph (b)(3) of
this section must include the following:
(i) The reason for transfer or
discharge;
(ii) The effective date of transfer or
discharge;
(iii) The location to which the
resident is expected to be transferred or
discharged;
(iv) A statement that the resident has
the right to appeal the action to the
State, the name, address (mailing and
email), and telephone number of the
State entity which receives such
requests; and information on how to
obtain an appeal form and assistance in
completing the form and submitting the
appeal hearing request;
(v) The name, address (mailing and
email) and telephone number of the
Office of the State Long-Term Care
Ombudsman;
(vi) For nursing facility residents with
intellectual and developmental
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disabilities, the mailing and email
address and telephone number of the
agency responsible for the protection
and advocacy of individuals with
developmental disabilities established
under Part C of the Developmental
Disabilities Assistance and Bill of Rights
Act of 2000 (42 U.S.C. 10802); and
(vii) For nursing facility residents
with mental illness, the mailing and
email address and telephone number of
the agency responsible for the
protection and advocacy of individuals
with mental illness established under
the Protection and Advocacy for
Mentally Ill Individuals Act.
(6) Changes to the notice. If the
information in the notice changes prior
to effecting the transfer or discharge, the
facility must update the recipients of the
notice as soon as practicable once the
updated information becomes available.
(7) Orientation for transfer or
discharge. A facility must provide and
document sufficient preparation and
orientation to residents to ensure safe
and orderly transfer or discharge from
the facility. This orientation must be
provided in a form and manner that the
resident can understand.
(8) Notice in advance of facility
closure. In the case of facility closure,
the individual who is the administrator
of the facility must provide written
notification prior to the impending
closure to the State Survey Agency, the
Office of the State Long-Term Care
Ombudsman, residents of the facility,
and the resident representatives of the
residents or other responsible parties, as
well as the plan for the transfer and
adequate relocation of the residents, as
required at § 483.70(l).
(9) Room changes in a composite
distinct part. Room changes in a facility
that is a composite distinct part (as
defined in § 483.5) are subject to the
requirements of § 483.10(d)(7) and must
be limited to moves within the
particular building in which the
resident resides, unless the resident
voluntarily agrees to move to another of
the composite distinct part’s locations.
(c) Notice of bed-hold policy and
readmission—(1) Notice before transfer.
Before a nursing facility transfers a
resident to a hospital or the resident
goes on therapeutic leave, the nursing
facility must provide written
information to the resident or resident
representative that specifies—
(i) The duration of the state bed-hold
policy, if any, during which the resident
is permitted to return and resume
residence in the nursing facility;
(ii) The reserve bed payment policy in
the state plan, under § 447.40 of this
chapter, if any;
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(iii) The nursing facility’s policies
regarding bed-hold periods, which must
be consistent with paragraph (c)(3) of
this section, permitting a resident to
return; and
(iv) The information specified in
paragraph (c)(3) of this section.
(2) Bed-hold notice upon transfer. At
the time of transfer of a resident for
hospitalization or therapeutic leave, a
nursing facility must provide to the
resident and the resident representative
written notice which specifies the
duration of the bed-hold policy
described in paragraph (c)(1) of this
section.
(3) Permitting resident to return to
facility. A nursing facility must establish
and follow a written policy on
permitting residents to return to the
facility after they are hospitalized or
placed on therapeutic leave. The policy
must provide for the following.
(i) A resident, whose hospitalization
or therapeutic leave exceeds the bedhold period under the State plan, is
readmitted to the facility to their
previous room if available or
immediately upon the first availability
of a bed in a semi-private room if the
resident—
(A) Requires the services provided by
the facility; and
(B) Is eligible for Medicaid nursing
facility services.
(ii) A resident who is hospitalized or
placed on therapeutic leave with an
expectation of returning to the facility
must be notified in writing by the
facility when the facility determines
that the resident cannot be readmitted to
the facility, the reason the resident
cannot be readmitted to the facility, and
the information specified in paragraphs
(b)(5)(iv) through (vii) of this section.
(4) Readmission to a composite
distinct part. When the nursing facility
to which a resident is readmitted is a
composite distinct part (as defined in
§ 483.5), the resident must be permitted
to return to an available bed in the
particular location of the composite
distinct part in which he or she resided
previously. If a bed is not available in
that location at the time of readmission,
the resident must be given the option to
return to that location upon the first
availability of a bed there.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.20
[Amended]
18. In § 483.20—
a. Revise paragraph (b)(1) introductory
text.
■ b. Revise paragraphs (b)(1)(xvi) and
(xviii).
■ c. Revise paragraph (e).
■ d. Remove paragraphs (k) and (l).
■ e. Redesignate paragraph (m) as
paragraph (k).
■
■
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f. Revise newly designated paragraph
(k).
The revisions read as follows:
■
§ 483.20
Resident assessment.
*
*
*
*
*
(b) * * *
(1) Resident assessment instrument. A
facility must make a comprehensive
assessment of a resident’s needs,
strengths, goals, life history and
preferences, using the resident
assessment instrument (RAI) specified
by CMS. The assessment must include
at least the following:
*
*
*
*
*
(xvi) Discharge planning.
*
*
*
*
*
(xviii) Documentation of participation
in assessment. The assessment process
must include direct observation and
communication with the resident, as
well as communication with licensed
and nonlicensed direct care/direct
access staff members on all shifts.
*
*
*
*
*
(e) Coordination. A facility must
coordinate assessments with the
preadmission screening and resident
review (PASARR) program under
Medicaid in subpart C of this part to the
maximum extent practicable to avoid
duplicative testing and effort.
Coordination includes—
(1) Incorporating the
recommendations from the PASARR
level II determination and the PASARR
evaluation report into a resident’s
assessment, care planning, and
transitions of care.
(2) Referring all level II residents and
all residents with newly evident or
possible serious mental illness,
intellectual disability, or a related
condition for level II resident review
upon a significant change in status
assessment.
*
*
*
*
*
(k) Preadmission screening for
individuals with mental illness and
individuals with intellectual disability.
(1) A nursing facility must not admit, on
or after January 1, 1989, any new
resident with—
(i) Mental illness as defined in
paragraph (k)(3)(i) of this section, unless
the State mental health authority has
determined, based on an independent
physical and mental evaluation
performed by a person or entity other
than the State mental health authority,
prior to admission,
(A) That, because of the physical and
mental condition of the individual, the
individual requires the level of services
provided by a nursing facility; and
(B) If the individual requires such
level of services, whether the individual
requires specialized services; or
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(ii) Intellectual disability, as defined
in paragraph (k)(3)(ii) of this section,
unless the State intellectual disability or
developmental disability authority has
determined prior to admission—
(A) That, because of the physical and
mental condition of the individual, the
individual requires the level of services
provided by a nursing facility; and
(B) If the individual requires such
level of services, whether the individual
requires specialized services for
intellectual disability.
(2) Exceptions. For purposes of this
section—
(i) The preadmission screening
program under paragraph (k)(1) of this
section need not provide for
determinations in the case of the
readmission to a nursing facility of an
individual who, after being admitted to
the nursing facility, was transferred for
care in a hospital.
(ii) The State may choose not to apply
the preadmission screening program
under paragraph (k)(1) of this section to
the admission to a nursing facility of an
individual—
(A) Who is admitted to the facility
directly from a hospital after receiving
acute inpatient care at the hospital,
(B) Who requires nursing facility
services for the condition for which the
individual received care in the hospital,
and
(C) Whose attending physician has
certified, before admission to the facility
that the individual is likely to require
less than 30 days of nursing facility
services.
(3) Definition. For purposes of this
section—
(i) An individual is considered to
have mental illness if the individual has
a serious mental illness as defined in
§ 483.102(b)(1).
(ii) An individual is considered to
have an intellectual disability if the
individual has an intellectual disability
as defined in § 483.102(b)(3) or is a
person with a related condition as
described in § 435.1010 of this chapter.
(4) A nursing facility must notify the
state mental health authority or state
intellectual disability authority, as
applicable, promptly after a significant
change in the mental or physical
condition of a resident who has mental
illness or intellectual disability for
resident review.
■ 19. Section 483.21 is added to read as
follows:
§ 483.21 Comprehensive person-centered
care planning.
(a) Baseline care plans. (1) The
facility must develop a baseline care
plan for each resident that includes the
instructions needed to provide effective
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and person-centered care of the resident
that meet professional standards of
quality care. The baseline care plan
must—
(i) Be developed within 48 hours of a
resident’s admission.
(ii) Include the minimum healthcare
information necessary to properly care
for a resident including, but not limited
to—
(A) Initial goals based on admission
orders.
(B) Physician orders.
(C) Dietary orders.
(D) Therapy services.
(E) Social services.
(F) PASARR recommendation, if
applicable.
(2) The facility may develop a
comprehensive care plan in place of the
baseline care plan if the comprehensive
care plan—
(i) Is developed within 48 hours of the
resident’s admission.
(ii) Meets the requirements set forth in
paragraph (b) of this section (excepting
paragraph (b)(2)(i) of this section).
(b) Comprehensive care plans. (1) The
facility must develop a comprehensive
person-centered care plan for each
resident, consistent with § 483.10(b)(1)
and § 483.11(b)(1), that includes
measurable objectives and timetables to
meet a resident’s medical, nursing, and
mental and psychosocial needs that are
identified in the comprehensive
assessment. The comprehensive care
plan must describe the following—
(i) The services that are to be
furnished to attain or maintain the
resident’s highest practicable physical,
mental, and psychosocial well-being as
required under § 483.25 or § 483.40; and
(ii) Any services that would otherwise
be required under § 483.25 or § 483.40
but are not provided due to the
resident’s exercise of rights under
§ 483.10, including the right to refuse
treatment under § 483.10(b)(4).
(iii) Any specialized services or
specialized rehabilitative services the
nursing facility will provide as a result
of PASARR recommendations. If a
facility disagrees with the findings of
the PASARR, it must indicate its
rationale in the resident’s medical
record.
(iv) In consultation with the resident
and the resident’s representative(s)—
(A) The resident’s goals for admission
and desired outcomes.
(B) The resident’s preference and
potential for future discharge. Facilities
must document whether the resident’s
desire to return to the community was
assessed and any referrals to local
contact agencies and/or other
appropriate entities, for this purpose.
(C) Discharge plans in the
comprehensive care plan, as
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appropriate, in accordance with the
requirements set forth in paragraph (c)
of this section.
(2) A comprehensive care plan must
be—
(i) Developed within 7 days after
completion of the comprehensive
assessment.
(ii) Prepared by an interdisciplinary
team, that includes but is not limited
to—
(A) The attending physician.
(B) A registered nurse with
responsibility for the resident.
(C) A nurse aide with responsibility
for the resident.
(D) A member of food and nutrition
services staff.
(E) A social worker.
(F) To the extent practicable, the
participation of the resident and the
resident’s representative(s). An
explanation must be included in a
resident’s medical record if the
participation of the resident and their
resident representative is determined
not practicable for the development of
the resident’s care plan.
(G) Other appropriate staff or
professionals in disciplines as
determined by the resident’s needs or as
requested by the resident.
(iii) Reviewed and revised by the
interdisciplinary team after each
assessment, including both the
comprehensive and quarterly review
assessments.
(3) The services provided or arranged
by the facility, as outlined by the
comprehensive care plan, must—
(i) Meet professional standards of
quality.
(ii) Be provided by qualified persons
in accordance with each resident’s
written plan of care.
(iii) Be culturally-competent and
trauma-informed.
(c) Discharge planning—(1) Discharge
planning process. The facility must
develop and implement an effective
discharge planning process that focuses
on the resident’s discharge goals and
preparing residents to be active partners
in post-discharge care, effective
transition of the resident from SNF to
post-SNF care, and the reduction of
factors leading to preventable
readmissions. The facility’s discharge
planning process must—
(i) Ensure that the discharge needs of
each resident are identified and result in
the development of a discharge plan for
each resident.
(ii) Include regular re-evaluation of
residents to identify changes that
require modification of the discharge
plan. The discharge plan must be
updated, as needed, to reflect these
changes.
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(iii) Involve the interdisciplinary
team, as defined by § 483.20(b)(2)(ii), in
the ongoing process of developing the
discharge plan.
(iv) Consider caregiver/support
person availability and the resident’s or
caregiver’s/support person(s) capacity
and capability to perform required care,
as part of the identification of discharge
needs.
(v) Involve the resident and resident
representative in the development of the
discharge plan and inform the resident
and resident representative of the final
plan.
(vi) Address the resident’s goals of
care and treatment preferences.
(vii) Document that a resident has
been asked about their interest in
receiving information regarding
returning to the community.
(A) If the resident indicates an interest
in returning to the community, the
facility must document any referrals to
local contact agencies or other
appropriate entities made for this
purpose.
(B) Facilities must update a resident’s
comprehensive care plan and discharge
plan, as appropriate, in response to
information received from referrals to
local contact agencies or other
appropriate entities.
(C) If discharge to the community is
determined to not be feasible, the
facility must document who made the
determination and why.
(viii) For residents who are
transferred to another SNF or who are
discharged to a HHA, IRF, or LTCH,
assist residents and their resident
representatives in selecting a post-acute
care provider by using data that
includes, but is not limited to SNF,
HHA, IRF, or LTCH standardized
patient assessment data, data on quality
measures, and data on resource use to
the extent the data is available. The
facility must ensure that the post-acute
care standardized patient assessment
data, data on quality measures, and data
on resource use is relevant and
applicable to the resident’s goals of care
and treatment preferences.
(ix) Document, complete on a timely
basis based on the resident’s needs, and
include in the clinical record, the
evaluation of the resident’s discharge
needs and discharge plan. The results of
the evaluation must be discussed with
the resident or resident’s representative.
All relevant resident information must
be incorporated into the discharge plan
to facilitate its implementation and to
avoid unnecessary delays in the
resident’s discharge or transfer.
(2) Discharge summary. When the
facility anticipates discharge a resident
must have a discharge summary that
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includes, but is not limited to, the
following:
(i) A recapitulation of the resident’s
stay that includes, but is not limited to,
diagnoses, course of illness/treatment or
therapy, and pertinent lab, radiology,
and consultation results.
(ii) A final summary of the resident’s
status to include items in paragraph
(b)(1) of § 483.20, at the time of the
discharge that is available for release to
authorized persons and agencies, with
the consent of the resident or resident’s
representative.
(iii) Reconciliation of all predischarge medications with the
resident’s post-discharge medications
(both prescribed and over-the-counter).
(iv) A post-discharge plan of care that
is developed with the participation of
the resident and, with the resident’s
consent, his or her family, which will
assist the resident to adjust to his or her
new living environment. The postdischarge plan of care must indicate
where the individual plans to reside,
any arrangements that have been made
for the resident’s follow up care and any
post-discharge medical and non-medical
services.
■ 20. Section 483.25 is revised to read
as follows:
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.25
Quality of care and quality of life.
Each resident must receive and the
facility must provide the necessary care
and services to attain or maintain the
highest practicable physical, mental,
and psychosocial well-being, consistent
with the resident’s comprehensive
assessment and plan of care.
(a) Based on the comprehensive
assessment of a resident and consistent
with the resident’s needs and choices,
the facility must provide the necessary
care and services to ensure that a
resident’s abilities in activities of daily
living do not diminish unless
circumstances of the individual’s
clinical condition demonstrate that such
diminution was unavoidable. This
includes the facility ensuring that:
(1) A resident is given the appropriate
treatment and services to maintain or
improve his or her ability to carry out
the activities of daily living, including
those specified in paragraph (b) of this
section,
(2) A resident who is unable to carry
out activities of daily living receives the
necessary services to maintain good
nutrition, grooming, and personal and
oral hygiene, and
(3) Personnel provide basic life
support, including CPR, to a resident
requiring such emergency care prior to
the arrival of emergency medical
personnel and subject to the resident’s
advance directives.
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(b) Activities of daily living. (1)
Hygiene—bathing, dressing, grooming,
and oral care,
(2) Mobility—transfer and
ambulation,
(3) Elimination-toileting,
(4) Dining-eating, including meals and
snacks,
(5) Communication, including
(i) Speech,
(ii) Language,
(iii) Other functional communication
systems.
(c) Activities. (1) The facility must
provide, based on the comprehensive
assessment and care plan and the
preferences of each resident, an ongoing
program to support residents in their
choice of activities, both facilitysponsored group and individual
activities and independent activities,
designed to meet the interests of and
support the physical, mental, and
psychosocial well-being of each
resident, encouraging both
independence and interaction in the
community.
(2) The activities program must be
directed by a qualified professional who
is a qualified therapeutic recreation
specialist or an activities professional
who—
(i) Is licensed or registered, if
applicable, by the State in which
practicing; and
(ii) Is:
(A) Eligible for certification as a
therapeutic recreation specialist or as an
activities professional by a recognized
accrediting body on or after October 1,
1990; or
(B) Has 2 years of experience in a
social or recreational program within
the last 5 years, 1 of which was full-time
in a therapeutic activities program; or
(C) Is a qualified occupational
therapist or occupational therapy
assistant; or
(D) Has completed a training course
approved by the State.
(d) Special care issues. Based on the
comprehensive assessment of a resident,
the facility must ensure that residents
receive treatment and care, in
accordance with professional standards
of practice and the residents choices,
related to the following special
concerns—
(1) Restraints. The facility must
ensure that the resident is free from
physical or chemical restraints imposed
for purposes of discipline or
convenience and that are not required to
treat the resident’s medical symptoms.
When the use of restraints is indicated,
the facility must use the least restrictive
alternative for the least amount of time
and document ongoing re-evaluation of
the need for restraints.
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(2) Bed rails. The facility must ensure
correct installation, use and
maintenance of bed rails, including but
not limited to the following elements.
(i) Attempt to use alternatives prior to
installing a side or bed rail.
(ii) Assess resident for risk of
entrapment from bed rails prior to
installation.
(iii) Review the risks and benefits of
bed rails with the resident or resident
representative and obtain informed
consent prior to installation
(iv) Ensure that the resident’s size and
weight are appropriate for the bed’s
dimensions.
(v) Follow the manufacturers’
recommendations and specifications for
installing and maintaining bed rails.
(3) Vision and hearing. To ensure that
residents receive proper treatment and
assistive devices to maintain vision and
hearing abilities, the facility must, if
necessary, assist the resident—
(i) In making appointments, and
(ii) By arranging for transportation to
and from the office of a practitioner
specializing in the treatment of vision or
hearing impairment or the office of a
professional specializing in the
provision of vision or hearing assistive
devices.
(4) Skin integrity—(i) Pressure ulcers.
Based on the comprehensive assessment
of a resident, the facility must ensure
that—
(A) A resident receives care,
consistent with professional standards
of practice, to prevent pressure ulcers
and does not develop pressure ulcers
unless the individual’s clinical
condition demonstrates that they were
unavoidable; and
(B) A resident with pressure ulcers
receives necessary treatment and
services, consistent with professional
standards of practice, to promote
healing, prevent infection and prevent
new ulcers from developing.
(ii) Foot care. To ensure that residents
receive proper treatment and care to
maintain mobility and good foot health,
the facility must:
(A) Provide foot care and treatment, in
accordance with professional standards
of practice, including to prevent
complications from the resident’s
medical condition(s) and
(B) If necessary, assist the resident in
making appointments with a qualified
person, and arranging for transportation
to and from such appointments.
(5) Mobility. (i) The facility must
ensure that a resident who enters the
facility without limited range of motion
does not experience reduction in range
of motion unless the resident’s clinical
condition demonstrates that a reduction
in range of motion is unavoidable; and
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(ii) A resident with limited range of
motion receives appropriate treatment
and services to increase range of motion
and/or to prevent further decrease in
range of motion.
(iii) A resident with limited mobility
receives appropriate services,
equipment, and assistance to maintain
or improve mobility with the maximum
practicable independence unless a
reduction in mobility is demonstrably
unavoidable.
(6) Incontinence. (i) The facility must
ensure that resident who is continent of
bladder and bowel on admission
receives services and assistance to
maintain continence unless his or her
clinical condition is or becomes such
that continence is not possible to
maintain.
(ii) For a resident with urinary
incontinence, based on the resident’s
comprehensive assessment, the facility
must ensure that—
(A) A resident who enters the facility
without an indwelling catheter is not
catheterized unless the resident’s
clinical condition demonstrates that
catheterization was necessary;
(B) A resident who enters the facility
with an indwelling catheter or
subsequently receives one is assessed
for removal of the catheter as soon as
possible unless the resident’s clinical
condition demonstrates that
catheterization is necessary and
(C) A resident who is incontinent of
bladder receives appropriate treatment
and services to prevent urinary tract
infections and to restore as much
normal bladder function as possible.
(iii) For a resident with fecal
incontinence, based on the resident’s
comprehensive assessment, the facility
must ensure that a resident who is
incontinent of bowel receives
appropriate treatment and services to
restore as much normal bowel function
as possible.
(7) Colostomy, ureterostomy, or
ileostomy care.
(8) Assisted nutrition and hydration.
(Includes naso-gastric and gastrostomy
tubes, both percutaneous endoscopic
gastrostomy and percutaneous
endoscopic jejunostomy, and enteral
fluids). Based on a resident’s
comprehensive assessment, the facility
must ensure that a resident—
(i) Maintains acceptable parameters of
nutritional status, such as usual body
weight or desirable body weight range
and protein levels, unless the resident’s
clinical condition demonstrates that this
is not possible or resident preferences
indicate otherwise;
(ii) Is offered sufficient fluid intake to
maintain proper hydration and health;
and
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(iii) Is offered a therapeutic diet when
there is a nutritional problem and the
health care provider orders a
therapeutic diet.
(iv) A resident who has been able to
eat enough alone or with assistance is
not fed by enteral methods unless the
resident’s clinical condition
demonstrates that enteral feeding was
clinically indicated and consented to by
the resident; and
(v) A resident who is fed by enteral
means receives the appropriate
treatment and services to restore, if
possible, oral eating skills and to
prevent complications of enteral feeding
including but not limited to aspiration
pneumonia, diarrhea, vomiting,
dehydration, metabolic abnormalities,
and nasal-pharyngeal ulcers.
(9) Parenteral fluids.
(10) Accidents. The facility must
ensure that—
(i) The resident environment remains
as free of accident hazards as is
possible; and
(ii) Each resident receives adequate
supervision and assistance devices to
prevent accidents.
(11) Respiratory care, including
tracheostomy care and tracheal
suctioning. See § 483.65 re: Specialized
rehabilitative services.
(12) Prostheses.
(13) Pain management.
(14) Dialysis.
(15) Trauma-informed care. The
facility must ensure that residents who
are trauma survivors receive culturallycompetent, trauma-informed care in
accordance with professional standards
of practice and accounting for residents’
experiences and preferences in order to
eliminate or mitigate triggers that may
cause re-traumatization of the resident.
■ 21. In the table below, each section
and paragraph indicated in the first
column is redesignated as the section
and paragraph indicated in the second
column:
Existing CFR section
§ 483.30
§ 483.35
§ 483.40
§ 483.45
§ 483.60
§ 483.65
§ 483.70
§ 483.75
....................................
....................................
....................................
....................................
....................................
....................................
....................................
....................................
New CFR
section
§ 483.35
483.60
483.30
483.65
483.45
483.80
483.90
483.70
22. In newly redesignated § 483.30—
a. Revise the introductory text.
b. Revise paragraph (b)(3).
c. Redesignate paragraphs (e) and (f)
as paragraphs (f) and (g), respectively.
■ d. Amend newly designated
paragraph (f)(1) introductory text by
■
■
■
■
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removing the reference ‘‘paragraph
(e)(2)’’ and adding in its place the
reference ‘‘paragraph (f)(4)’’.
■ e. Add a new paragraph (e).
■ f. Amend newly redesignated
paragraph (f) by further redesignating
paragraph (f)(2) as paragraph (f)(4).
■ g. Add new paragraphs (f)(2) and
(f)(3).
The revisions and additions read as
follows:
§ 483.30
Physician services.
A physician must personally approve
in writing a recommendation that an
individual be admitted to a facility.
Each resident must remain under the
care of a physician. A physician,
physician assistant, nurse practitioner,
or clinical nurse specialist must provide
orders for the resident’s immediate care
and needs.
*
*
*
*
*
(b) * * *
(3) Sign and date all orders with the
exception of influenza and
pneumococcal vaccines, which may be
administered per physician-approved
facility policy after an assessment for
contraindications.
*
*
*
*
*
(e) Availability of a physician,
physician assistant, nurse practitioner,
or clinical nurse specialist to evaluate
resident for non-emergent transfer to a
hospital. The facility must provide or
arrange for an in-person evaluation of a
resident by a physician, a physician
assistant, nurse practitioner, or clinical
nurse specialist prior to transferring the
resident to a hospital.
(1) The evaluation must occur
expeditiously once the potential need
for a transfer is identified.
(2) This requirement does not apply
in emergency situations where the
health or safety of the individual would
be endangered.
(f) * * *
(2) A physician may delegate the task
of writing dietary orders, consistent
with § 483.60, to a qualified dietitian or
other clinically qualified nutrition
professional who—
(i) Is acting within the scope of
practice as defined by State law; and
(ii) Is under the supervision of the
physician.
(3) A physician may delegate the task
of writing therapy orders, consistent
with § 483.65, to a qualified therapist
who—
(i) Is acting within the scope of
practice as defined by State law; and
(ii) Is under the supervision of the
physician.
*
*
*
*
*
■ 23. In newly redesignated § 483.35—
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a. Revise the introductory text.
b. Amend paragraph (a)(1)(i) by
removing the reference ‘‘paragraph (c)’’
and adding in its place the reference
‘‘paragraph (e)’’.
■ c. Revise paragraph (a)(1)(ii).
■ d. Add paragraphs (a)(3) and (4).
■ e. Amend paragraphs (b)(1) and (b)(2)
by removing the reference ‘‘paragraph
(c) or (d)’’ and adding in its place the
reference ‘‘paragraph (e) or (f)’’.
■ f. Redesignate paragraphs (c), (d) and
(e) as paragraphs (e), (f), and (g),
respectively.
■ g. Add new paragraphs (c) and (d).
■ h. Revise redesignated paragraphs
(e)(6) and (7).
■ i. Revise redesignated paragraphs
(f)(1)(iv) and (v).
The revisions and additions read as
follows:
■
■
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.35
Nursing services.
The facility must have sufficient
nursing staff with the appropriate
competencies and skills sets to provide
nursing and related services to assure
resident safety and attain or maintain
the highest practicable physical, mental,
and psychosocial well-being of each
resident, as determined by resident
assessments and individual plans of
care and considering the number, acuity
and diagnoses of the facility’s resident
population in accordance with the
facility assessment required at
§ 483.70(e).
(a) * * *
(1) * * *
(ii) Other nursing personnel,
including but not limited to nurse aides.
*
*
*
*
*
(3) The facility must ensure that
licensed nurses have the specific
competencies and skill sets necessary to
care for residents’ needs, as identified
through resident assessments, and
described in the plan of care.
(4) Providing care includes but is not
limited to assessing, evaluating,
planning and implementing resident
care plans and responding to resident’s
needs.
*
*
*
*
*
(c) Proficiency of nurse aides. The
facility must ensure that nurse aides are
able to demonstrate competency in
skills and techniques necessary to care
for residents’ needs, as identified
through resident assessments, and
described in the plan of care.
(d) Requirements for facility hiring
and use of nursing aides—(1) General
rule. A facility must not use any
individual working in the facility as a
nurse aide for more than 4 months, on
a full-time basis, unless:
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(i) That individual is competent to
provide nursing and nursing related
services; and
(ii)(A) That individual has completed
a training and competency evaluation
program, or a competency evaluation
program approved by the State as
meeting the requirements of §§ 483.151
through 483.154; or
(B) That individual has been deemed
or determined competent as provided in
§ 483.150(a) and (b).
(2) Non-permanent employees. A
facility must not use on a temporary, per
diem, leased, or any basis other than a
permanent employee any individual
who does not meet the requirements in
paragraphs (d)(1) (i) and (ii) of this
section.
(3) Minimum competency. A facility
must not use any individual who has
worked less than 4 months as a nurse
aide in that facility unless the
individual—
(i) Is a full-time employee in a Stateapproved training and competency
evaluation program;
(ii) Has demonstrated competence
through satisfactory participation in a
State-approved nurse aide training and
competency evaluation program or
competency evaluation program; or
(iii) Has been deemed or determined
competent as provided in § 483.150(a)
and (b).
(4) Registry verification. Before
allowing an individual to serve as a
nurse aide, a facility must receive
registry verification that the individual
has met competency evaluation
requirements unless—
(i) The individual is a full-time
employee in a training and competency
evaluation program approved by the
State; or
(ii) The individual can prove that he
or she has recently successfully
completed a training and competency
evaluation program or competency
evaluation program approved by the
State and has not yet been included in
the registry. Facilities must follow up to
ensure that such an individual actually
becomes registered.
(5) Multi-State registry verification.
Before allowing an individual to serve
as a nurse aide, a facility must seek
information from every State registry
established under sections 1819(e)(2)(A)
or 1919(e)(2)(A) of the Act that the
facility believes will include
information on the individual.
(6) Required retraining. If, since an
individual’s most recent completion of
a training and competency evaluation
program, there has been a continuous
period of 24 consecutive months during
none of which the individual provided
nursing or nursing-related services for
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monetary compensation, the individual
must complete a new training and
competency evaluation program or a
new competency evaluation program.
(7) Regular in-service education. The
facility must complete a performance
review of every nurse aide at least once
every 12 months, and must provide
regular in-service education based on
the outcome of these reviews. In-service
training must comply with the
requirements of § 483.95(g).
(e) * * *
(6) The State agency granting a waiver
of such requirements provides notice of
the waiver to the Office of the State
Long-Term Care Ombudsman
(established under section 712 of the
Older Americans Act of 1965) and the
protection and advocacy system in the
State for individuals with
developmental disabilities or mental
illnesses; and
(7) The nursing facility that is granted
such a waiver by a State notifies
residents of the facility and their
resident representatives of the waiver.
(f) * * *
(1) * * *
(iv) The Secretary provides notice of
the waiver to the Office of the State
Long-Term Care Ombudsman
(established under section 712 of the
Older Americans Act of 1965) and the
protection and advocacy system in the
State for individuals with
developmental disabilities or mental
illnesses; and
(v) The facility that is granted such a
waiver notifies residents of the facility
and their resident representatives of the
waiver.
*
*
*
*
*
■ 24. Section 483.40 is added to read as
follows:
§ 483.40
Behavioral health services.
Each resident must receive and the
facility must provide the necessary
behavioral health care and services to
attain or maintain the highest
practicable physical, mental, and
psychosocial well-being, in accordance
with the comprehensive assessment and
plan of care.
(a) The facility must have sufficient
direct care/direct access staff with the
appropriate competencies and skills sets
to provide nursing and related services
to assure resident safety and attain or
maintain the highest practicable
physical, mental and psychosocial wellbeing of each resident, as determined by
resident assessments and individual
plans of care and considering the
number, acuity and diagnoses of the
facility’s resident population in
accordance with § 483.70(e). These
competencies and skills sets include,
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but are not limited to, knowledge of and
appropriate training and supervision
for:
(1) Caring for residents with mental
illnesses and psychosocial disorders, as
well as residents with a history of
trauma and/or post-traumatic stress
disorder, that have been identified in
the facility assessment conducted
pursuant to § 483.70(e), and
(2) Implementing nonpharmacological interventions.
(b) Based on the comprehensive
assessment of a resident, the facility
must ensure that—
(1) A resident who displays or is
diagnosed with mental or psychosocial
adjustment difficulty, or who has a
history of trauma and/or post-traumatic
stress disorder, receives appropriate
treatment and services to correct the
assessed problem or to attain the highest
practicable mental and psychosocial
well-being, and
(2) A resident whose assessment did
not reveal or who does not have a
diagnosis of a mental or psychosocial
adjustment difficulty or a documented
history of trauma and/or post-traumatic
stress disorder does not display a
pattern of decreased social interaction
and/or increased withdrawn, angry, or
depressive behaviors, unless the
resident’s clinical condition
demonstrates that development of such
a pattern was unavoidable.
(c) If rehabilitative services such as
but not limited to physical therapy,
speech-language pathology,
occupational therapy, and rehabilitative
services for mental illness and
intellectual disability, are required in
the resident’s comprehensive plan of
care, the facility must—
(1) Provide the required services,
including specialized rehabilitation
services as required in § 483.45; or
(2) Obtain the required services from
an outside resource (in accordance with
§ 483.75(g) of this part) from a Medicare
and/or Medicaid provider of specialized
rehabilitative services.
(d) The facility must provide
medically-related social services to
attain or maintain the highest
practicable mental and psychosocial
well-being of each resident.
■ 25. In newly redesignated § 483.45—
■ a. Amend the introductory text by
removing the reference ‘‘§ 483.75(h) of
this part’’ and add in its place the
reference ‘‘§ 483.70(g)’’.
■ b. Redesignate paragraph (c)(2) as
paragraph (c)(4).
■ c. Add new paragraphs (c)(2) and (3).
■ d. Revise newly designated paragraph
(c)(4).
■ e. Redesignate paragraphs (d) and (e)
as paragraphs (g) and (h), respectively.
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f. Add new paragraphs (d), (e), and (f).
The additions and revisions read as
follows:
■
§ 483.45
Pharmacy services.
*
*
*
*
*
(c) * * *
(2) This review must include a review
of the resident’s medical chart at least
every 6 months and:
(i) When the resident is new, that is
the individual has not previously been
a resident in that facility; or
(ii) When the resident returns or is
transferred from a hospital or other
facility; and
(iii) During each monthly drug
regimen review when the resident has
been prescribed or is taking a
psychotropic drug, an antibiotic, or any
drug the QAA Committee has requested
be included in the pharmacist’s monthly
drug review.
(3) A psychotropic drug is any drug
that affects brain activities associated
with mental processes and behavior.
These drugs include, but are not limited
to, drugs in the following categories:
(i) Anti-psychotic;
(ii) Anti-depressant;
(iii) Anti-anxiety;
(iv) Hypnotic;
(v) Opioid analgesic; and
(vi) Any other drug that results in
effects similar to the drugs listed in
paragraphs (c)(3)(i) through (v) of this
section.
(4) The pharmacist must report any
irregularities to the attending physician
and the facility’s medical director and
director of nursing, and these reports
must be acted upon.
(i) Irregularities include, but are not
limited to, any drug that meets the
criteria set forth in paragraph (d) of this
section for an unnecessary drug.
(ii) Any irregularities noted by the
pharmacist during this review must be
documented on a separate, written
report that is sent to the attending
physician and the facility’s medical
director and director of nursing and
lists, at a minimum, the resident’s name,
the relevant drug, and the irregularity
the pharmacist identified.
(iii) The attending physician must
document in the resident’s medical
record that the identified irregularity
has been reviewed and what, if any,
action has been taken to address it. If
there is to be no change in the
medication, the attending physician
should document his or her rationale in
the resident’s medical record.
(d) Unnecessary drugs—General. Each
resident’s drug regimen must be free
from unnecessary drugs. An
unnecessary drug is any drug when
used:
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(1) In excessive dose (including
duplicate drug therapy); or
(2) For excessive duration; or
(3) Without adequate monitoring; or
(4) Without adequate indications for
its use; or
(5) In the presence of adverse
consequences which indicate the dose
should be reduced or discontinued; or
(6) Any combinations of the reasons
stated in paragraphs (d)(1) through (5) of
this section.
(e) Psychotropic drugs. Based on a
comprehensive assessment of a resident,
the facility must ensure that—
(1) Residents who have not used
psychotropic drugs are not given these
drugs unless the medication is
necessary to treat a specific condition as
diagnosed and documented in the
clinical record;
(2) Residents who use psychotropic
drugs receive gradual dose reductions,
and behavioral interventions, unless
clinically contraindicated, in an effort to
discontinue these drugs;
(3) Residents do not receive
psychotropic drugs pursuant to a PRN
order unless that medication is
necessary to treat a diagnosed specific
condition that is documented in the
clinical record; and
(4) PRN orders for psychotropic drugs
are limited to 48 hours and cannot be
continued beyond that time unless the
resident’s physician or primary care
provider documents the rationale for
this continuation in the resident’s
clinical record.
(f) Medication errors. The facility
must ensure that its—
(1) Medication error rates are not five
percent or greater; and
(2) Residents are free of any
significant medication errors.
*
*
*
*
*
■ 26. A new § 483.50 is added and is
amended as follows:
■ a. Section heading is added.
■ b. New paragraphs (a) and (b) are
redesignated from paragraphs (j) and (k)
of newly redesignated § 483.70.
■ c. Newly designated paragraphs
(a)(2)(i), (a)(2)(ii), (b)(2)(i) and (b)(2)(ii)
are revised.
The additions and revisions read as
follows:
§ 483.50 Laboratory, radiology, and other
diagnostic services.
(a) * * *
(2) * * *
(i) Provide or obtain laboratory
services only when ordered by a
physician; physician assistant; nurse
practitioner or clinical nurse specialist
in accordance with State law, including
scope of practice laws.
(ii) Promptly notify the ordering
physician, physician assistant, nurse
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practitioner, or clinical nurse specialist
of laboratory results that fall outside of
clinical reference ranges in accordance
with facility policies and procedures for
notification of a practitioner or per the
ordering physician’s orders.
*
*
*
*
*
(b) * * *
(2) * * *
(i) Provide or obtain radiology and
other diagnostic services only when
ordered by a physician; physician
assistant; nurse practitioner or clinical
nurse specialist in accordance with
State law, including scope of practice
laws.
(ii) Promptly notify the ordering
physician, physician assistant, nurse
practitioner, or clinical nurse specialist
of results that fall outside of clinical
reference ranges in accordance with
facility policies and procedures for
notification of a practitioner or per the
ordering physician’s orders.
*
*
*
*
*
■ 27. Section 483.55 is amended by—
■ a. Amending paragraph (a)(1) by
removing the reference ‘‘§ 483.75(h) of
this part’’ and adding in its place the
reference ‘‘§ 483.70(g)’’.
■ b. Redesignating paragraph (a)(3) and
(4) as paragraphs (a)(4) and (5),
respectively.
■ c. Adding a new paragraph (a)(3).
■ d. Revising newly redesignated
paragraph (a)(4) introductory text and
(a)(4)(ii).
■ e. Revising newly redesignated
paragraph (a)(5).
■ f. Amending paragraph (b)(1)
introductory text by removing the
reference ‘‘§ 483.75(h) of this part’’ and
adding in its place the reference
‘‘§ 483.70(g)’’.
■ g. Revising paragraph (b)(2)
introductory text, (b)(2)(ii), and (b)(3).
■ h. Adding paragraphs (b)(4) and (5).
The revisions and additions read as
follows:
§ 483.55
Dental services.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
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*
*
*
*
(a) * * *
(3) May not charge a resident for the
loss or damage of dentures determined
in accordance with facility policy to be
the facility’s responsibility;
(4) Must if necessary or if requested,
assist the resident—
*
*
*
*
*
(ii) By arranging for transportation to
and from the dental services location;
and
(5) Promptly, within three days, refer
residents with lost or damaged dentures
for dental services. If a referral does not
occur within three days, the facility
must provide documentation of the
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extenuating circumstances that led to
the delay.
(b) * * *
(2) Must, if necessary or if requested,
assist the resident—
*
*
*
*
*
(ii) By arranging for transportation to
and from the dental services locations;
(3) Must promptly, within three days,
refer residents with lost or damaged
dentures for dental services. If a referral
does not occur within three days, the
facility must provide documentation of
the extenuating circumstances that led
to the delay;
(4) May not charge a resident for the
loss or damage of dentures determined
in accordance with facility policy to be
the facility’s responsibility; and
(5) Must assist residents who are
eligible and wish to participate to apply
for reimbursement of dental services as
an incurred medical expense under the
State plan.
■ 28. Newly redesignated § 483.60 is
revised to read as follows:
§ 483.60
Food and nutrition services.
The facility must provide each
resident with a nourishing, palatable,
well-balanced diet that meets his or her
daily nutritional and special dietary
needs, taking into consideration the
preferences of each resident.
(a) Staffing. The facility must employ
sufficient staff with the appropriate
competencies and skills sets to carry out
the functions of the food and nutrition
service, taking into consideration
resident assessments, individual plans
of care and the number, acuity and
diagnoses of the facility’s resident
population in accordance with the
facility assessment required at
§ 483.70(e). This includes:
(1) A qualified dietitian or other
clinically qualified nutrition
professional either full-time, part-time,
or on a consultant basis. A qualified
dietitian or other clinically qualified
nutrition professional is one who is
qualified based on:
(i) Meeting State requirements to
practice dietetics, including licensure or
certification, or
(ii) If the state does not have
requirements, registration by the
Commission on Dietetic Registration of
the Academy of Nutrition and Dietetics,
or
(iii) For dietitians hired or contracted
with prior to [effective date of final
rule], meets these requirements no later
than 5 years after [effective date of final
rule] or as required by state law.
(2) If a qualified dietitian or other
clinically qualified nutrition
professional is not employed full-time,
the facility must designate a person to
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serve as the director of food and
nutrition services who:
(i) For designations prior to [effective
date of final rule], meets the following
requirements no later than 5 years after
[effective date of final rule], is:
(A) A certified dietary manager; or
(B) A certified food service manager,
or
(C) Has similar national certification
for food service management and safety
from a national certifying body; or
(D) Has an associate’s or higher degree
in food service management or
hospitality from an accredited
institution of higher learning; or
(ii) In States that have established
standards for food service managers or
dietary managers, meets State
requirements for food service managers
or dietary managers, and
(iii) Receives frequently scheduled
consultations from a qualified dietitian
or other clinically qualified nutrition
professional.
(3) Support staff. The facility must
provide sufficient support personnel to
safely and effectively carry out the
functions of the food and nutrition
service.
(b) A member of the Food and
Nutrition Services staff must participate
on the interdisciplinary team as
required in § 483.21(b)(2)(ii).
(c) Menus and nutritional adequacy.
Menus must—
(1) Meet the nutritional needs of
residents in accordance with established
national guidelines or industry
standards.;
(2) Be prepared in advance;
(3) Be followed;
(4) Reflect the religious, cultural and
ethnic needs of the residents, as well as
input received from residents and
resident groups;
(5) Be updated periodically;
(6) Be reviewed by the facility’s
dietitian or other clinically qualified
nutrition professional for nutritional
adequacy; and
(7) Nothing in this paragraph should
be construed to limit the resident’s right
to make personal dietary choices.
(d) Food and drink. Each resident
receives and the facility provides—
(1) Food prepared by methods that
conserve nutritive value, flavor, and
appearance;
(2) Food and drink that is palatable,
attractive, and at a safe and appetizing
temperature;
(3) Food prepared in a form designed
to meet individual needs;
(4) Food that accommodates resident
allergies, intolerances, and preferences;
(5) Appealing substitutes of similar
nutritive value to residents who choose
not to eat food that is initially served or
who request an alternative meal; and
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(6) Drinks, including water and other
liquids consistent with resident needs
and preferences and sufficient to
maintain resident hydration.
(e) Therapeutic diets. (1) Therapeutic
diets must be prescribed by the
attending physician.
(2) The attending physician may
delegate to a registered or licensed
dietitian the task of prescribing a
resident’s diet, including a therapeutic
diet, to the extent allowed by State law.
(f) Frequency of meals. (1) Each
resident must receive and the facility
must provide at least three meals daily,
at regular times comparable to normal
mealtimes in the community or in
accordance with resident needs,
preferences, requests, and plan of care.
(2) Suitable, nourishing alternative
meals and snacks must be available for
residents who want to eat at nontraditional times or outside of scheduled
meal service times and in accordance
with the resident plan of care.
(g) Assistive devices. The facility must
provide special eating equipment and
utensils for residents who need them
and appropriate assistance to ensure
that the resident can use the assistive
devices when consuming meals and
snacks.
(h) Paid feeding assistants—(1) Stateapproved training course. A facility may
use a paid feeding assistant, as defined
in § 488.301 of this chapter, if—
(i) The feeding assistant has
successfully completed a Stateapproved training course that meets the
requirements of § 483.160 before feeding
residents; and
(ii) The use of feeding assistants is
consistent with State law.
(2) Supervision. (i) A feeding assistant
must work under the supervision of a
registered nurse (RN) or licensed
practical nurse (LPN).
(ii) In an emergency, a feeding
assistant must call a supervisory nurse
for help.
(3) Resident selection criteria. (i) A
facility must ensure that a feeding
assistant provides dining assistance
only for residents who have no
complicated feeding problems.
(ii) Complicated feeding problems
include, but are not limited to, difficulty
swallowing, recurrent lung aspirations,
and tube or parenteral/IV feedings.
(iii) The facility must base resident
selection on the interdisciplinary team’s
assessment and the resident’s latest
assessment and plan of care.
Appropriateness for this program
should be reflected in the
comprehensive care plan.
(i) Food safety requirements. The
facility must—
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(1) Procure food from sources
approved or considered satisfactory by
Federal, State, or local authorities;
(i) This may include food items
obtained directly from local producers,
subject to applicable State and local
laws or regulations.
(ii) This provision does not prohibit
or prevent facilities from using produce
grown in facility gardens, subject to
compliance with applicable safe
growing and food-handling practices.
(iii) This provision does not preclude
residents from consuming foods not
procured by the facility.
(2) Store, prepare, distribute, and
serve food in accordance with
professional standards for food service
safety.
(3) Have a policy regarding use and
storage of foods brought to residents by
family and other visitors to ensure safe
and sanitary storage, handling, and
consumption, and
(4) Dispose of garbage and refuse
properly.
■ 29. In newly redesignated 483.65,
revise paragraphs (a) introductory text
and (a)(2) to read as follows:
§ 483.65 Specialized rehabilitative
services.
(a) Provision of services. If specialized
rehabilitative services such as but not
limited to physical therapy, speechlanguage pathology, occupational
therapy, respiratory therapy, and
rehabilitative services for mental illness
and intellectual disability or services of
a lesser intensity as set forth at
§ 483.120(c), are required in the
resident’s comprehensive plan of care,
the facility must—
*
*
*
*
*
(2) Obtain the required services from
an outside resource (in accordance with
§ 483.70(g)) from a Medicare and/or
Medicaid provider of specialized
rehabilitative services.
*
*
*
*
*
■ 30. Section 483.67 is added to read as
follows:
§ 483.67
Outpatient rehabilitation services.
If the facility provides outpatient
rehabilitation, physical therapy,
occupational therapy, audiology, or
speech pathology services, the services
must meet the needs of the patients in
accordance with acceptable standards of
practice and the facility must meet the
following requirements.
(a) Organization and staffing. (1) The
organization of the service must be
appropriate to the scope of the services
offered.
(2) The facility must ensure the
services are organized and staffed to
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42263
ensure the health and safety of
residents.
(b) Personnel. (1) The facility must
assign one or more individuals to be
responsible for outpatient rehabilitative
services. The individual responsible for
the outpatient rehabilitative services
must have the necessary knowledge,
experience, and capabilities to properly
supervise and administer the services.
(2) The facility must have appropriate
professional and nonprofessional
personnel available at each location
where outpatient services are offered,
based on the scope and complexity of
outpatient services.
(3) Physical therapy, occupational
therapy, speech-language pathology or
audiology services, if provided, must be
provided by qualified physical
therapists, physical therapist assistants,
occupational therapists, occupational
therapy assistants, speech-language
pathologists, or audiologists as defined
in part 484 of this chapter.
(c) Delivery of services. (1) Services
must only be provided under the orders
of a qualified and licensed practitioner
who is responsible for the care of the
patient, acting within his or her scope
of practice under state law.
(2) All rehabilitation services orders
and progress notes must be documented
in the patient’s clinical record in
accordance with the requirements at
§ 483.70(i).
(3) The provision of care and the
personnel qualifications must be in
accordance with national acceptable
standards of practice.
■ 31. In newly redesignated § 483.70—
■ a. Revise paragraph (c).
■ b. Revise paragraph (d)(2).
■ c. Add paragraph (d)(3).
■ d. Revise paragraph (e).
■ e. Remove paragraphs (f), (j), (k), (m),
(o), and (q).
■ f. Redesignate paragraphs (g), (h), (i),
(l), (n), (p), (r), (s), and (t) as paragraphs
(f), (g), (h), (i), (j), (k), (l), (m), and (o),
respectively.
■ g. Revise newly redesignated
paragraphs (i)(1) introductory text, and
(i)(2), (3), (4), and (5).
■ h. Revise newly redesignated
paragraphs (j)(1)(i) and (ii).
■ i. Revise newly redesignated
paragraph (m).
■ j. Add new paragraph (n).
■ k. Add new paragraph (p).
■ l. In the table below, for each newly
redesignated paragraph indicated in the
first and second columns, remove the
reference indicated in the third column
and add the reference indicated in the
fourth column.
Paragraphs
Remove
(g)(1) .....................
(h)(2) ........
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(g)(2).
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Paragraphs
Remove
Add
(k)(3) .....................
(m) ........................
(o)(2) introductory
text.
(p)(2) ........
(r) .............
(t)(1)(i) ......
(k)(2).
(l).
(o)(1)(i).
The revisions and additions read as
follows:
§ 483.70
Administration.
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*
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(c) Relationship to other HHS
regulations. In addition to compliance
with the regulations set forth in this
subpart, facilities are obliged to meet the
applicable provisions of other HHS
regulations, including but not limited to
those pertaining to nondiscrimination
on the basis of race, color, or national
origin (45 CFR part 80);
nondiscrimination on the basis of
disability (45 CFR part 84);
nondiscrimination on the basis of age
(45 CFR part 91); protection of human
subjects of research (45 CFR part 46);
and fraud and abuse (42 CFR part 455)
and protection of individually
identifiable health information (45 CFR
parts 160 and 164). Violations of such
other provisions may result in a finding
of non-compliance with this paragraph.
(d) * * *
(2) The governing body appoints the
administrator who is—
(i) Licensed by the State;
(ii) Responsible for management of
the facility; and
(iii) Reports to and is accountable to
the governing body.
(3) The governing body is responsible
and accountable for the QAPI program,
in accordance with § 483.75(f).
(e) Facility assessment. The LTC
facility must conduct and document a
facility-wide assessment to determine
what resources are necessary to care for
its residents competently during both
day-to-day operations and emergencies.
The facility must review and update
that assessment, as necessary, and at
least annually. The facility must also
review and update this assessment
whenever there is, or the facility plans
for, any change that would require a
substantial modification to any part of
this assessment. The facility assessment
must address or include:
(1) The facility’s resident population,
including, but not limited to,
(i) Both the number of residents and
the facility’s resident capacity;
(ii) The care required by the resident
population considering the types of
diseases, conditions, physical and
cognitive disabilities, overall acuity, and
other pertinent facts that are present
within that population;
(iii) The staff competencies that are
necessary to provide the level and types
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of care needed for the resident
population;
(iv) The physical environment,
equipment, services, and other physical
plant considerations that are necessary
to care for this population; and
(v) Any ethnic, cultural, or religious
factors that may potentially affect the
care provided by the facility, including,
but not limited to, activities and food
and nutrition services.
(2) The facility’s resources, including
but not limited to,
(i) All buildings and/or other physical
structures and vehicles;
(ii) Equipment (medical and nonmedical);
(iii) Services provided, such as
physical therapy, pharmacy, and
specific rehabilitation therapies;
(iv) All personnel, including
managers, staff (both employees and
those who provide services under
contract), and volunteers, as well as
their education and/or training and any
competencies related to resident care;
(v) Contracts, memorandums of
understanding, or other agreements with
third parties to provide services or
equipment to the facility during both
normal operations and emergencies; and
(vi) Health information technology
resources, such as systems for
electronically managing patient records
and electronically sharing information
with other organizations.
(3) A facility-based and communitybased risk assessment, utilizing an allhazards approach.
*
*
*
*
*
(i) Medical records. (1) In accordance
with accepted professional standards
and practices, the facility must maintain
medical records on each resident that
are—
*
*
*
*
*
(2) The facility must keep confidential
all information contained in the
resident’s records, regardless of the form
or storage method of the records, except
when release is—
(i) To the individual, or their resident
representative where permitted by
applicable law;
(ii) Required by Law;
(iii) For treatment, payment, or health
care operations, as permitted by and in
compliance with 45 CFR 164.506;
(iv) For public health activities,
reporting of abuse, neglect, or domestic
violence, health oversight activities,
judicial and administrative proceedings,
law enforcement purposes, organ
donation purposes, research purposes,
or to coroners, medical examiners,
funeral directors, and to avert a serious
threat to health or safety as permitted by
and in compliance with 45 CFR
164.512.
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(3) The facility must safeguard
medical record information against loss,
destruction, or unauthorized use;
(4) Medical records must be retained
for—
(i) The period of time required by
State law; or
(ii) Five years from the date of
discharge when there is no requirement
in State law; or
(iii) For a minor, three years after a
resident reaches legal age under State
law.
(5) The medical record must
contain—
(i) Sufficient information to identify
the resident;
(ii) A record of the resident’s
assessments;
(iii) The comprehensive plan of care
and services provided;
(iv) The results of any preadmission
screening and resident review
evaluations and determinations
conducted by the State;
(v) Physician’s, nurse’s, and other
licensed professional’s progress notes;
and
(vi) Laboratory, radiology and other
diagnostic services reports as required
under § 483.50.
(j) * * *
(1) * * *
(i) Residents will be transferred from
the facility to the hospital, and ensured
of timely admission to the hospital
when transfer is medically appropriate
as determined by the attending
physician or, in an emergency situation,
by another practitioner in accordance
with facility policy and consistent with
state law; and
(ii) Medical and other information
needed for care and treatment of
residents and, when the transferring
facility deems it appropriate, for
determining whether such residents can
receive appropriate services or receive
services in a less restrictive setting than
either the facility or the hospital, or
reintegrated into the community, will be
exchanged between the providers,
including but not limited to the
information required under
§ 483.15(b)(2)(iii).
*
*
*
*
*
(m) Facility closure. The facility must
have in place policies and procedures to
ensure that the administrator’s duties
and responsibilities involve providing
the appropriate notices in the event of
a facility closure, as required at
paragraph (l) of this section.
(n) Binding arbitration agreements. If
the facility enters into an agreement for
binding arbitration with its residents:
(1) The facility must ensure that:
(i) The agreement is explained to the
resident in a form and manner that he
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or she understands, including in a
language the resident understands, and
(ii) The resident acknowledges that he
or she understands the agreement.
(2) The agreement must:
(i) Be entered into by the resident
voluntarily;
(ii) Provide for the selection of a
neutral arbiter;
(iii) Provide for selection of a venue
convenient to both parties.
(3) Admission to the facility must not
be contingent upon the resident or the
resident representative signing a
binding arbitration agreement.
(4) The agreement must not contain
any language that prohibits or
discourages the resident or anyone else
from communicating with Federal,
State, or local officials, including but
not limited to, Federal and State
surveyors, other federal or state health
department employees, and
representatives of the Office of the State
Long-Term Care Ombudsman, in
accordance with § 483.11(i).
(5) The agreement may be signed by
another individual if:
(i) Allowed by state law;
(ii) All of the requirements in this
section are met; and
(iii) That individual has no interest in
the facility.
*
*
*
*
*
(p) Social worker. Any facility with
more than 120 beds must employ a
qualified social worker on a full-time
basis. A qualified social worker is:
(1) An individual with a minimum of
a bachelor’s degree in social work or a
bachelor’s degree in a human services
field including, but not limited to,
sociology, gerontology, special
education, rehabilitation counseling,
and psychology; and
(2) One year of supervised social work
experience in a health care setting
working directly with individuals.
■ 32. A new § 483.75 is added to read
as follows:
tkelley on DSK3SPTVN1PROD with PROPOSALS2
§ 483.75 Quality assurance and
performance improvement.
(a) Quality assurance and
performance improvement (QAPI)
program. Each LTC facility, including a
facility that is part of a multiunit chain,
must develop, implement, and maintain
an effective, comprehensive, data-driven
QAPI program that focuses on indicators
of the outcomes of care and quality of
life. The facility must:
(1) Maintain documentation and
demonstrate evidence of its ongoing
QAPI program that meets the
requirements of this section;
(2) Present its QAPI plan to the State
Agency Surveyor at the first annual
recertification survey that occurs after
[the effective date of this regulation];
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(3) Present its QAPI plan to a State
Agency or Federal surveyor at each
annual recertification survey and upon
request during any other survey and to
CMS upon request; and
(4) Present documentation and
evidence of its ongoing QAPI program’s
implementation and the facility’s
compliance with requirements to a State
Agency, Federal surveyor or CMS upon
request.
(b) Program design and scope. A
facility must design its QAPI program to
be ongoing, comprehensive, and to
address the full range of care and
services provided by the facility. It
must:
(1) Address all systems of care and
management practices;
(2) Include clinical care, quality of
life, and resident choice;
(3) Utilize the best available evidence
to define and measure indicators of
quality and facility goals that reflect
processes of care and facility operations
that have been shown to be predictive
of desired outcomes for residents of a
SNF or NF.
(4) Reflect the complexities, unique
care, and services that the facility
provides.
(c) Program feedback, data systems
and monitoring. A facility must
establish and implement written
policies and procedures for feedback,
data collections systems, and
monitoring, including adverse event
monitoring. The policies and
procedures must include, at a
minimum, the following:
(1) Facility maintenance of effective
systems to obtain and use of feedback
and input from direct care/direct access
workers, other staff, residents, and
resident representatives, including how
such information will be used to
identify problems that are high risk,
high volume, or problem-prone, and
opportunities for improvement.
(2) Facility maintenance of effective
systems to identify, collect, and use data
from all departments, including but not
limited to the facility assessment
required at § 483.75(e) and including
how such information will be used to
develop and monitor performance
indicators.
(3) Facility development, monitoring,
and evaluation of performance
indicators, including the methodology
and frequency for such development,
monitoring, and evaluation.
(4) Facility adverse event monitoring,
including the methods by which the
facility will systematically identify,
report, track, investigate, analyze and
use data and information relating to
adverse events in the facility, including
how the facility will use the data to
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develop activities to prevent adverse
events.
(d) Program systematic analysis and
systemic action. (1) The facility must
take actions aimed at performance
improvement and, after implementing
those actions, measure its success, and
track performance to ensure that
improvements are realized and
sustained.
(2) The facility will develop and
implement policies addressing:
(i) How they will use a systematic
approach (such as root cause analysis,
reverse tracer methodology, or health
care failure and effects analysis) to
determine underlying causes of
problems impacting larger systems;
(ii) Development of corrective actions
that will be designed to effect change at
the systems level to prevent quality of
care, quality of life, or safety problems;
and
(iii) How the facility will monitor the
effectiveness of its performance
improvement activities to ensure that
improvements are sustained.
(e) Program activities. (1) The facility
must set priorities for its performance
improvement activities that focus on
high-risk, high-volume, or problemprone areas; consider the incidence,
prevalence, and severity of problems in
those areas; and affect health outcomes,
resident safety, resident autonomy,
resident choice, and quality of care.
(2) Performance improvement
activities must track medical errors and
adverse resident events, analyze their
causes, and implement preventive
actions and mechanisms that include
feedback and learning throughout the
facility.
(3) The facility must conduct distinct
performance improvement projects. The
number and frequency of improvement
projects conducted by the facility must
reflect the scope and complexity of the
facility’s services and available
resources, as reflected in the facility
assessment required at § 483.70(e).
Improvement projects must include at
least annually a project that focuses on
high risk or problem-prone areas
identified through the data collection
and analysis described in paragraphs (c)
and (d) of this section.
(f) Governance and leadership. The
governing body and/or executive
leadership (or organized group or
individual who assumes full legal
authority and responsibility for
operation of the facility) is responsible
and accountable for ensuring that:
(1) An ongoing QAPI program is
defined, implemented, and maintained
and addresses identified priorities.
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(2) The QAPI program is sustained
during transitions in leadership and
staffing;
(3) The QAPI program is adequately
resourced, including ensuring staff time,
equipment, and technical training as
needed;
(4) The QAPI program identifies and
prioritizes problems and opportunities
based on performance indicator data,
and resident and staff input that reflects
organizational processes, functions, and
services provided to residents.
(5) Corrective actions address gaps in
systems, and are evaluated for
effectiveness; and
(6) Clear expectations are set around
safety, quality, rights, choice, and
respect.
(g) Quality assessment and assurance.
(1) A facility must maintain a quality
assessment and assurance committee
consisting at a minimum of:
(i) The director of nursing services;
(ii) The Medical Director or his/her
designee;
(iii) At least 3 other members of the
facility’s staff, at least one of who must
be the administrator, owner, a board
member or other individual in a
leadership role; and
(iv) The infection control and
prevention officer.
(2) The quality assessment and
assurance committee reports to the
facility’s governing body, or designated
person(s) functioning as a governing
body regarding its activities, including
implementation of the QAPI program
required under paragraphs (a) through
(e) of this section. The committee must:
(i) Meet at least quarterly and as
needed to coordinate and evaluate
activities under the QAPI program, such
as identifying issues with respect to
which quality assessment and assurance
activities, including performance
improvement projects required under
the QAPI program, are necessary; and
(ii) Develop and implement
appropriate plans of action to correct
identified quality deficiencies; and
(iii) Regularly review and analyze
data, including data collected under the
QAPI program and data resulting from
drug regimen reviews, and act on
available data to make improvements.
(h) Disclosure of information. (1) A
State or the Secretary may not require
disclosure of the records of such
committee except in so far as such
disclosure is related to the compliance
of such committee with the
requirements of this section.
(2) Demonstration of compliance with
the requirements of this section may
require State or Federal surveyor access
to:
(i) Systems and reports demonstrating
systematic identification, reporting,
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investigation, analysis, and prevention
of adverse events;
(ii) Documentation demonstrating the
development, implementation, and
evaluation of corrective actions or
performance improvement activities;
and
(iii) Other documentation considered
necessary by a State or Federal surveyor
in assessing compliance.
(i) Sanctions. Good faith attempts by
the committee to identify and correct
quality deficiencies will not be used as
a basis for sanctions.
■ 33. Newly redesignated § 483.80 is
revised to read as follows:
§ 483.80
Infection control.
The facility must establish and
maintain an infection prevention and
control program designed to provide a
safe, sanitary, and comfortable
environment and to help prevent the
development and transmission of
communicable diseases and infections.
(a) Infection prevention and control
program. The facility must establish an
infection prevention and control
program (IPCP) that must include, at a
minimum, the following elements:
(1) A system for preventing,
identifying, reporting, investigating, and
controlling infections and
communicable diseases for all residents,
staff, volunteers, visitors, and other
individuals providing services under a
contractual arrangement based upon the
facility assessment conducted according
to § 483.75(e) and following accepted
national standards;
(2) Written standards, policies, and
procedures for the program, which must
include, but are not limited to:
(i) A system of surveillance designed
to identify possible communicable
diseases or infections before they can
spread to other persons in the facility;
(ii) When and to whom possible
incidents of communicable disease or
infections should be reported;
(iii) Standard and transmission-based
precautions to be followed to prevent
spread of infections;
(iv) When isolation should be used for
a resident;
(v) The circumstances under which
the facility must prohibit employees
with a communicable disease or
infected skin lesions from direct contact
with residents or their food, if direct
contact will transmit the disease; and
(vi) The hand hygiene procedures to
be followed by staff involved in direct
resident contact,
(3) An antibiotic stewardship program
that includes antibiotic use protocols
and a system to monitor antibiotic use.
(4) A system for recording incidents
identified under the facility’s IPCP and
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the corrective actions taken by the
facility.
(b) Infection prevention and control
officer. The facility must designate one
individual as the infection prevention
and control officer (IPCO) for whom the
IPCP at that facility is a major
responsibility. The IPCO must:
(1) Be a clinician who works at least
part-time at the facility, and
(2) Have specialized training in
infection prevention and control beyond
their initial professional degree.
(c) IPCO participation on quality
assessment and assurance committee.
The person designated as the IPCO must
be a member of the facility’s quality
assessment and assurance committee
and report to the committee on the IPCP
on a regular basis.
(d) Influenza and pneumococcal
immunizations—(1) Influenza. The
facility must develop policies and
procedures to ensure that—
(i) Before offering the influenza
immunization, each resident or the
resident’s representative receives
education regarding the benefits and
potential side effects of the
immunization;
(ii) Each resident is offered an
influenza immunization October 1
through March 31 annually, unless the
immunization is medically
contraindicated or the resident has
already been immunized during this
time period;
(iii) The resident or the resident’s
representative has the opportunity to
refuse immunization; and
(iv) The resident’s medical record
includes documentation that indicates,
at a minimum, the following:
(A) That the resident or resident’s
representative was provided education
regarding the benefits and potential side
effects of influenza immunization; and
(B) That the resident either received
the influenza immunization or did not
receive the influenza immunization due
to medical contraindications or refusal.
(2) Pneumococcal disease. The facility
must develop policies and procedures to
ensure that—
(i) Before offering the pneumococcal
immunization, each resident or the
resident’s representative receives
education regarding the benefits and
potential side effects of the
immunization;
(ii) Each resident is offered a
pneumococcal immunization, unless the
immunization is medically
contraindicated or the resident has
already been immunized;
(iii) The resident or the resident’s
representative has the opportunity to
refuse immunization; and
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(iv) The resident’s medical record
includes documentation that indicates,
at a minimum, the following:
(A) That the resident or resident’s
representative was provided education
regarding the benefits and potential side
effects of pneumococcal immunization;
and
(B) That the resident either received
the pneumococcal immunization or did
not receive the pneumococcal
immunization due to medical
contraindication or refusal.
(e) Linens. Personnel must handle,
store, process, and transport linens so as
to prevent the spread of infection.
(f) Annual review. The facility will
conduct an annual review of its IPCP
and update their program, as necessary.
■ 34. Section 483.85 is added to read as
follows:
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§ 483.85
Compliance and ethics program.
(a) Definitions. For purposes of this
section, the following definitions apply:
Compliance and ethics program
means, with respect to a facility, a
program of the operating organization
that—
(i) Has been reasonably designed,
implemented, and enforced so that it is
likely to be effective in preventing and
detecting criminal, civil, and
administrative violations under the Act
and in promoting quality of care; and
(ii) Includes, at a minimum, the
required components specified in
paragraph (c) of this section.
High-level personnel means
individual(s) who have substantial
control over the operating organization
or who have a substantial role in the
making of policy within the operating
organization.
Operating organization means the
individual(s) or entity that operates a
facility.
(b) General rule. Beginning on [1 year
after the effective date of the final rule],
the operating organization for each
facility must have in operation a
compliance and ethics program (as
defined in paragraph (a) of this section)
that meets the requirements of this
section.
(c) Required components for all
facilities. The operating organization for
each facility must develop, implement,
and maintain an effective compliance
and ethics program that contains, at a
minimum, the following components:
(1) Established written compliance
and ethics standards, policies, and
procedures to follow that are reasonably
capable of reducing the prospect of
criminal, civil, and administrative
violations under the Act and promote
quality of care, which include, but are
not limited to, the designation of an
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appropriate compliance and ethics
program contact to which individuals
may report suspected violations, as well
as an alternate method of reporting
suspected violations anonymously
without fear of retribution; and
disciplinary standards that set out the
consequences for committing violations
for the operating organization’s entire
staff; individuals providing services
under a contractual arrangement; and
volunteers, consistent with the
volunteers’ expected roles.
(2) Assignment of specific individuals
within the high-level personnel of the
operating organization with the overall
responsibility to oversee compliance
with the operating organization’s
compliance and ethics program’s
standards, policies, and procedures,
such as, but not limited to, the chief
executive officer (CEO), members of the
board of directors, or directors of major
divisions in the operating organization.
(3) Sufficient resources and authority
to the specific individuals designated in
paragraph (c)(2) of this section to
reasonably assure compliance with such
standards, policies, and procedures.
(4) Due care not to delegate
substantial discretionary authority to
individuals who the operating
organization knew, or should have
known through the exercise of due
diligence, had a propensity to engage in
criminal, civil, and administrative
violations under the Social Security Act.
(5) The facility takes steps to
effectively communicate the standards,
policies, and procedures in the
operating organization’s compliance and
ethics program to the operating
organization’s entire staff; individuals
providing services under a contractual
arrangement; and volunteers, consistent
with the volunteers’ expected roles.
Requirements include, but are not
limited to, mandatory participation in
training as set forth at § 483.95(f) or
orientation programs, or disseminating
information that explains in a practical
manner what is required under the
program.
(6) The facility takes reasonable steps
to achieve compliance with the
program’s standards, policies, and
procedures. Such steps include, but are
not limited to, utilizing monitoring and
auditing systems reasonably designed to
detect criminal, civil, and
administrative violations under the
Social Security Act by any of the
operating organization’s staff,
individuals providing services under a
contractual arrangement, or volunteers,
having in place and publicizing a
reporting system whereby any of these
individuals could report violations by
others anonymously within the
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operating organization without fear of
retribution, and having a process for
ensuring the integrity of any reported
data.
(7) Consistent enforcement of the
operating organization’s standards,
policies, and procedures through
appropriate disciplinary mechanisms,
including, as appropriate, discipline of
individuals responsible for the failure to
detect and report a violation to the
compliance and ethics program contact
identified in the operating
organization’s compliance and ethics
program.
(8) After a violation is detected, the
operating organization must ensure that
all reasonable steps identified in its
program are taken to respond
appropriately to the violation and to
prevent further similar violations,
including any necessary modification to
the operating organization’s program to
prevent and detect criminal, civil, and
administrative violations under the Act.
(d) Additional required components
for operating organizations with five or
more facilities. In addition to all of the
other requirements in paragraphs (a),
(b), (c), and (e) of this section, operating
organizations that operate five or more
facilities must also include, at a
minimum, the following components in
their compliance and ethics program:
(1) A mandatory annual training
program on the operating organization’s
compliance and ethics program that
meets the requirements set forth in
§ 483.95(f).
(2) A designated compliance officer
for whom the operating organization’s
compliance and ethics program is a
major responsibility. This individual
must report directly to the operating
organization’s governing body and not
be subordinate to the general counsel,
chief financial officer or chief operating
officer.
(3) Designated compliance liaisons
located at each of the operating
organization’s facilities.
(e) Annual review. The operating
organization for each facility must
review its compliance and ethics
program annually and revise its program
as needed to reflect changes in all
applicable laws or regulations and
within the operating organization and
its facilities to improve its performance
in deterring, reducing, and detecting
violations under Act and in promoting
quality of care.
■ 35. In newly redesignated § 483.90—
■ a. Revise paragraph (c).
■ b. Revise paragraphs (d)(1)(i) and
(d)(2)(i).
■ c. Revise paragraph (e).
■ d. Revise paragraphs (f) introductory
text and (f)(1).
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e. Revise paragraph (g)(2).
f. Add paragraph (h)(5).
The revisions and additions read as
follows:
■
■
§ 483.90
Physical environment.
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(c) Space and equipment. The facility
must—
(1) Provide sufficient space and
equipment in dining, health services,
recreation, living, and program areas to
enable staff to provide residents with
needed services as required by these
standards and as identified in each
resident’s assessment and plan of care;
and
(2) Maintain all mechanical,
electrical, and patient care equipment in
safe operating condition.
(3) Conduct regular inspection of all
bed frames, mattresses, and bed rails, if
any, as part of a regular maintenance
program to identify areas of possible
entrapment. When bed rails and
mattresses are used and purchased
separately from the bed frame, the
facility must ensure that the bed rails,
mattress, and bed frame are compatible.
(d) * * *
(1) * * *
(i) Accommodate no more than four
residents. For facilities that receive
approval of construction or
reconstruction plans by State and local
authorities or are newly certified after
[effective date of final rule], bedrooms
must accommodate no more than two
residents.
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(2) * * *
(i) A separate bed of proper size and
height for the safety and convenience of
the resident;
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(e) Toilet facilities. Each resident
room must be equipped with or located
near toilet and bathing facilities. For
facilities that receive approval of
construction or reconstruction plans
from State and local authorities or are
newly certified after [effective date of
the final rule], each resident room must
have its own bathroom equipped with at
least a toilet, sink and shower.
(f) Resident call system. The facility
must be adequately equipped to allow
residents to call for staff assistance
through a communication system which
relays the call directly to a staff member
or to a centralized staff work area
from—
(1) Each resident’s bedside; and
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(g) * * *
(2) Be well ventilated;
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(h) * * *
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(5) Establish policies, in accordance
with applicable Federal, State, and local
laws and regulations, regarding
smoking, including tobacco cessation,
smoking areas and safety, including but
not limited to non-smoking residents.
■ 36. Section 483.95 is added to subpart
B to read as follows:
§ 483.95
Training requirements.
A facility must develop, implement,
and maintain an effective training
program for all new and existing staff;
individuals providing services under a
contractual arrangement; and
volunteers, consistent with their
expected roles. A facility must
determine the amount and types of
training necessary based on a facility
assessment as specified at § 483.70(e).
Training topics must include but are not
limited to—
(a) Communication. A facility must
include effective communications as
mandatory training for direct care/direct
access personnel.
(b) Resident’s rights and facility
responsibilities. A facility must ensure
that staff members are educated on the
rights of the resident and the
responsibilities of a facility to properly
care for its residents as set forth at
§ 483.10 and § 483.11, respectively.
(c) Abuse, neglect, and exploitation.
In addition to the freedom from abuse,
neglect, and exploitation requirements
in § 483.12, facilities must also provide
training to their staff that at a minimum
educates staff on—
(1) Activities that constitute abuse,
neglect, exploitation, and
misappropriation of resident property as
set forth at § 483.12.
(2) Procedures for reporting incidents
of abuse, neglect, exploitation, or the
misappropriation of resident property.
(d) Quality assurance and
performance improvement. A facility
must include as part of its QAPI
program mandatory training that
outlines and informs staff of the
elements and goals of the facility’s QAPI
program as set forth at § 483.75.
(e) Infection control. A facility must
include as part of its infection
prevention and control program
mandatory training that includes the
written standards, policies, and
procedures for the program as described
at § 483.80(a)(2).
(f) Compliance and ethics. The
operating organization for each facility
must include as part of its compliance
and ethics program, as set forth at
§ 483.85—
(1) An effective way to communicate
that program’s standards, policies, and
procedures through a training program
or in another practical manner which
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explains the requirements under the
program.
(2) Annual training if the operating
organization operates five or more
facilities.
(g) Required in-service training for
nurse aides. In-service training must—
(1) Be sufficient to ensure the
continuing competence of nurse aides,
but must be no less than 12 hours per
year.
(2) Include dementia management
training and resident abuse prevention
training.
(3) Address areas of weakness as
determined in nurse aides’ performance
reviews and facility assessment at
§ 483.70(e) and may address the special
needs of residents as determined by the
facility staff.
(4) For nurse aides providing services
to individuals with cognitive
impairments, also address the care of
the cognitively impaired.
(h) Required training of feeding
assistants. A facility must not use any
individual working in the facility as a
paid feeding assistant unless that
individual has successfully completed a
State-approved training program for
feeding assistants, as specified in
§ 483.160.
(i) Behavioral health. A facility must
provide behavioral health training
consistent with the requirements at
§ 483.40 and as determined by the
facility assessment at § 483.70(e).
§ 483.118
[Amended]
37. In § 483.118, amend paragraphs
(b)(1) and (c)(2)(i) by removing the
reference ‘‘§ 483.12(a)’’ and adding in its
place the reference ‘‘§ 483.15(b)’’.
■
§ 483.130
[Amended]
38. In § 483.130, amend paragraphs
(m)(5) and (m)(6) by removing the
reference ‘‘§ 483.12(a)’’ and adding in its
place the reference § 483.15(b)’’.
■
§ 483.138
[Amended]
39. In § 483.138, amend paragraphs (a)
introductory text and (b)(1) by removing
the reference ‘‘§ 483.12(a)’’ and adding
in its place the reference ‘‘§ 483.15(b)’’.
■
§ 483.151
[Amended]
40. In § 483.151, amend paragraph
(a)(3) by removing the reference
‘‘§ 483.75(e)’’ and adding in its place the
reference ‘‘§ 483.35(c) and (d) and
§ 483.95(g)’’.
■
§ 483.204
[Amended]
41. In § 483.204, amend paragraph (b)
by removing the reference ‘‘§ 483.12 of
this part’’ and adding in its place the
reference ‘‘§ 483.15(h)’’.
■
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§ 483.206
[Amended]
42. In § 483.206, amend paragraph (a)
by removing the reference ‘‘(See
§§ 483.5 and 483.12(a)(1))’’ and adding
in its place the reference ‘‘(See
§ 483.5)’’.
■
PART 485—CONDITIONS OF
PARTICIPATION: SPECIALIZED
PROVIDERS
43. The authority citation for part 485
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395(hh)).
§ 485.635
[Amended]
44. In § 485.635, amend paragraph
(a)(3)(vii) by removing the reference
‘‘§ 483.25(i)’’ and adding in its place the
reference ‘‘§ 483.25(d)(8)’’.
■ 45. In § 485.645, paragraphs (d)(1)
through (9) are revised and paragraph
(d)(10) is added to read as follows:
■
§ 485.645 Special requirements for CAH
providers of long-term care services
(‘‘swing-beds’’).
*
*
*
*
(d) * * *
(1) Resident rights (§ 483.10(a)(4)(iv),
(b), (c), (d)(1), (d)(3), (e)(8), (g), and
(h)(3)).
(2) Facility responsibilities
(§ 483.11(d)(1)(i), (d)(1)(iii), (d)(4),
(e)(11), (e)(12), (e)(14)(iii), and (f)(1)(i)).
(3) Transitions of care (§ 483.5(n),
§ 483.15(b)(1), (b)(2), (b)(3)(i) through
(iii), (b)(4), (b)(5)(i) through (vii), and
(b)(7)).
(4) Freedom from abuse, neglect and
exploitation (§ 483.12).
(5) Patient activities (§ 483.25(c)),
except that the services may be directed
either by a qualified professional
meeting the requirements of
§ 485.25(c)(2), or by an individual on
the facility staff who is designated as the
activities director and who serves in
consultation with a therapeutic
recreation specialist, occupational
therapist, or other professional with
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experience or education in recreational
therapy.
(6) Social services (§ 483.40(d) and
§ 483.75(p)).
(7) Comprehensive assessment,
comprehensive care plan, and discharge
planning (§ 483.20(b), and § 483.21(b)
and (c)), except that the CAH is not
required to use the resident assessment
instrument (RAI) specified by the State
that is required under § 483.20(b), or to
comply with the requirements for
frequency, scope, and number of
assessments prescribed in § 413.343(b)
of this chapter).
(8) Specialized rehabilitative services
(§ 483.65).
(9) Dental services (§ 483.55).
(10) Nutrition (§ 483.25(d)(8) of this
chapter).
PART 488—SURVEY, CERTIFICATION,
AND ENFORCEMENT PROCEDURES
46. The authority citation for part 488
continues to read as follows:
■
Authority: Secs. 1102, 1128I and 1871 of
the Social Security Act, unless otherwise
noted (42 U.S.C. 1302, 1320a-7j, and
1395hh); Pub. L. 110–149, 121 Stat. 1819.
Sec. 1102 of the Social Security Act (42
U.S.C. 1302).
§ 488.56
[Amended]
47. In § 488.56, paragraph (a)
introductory text is amended by
removing the reference ‘‘§ 483.30’’ and
adding in its place the reference
‘‘§ 483.35’’.
■ 48. Section 488.301 is amended by
revising the definitions of ‘‘nurse aide’’,
‘‘paid feeding assistant’’, and
‘‘substandard quality of care’’ to read as
follows:
■
§ 488.301
Definitions.
*
*
*
*
*
Nurse aide means an individual, as
defined in § 483.5(n) of this chapter.
*
*
*
*
*
Paid feeding assistant means an
individual who meets the requirements
specified in § 483.60(h)(1) of this
chapter and who is paid to feed
PO 00000
Frm 00103
Fmt 4701
Sfmt 9990
42269
residents by a facility, or who is used
under an arrangement with another
agency or organization.
*
*
*
*
*
Substandard quality of care means
one or more deficiencies related to
participation requirements under
§ 483.10 ‘‘Resident rights’’, paragraphs
(d) and (e); § 483.11 ‘‘Facility
Responsibilities’’, paragraphs (d) and
(g); § 483.12 ‘‘Freedom from abuse,
neglect, and exploitation’’; § 483.25
‘‘Quality of care, and quality of life’’;
§ 483.40 ‘‘Behavioral health services’’,
paragraphs (b) and (d); § 483.45
‘‘Pharmacy services’’, paragraphs (d),
(e), and (f); and § 483.80 ‘‘Infection
control’’, paragraph (d) of this chapter,
which constitute either immediate
jeopardy to resident health or safety; a
pattern of or widespread actual harm
that is not immediate jeopardy; or a
widespread potential for more than
minimal harm, but less than immediate
jeopardy, with no actual harm.
*
*
*
*
*
§ 488.426
[Amended]
49. In § 488.426, paragraph (b) is
amended by removing the reference
‘‘§ 483.75(r)’’ and adding in its place the
reference ‘‘§ 483.70(l)’’ and paragraph
(c) is amended by removing the
reference ‘‘§ 483.75(r)(1)(ii)’’ and adding
in its place the reference ‘‘§ 483.70(l)’’.
■
§ 488.446
[Amended]
50. In § 488.446, the introductory text
is amended by removing the reference
‘‘§ 483.75(r)’’ and adding in its place the
reference ‘‘§ 483.70(l)’’.
■
Dated: May 12, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: July 8, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2015–17207 Filed 7–13–15; 8:45 am]
BILLING CODE 4120–01–P
E:\FR\FM\16JYP2.SGM
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]]>Agencies
[Federal Register Volume 80, Number 136 (Thursday, July 16, 2015)]
[Proposed Rules]
[Pages 42167-42269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17207]
[[Page 42167]]
Vol. 80
Thursday,
No. 136
July 16, 2015
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 431, 447, et al.
Medicare and Medicaid Programs; Reform of Requirements for Long-Term
Care Facilities; Proposed Rule
Federal Register / Vol. 80 , No. 136 / Thursday, July 16, 2015 /
Proposed Rules
[[Page 42168]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 431, 447, 482, 483, 485, and 488
[CMS-3260-P]
RIN 0938-AR61
Medicare and Medicaid Programs; Reform of Requirements for Long-
Term Care Facilities
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would revise the requirements that Long-
Term Care facilities must meet to participate in the Medicare and
Medicaid programs. These proposed changes are necessary to reflect the
substantial advances that have been made over the past several years in
the theory and practice of service delivery and safety. These proposals
are also an integral part of our efforts to achieve broad-based
improvements both in the quality of health care furnished through
federal programs, and in patient safety, while at the same time
reducing procedural burdens on providers.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 14,
2015.
ADDRESSES: In commenting, please refer to file code CMS-3260-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to https://www.regulations.gov. Follow the ``Submit a
comment'' instructions.
2. By regular mail. You may mail written comments to the following
address only:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-3260-P, P.O. Box 8010, Baltimore, MD
21244.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address only:
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Attention: CMS-3260-P, Mail Stop C4-26-05, 7500
Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. Alternatively, you may deliver (by hand or
courier) your written comments only to the following addresses prior to
the close of the comment period:
a. For delivery in Washington, DC--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as
appropriate for hand or courier delivery may be delayed and received
after the comment period.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Sheila Blackstock, (410) 786-6633, for issues related to Care
transitions, QAPI.
Ronisha Blackstone, (410) 786-6633, for issues related to
Comprehensive care planning, training.
Diane Corning, (410) 786-6633, for issues related to Behavioral
health, infection control, facility assessment.
Lisa Parker, (410) 786-6633, for issues related to the Regulatory
Impact Analysis.
Jeannie Miller, (410) 786-6633, for General information.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: https://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Acronyms
Because of the many terms to which we refer by acronym in this
proposed rule, we are listing the acronyms used and their corresponding
meanings in alphabetical order below:
AAA Area Agencies on Aging
ACL Administration for Community Living
ADL Activities of Daily Living
ADRCS Aging and Disability Resource Center
AHCA American Health Care Association
AHLA American Health Lawyers Association
ANSI American National Standards Institute
ASPE Assistant Secretary for Planning and Evaluation
BPSD Behavioral and Psychological Symptoms of Dementia
CARIE Center for Advocacy Rights and Interests
CASPER Certification and Survey Provider Enhanced Reports
CIL Centers for Independent Living
CLIA Clinical Laboratory Improvement Amendment
CMS Centers for Medicare & Medicaid Services
CNS Clinical Nurse Specialist
CPR Cardiopulmonary Resuscitation
DON Director of Nursing
EHR Electronic Health Records
FDA Food and Drug Administration
GAO Government Accountability Office
HACCP Hazard Analysis and Critical Control Point
HAI Healthcare-Associated Infection
HHS U.S. Department of Health and Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996
ICN International Council of Nurses
IDT Interdisciplinary Team
IG Interpretive Guidance
IPCO Infection Prevention and Control Officer
IPCP Infection Prevention and Control Program
LSC Life Safety Code
LTC Long-Term Care
NATCEP Nurse Aide Training Competency Evaluation Program
NCEA National Center on Elder Abuse
MAR Medication Administration Record
MDS Minimum Data Set
NA Nurse Aide
NF Nursing Facility
NP Nurse Practitioner
OIG Office of the Inspector General
OMB Office of Management and Budget
[[Page 42169]]
ONC Office of the National Coordinator
PA Physician Assistant
PASARR Preadmission Screening and Resident Review
PIPs Performance Improvement Projects
PEU Protein-Energy under Nutrition
QA Quality Assurance
QAA Quality Assessment and Assurance
QAPI Quality Assurance and Performance Improvement
QIO Quality Improvement Organization
RFA Regulatory Flexibility Act
RN Registered Nurse
SMA State Medicaid Agency
SNF Skilled Nursing Facility
WHO World Health Organization
Table of Contents
This proposed rule is organized as follows:
I. Background
A. Executive Summary
1. Purpose
2. Summary of the Major Provisions
3. Summary of Costs and Benefits
a. Overall Impact
b. Section-by-Section Economic Impact Estimates
B. Statutory and Regulatory Authority of the Long-term care
Requirements
C. Summary of Stakeholder Comments
D. Why revise the LTC requirements?
II. Provisions of the Proposed Regulation
A. Basis and scope. (Sec. 483.1)
B. Definitions (Sec. 483.5)
C. Resident rights (Sec. 483.10)
D. Facility responsibilities (Sec. 483.11)
E. Freedom from abuse, neglect, and exploitation (Sec. 483.12)
F. Transitions of care (Sec. 483.15)
G. Resident assessments (Sec. 483.20)
H. Comprehensive resident-centered care plans (Sec. 483.21)
I. Quality of care and quality of life (Sec. 483.25)
J. Physician services (Sec. 483.30)
K. Nursing services (Sec. 483.35)
L. Behavioral health services (Sec. 483.40)
M. Pharmacy services (Sec. 483.45)
N. Laboratory, radiology, and other diagnostic services (Sec.
483.50)
O. Dental services (Sec. 483.55)
P. Food and nutrition services (Sec. 483.60)
Q. Specialized rehabilitative services (Sec. 483.65)
R. Outpatient Rehabilitative Services (Sec. 483.67)
S. Administration (Sec. 483.70)
T. Quality assurance and performance improvement (Sec. 483.75)
U. Infection control (Sec. 483.80)
V. Compliance and ethics program (Sec. 483.85)
W. Physical environment (Sec. 483.90)
X. Training requirements (Sec. 483.95)
III. Long-Term Care Facilities Crosswalk
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impacts
I. Background
A. Executive Summary
1. Purpose
Consolidated Medicare and Medicaid requirements for participation
(requirements) for long term care (LTC) facilities (42 CFR part 483,
subpart B) were first published in the Federal Register on February 2,
1989 (54 FR 5316). These regulations have been revised and added to
since that time, principally as a result of legislation or a need to
address a specific issue. However, they have not been comprehensively
reviewed and updated since 1991 (56 FR 48826, September 26, 1991),
despite substantial changes in service delivery in this setting.
Since the current requirements were developed, significant
innovations in resident care and quality assessment practices have
emerged. In addition, the population of nursing homes has changed, and
has become more diverse and more clinically complex. Over the last two
to three decades, extensive, evidence-based research has been conducted
and has enhanced our knowledge about resident safety, health outcomes,
individual choice, and quality assurance and performance improvement.
In light of these changes, we recognized the need to evaluate the
regulations on a comprehensive basis, from both a structural and a
content perspective. Therefore, we are reviewing regulations in an
effort to improve the quality of life, care, and services in LTC
facilities, optimize resident safety, reflect current professional
standards, and improve the logical flow of the regulations.
Specifically, we are proposing to add new requirements where necessary,
eliminate duplicative or unnecessary provisions, and reorganize the
regulations as appropriate. Many of the revisions are aimed at aligning
requirements with current clinical practice standards to improve
resident safety along with the quality and effectiveness of care and
services delivered to residents. Additionally, we believe that these
proposed revisions may eliminate or significantly reduce those
instances where the requirements are duplicative, unnecessary, and/or
burdensome.
2. Summary of the Major Provisions
Basis and Scope (Sec. 483.1)
The Patient Protection and Affordable Care Act of 2010
(Pub. L. 111-148), as amended by the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111-152) (collectively known as the
Affordable Care Act) provisions: We propose to add the statutory
authority citations for sections 1128I(b) and (c) and section 1150B of
the Act to include the compliance and ethics program, quality assurance
and performance improvement (QAPI), and reporting of suspicion of a
crime requirements.
Definitions (Sec. 483.5)
Expanded Definitions: We propose to add the definitions
for ``adverse event'', ``documentation'', ``posting/displaying'',
``resident representative'', ``abuse'', ``sexual abuse'', ``neglect'',
``exploitation'', ``misappropriation of resident property'', and
``person-centered care''.
Resident Rights (Sec. 483.10)
Comprehensive Restructuring: We propose to retain all
existing residents' rights but update the language and organization of
the resident rights provisions to improve logical order and
readability, clarify aspects of the regulation where necessary, and to
update provisions to include advances such as electronic
communications. This includes--
[cir] Eliminating language, such as ``interested family member''
and replacing the term ``legal representative'' with ``resident
representative.''
[cir] Addressing roommate choice.
[cir] Adding language regarding physician credentialing to specify
that the physician chosen by the resident must be licensed to practice
medicine in the state where the resident resides, and must meet
professional credentialing requirements of the facility.
Facility Responsibilities (Sec. 483.11) *New Section*
New Section: We propose to add a new section to subpart B
that focuses on the responsibilities of the facility (that is,
protecting the rights of their residents, enhancing a resident's
quality of life) and brings together many of the facility
responsibilities currently dispersed throughout existing regulations.
This section parallels many residents' rights provisions.
Visitation: We propose to revise visitation requirements
to establish open visitation, similar to the hospital conditions of
participation (CoPs).
Re-designation of Requirements: We propose to--
[cir] Relocate provisions from existing Resident's Rights (Sec.
483.10) section that pertain to the responsibilities of the facility
into this section.
[cir] Relocate the existing requirements in Quality of Life (Sec.
483.15) into this section.
Freedom From Abuse, Neglect, and Exploitation (Sec. 483.12)
Revised Title: Formerly ``Resident behavior and facility
practices,'' we propose to revise the title to ``Freedom from abuse,
neglect, and exploitation.''
[[Page 42170]]
Prohibiting abuse, neglect, and exploitation: We propose
to--
[cir] Specify that facilities cannot employ individuals who have
had a disciplinary action taken against their professional license by a
state licensure body as a result of a finding of abuse, neglect,
mistreatment of residents or misappropriation of their property.
[cir] Require facilities to develop and implement written policies
and procedures that prohibit and prevent abuse, neglect, and
mistreatment of residents or misappropriation of their property.
Transitions of Care (Sec. 483.15)
Revised Title: Formerly ``Admission, transfer and
discharge rights,'' we propose to revise the title to reflect current
terminology that applies to all instances where care of a resident is
transferred.
Transfers or Discharge: We propose to require not only
that a transfer or discharge be documented in the clinical record, but
also that specific information, such as history of present illness,
reason for transfer and past medical/surgical history, be exchanged
with the receiving provider or facility when a resident is transferred.
We are not proposing to require a specific form, format, or methodology
for this communication.
Resident Assessments (Sec. 483.20)
Preadmission Screening and Resident Review (PASARR): We
propose to clarify what constitutes appropriate coordination of a
resident's assessment with the PASARR program under Medicaid.
Technical Corrections:
[cir] We propose to add references to statutory requirements that
were inadvertently omitted from the regulation when we first
implemented sections 1819 and 1919 of the Act.
[ssquf] Section 1919(e)(7)(A)(ii) and (iii) of the Act: We propose
to add exceptions to the preadmission screening requirements for
individuals with mental illness and individuals with intellectual
disabilities for admittance into a nursing facility, with respect to
transfer to or from a hospital.
[ssquf] Section 1919(e)(7)(B)(iii) of the Act: We propose to add a
requirement that a nursing facility must notify the state mental health
authority or intellectual disability authority for resident evaluation
promptly after a significant change in the mental or physical condition
of a resident with a mental illness or intellectual disability.
[cir] We propose to replace the term ``mental retardation'' with
``intellectual disability'' throughout the section, as appropriate.
Comprehensive Person-Centered Care Planning (Sec. 483.21) *New
Section*
Baseline Care Plan: We propose to require facilities to
develop a baseline care plan for each resident, within 48 hours of
their admission, which includes the instructions needed to provide
effective and person-centered care that meets professional standards of
quality care.
PASARR: We propose to add a requirement to include as part
of a resident's care plan any specialized services or specialized
rehabilitation services the nursing facility will provide as a result
of PASARR recommendations. If a facility disagrees with the findings of
the PASARR, it must indicate its rationale in the resident's medical
record.
Interdisciplinary Team (IDT):
[cir] We propose to add a nurse aide, a member of the food and
nutrition services staff, and a social worker to the required members
of the interdisciplinary team that develops the comprehensive care
plan.
[cir] We propose to require facilities to provide a written
explanation in a resident's medical record if the participation of the
resident and their resident representative is determined to not be
practicable for the development of the resident's care plan.
Discharge Planning:
[cir] The Improving Medicare Post-Acute Care Transformation Act of
2014 (IMPACT Act) (Pub. L. 113-185) amended Title XVIII of the Social
Security Act by, among other things, adding Section 1899B to the Social
Security Act. Section 1899B(i) requires that certain providers,
including long term care facilities, take into account, quality,
resource use, and other measures to inform and assist with the
discharge planning process, while also accounting for the treatment
preferences and goals of care of residents. We propose to implement the
discharge planning requirements mandated by the IMPACT Act by revising,
or adding where appropriate, discharge planning requirements for LTC
facilities.
[cir] We propose to require facilities to document in a resident's
care plan the resident's goals for admission, assess the resident's
potential for future discharge, and include discharge planning in the
comprehensive care plan, as appropriate.
[cir] We propose to require that the resident's discharge summary
include a reconciliation of all discharge medications with the
resident's pre-admission medications (both prescribed and over-the-
counter).
[cir] We propose to add to the post discharge plan of care a
summary of what arrangements have been made for the resident's follow
up care and any post-discharge medical and non-medical services.
Quality of Care and Quality of Life (Sec. 483.25)
Overarching Principles: We propose to clarify that quality
of care and quality of life are overarching principles in the delivery
of care to residents of nursing homes and should be applied to every
service provided.
Activities of Daily Living (ADLs): We propose to clarify
the requirements regarding a resident's ability to perform ADLs.
Director of Activities Qualifications: We propose to
solicit comments on whether the requirements for the director of the
activities program remain appropriate and what should serve as minimum
requirements for this position. We are not proposing specific changes
at this time.
Updating Current Practices: We propose to modify existing
requirements for nasogastric tubes to reflect current clinical
practice, and to include enteral fluids in the requirements for
assisted nutrition and hydration.
Special Need Issues: We propose to add a new requirement
that facilities must ensure that residents receive necessary and
appropriate pain management.
Re-designation of Requirements: We propose to relocate the
provisions regarding unnecessary drugs, antipsychotic drugs, medication
errors, and influenza and pneumococcal immunizations to Sec. 483.45
Pharmacy services.
Physician Services (Sec. 483.30)
In-person Evaluation: We propose to require an in-person
evaluation of a resident by a physician, a physician assistant, nurse
practitioner, or clinical nurse specialist before an unscheduled
transfer to a hospital.
Delegation of Orders: We propose to allow physicians to
delegate dietary orders to dietitians and therapy orders to therapists.
Nursing Services (Sec. 483.35)
Sufficient Staffing: We propose to add a competency
requirement for determining sufficient nursing staff based on a
facility assessment, which includes but is not limited to the number of
residents, resident acuity, range of diagnoses, and the content of care
plans.
[[Page 42171]]
Behavioral Health Services (Sec. 483.40) *New Section*
New Section: We propose to add a new section to subpart B
that focuses on the requirement to provide the necessary behavioral
health care and services to residents in accordance with their
comprehensive assessment and plan of care.
Staffing:
[cir] Facility Assessment: We propose to require facilities to
determine their direct care staff needs, based on the facility's
assessment.
[cir] Competency Approach: We propose to require that staff must
have the appropriate competencies and skills to provide behavioral
health care and services, which include caring for residents with
mental and psychosocial illnesses and implementing non-pharmacological
interventions.
[cir] Social Worker: We propose to add ``gerontology'' to the list
of possible human services fields from which a bachelor degree could
provide the minimum educational requirement for a social worker.
Pharmacy Services (Sec. 483.45)
Drug Regimen Review:
[cir] We propose to add the requirement that a pharmacist review a
resident's medical chart at least every 6 months and when the resident
is new to the facility, a prior resident returns or is transferred from
a hospital or other facility, and during each monthly drug regimen
review when the resident has been prescribed or is taking a
psychotropic drug, an antibiotic or any drug the QAA Committee has
requested be included in the pharmacist's monthly drug review.
[cir] We propose to require the pharmacist to document in a written
report any irregularities noted during the drug regimen review that
lists at a minimum, the resident's name, the relevant drug, and the
irregularity identified, to be sent to the attending physician and the
facility's medical director and director of nursing.
[cir] We propose to require that the attending physician document
in the resident's medical record that he or she has reviewed the
identified irregularity and what, if any, action they have taken to
address it. If there is to be no change in the medication, the
attending physician should document his or her rationale in the
resident's medical record.
Irregularities: We propose to add a definition of
``irregularities'' that would include, but not be limited to, the
definition of ``unnecessary drugs.''
Psychotropic Drugs: We propose to revise existing
requirements regarding ``antipsychotic'' drugs to refer to
``psychotropic'' drugs.
[cir] We propose to require that facilities ensure residents who
have not used psychotropic drugs not be given these drugs unless
medically necessary.
[cir] We propose that residents who use psychotropic drugs receive
gradual dose reductions, and behavioral interventions, unless
clinically contraindicated, in an effort to discontinue use of these
psychotropic drugs.
[cir] We propose to define ``psychotropic drug'' as any drug that
affects brain activities associated with mental processes and behavior.
[cir] We propose that PRN (Pro re nata or as needed) orders for
psychotropic drugs be limited to 48 hours. Orders could not be
continued beyond that time unless the primary care provider (for
example, the resident's physician) reviewed the need for the
medications prior to renewal of the order, and documented the rationale
for the order in the resident's clinical record.
Re-designation of Requirements: We propose to relocate
provisions in Sec. 483.25 ``Quality of Care'' regarding unnecessary
drugs, antipsychotic drugs, medication errors, and influenza and
pneumococcal immunizations into this section.
Laboratory, Radiology, and Other Diagnostic Services (Sec. 483.50)
*New Section*
Ordering Services: We propose to clarify that a physician
assistant, nurse practitioner or clinical nurse specialist may order
laboratory, radiology, and other diagnostic services for a resident in
accordance with state law, including scope of practice laws.
Laboratory Services: We propose to clarify that the
ordering physician; physician assistant; nurse practitioner or clinical
nurse specialist, be notified of abnormal laboratory results when they
fall outside of clinical reference ranges, in accordance with facility
policies and procedures for notification of a practitioner or per the
ordering physician's, physician assistant's; nurse practitioner's or
clinical nurse specialist's orders.
Dental Services (Sec. 483.55)
For Skilled Nursing Facilities (SNFs): We propose to
prohibit SNFs from charging a Medicare resident for the loss or damage
of dentures determined in accordance with facility policy to be the
facility's responsibility.
For Nursing Facilities (NFs): We propose to require NFs to
assist residents who are eligible to apply for reimbursement of dental
services as an incurred medical expense under the Medicaid state plan.
For both SNFs and NFs: We propose to clarify that with
regard to a referral for lost or damaged dentures ``promptly'' means
within 3 business days unless there is documentation of extenuating
circumstances.
Food and Nutrition Services (Sec. 483.60)
Staffing: We propose to require facilities to employ
sufficient staff with the appropriate competencies and skills sets to
carry out the functions of the dietary service while taking into
consideration resident assessments, and individual plans of care,
including diagnoses and acuity, as well as the facility's resident
census..
Dietitian Qualification: We propose to clarify that a
``qualified dietitian'' is one who is registered by the Commission on
Dietetic Registration of the Academy of Nutrition and Dietetics or who
meets state licensure or certification requirements. For dietitians
hired or contracted with prior to the effective date of these
regulations, we propose to allow up to 5 years to meet the new
requirements.
Director of Food Service: We propose to add to the
requirement for the designation of a director of food and nutrition
service that the person serving in this position be a certified dietary
manager, certified food service manager, or have a certification for
food service management and safety from a national certifying body or
have an associate's or higher degree in food service management or
hospitality from an accredited institution of higher learning. In
states that have established standards for food service managers, this
person must meet state requirements for food service managers.
Menus and Nutritional Adequacy: We propose to add to the
requirements that menus reflect the religious, cultural and ethnic
needs and preferences of the residents, be updated periodically, and be
reviewed by the facility's qualified dietitian or other clinically
qualified nutrition professional for nutritional adequacy while not
limiting the resident's right to make personal dietary choices.
Providing Food and Drink: We propose to add to the
requirements that facilities provide food and drink that take into
consideration resident allergies, intolerances, and preferences and
ensure adequate hydration.
Ordering Therapeutic Diets: We propose to allow the
attending physician to delegate to a registered or licensed dietitian
the task of prescribing a resident's diet, including a therapeutic
diet, to the extent allowed by state law.
[[Page 42172]]
Frequency of Meals: We propose to require facilities to
have available suitable and nourishing alternative meals and snacks for
residents who want to eat at non-traditional times or outside of
scheduled meal times in accordance with the resident's plan of care.
Use of Feeding Assistants: We propose to require that
facilities document the clinical need of a feeding assistant and the
extent to which dining assistance is needed in the resident's
comprehensive care plan.
Food Safety: We propose to--
[cir] Clarify that facilities may procure food items obtained
directly from local producers and are not prohibited from using produce
grown in facility gardens, subject to compliance with applicable safe
growing and food-handling practices.
[cir] Clarify that residents are not prohibited from consuming
foods that are not procured by the facility.
[cir] Require facilities to have a policy regarding the use and
storage of foods brought to residents by family and other visitors.
Specialized Rehabilitative Services (Sec. 483.65)
Provision of Services. We propose to--
[cir] Add respiratory services to those services identified as
specialized rehabilitative services.
[cir] Clarify what constitutes as rehabilitative services for
mental illness and intellectual disability.
Outpatient Rehabilitative Services (Sec. 483.67)
Providing Services: We propose to establish new health and
safety standards for facilities that choose to provide outpatient
rehabilitative therapy services.
Administration (Sec. 483.70)
Organization: We propose to largely relocate various
portions of this section into other sections of subpart B as deemed
appropriate.
Facility Assessment: We propose to require facilities to--
[cir] Conduct and document a facility-wide assessment to determine
what resources are necessary to care for its residents competently
during both day-to-day operations and emergencies. The facility must
review and update that assessment, as necessary, and at least annually.
[cir] Review and update this assessment whenever there is, or the
facility plans for, any change that would require a substantial
modification to any part of this assessment.
[cir] Address in the facility assessment the facility's resident
population (that is, number of residents, overall types of care and
staff competencies required by the residents, and cultural aspects),
resources (for example, equipment, and overall personnel), and a
facility-based and community-based risk assessment.
Clinical Records: We propose to establish requirements
that mirror some of those found in the HIPAA Privacy Rule (45 CFR part
160, and subparts A and E of part 164).
Binding Arbitration Agreements: We propose specific
requirements for the facility and the agreement itself to ensure that
if a facility presents binding arbitration agreements to its residents
that the agreements be explained to the residents and they acknowledge
that they understand the agreement; the agreements be entered into
voluntarily; and arbitration sessions be conducted by a neutral
arbitrator in a location that is convenient to both parties. Admission
to the facility could not be contingent upon the resident or the
resident representative signing a binding arbitration agreement.
Moreover, the agreement could not prohibit or discourage the resident
or anyone else from communicating with federal, state, or local health
care or health-related officials, including representatives of the
Office of the State Long-Term Care Ombudsman.
Quality Assurance and Performance Improvement (QAPI) (Sec. 483.75)
*New Section*
QAPI Program: In accordance with the statute, we propose
to require all LTC facilities to develop, implement, and maintain an
effective comprehensive, data-driven QAPI program that focuses on
systems of care, outcomes of care and quality of life.
Infection Control (Sec. 483.80)
Infection Prevention and Control Program (IPCP): We
propose to require facilities to have a system for preventing,
identifying, reporting, investigating, and controlling infections and
communicable diseases for all residents, staff, volunteers, visitors,
and other individuals providing services under an arrangement based
upon its facility and resident assessments that is reviewed and updated
annually.
Infection Prevention and Control Officer (IPCO): We
propose to require facilities to designate an IPCO for whom the IPCP is
their major responsibility and who would serve as a member of the
facility's quality assessment and assurance (QAA) committee.
Compliance and Ethics Program (Sec. 483.85) *New Section*
Compliance and Ethics Program: We propose to require the
operating organization for each facility to have in operation a
compliance and ethics program that has established written compliance
and ethics standards, policies and procedures that are capable of
reducing the prospect of criminal, civil, and administrative violations
in accordance with section 1128I(b) of the Act.
Physical Environment (Sec. 483.90)
Resident Rooms: We propose to require facilities initially
certified after the effective date of this regulation to accommodate no
more than two residents in a bedroom.
Toilet Facilities: We propose to require facilities
initially certified after the effective date of this regulation to have
a bathroom equipped with at least a toilet, sink and shower in each
room.
Smoking: We propose to require facilities to establish
policies, in accordance with applicable federal, state and local laws
and regulations, regarding smoking, including tobacco cessation,
smoking areas and safety.
Training Requirements (Sec. 483.95) *New Section*
We propose to add a new section to subpart B that sets
forth all the requirements of an effective training program that
facilities must develop, implement, and maintain for all new and
existing staff, individuals providing services under a contractual
arrangement, and volunteers, consistent with their expected roles. We
propose that training topics must include--
[cir] Communication: We propose to require facilities to include
effective communications as a mandatory training for direct care
personnel.
[cir] Resident Rights and Facility Responsibilities: We propose to
require facilities to ensure that staff members are educated on the
rights of the resident and the responsibilities of a facility to
properly care for its residents as set forth in the regulations.
[cir] Abuse, Neglect, and Exploitation: We propose to require
facilities, at a minimum, to educate staff on activities that
constitute abuse, neglect, exploitation, and misappropriation of
resident property, and procedures for reporting these incidents.
[cir] QAPI & Infection Control: We propose to require facilities to
include mandatory training as a part of their QAPI and infection
prevention and control programs that educate staff on the written
standards, policies, and procedures for each program.
[[Page 42173]]
[cir] Compliance and Ethics: In accordance with section 1128I of
the Act, as added by the Affordable Care Act, we would require the
operating organization for each facility to include training as a part
of their compliance and ethics program. We propose to require annual
training if the operating organization operates five or more
facilities.
[cir] In-Service Training for Nurse Aides: In accordance with
sections 1819(f)(2)(A)(i)(I) and 1919(f)(2)(A)(i)(I) of the Act, as
amended by the Affordable Care Act, we propose to require dementia
management and resident abuse prevention training to be a part of 12
hours per year in-service training for nurse aides.
[cir] Behavioral Health Training: We propose to require that
facilities provide behavioral health training to its entire staff,
based on the facility assessment at Sec. 483.70(e).
3. Summary of Costs and Benefits
a. Overall Impact
We estimate the total projected cost of this rule would be
$729,495,614 in the first year. This results in an estimated first-year
cost of approximately $46,491 per facility and a subsequent-year cost
of $40,685 per facility on 15,691 LTC facilities.
b. Section-by-Section Economic Impact Estimates
Estimated Cost To Comply With All the Requirements of the Proposed Rule
----------------------------------------------------------------------------------------------------------------
Total cost in
Regulatory area Section First year total year 2 and
cost thereafter
----------------------------------------------------------------------------------------------------------------
Resident Rights........................................ 483.10 $10,436,051 $10,436,051
Facility Obligations................................... 483.11 1,935,785 999,345
Transitions of Care.................................... 483.15 3,331,225 3,331,225
Comprehensive Resident Centered Care Planning.......... 483.21 118,184,092 118,184,092
Physician Services..................................... 483.30 35,660,786 35,660,786
Nursing Services....................................... 483.35 3,640,312 3,640,312
Food and Nutrition Services............................ 483.60 1,788,774 1,663,246
QAPI................................................... 483.75 118,419,977 47,402,511
Infection Control...................................... 483.80 283,944,336 283,944,336
Compliance and Ethics Program.......................... 483.85 139,356,716 120,327,296
Training............................................... 483.95 ................. .................
General Training Topics................................ 483.95(a) 7,280,624 7,280,624
Compliance and Ethics Training......................... 483.95(f) 1,876,624 1,876,624
Dementia Management and Abuse Training................. 483.95(g) 3,640,312 3,640,312
--------------------------------------------------------
Total.............................................. ................. 729,495,614 638,386,760
----------------------------------------------------------------------------------------------------------------
B. Statutory and Regulatory Authority of the Requirements for Long-Term
Care Facilities
In addition to specific statutory requirements set out in sections
1819 and 1919 and elsewhere in the Social Security Act, sections
1819(d)(4)(B) and 1919(d)(4)(B) of the Act permit the Secretary of the
Department of Health and Human Services (the Secretary) to establish
any additional requirements relating to the health, safety, and well-
being of SNF and NF residents respectively as the Secretary finds
necessary.
Under sections 1866 and 1902 of the Act, providers of services
seeking to participate in the Medicare or Medicaid program, or both,
must enter into an agreement with the Secretary or the state Medicaid
agency, as appropriate. LTC facilities seeking to be Medicare and
Medicaid providers of services must be certified as meeting federal
participation requirements. LTC facilities include SNFs for Medicare
and NFs for Medicaid. The federal participation requirements for SNFs,
NFs, or dually certified facilities, are set forth in sections 1819 and
1919 of the Act and codified in the implementing regulations at 42 CFR
part 483, subpart B. Sections 1819(b)(1)(A) and 1919(b)(1)(A) of the
Act provide 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 quality of life of each resident. In addition, the
IMPACT Act (Pub. L. 113-185) amended Title XVIII of the Act by, among
other things, adding Section 1899B to the Act. Section 1899B(i)
requires that certain providers, including long term care facilities,
take into account, quality, resource use, and other measures to inform
and assist with the discharge planning process, while also accounting
for the treatment preferences and goals of care of residents.
The Affordable Care Act made a number of changes to the Medicare
and Medicaid programs. For instance, in an effort to increase
accountability for SNFs and NFs, section 6102 of the Affordable Care
Act established a new section 1128I of the Act. In general, section
1128I(b) of the Act requires LTC facilities to have in operation an
effective compliance and ethics program that is effective in preventing
and detecting criminal, civil, and administrative violations and in
promoting quality of care. Section 1128I(b)(2) of the Act specifies
that the Secretary, working jointly with the Inspector General of the
Department of Health and Human Services (HHS), shall promulgate
regulations for an effective compliance and ethics program for
operating organizations, which may include a model compliance program.
Further, section 1128I(c) of the Act adds a requirement for a quality
assurance and performance improvement program (QAPI). Lastly, in an
effort to promote dementia management and prevent abuse, section 6121
of the Affordable Care Act amended section 1819(f)(2)(A)(i)(I) and
section 1919(f)(2)(A)(i)(I) of the Act by requiring dementia and abuse
prevention training to be included as part of training requirements for
nurse aides.
C. Summary of Stakeholder Comments
In order to evaluate the need to update the requirements for long
term care facilities, CMS provided LTC stakeholders and members of the
general public with opportunities to provide suggestions and
recommendations for our revision of the requirements. Specifically, we
reached out to industry groups, advocates and other stakeholders by
announcing our intention to conduct a comprehensive review of the
requirements during CMS open door forums and other regularly scheduled
stakeholder calls. We established an email box to receive
[[Page 42174]]
comments and feedback. In response to our outreach, we received more
than 20 comments from a variety of stakeholder organizations and
individuals. Comments ranged from those who were concerned that burden-
reducing changes would weaken important protections for vulnerable
seniors to those who believe the existing regulations are working well
and no changes were necessary. We also received a number of comments
that included very detailed and comprehensive recommendations for
changes to our regulations. One consistent theme of the comments was
the need to address staffing levels. Most comments suggested that we
increase the required number of registered nurse (RN) hours of onsite
duty per resident day. They also suggested that we strengthen our
training requirements for staff and require trainings for specific
skills and procedures. Another common theme in the comments was the
need to revise the regulations so that they reflect a person-centered
care approach and improve the quality of care and life for the
residents. For example, commenters requested that residents be included
in the care planning process and given complete control over their meal
choices. Commenters also requested that we ensure the regulations are
current and consistent with federal privacy legislation and the
associated implementing regulations, such as the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) and the HIPAA
Privacy Rule (45 CFR part 160 and subparts A and E of part 164).
We have reviewed all of the stakeholder's comments and have taken
them into consideration while drafting this proposed rule. We note that
some commenters requested changes that conflicted directly with
statute. Moreover, some of the comments we received were outside the
scope of our review (that is, comments related to the LTC facility
survey process or the interpretive guidance (IG)). However, we have
shared all of the stakeholder's comments with appropriate CMS staff for
their review and consideration. We appreciate all of the stakeholders
input and responses to our outreach efforts thus far and believe that
this proposed rule reflects our desire to promote person-centered care
and improve the quality of care and services, while further protecting
resident's safety, choice and well-being.
D. Why revise the LTC requirements?
Although there have been many discrete changes to specific
provisions, the requirements for LTC facilities have not been
comprehensively reviewed and updated since 1991. The number of Medicare
beneficiaries who accessed care in a SNF increased from 636,000 (or 19
per 1,000 enrollees) in 1989 to 1,839,000 (or 52 per 1,000 enrollees)
in 2010, not including managed care enrollees (Data Compendium. 2002
edition. Centers for Medicare & Medicaid Services [on-line]. https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/DataCompendium/).
In addition to the increase in the number of individuals accessing
SNF care, the health concerns of individuals residing in LTC facilities
have become more clinically complex. The LTC population includes a mix
of elderly individuals, younger residents with intellectual or
developmental disabilities who are chronically ill, and residents in
need of post-acute rehabilitation services. Since the 1980's, the
nursing home resident population has had some significant changes. Some
of these changes have resulted in nursing homes having to care for many
residents that generally have a higher acuity. One change has been a
dramatic increase in the number of residents who are recuperating from
an acute episode of an illness or injury and who would have usually
been discharged from a hospital to their homes. In 1983, Medicare
implemented the prospective payment system for hospitals (Decker, FH.
Nursing homes, 1977-99: What has changed, what has not? Hyattsville,
Maryland Center for Health Statistics. 2005, p. 3). In the subsequent
years, there have been shorter hospital stays for Medicare
beneficiaries and increased Medicare-funding for post-acute stays in
nursing homes. Decker noted that while the discharge rate for
individuals who had nursing home stays of 3 months or more had not
changed significantly, the discharge rate for individuals who were
discharged after a nursing home stay of 90 days or less accounted for
virtually all of the increase. Thus, Decker used this as a benchmark
for short versus long stays. The number of discharges per 100 nursing
home beds in 1977 and 1985 were 86 and 77, respectively. However, by
1999, the discharge rate per 100 nursing home beds had increased by
about 56 percent to 134 (Decker, p. 2). In addition, the percentage of
these stays in which Medicare was the primary payer had more than
tripled from 11 percent in 1985 to 39 percent in 1999. Medicare
generally only covers the first 100 days of a stay in a skilled nursing
facility (https://www.medicare.gov/Pubs/pdf/10153.pdf).
Another factor that has resulted in a higher acuity in the nursing
home resident population has been the increase in assisted-living
facilities and other alternatives to nursing home care, such as home
care (Decker, p. 5 and Harris-Kojetin, L., Sengupta, M., Park-Lee, E.,
and Valverde, R. Long-term care services in the United States: 2013
overview. National health care statistics reports; no 1. Hyattsville,
MD: National Center for Health Statistics, 2013). This has resulted in
nursing homes caring for residents that require more medical care and
rehabilitation services. This is supported by the significant decrease
in the percentage of residents that could perform their ADLs
independently. In 1977, almost 67 percent of residents could eat
independently (Decker, p. 5, Figure 6). However, by 1999, that
percentage had decreased to almost 53 percent and by 2004 it was down
to only about 41 percent (Decker and Jones, AL, Dwyer, LL, Bercovitz,
AR, Strahan, GW. The National Nursing Home Survey: 2004 Overview.
National Center for Health Statistics. Vital Health Stat 13(167). 2009,
Figure 5.). In 1977, almost 30 percent of residents were independent in
dressing; however, by 1999, that percent was down to almost 13 percent
and by 2004 it was down to about 10 percent (Decker and Jones). By
2004, more than 50 percent of all nursing home residents either
required extensive assistance with bathing, dressing, toileting, and
transferring or were totally dependent for these ADLs (Jones, Figure 5
and Harris-Kojetin, Figure 24). Only 1.6 percent of all nursing home
residents received no assistance for any ADL (Jones, Figure 4).
Nursing homes are also caring for a significant number of residents
who require behavioral health services. In 2004, over 16 percent of
nursing home residents received a primary diagnosis of a mental
disorder upon admission (Jones, Figure 7). By the time residents were
interviewed for the National Nursing Home Survey that percentage
increased to almost 22 percent. The 1999 estimate was about 18 percent.
In addition, nursing homes are caring for a significant number of
patients with dementia and depression. By 2012, over 48 percent of
nursing home residents had a diagnosis of Alzheimer's disease or
another dementia and/or depression (Harris-Kojetin, p. 35, Figure 23).
Similiarly, in looking at the prevalence of four mental health
conditions (depression, anxiety disorders, bipolar disorder, and
schizophrenia) in nursing home residents 65 and older, the Institute of
Medicine (IOM) found almost 50 percent had depression and almost 57
percent had one or more of those conditions (IOM (Institute of
[[Page 42175]]
Medicine) 2012. The mental health and substance use workforce for older
adults: In whose hands? Washington, DC: The National Academies Press).
In addition, substance abuse disorders are also increasing in the
nursing home population. Substance abuse disorders are described in the
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
(DSM-5) (https://www.dsm5.org/Documents/Substance%20Use%20Disorder%20Fact%20Sheet.pdf Accessed on June 17,
2015). Thus, in this rule, when we discuss behavioral health or mental
illness, we are also discussing substance abuse disorders.
To accommodate a more diverse population, the current care and
service delivery practices of LTC facilities have changed to meet these
changing service needs. These factors not only demonstrated a need to
comprehensively review the regulations, but also informed our approach
for revising the regulations. The following discussion highlights our
approach to proposing revisions as well as some of the most significant
revisions set forth in this proposed rule.
Facility Assessment and Competency-Based Approach
One of our goals in revising our minimum health and safety
requirements for LTC facilities is to ensure that our regulations align
with current clinical practice and allow flexibility to accommodate
multiple care delivery models to meet the needs of the diverse
populations that are provided services in these facilities. We
considered prescriptive approaches, such as requiring specific numbers
and types of staff based on facility size and acuity of residents, but
were concerned that such an approach would conflict with requirements
already established in many states, and would limit flexibility and
innovation in designing new models of person-centered care delivery for
residents. Thus, we are instead taking a competency-based approach that
focuses on achieving the statutorily mandated outcome of ensuring that
each resident is provided care that allows the resident to maintain or
attain their highest practicable physical, mental, and psychosocial
well-being. Under this competency-based approach, we are proposing
requirements that are compatible with existing state requirements and
consistent with what we believe are already common practices by
facilities. As discussed in further detail in this proposed rule in
section II, ``Provisions of the Proposed Rule,'' we propose to require
facilities to assess their facility capabilities and their resident
population. Using the information from that assessment, facilities
would be required to provide sufficient staff with the necessary
competencies and skills to meet each resident's needs based on acuity,
diagnosis, and the resident's person-centered comprehensive care plan.
Based on our experience with LTC facilities, we believe most facilities
already make these assessments, at least informally, in order to
determine staffing needs; our revisions will ensure it is consistently
performed and documented in all SNFs and NFs.
Application of facility assessments and competence-based staffing
decisions would involve every service provided by a NF or SNF and apply
to all members of the staff, including the interdisciplinary team. For
example, a facility that provides dementia care would need to ensure it
has sufficient numbers of staff and that the staff has the necessary
training, education, and/or experience to care for individuals with
dementia. These staff may be nursing service staff, behavioral health
staff, or other appropriate care providers. Similarly, adding a
competence-based requirement would ensure that a facility serving
residents requiring post-acute rehabilitation care had sufficient staff
with the required training, education and/or experience to care for
individuals requiring those services. We propose that the focus be on
the competencies and skill sets of the individuals delivering care and
services rather than just on the overall number of care givers
available. This competence-based approach is compatible with existing
state requirements and business practices, and promotes both efficiency
and effectiveness in care delivery. In addition to a competence-based
approach, this proposed rule is intended to meet the spirit of current
HHS quality initiatives that cut across various providers.
Current HHS Quality Initiatives
As an effective steward of public funds, CMS is committed to
strengthening and modernizing the nation's health care system to
provide access to high quality care and improved health at lower cost.
This includes improving the patient experience of care, both quality
and satisfaction, improving the health of populations, and reducing the
per capita cost of health care. In drafting the proposed rule, we
considered current initiatives underway to support these aims and
improve care across providers as well as initiatives targeted
specifically at nursing home residents. As discussed below, we are
proposing several revisions consistent with these efforts.
Reducing Avoidable Hospitalization
Nearly two-thirds of nursing home residents are enrolled in
Medicaid, and most are also enrolled in Medicare. These Medicare-
Medicaid enrollees are among the most fragile and chronically ill
individuals served by both programs. Although estimates vary, CMS
research found that approximately 45 percent of hospitalizations among
Medicare-Medicaid enrollees receiving either Medicare skilled nursing
facility services or Medicaid nursing facility services could have been
avoided (https://innovation.cms.gov/initiatives/rahnfr/). One goal of
the HHS Partnership for Patients Initiative is to reduce the number of
individuals who experience a preventable complication requiring
rehospitalization. This effort aims to improve the quality of care and
services for individuals cared for in LTC facilities. In support of
this initiative, CMS has launched the ``Initiative to Reduce Avoidable
Hospitalizations among Nursing Facility Residents'' (https://innovation.cms.gov/initiatives/rahnfr/). CMS is supporting
organizations that partner with nursing facilities to implement
evidence-based interventions that both improve care and lower costs.
The initiative is focused on long-stay nursing facility residents who
are enrolled in the Medicare and Medicaid programs. Additional
information and resources are available at https://innovation.cms.gov/initiatives/rahnfr/.
Consistent with the HHS focus on reducing unnecessary
hospitalization, in drafting this proposed rule, we looked at what, if
any, minimum health and safety standards could be developed or
strengthened that would contribute to a reduction in unnecessary
hospital admissions of nursing home residents. First, we considered
many factors that contribute to a decision to transfer a nursing home
resident to a hospital. This is primarily a clinical decision, but it
may be impacted by environmental or financial factors that are not
amenable to change based on regulatory requirements. These concerns
include family and resident preferences and demands, concern regarding
the LTC facility's liability, and payment incentives. We believe,
however, that there are some regulatory changes that would help reduce
avoidable hospitalization of nursing home residents. We discuss those
changes in section II, ``Provisions of the Proposed Rule''.
[[Page 42176]]
Healthcare Associated Infections
HHS is also working to reduce the incidence of healthcare
associated infections (HAIs) across providers. In recognition of HAIs
as an important public health and patient safety issue, HHS is
sponsoring the ``National Action Plan to Prevent HAIs''. This
initiative seeks to coordinate and maximize the efficiency of
prevention efforts across the federal government (https://www.hhs.gov/ash/initiatives/hai/actionplan/). Given the growing number of
individuals receiving care in LTC settings and the presence of more
complex medical care, these individuals are at an increased risk for
HAIs. Therefore, to advance these initiatives, we have proposed
revisions that we believe will provide more opportunities to achieve
broad based improvement and contribute to reduced healthcare costs. We
also believe this approach would be flexible enough to be adapted to
any business model and would allow for targeted interventions specific
to the facility.
Behavioral Health
On March 29, 2012, CMS launched an initiative aimed at improving
behavioral healthcare and safeguarding nursing home residents from the
use of unnecessary antipsychotic medications. As part of the
initiative, CMS has developed a national action plan that uses a
multidimensional approach including public reporting, raising public
awareness, regulatory oversight, and technical assistance/training and
research. This plan is targeted at enhancing person-centered care for
nursing home residents, particularly those with dementia-related
behaviors (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Spotlight/html).
Similarly, with regard to minimum health and safety standards, we
looked at possible regulatory changes that could lead to a reduction in
the unnecessary use of antipsychotic medication and improvements in the
quality of behavioral healthcare. After conducting a review of
literature, stakeholder comments, and available Office of Inspector
General (OIG) reports we found that many residents are not receiving
the individualized quality of care mandated by the current
requirements. We address this issue further in section II, ``Provisions
of the Proposed Rule''.
Health Information Technology
HHS also has a number of initiatives designed to encourage and
support the adoption of health information technology and to promote
nationwide health information exchange to improve health care. HHS
believes all patients, their families, and their healthcare providers
should have consistent and timely access to their health information in
a standardized format that can be securely exchanged between the
patient, providers, and others involved in the patient's care (HHS
August 2013 Statement, ``Principles and Strategies for Accelerating
Health Information Exchange.''). The Department is committed to
accelerating health information exchange (HIE) through initiatives
including: (1) Establishing a coordinated governance framework and
process for nationwide health IT interoperability; (2) improving
technical standards and implementation guidance for sharing and using a
common clinical data set; (3) enhancing incentives for sharing
electronic health information according to common technical standards,
starting with a common clinical data set; and (4) clarifying privacy
and security requirements that enable interoperability. Ensuring that
individuals and care providers can send, receive, find, and use a basic
set of essential health information across the health care continuum
will enhance care coordination and enable health system reform to
improve care quality. This strategy is described in greater detail in
``Connecting Health and Care for the Nation: A Shared Nationwide
Interoperability Roadmap, available at https://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf. Developed with significant stakeholder input, this 10-year
Roadmap describes barriers to interoperability across the current
health IT landscape, the desired future state that the industry
believes will be necessary to enable a learning health system, and a
suggested path for moving from the current state to the desired future
state. In addition, ONC has released the 2015 Interoperability
Standards Advisory (available at https://www.healthit.gov/standards-advisory), which provides a list of the best available standards and
implementation specifications to enable priority health information
exchange functions. ONC expects to annually update the Advisory through
a transparent and structured process that includes advice from the
Health IT Standards Committee (ONC's federal advisory committee) and
the public at large.
HHS is committed to encouraging HIE among all health care
providers, including those who are not eligible for the EHR Incentive
Programs, to improve care delivery and coordination across the entire
care continuum. Our revisions to this rule are intended to recognize
the advent of electronic health information technology and to
accommodate and support adoption of ONC certified health IT and
interoperable standards. We believe that the use of such technology can
effectively and efficiently help facilities and other providers improve
internal care delivery practices, support the exchange of important
information across care team members (including patients and
caregivers) during transitions of care, and enable reporting of
electronically specified clinical quality measures (eCQMs). For more
information, we direct stakeholders to the ONC guidance for EHR
technology developers serving providers ineligible for the Medicare and
Medicaid EHR Incentive Programs titled, ``Certification Guidance for
EHR Technology Developers Serving Health Care Providers Ineligible for
Medicare and Medicaid EHR Incentive Payments,'' which addresses use of
the 2014 Edition of ONC certification criteria (available at https://www.healthit.gov/sites/default/files/generalcertexchangeguidance_final_9-9-13.pdf). ONC anticipates updating
the 2014 Edition Certification Guidance once the ONC 2015 Edition
Certification becomes final. Information on the development of
standards applicable to the long-term care setting can be found at:
https://wiki.siframework.org/LCC+LTPAC+Care+Transition+SWG and https://wiki.siframework.org/Longitudinal+Coordination+of+Care.
Trauma-Informed Care
HHS has also undertaken broad-based activities to support Americans
that have specific needs to be considered in delivering health care and
other services. Activities include raising awareness about the special
care needs of trauma survivors, including a targeted effort to support
the needs of Holocaust survivors living in the United States. Trauma
survivors, including veterans, survivors of large-scale natural and
human-caused disasters, Holocaust survivors and survivors of abuse, are
among those who may be residents of long-term care facilities. For
these individuals, the utilization of trauma-informed approaches is an
essential part of person-centered care. For many trauma survivors, the
transition to living in an institutional setting (and the associated
loss of independence) can trigger profound re-traumatization. In
addition, aspects of institutional settings can be significant
triggers. While these triggers are highly individualized, some common
triggers include: Experiencing
[[Page 42177]]
a lack of privacy or confinement in a crowded or small space; or being
exposed to certain loud noises, or bright/flashing lights. It is also
important to note that cognitive impairment, such as dementia, may
worsen or further complicate a trauma survivor's response to triggers
and may also introduce additional language barriers as individuals
return to their first (non-English) languages. Culturally-competent,
trauma-informed approaches that help to minimize triggers and re-
traumatization, including those that address the unique care needs of
Holocaust survivors and survivors of war, disasters, and other profound
trauma are an important aspect of person-centered care for these
individuals. Person-centered care that reflects the principles set
forth in SAMSHA's Concept of Trauma and Guidance for a Trauma-Informed
Approach, HHS Publication No. (SMA) 14-4884, available at https://store.samhsa.gov/shin/content/SMA14=4884/SMA14-4884.pdf, would help
advance the quality of care that a resident receives and, in turn, can
substantially improve a resident's quality of life.
Requirements for Long Stay Residents
Ninety five percent of nursing homes in the United States are
dually certified as SNF/NFs. That is, they provide both the Medicare
SNF benefit, and the Medicaid NF benefit. Both benefits cover skilled
nursing care and rehabilitation services, with a few minor differences,
as noted in these proposed regulations. In addition, Medicaid NFs
provide long term care for residents who require support for activities
of daily living. Some residents covered by long term care insurance or
paying privately may also be receiving long-term care in the nursing
home indefinitely. For these residents, the facility is their home. For
both residents and facilities, making the nursing facility a home is a
different experience and undertaking than is a course of rehabilitation
followed by discharge to the individual's residence in the community.
The requirements have not reflected this distinction.
We received some comments that would apply primarily to serving
long term residents. Some of the ideas and practices, known
collectively as ``Culture Change,'' are of benefit to all nursing home
residents by making services and supports more person-centered, but are
particularly crucial to the quality of life of long stay facility
residents. Person-centered care is an aspect of culture change that
focuses on the resident as the locus of control, supported in making
their own choices and having control over their daily lives. According
to the authors of the ``Long-Term Care Improvement Guide,'' ``culture
change'' refers to the progression from institutional or traditional
models of care to more individualized, consumer-directed practices that
embrace choice and autonomy for care providers and recipients
(Frampton, Susan, et al. ``Making the Case for Change'' Long-Term Care
Improvement Guide 2010, retrieved from https://www.residentcenteredcare.org/Pages/About%20the%20guide.html). The
authors go on to explain that this kind of care not only enhances
quality for consumers and staff but also creates opportunities for the
organization to improve operational benchmarks in areas such as quality
of care, efficiency of operation, revenue generation and stabilized
staffing. CMS has participated in the culture change movement and we
are familiar with both the goals and challenges of this effort. We note
that the many present efforts to serve individuals in the community
rather than in an institution, for example, in compliance with the
Supreme Court Olmstead decision (Olmstead v. L.C ex rel. Zimring, 527
U.S. 581, 119 S. Ct. 2176 (1999)), are primarily directed at long-stay
nursing home residents rather than those receiving rehabilitation or
skilled nursing care, and this characteristic may be relevant to
facility requirements.
While CMS is engaged in the issues around long stay nursing home
residents, we do not have enough verifiable information to propose
specific changes to the regulations specifically applicable to long-
stay situations at this time. We solicit comments on how the
requirements could acknowledge the special needs of the long stay
resident. In addition, because we also received comments regarding the
need to specifically address the needs of short stay residents, we
solicit comments on how the requirements could acknowledge the special
needs of short stay residents. Nursing facility providers describe the
challenges of serving these two rather different populations in a
single model of care. We are particularly interested in any suggestions
to improve existing requirements, within the authority of existing
statute, where they make serving one or the other population difficult
or less effective. The most useful comments will be those that offer
suggestions to amend specific sections of the existing requirements or
offer particular additions. For example, should new construction or
capitalized renovations be based on models of effective long term
residence?
In addition to the requirements for participation, CMS is seeking
comment on a number of issues related to the finalization and
implementation of the proposed rule: Unintended consequences and
unanticipated risks to SNF and NF residents, the involvement of
stakeholders in developing sub-regulatory requirements and in
implementing changes, and the timeline for proposed implementation
following finalization of the rule.
The requirements for participation have not been substantially
updated since the regulations implementing the Omnibus Budget
Reconciliation Act of 1987 were finalized. As such, the intent of the
proposed rule is modernization of the regulation, harmonization with
other federal laws, and implementation of certain provisions of the
Affordable Care Act. CMS is seeking comments on the scope and type of
changes proposed here. Given the comprehensive nature of our proposed
revisions, we are soliciting comments regarding potential unintended
consequences or unanticipated risks to SNF and NF residents, either
related to a specific proposal or in general, and what those concerns
might be. In addition, we are interested in stakeholder comments
related to an appropriate timeframe for nursing homes to implement
these regulations. CMS generally implements changes to regulatory
requirements for the survey and certification process within 12 months
of a final rule. Following finalization of this proposed rule, CMS
anticipates that it may require a longer period of time to implement
the changes outlined in the final rule. The additional time may be
needed to develop revised interpretive guidance and survey processes,
conduct surveyor training on the changes, and implement the software
changes in the Quality Indicator Survey (QIS) system, which would
include changing the underlying framework of the QIS system as many of
the existing requirements have been re-organized. We also expect that
it may take a longer period for nursing facilities to implement these
changes and seek stakeholder suggestions regarding an appropriate
implementation timeframes. Lastly, we seek comment on additional
streamlining and reduction of outdated policies as a means of balancing
the new policies being proposed.
Implementation of the Affordable Care Act Provisions
We are proposing to implement several provisions required by the
Affordable Care Act. First, section 6102 of the Affordable Care Act,
which added
[[Page 42178]]
new section 1128I to the Act requires the operating organizations for
facilities (both SNFs and NFs as defined in sections 1819(a) and
1919(a) of the Act) to have in operation a compliance and ethics
program. The compliance and ethics programs must be effective in
preventing and detecting criminal, civil, and administrative violations
under the Act and in promoting quality of care consistent with
regulations that are promulgated under this new section.
Second, section 1128I of the Act requires the Secretary to
establish and implement Quality Assurance and Performance Improvement
(QAPI) program requirements for facilities, including multi-unit chains
of facilities. Under this requirement, the Secretary must establish and
implement standards relating to QAPI and provide technical assistance
to facilities on the development of best practices in order to meet
these standards. A facility must submit to the Secretary a plan for the
facility to meet such standards and implement the best practices,
including how to coordinate the implementation of a plan with quality
assessment and assurance (QAA) activities already required under
sections 1819(b)(1)(B) and 1919(b)(1)(B) of the Act as implemented at
42 CFR 483.75(o). This proposed rule would establish standards relating
to QAPI for SNFs and NFs, as required by the Affordable Care Act.
Finally, section 6121 of the Affordable Care Act, amending sections
1819(f)(2)(A)(i)(I) and 1919(f)(2)(A)(i)(I) of the Act, requires
dementia management and abuse prevention to be included as part of
training requirements for nurse aides. We are proposing to amend the
requirements that an institution must meet in order to participate as a
SNF/NF in the Medicare and Medicaid programs, by requiring that the
current mandatory on-going training requirements for nurse aides (NAs)
include dementia management and resident abuse prevention training.
This proposed rule would also clarify that the definition of NA
includes an individual who provides NA services through an agency or
under contract with a LTC facility, as provided in sections 6121(a)(2)
and (b)(2) of the Affordable Care Act.
Executive Order 13563
In January 2011 the President issued Executive Order 13563
``Improving Regulation and Regulatory Review,'' which directs agencies
to select the least burdensome approaches, to minimize cumulative
costs, to simplify and harmonize overlapping regulations, and to
identify and consider flexible approaches that maintain freedom of
choice for the American public. Executive Order 13563 also requires
agencies to engage in a process of reviewing existing regulations to
see if those rules make sense and continue to be justified. The
provisions of this proposed rule are intended to meet the letter and
spirit of Executive Order 13563, for reviewing existing regulations to
see if those rules make sense and continue to be justified. The
provisions of this proposed rule also meet the objectives of section
610 of the Regulatory Flexibility Act (RFA), which also requires
agencies to review the impact of existing rules on small businesses or
other small entities for possible reforms to reduce burden and costs.
We conducted a general review of the regulations for outdated,
confusing, and unnecessarily burdensome requirements and considered
areas for improvement.
II. Provisions of the Proposed Regulation
Reorganization of Part 483 Subpart B
In our comprehensive review of part 483 subpart B, we felt that
improvements could be made to the overall readability and logical order
of the regulatory provisions. Therefore, we propose to revise the order
of the regulatory provisions. As in the existing subpart B, required
sections including basis and scope and definitions, would come first.
Similar to the existing regulations, we propose to follow these
sections with provisions assuring resident-centered care, including
resident rights, facility responsibilities, freedom from abuse, neglect
and exploitation, transitions of care, and individualized resident
assessment and care planning. We propose to then include service-
specific provisions, including quality of care, starting with physician
services and concluding with administration. We propose to conclude
subpart B with requirements for facility-wide programs such as
infection control, compliance and ethics, training, and facility
physical environment. We believe our proposed revised order
significantly improves the readability and logical order of the
regulations and would allow individuals less familiar with the
regulations to find information they are seeking more easily. A
crosswalk of the current provisions to the proposed provisions is
included as Table A in section III of this proposed rule.
Cross Cutting Proposals
While some proposed changes require revisions that are contained in
one specific section of the requirements, other issues apply across
multiple sections and thus would require changes in several sections of
the regulations. These cross-cutting topics include proposals regarding
unnecessary hospitalization, HAIs, antipsychotic medications, care
planning, and QAPI. Below is a general discussion of our approach to
revising the regulations to address these issues. Specific changes to
the regulatory text are discussed in detail in the relevant
requirements.
Unnecessary Hospitalization
The transfer to an acute care hospital is a stressful event for a
resident of a SNF or NF. As noted by The Office of the Assistant
Secretary for Planning and Evaluation (ASPE) in its June 2011 report on
Hospitalizations of Nursing Home Residents, such hospitalizations
impose a high personal cost on nursing home residents, causing
disruption, risk of complications and infections, and likelihood of
reduced functioning on return to the nursing home (Ouslander, J.G.,
Lamb, G., Perloe, M., Givens, J.H., Kluge, L., Rutland, T., et al.
(2010). Potentially avoidable hospitalizations of nursing home
residents: Frequency, causes, and costs. Journal of the American
Geriatrics Society, 58, 627-635.). Nursing home residents are
especially vulnerable to the risks that accompany hospitalizations and
transitions of care, including medication errors and hospital-acquired
infections. Hospital episodes are even more difficult for residents
with dementia, who become disoriented in new, unfamiliar settings.
Preventing potentially avoidable hospitalizations of nursing home
residents is an important quality-improvement initiative from the
standpoint of the residents and their families, and also may yield cost
reductions (Polniaszek, Susan, Walsh, Edith G. and Wiener, Joshua M.
(2011) Hospitalizations of Nursing Home Residents: Background and
Options. U.S. Department of Health and Human Services, Assistant
Secretary for Planning and Evaluation, Office of Disability, Aging and
Long-Term Care Policy).
In order to decrease unnecessary hospitalizations, the June 2011
report from ASPE gives options such as reporting potentially avoidable
hospitalization rates on the CMS Nursing Home Compare Web site,
increasing registered nurse (RN) staffing and the use of nurse
practitioners (NPs), modifying the Medicare 3-day qualifying stay
requirement, providing education and care tools, and changing Medicaid
coverage policy to direct incentives to reduce avoidable
[[Page 42179]]
hospitalization of nursing home residents (``Hospitalizations of
Nursing Home Residents: Background and Options'' U.S. DHHS, Assistant
Secretary for Planning and Evaluation, Office of Disability, Aging and
Long-Term Care Policy. June 2011). Of these options, we believe
education is one of the areas that is most amenable to addressing
through revising the requirements. Young et al. conclude, based on a
cross-sectional survey of randomly selected nursing homes in New York
State, that contributing factors to unnecessary hospitalizations
amenable to change include communication effectiveness training,
ensuring adequate access to prior medical history, laboratory results
and ECGs, and encouraging physicians who practice at nursing homes to
treat residents within the nursing home whenever possible (Journal of
the American Geriatric Society, 58:901-907, May 2010). The availability
of patient information, including resident medical history, assessment
of current condition including recent laboratory and radiology results,
availability of physicians or other practitioners to evaluate the
patient if needed, and effective interdisciplinary team communication
are areas we can impact through the requirements.
In this proposed rule, we propose to take a multifaceted approach
to reducing unnecessary hospitalization which includes:
Requiring that a facility notify the resident's physician
when there is a change in a resident's status, including any pertinent
information specified in Sec. 483.15(b)(2)-(Sec. 483.11(e)(7)(ii))
Addressing communication through a robust
interdisciplinary team, comprehensive person-centered care planning
process and through training requirements (Sec. 483.21).
Proposing a requirement for practitioner assessment prior
to transfer to a hospital, except in an emergency situation (Sec.
483.30(e)).
Enhancing nursing care through a competency-based approach
(Sec. 483.35).
Strengthening the clinical record requirements to ensure
adequate and appropriate information is available to evaluating
practitioners (Sec. 483.70(i)).
Ensuring ongoing evaluation of care process through
implementation of a robust QAPI plan (Sec. 483.75)
This multifaceted approach would build on existing requirements and
standard business practices through incremental change. We also believe
that this approach would not only have a positive impact on reducing
unnecessary readmissions, but may also improve other quality areas as
well and is intended to be flexible enough to encompass any care model
and all facility populations.
Reduction in Inappropriate Use of Antipsychotic Medications
Antipsychotic medications are frequently prescribed off-label,
which means that the drug is being prescribed for a use that is not
approved by the U.S. Food and Drug Administration (FDA), to residents
with behavioral and psychological symptoms of dementia (BPSD). This has
led to increased attention to the behavioral health management of
nursing home residents with dementia and the potentially inappropriate
use of antipsychotics in this population. Evidence suggests that
antipsychotics have limited benefits in this population, and the
potential to lead to adverse consequences such as the risk of movement
disorders, falls, hip fractures, cerebrovascular accidents, and death.
Additionally, the health profiles of this population are often
medically complex and residents may take multiple medications that
increase their risk of adverse effects and drug interactions. A
previous OIG study found that when this population received these
drugs, about half of the drugs were not given for medically accepted
indications as required for Medicare coverage or recorded as being
administered to the resident and one-fifth of the drugs were not given
in accordance with federal safeguards to protect nursing facility
residents from unnecessary antipsychotic drug use (OEI-07-08-00150).
The potential overuse of antipsychotic agents is a symptom of a much
larger problem--namely, that many nursing facilities may not have a
systematic plan to provide comprehensive behavioral health care to
residents with diagnoses such as dementia and BPSD.
In this proposed rule, we would take a multifaceted approach to
reducing the unnecessary use of antipsychotic medications which would
include:
Requiring that each nursing home conduct a comprehensive
assessment, including its physical characteristics (that is, size,
location, and number of residents), its resident population (including
both a psychosocial and mental health assessment), the competencies and
knowledge of its staff, and the identification of any resources or
support, including training and additional staff, that the facility
would need to ensure the appropriate care and treatment for all
residents (Sec. 483.70)
Revising the current requirements that apply to
antipsychotic drugs to also apply to any psychotropic drug; that is,
any drug that affects brain activities associated with mental processes
and behavior (Sec. 483.45)
Including a requirement that once the facility's
consultant pharmacist has identified an irregularity (such as, a drug
given for an excessive duration of time or prescribed without adequate
indications documented in the resident's medical record), or has
recommended a gradual dose reduction for one or more medication, the
attending physician would be required to document in the resident's
medical record that he or she has reviewed the identified irregularity
and what, if any, action they took to address it. If there is to be no
change in the medication, the attending physician should document his
or her rationale in the resident's medical record (Sec. 483.45)
Similar to our proposals for reducing unnecessary hospitalizations,
this multifaceted approach would build on existing requirements and
standard health care practices through incremental change. We believe
that this approach would provide the best opportunity for a broad-based
improvement in the areas of mental, behavioral, and psychosocial-
related health care concerns, while also providing facilities with
flexibility regarding how to address the type of staff and training or
other resources and support they need to provide care and services in
these areas.
Healthcare Associated Infections (HAIs)
Although estimates vary widely, there are between 1.6 and 3.8
million HAIs in nursing homes every year. Annually, these infections
result in an estimated 150,000 hospitalizations, 388,000 deaths, and
between $673 million and $2 billion dollars in additional healthcare
costs (Castle, et al. Nursing home deficiency citations for infection
control, American Journal of Infection Control, May 2011; 39, 4). In
some ways, the resident population in nursing homes presents unique
regulatory challenges, particularly with respect to infection control.
Residents in nursing homes not only receive skilled nursing care in
these facilities, but for many individuals, these facilities are also
their homes. In addition, nursing homes are required to provide social
activities for residents which may include group activities or
functions. These activities or functions, such as dining, social
events, and religious services, may increase the risk of transmission
and exposure to communicable diseases and infections. The diversity of
the nursing home community presents each facility with unique
challenges to meet the needs and choices of all of the
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individuals they serve, creating a much harder task of regulating and
managing infection control and prevention activities. Nursing home
residents are often frail, elderly individuals and individuals with
disabilities who have increased susceptibility to infections from
malnutrition, dehydration, comorbidities, or functional impairments
(for example, urinary and fecal incontinence), and medications that
diminish immunity or immobility. In addition, as patients are
discharged from hospitals to nursing homes sooner, the nursing home
population increasingly has more residents with greater medical needs,
which not only increases the acuity level but also likely results in
higher invasive device use (for example, mechanical ventilators,
central venous catheters, and enteral feeding tubes). Therefore, when
developing our approach to promote prevention and control of HAIs, we
took into consideration this diverse resident population, as well as
the interaction residents will have with staff, visitors, and each
other.
Similar to our approach to address unnecessary hospitalizations, we
identified the following areas to consider addressing HAIs when
revising the nursing home infection control requirements:
Requirements for the facility to perform a facility-
specific assessment of their resident population and facility (Sec.
483.70)
Integration of the infection prevention and control
program (IPCP) with the facility's QAPI processes (Sec. 483.75)
Revising the description of the infection control program
and adding a requirement to periodically review and update the program
(Sec. 483.80)
Requiring an antibiotic stewardship program that includes
antibiotic use protocols and a system for monitoring antibiotic use
(Sec. 483.80)
Designation of specific infection prevention and control
officers (IPCOs) (Sec. 483.80)
Written policies and procedures for the IPCP (Sec.
483.80)
Education or training related to the infection control
program (Sec. 483.80)
Likewise, with the other cross-cutting provisions, we believe that
taking a multifaceted approach when revising the infection control
requirements would provide the best opportunity to achieve broad-based
improvement while also being flexible enough to be adapted to any
health care delivery model. These revisions may also result in positive
impacts in the care and services to residents, reducing unnecessary
hospitalizations and overall lowered healthcare costs.
In the following sections we detail our proposed revisions to the
requirements. The discussion follows our proposed reorganization of
subpart B.
A. Basis and Scope (Sec. 483.1)
We propose to revise Sec. 483.1 ``Basis and Scope'' to include
references to sections 1819(f), 1919(f), 1128I (b) and (c), and 1150B
of the Act. Sections 1819(f) and 1919(f) of the Act require that the
current mandatory on-going training for NAs include dementia management
and resident abuse prevention training. New section 1128I (b) of the
Act requires the operating organizations for SNFs and NFs to have a
compliance and ethics program and new section 1128I(c) of the Act
requires the Secretary to establish and implement a QAPI program for
facilities. New section 1150B of the Act establishes requirements for
reporting to law enforcement suspicion of crimes occurring in federally
funded LTC facilities. In addition, we propose to spell out the term
``skilled nursing facility''.
B. Definitions (Sec. 483.5)
Current regulations at Sec. 483.5 provide definitions for terms
commonly used in the LTC requirements. We propose to revise some of the
existing terms for clarity and define new terms that we believe are
widely used within the LTC setting, and that we believe would add value
to the LTC requirements while promoting resident choice and safety.
We have retained the existing definitions for ``facility'' and
``distinct part''. We are aware of stakeholder concerns that defining
``distinct part'' and ``composite distinct part'' possibly allow
facilities to segregate residents by payment source. On August 4, 2003,
we published a final rule entitled, ``Medicare Program; Prospective
Payment System and Consolidated Billing for Skilled Nursing Facilities-
Update'' (68 FR 46036). Through this final rule, the definitions of
``distinct part'' and ``composite distinct part'' were added to this
section and we believe the rationale for the addition at that time
remains valid. While some SNFs function as separate, independent
entities, we have recognized since the inception of the Medicare
program that it is also possible for a SNF to operate as a component,
or ``distinct part'' or ``composite distinct part'' of a larger
organization. While we do not agree that ``distinct part'' and
``composite distinct part'' should be removed from the current
regulations, based on concerns raised by some stakeholders, we have
modified the definition of ``composite distinct part'' to make it clear
that a composite distinct part designation cannot be used as a means to
segregate residents by payment status or on any basis other than care
needs. Such segregation may violate a patient's privacy by implicitly
revealing their payment source and lends itself to creating inequitable
care situations. In addition, we have retained the definition of
``major modification'', which was added to the LTC regulations in the
May 12, 2014 final rule, ``Regulatory Provisions to Promote Program
Efficiency, Transparency, and Burden Reduction; Part II'' (79 FR
27106). We also propose to make minor revisions to the definition of
``common area'' to recognize that some facilities have living rooms or
other areas where residents gather.
As discussed in detail below, based on our internal review and
feedback from stakeholders, we propose to expand this section to
include the following definitions: ``abuse,'' ``adverse event,''
``exploitation,'' ``misappropriation of resident property,''
``neglect,'' ``person-centered care,'' ``resident representative,'' and
``sexual abuse''. In addition, we propose to relocate the definitions
for ``licensed health professional'' and ``nurse aide'' to this section
from the ``Administration'' section at Sec. 483.75(e)(1). We believe
that these definitions apply broadly to the regulations and would more
appropriately be defined in this section of definitions. In addition,
we propose to revise the definition of ``nurse aide'' in accordance
with amendments to sections 1819(b)(5)(F) and 1919(b)(5)(F) of the Act
made by sections 6121(a)(2) and (b)(2) of the Affordable Care Act.
``Nurse aide'' is currently defined as any individual providing nursing
or nursing-related services to residents in a facility who is not a
licensed health professional, a registered dietitian, or someone who
volunteers to provide these services without pay. ``Nurse aides'' do
not include those individuals who furnish services to residents only as
paid feeding assistants as defined in Sec. 488.301. Section 6121 of
the Affordable Care Act added the following clarification to the
definition of ``nurse aide'': ``Such term includes an individual who
provides such services through an agency or under a contract with the
facility.'' We propose to amend the regulatory definition accordingly.
We propose to add the term ``adverse event'' to ensure clarity in
our requirements relating to proposed requirements for QAPI. We discuss
this definition further in section II.T. of the preamble and welcome
comment on our
[[Page 42181]]
proposed definition. We also propose the addition of the term
``resident representative'' because the use of a representative is
often common practice within the nursing home setting. We believe a
resident can designate an individual to have certain rights and/or
responsibilities, such as the ability to make decisions about a
resident's care, the ability to manage a resident's finances, or the
ability to participate in discussions about the residents care and the
ability to access a resident's medical information. For purposes of
this regulation, we would define the term ``resident representative''
broadly to include both an individual of the resident's choice who has
access to information and participates in healthcare discussions as
well as personal representative with legal standing, such as a power of
attorney for healthcare, legal guardian, or health care surrogate or
proxy appointed in accordance with state law to act in whole or in part
on the resident's behalf. One individual may or may not fulfill both of
these roles. We also note that the same-sex spouse of a resident would
be afforded treatment equal to that afforded to an opposite-sex spouse
if the marriage was valid in the jurisdiction in which it was
celebrated. Throughout this proposed regulation, where we use the term
resident, it includes, as applicable, the resident representative. In
addition, we propose to add a definition of ``person-centered care''.
For purposes of this subpart, we would define person-centered care as
focusing on the resident as the locus of control and supporting the
resident in making their own choices and having control over their
daily lives.
The addition of the definitions of ``abuse'', ``sexual abuse'',
``neglect'', ``exploitation'', and ``misappropriation of resident's
property'' are being proposed to achieve clarity within the current
regulations and eliminate confusion regarding what actions or
circumstances rise to the level of these terms. For purposes of these
regulations, ``abuse'' would include actions such as the willful
infliction of injury, unreasonable confinement, intimidation, or
punishment with resulting physical harm, pain or mental anguish. As
used in this definition of ``abuse'', ``willful'' means the individual
must have acted deliberately, not that the individual must have
intended to inflict injury or harm. ``Abuse'' would also include the
deprivation by an individual of goods or services that are necessary to
attain or maintain physical, mental, and psychosocial well-being. The
term ``sexual abuse'' would extend the meaning of ``abuse'' to include
non-consensual sexual contact of any type with a resident. We propose
to define the term ``neglect'' as ``the failure of the facility, its
employees or service providers to provide goods and services to a
resident that are necessary to avoid physical harm, pain, mental
anguish or mental illness.'' We would define ``exploitation'' as ``the
unfair treatment or use of a resident or the taking of a selfish or
unfair advantage of a resident for personal gain, through manipulation,
intimidation, threats, or coercion.'' Based on internal discussions and
stakeholder input, we are aware of industry concerns regarding certain
incidents that can take place within a nursing home that are not easily
classified as abuse or neglect, but nonetheless are inappropriate and
harmful. For example, there has been a substantial increase in the use
of technology to exploit the elderly since these regulations were first
implemented. When these regulations were originally implemented, social
media and the wide use of cellular and personal electronic devices were
not a major concern or topic of consideration in the protection of
residents. These advances in technology have made it easier to invade
someone's privacy and therefore increase the risk of exploitation. We
feel that there is a need to account for these technological changes to
ensure that all nursing home residents are protected. We believe the
addition of the terms ``abuse'', ``sexual abuse'', ``neglect'', and
``exploitation'' would help to eliminate confusion as to what behaviors
rise to the level of these terms and promote resident safety and would
clarify that abuse includes abuse facilitated or enabled through the
use of technology.
We also propose to add the term ``misappropriation of resident
property'' to provide clarity. The term ``misappropriation of resident
property'' is widely used throughout the regulations and in our
interpretive guidance for surveyors of nursing homes; therefore, we
felt that there was a need to ensure that the term was clearly defined
as ``the deliberate misplacement, exploitation, or wrongful, temporary,
or permanent use of a resident's belongings or money without the
resident's consent.''
Finally, we move the existing definition of ``transfer and
discharge'' from Sec. 483.12(a)(1) to Sec. 483.5(p).
C. Resident Rights (Sec. 483.10)
Current regulations at Sec. 483.10 address a number of resident
rights and facility requirements, including those establishing a
resident's right to exercise his or her rights, including rights
associated with a dignified existence, self-determination, planning and
implementing care, access to information, privacy and confidentiality.
Resident rights are also addressed in existing Sec. 483.15. Based on a
review of these regulations, we propose to retain all existing
residents' rights but update the language and organization of the
resident rights provisions to improve logical order and readability, to
clarify aspects of the regulation that warrant it, and to update
provisions to include technological advances such as electronic
communications. In order to achieve these objectives, we propose to
revise existing Sec. 483.10 to include only those provisions
specifying resident rights, including a number of provisions that are
currently included in Sec. 483.15. We further propose to add a new
Sec. 483.11, which would focus on the responsibilities of the
facility, including relevant provisions currently included in Sec.
483.10 and Sec. 483.15. We propose multiple re-designations and
revisions to improve logical order and readability, clarify aspects of
the regulation that warrant it, and reflect technological advances such
as electronic communications. Under our proposal, some existing
provisions will have components in both Sec. 483.10 and Sec. 483.11.
A detailed crosswalk of all of the proposed re-designations is provided
in Table A in section III of this proposed rule. Re-designations
without substantive changes are not discussed in detail below. We
discuss below our proposed revisions to those provisions retained in or
moved to Sec. 483.10. Regulatory citations have been updated
throughout to reflect the proposed new structure.
We propose to revise Sec. 483.10 to focus specifically on resident
rights. In proposed Sec. 483.10(a)(2), we would clarify the resident's
right to be supported in his or her exercise of rights under this
subpart. In proposed Sec. 483.10(a)(3), we would clarify the
resident's right to designate a representative, the resident
representative's limitation to those rights delegated by the resident,
and the resident's retention of those rights not delegated, including
the right to revoke a delegation. We have heard concerns that resident
representatives may be accorded more decision making authority than
their appointment or delegation permits. Our proposed clarification is
intended to ensure that facilities do not afford more decision making
authority to a resident representative than is intended by the
[[Page 42182]]
resident or permitted under applicable law. We note that resident
representatives fall into three categories: court-ordered or otherwise
designated under applicable law (e.g., state law), supported by
documentation (that is, an advance directive), and informal/oral. The
scope of resident representative authority may vary based on how they
are designated.
In Sec. 483.10(a)(4) we would address those residents who have
been adjudged incompetent under the laws of a state. We would clarify
the resident representative's limitation to exercising only the rights
delegated, and the resident's retention of rights not delegated.
Specifically, we would clarify that the resident who has been adjudged
incompetent under the laws of a state retains the right to exercise
those rights not addressed by a court order, that the resident
representative can only exercise the rights that devolve to them as a
result of the court order, that the resident's wishes and preferences
should continue to be considered, and that the resident should continue
to be involved in the care planning process to the extent practicable,
as the resident is at the center of the care team. We believe that it
is important for a resident who has been adjudicated incompetent to be
treated with respect and dignity and to continue to make those
decisions that are appropriate for him or her to make. Continuing to
honor these residents' preferences and involving them in care planning
will improve both quality of life and quality of care, resulting in
better outcomes. Lastly, in our proposed rule ``Medicare and Medicaid
Programs; Revisions to Certain Patient's Rights Conditions of
Participation and Conditions for Coverage'' (CMS-3302-P) (79 FR 73873),
published on December 12, 2014, at Sec. 483.10(a)(4), we proposed to
require that the same-sex spouse of a resident must be afforded
treatment equal to that afforded to an opposite-sex spouse if the
marriage was valid in the jurisdiction in which it was celebrated. In
this regulation, we are proposing to redesignate this requirement from
Sec. 483.10(a)(4) (as set out in the December 2014 proposed rule at 79
FR 73811) to Sec. 483.10(a)(5). We believe that this revision is
necessary to implement the Supreme Court decision in United States v.
Windsor, 570 U.S.12, 133 S.Ct. 2675 (2013).
In proposed Sec. 483.10(b), we have included resident rights
related to planning and implementing care. It is important for each
resident to understand his or her health conditions and the care and
services he or she will receive and to be able to participate in the
care planning process. These rights are already included for the most
part in the regulations, but we would update the language and co-locate
related provisions. Thus, we propose to re-designate and revise in this
provision current Sec. 483.10(b)(3), Sec. 483.10(b)(4) and Sec.
483.10(b)(8), relating to the resident's right to be informed of his or
her total health status, including medical conditions; the right to be
informed in advance of the risks and benefits of proposed care,
including treatment and treatment alternatives or treatment options so
that the resident can choose the alternative or option he or she
prefers; the right to request, refuse and/or discontinue treatment,
including participating in or refusing to participate in experimental
research; and the right to formulate advance directives. We propose to
add new requirements in Sec. 483.10(b)(5) to specify that the resident
has the right to participate in the care planning process, including
the right to identify individuals or roles to be included in the
planning process, the right to request meetings and the right to
request revisions to the person-centered plan of care. These
requirements support the standards set forth by the Secretary in the
``Guidance for Implementing Standards for Person-Centered Planning and
Self-Direction in Home and Community-Based Services Programs'' on June
6, 2014 (see https://www.acl.gov/Programs/CDAP/OIP/docs/2402-a-Guidance.pdf). We further specify in Sec. 483.10(b)(5)(iv) that the
resident has the right to receive the services and items included in
the plan of care. We also propose to re-designate and revise existing
Sec. 483.10(d)(2) to specify that the resident has the right, in
advance, to be informed of and to participate in, his or her care and
treatment, including the right to be informed, in advance, of the care
to be furnished and the disciplines that will furnish care. In
addition, we propose to specify the resident's right to participate in
the development of his or her comprehensive care plan. We also propose
at Sec. 483.10(b)(6) to include the resident's right to self-
administer medication if the interdisciplinary team has determined that
doing so would be clinically appropriate. Finally, we propose to add a
new section at Sec. 483.10(b)(7) to specify that these rights cannot
be construed as a right to receive medical care that is not medically
necessary or appropriate.
The ability of the resident to select his or her attending
physician remains an important right. However, it is also important
that the selected physician meet licensure requirements and be willing
and able to comply with the requirements of this subpart. Therefore, we
propose to require that the facility ensure that the attending
physician is appropriately licensed and credentialed to provide care
and meet the requirements of applicable regulations. In proposed Sec.
483.10(c), we would add new Sec. 483.10(c)(1), (2) and (3) to specify
that the physician chosen by the resident must be licensed to practice
medicine, and must meet professional credentialing requirements of the
facility. If the physician chosen by the resident refuses or is unable
to meet requirements specified in this part, we specify that the
facility has the right, after informing and discussing with the
resident, to seek alternate physician participation to assure the
provision of appropriate and adequate care and treatment. If the
resident chooses a new physician that meets the necessary requirements,
the facility must respect that choice.
As indicated earlier, NFs not only provide medical care, but may
also serve as a resident's home. This makes issues of respect and
dignity particularly important. In Sec. 483.10(d), we propose to re-
designate a number of provisions relating to resident respect and
dignity, based on existing Sec. 483.13(a) and Sec. 483.15. We further
propose to add a new Sec. 483.10(d)(5) to specify that a resident has
the right to share a room with his or her roommate of choice, when both
residents live in the same facility, both residents consent to the
arrangement, and the facility can reasonably accommodate the
arrangement. We note that married couples, whether opposite or same
sex, are addressed by Sec. 483.10(d)(5). Our proposed provision would
provide for a rooming arrangement that could include a same-sex couple,
siblings, other relatives, long term friends or any other combination
as long as the requirements above are met. We recognize that in some
instances, specific roommates requests cannot be accommodated by a
facility for clinical, safety, or logistical reasons. However, we
believe it is an important aspect of respect and dignity, as well as
self-determination, for individuals to be able to choose who they live
with, especially for long-term residents.
Self-determination is a critical element in the care and treatment
of nursing home residents. In proposed Sec. 483.10(e), we propose to
revise a number of provisions relating to resident self-determination.
We propose to revise Sec. 483.10(e)(3) to ensure not only that
specified individuals and/or organizations have access to the resident,
but also to ensure that the
[[Page 42183]]
resident can receive his or her visitors of choice at the time of his
or her choosing. We discuss our rationale further in our discussion of
proposed Sec. 483.11(d)(2). We propose to revise Sec. 483.10(e)(4)
and (5), clarifying that it is the resident's right to participate in
family groups and have his or her family members or resident
representatives participate in family groups in the facility.
The ability to have access to information such as personal medical
records and facility-specific information has changed significantly
since the promulgation of the original requirements for long-term care
facilities. We propose to co-locate provisions related to the
resident's right to access facility specific information, medical
records, information about advocacy and fraud control organizations,
Medicare and Medicaid coverage, and notices that the facility is
required to provide to the resident. These notices include, but are not
limited to a written description of legal rights, a written description
of the facility's policies to implement advance directives and
applicable state law pertaining to advance directives, and information
on how to apply for and use Medicare and Medicaid benefits. In
addition, we will update the provisions as appropriate to take into
account electronic medical records and other electronic communications.
Specifically, in proposed Sec. 483.10(f), we propose to re-designate
and revise a number of provisions relating to resident access to
information. First, we propose to specify in Sec. 483.10(f)(2) that
the resident has the right to receive notices verbally (meaning spoken)
and in writing (including Braille) in a format and a language he or she
understands. We note that effective communication for some residents
requires the use of auxiliary aids and services and have revised this
provision to reflect that. Next, we propose to add a new Sec.
483.10(f)(2)(i) to reference required notices and a new Sec.
483.10(f)(2)(iv) to ensure residents are aware of and can contact an
Aging and Disability Resource Center or other No Wrong Door program.
The Aging and Disability Resource Center Program (ADRC), established
under Section 202(20)(B)(iii) of the Older Americans Act; is a
collaborative effort of the U.S. Administration on Community Living and
the Centers for Medicare & Medicaid Services (CMS). ADRCs serve as
single points of entry into the long-term supports and services system
for older adults and people with disabilities. Sometimes referred to as
a ``one-stop shops'' or ``no wrong door'' systems, ADRCs address many
of the frustrations consumers and their families experience when trying
to find needed information, services, and supports. Through integration
or coordination of existing aging and disability service systems, ADRC
programs raise visibility about the full range of options that are
available, provide objective information, advice, counseling and
assistance, empower people to make informed decisions about their long
term supports, and help people more easily access public and private
long term supports and services programs. Additional information on
ADRC programs is available at https://www.adrc-tae.acl.gov/tiki-index.php?page_ref_id=1325.
Federal requirements and expectations related to the privacy and
confidentiality of patient records, especially with regard to protected
health information, changed substantially with the enactment of the
Health Insurance Portability and Accountability Act of 1996 (HIPAA) and
subsequent promulgation of the HIPAA Privacy and Security Rules (see 45
CFR part 160 and subparts A, C, and E of part 164) as well as the
subsequent enactment of the Health Information Technology for Economic
and Clinical (HITECH) Act as title XIII of division A and title IV of
division B of the American Recovery and Reinvestment Act of 2009 (ARRA)
and the promulgation of the Omnibus HIPAA Final Rule (78 FR 5566). For
simplicity, we will hereinafter collectively refer to these laws and
their implementing regulations as ``HIPAA.'' We note that
administration and enforcement of the privacy and security-related
portions of the HIPAA regulatory scheme are delegated to the HHS Office
for Civil Rights (OCR) and more detailed information related to these
provisions can be accessed through the OCR Web site at https://www.hhs.gov/ocr/privacy.
We propose to retain the requirements of current Sec.
483.10(b)(2)(i) and (ii), subject to the clarifying revisions described
below, at new Sec. 483.10(f)(3). In doing so, we recognize that the
HIPAA Rules establish a federal floor of privacy and security
protections and individual rights with respect to protected health
information held by covered entities (and their business associates),
and the rights granted in this proposed regulation are not intended to
conflict in any way with those HIPAA regulations. In addition, to the
extent that HIPAA provides additional rights to individuals (that is,
residents, in the long-term care context) beyond what is provided in
this proposal, this proposed regulation would not diminish those
rights. Therefore, we propose revisions that would clarify the
relationship between the requirements of 45 CFR 164.524 and the revised
version of Sec. 483.10(f)(3)(i) and (ii). We propose to specify in
paragraph (f)(3) that the resident has the right to access medical
records pertaining to him or herself and to further specify in proposed
(f)(3)(i) that the resident, upon oral or written request, has the
right to receive requested medical records in the form and format
requested by the resident, if it is readily producible in such form and
format (including in an electronic form or format when such records are
maintained electronically); or, if not, in a readable hard copy form or
such other form and format as agreed to by the facility and the
individual. This is consistent with the requirements of 45 CFR
164.524(c)(2). Finally, we propose to specify in paragraph (f)(3)(ii)
that the facility may impose a reasonable, cost-based fee for providing
copies of the medical records, provided that the fee includes only the
cost of labor for copying the health information requested by the
individual, whether in paper or electronic form; the supplies for
creating the paper copy or electronic media if the individual requests
that the electronic copy be provided on portable media; and postage,
when the individual has requested the copy be mailed. This is
consistent with 45 CFR 164.524(c)(4).This proposal does not address the
creation or provision of summary reports, which may be provided in
accordance with applicable law.
In Sec. 483.10(g)(1) we propose to revise a number of provisions
related to resident privacy and confidentiality to update the language
to accommodate electronic communications. We propose to retain existing
Sec. 483.10(c)(1) at proposed Sec. 483.10(g)(2), reiterate the
residents' right to a secure and confidential medical record at
proposed Sec. 483.10(g)(3) and, in proposed Sec. 483.10(g)(4), we
would retain the provisions of existing Sec. 483.10(e)(2) and (3).
Today, individuals have a number of electronic options for
communicating with others that are not addressed in the existing
regulations for LTC facilities. Thus, we propose to update these
regulations to take into consideration widespread advances in
electronic communications technologies. In proposed Sec. 483.10(h), we
propose to re-designate and revise a number of provisions relating to
resident communications. Specifically, we propose a new Sec. 483.10(h)
[[Page 42184]]
Communications, with Sec. 483.10(h)(1) revised to include TTY and TDD
services and cellular telephones; and a new Sec. 483.10(h)(2) to
provide reasonable access and privacy for electronic communications
such as email or internet-based interpersonal video communications. We
also include internet access, which can serve as a communications
medium as well as a means for residents to interact with entities and
persons outside of the facility or to use various programs and tools
for entertainment, shopping, conducting research and obtaining
information.
In proposed Sec. 483.10(i), we propose to revise the language to
state that the resident has a right to a safe, clean, comfortable,
homelike environment, and a right to receive treatment safely. In
proposed Sec. 483.10(j), we propose to revise language relating to
resident grievances to add that a resident cannot be deterred from
voicing a grievance for fear of reprisal or discrimination. This
clarifies that even when no actual reprisal or discrimination occurs,
intimidation and threats of reprisal or discrimination are not
permissible.
D. Facility Responsibilities (Sec. 483.11)
We propose a new Sec. 483.11 ``Facility Responsibilities,'' in
which we combine many of the regulations addressing facility
responsibilities which are currently dispersed throughout the existing
provisions regarding resident rights and quality of life. This proposed
revision is consistent with our overall objectives of updating the
language and organization of the resident rights provisions to improve
the logical order and readability, clarifying aspects of the
regulation, and updating provisions to include advances such as
electronic communications.
Consistent with Sec. 483.10, the introductory language for
proposed Sec. 483.11 would establish, based on existing requirements,
that the facility must treat its residents with respect and dignity and
provide care and services for its residents in a manner and in an
environment that promotes maintenance or enhancement of the resident's
quality of life and must protect and promote the resident's rights as
specified in Sec. 483.10. Further, the facility must recognize each
resident's individuality and provide services in a person-centered
manner. We propose to establish sections similar to those proposed in
Sec. 483.10. The proposed sections are ``Exercise of Rights,''
``Planning and Implementing Care,'' ``Attending Physician,'' ``Self-
Determination,'' ``Information and Communication,'' ``Privacy and
Confidentiality,'' ``Safe Environment,'' and Grievances.''
In a new section proposed at Sec. 483.11(a), ``Exercise of
Rights,'' we establish our expectation that the facility promote and
protect the rights of the resident. These expectations are not new
requirements, and are already set out in our regulations as resident's
rights. In order to ensure clarity, we have restated them clearly in
this provision as the responsibility of the facility to recognize and
effectuate those rights. Proposed Sec. 483.11(a)(1) would provide that
the facility ensure that the resident can exercise his or her rights
without interference, coercion, discrimination, or reprisal from the
facility. We propose to re-designate current Sec. 483.12(c)(1) as new
Sec. 483.11(a)(2) and move to this section the requirement that the
facility provide equal access to quality care regardless of diagnosis,
severity of condition, or payment source and establish and maintain
identical policies and practices regarding transfer, discharge, and the
provision of services for all residents regardless of source of
payment. In proposed Sec. 483.11(a)(3) and (4), we would specify that
the facility must treat the decisions of a resident representative as
the decisions of the resident to the extent required by the court or as
delegated by the resident, with the condition that the facility could
not extend greater authority to the resident representative than is
permitted under applicable law. We reiterate this point in the proposed
regulation as we respect the need to establish alternative decision
makers under certain circumstances. However, we received and are
concerned by external input suggesting that some facilities or staff
members defer to resident representatives for decisions that exceed the
scope of a court order, resident delegation, or other applicable law.
Proposed Sec. 483.11(a)(3) and (4) would clarify our expectations. In
addition, we propose to add a new Sec. 483.11(a)(5) that would clarify
for facilities that if facility staff believed that a resident
representative was making decisions or taking actions that are not in
the best interest of the resident, we would expect the facility to
comply with any state reporting requirements that might apply. We
understand that there is the potential for abuse and neglect in this
relationship and want to ensure that facilities recognize their role in
appropriately identifying and reporting concerns that rise to the level
of abuse, neglect or exploitation. The United States Government
Accountability Office (GAO) has published two reports related to abuses
that occur specifically in the context of guardianships. In September
2010, the GAO published ``Guardianships: Cases of Financial
Exploitation, Neglect and Abuse of Seniors'' (GAO-10-1046). In July
2011, the GAO published ``Incapacitated Adults: Oversight of Federal
Fiduciaries and Court-Appointed Guardians Needs Improvement'' (GAO-11-
678). While these reports focus on the need for improved screening and
monitoring of guardians, they also highlight the potential for abuse
and neglect in this relationship. According to the National Center on
Elder Abuse in the Administration on Aging, ``the laws in most states
require helping professions in the front lines--such as doctors and
home health providers--to report suspected abuse or neglect. . . .
Under the laws of eight states, `any person' is required to report a
suspicion of mistreatment'' (https://www.ncea.aoa.gov/Stop_Abuse/Get_Help/Report/index.aspx). These reporting requirements may apply to
abuse, neglect or exploitation by resident representatives.
In proposed Sec. 483.11(b), facility responsibilities include
ensuring that the resident is informed of, and participates in, his or
her treatment to the extent practicable, consistent with Sec.
483.10(b), and that the resident participates in care planning, making
informed decisions, and self-administering drugs when appropriate. In
addition to the self-administration of drugs, residents may also self-
administer or take part in other health care practices, such as
dialysis. We also expect that the facility, through the IDT and the
care planning process, would determine if, and under what
circumstances, this is appropriate. We also propose new requirements in
Sec. 483.11(b)(1) to require that the facility ensures that the care
planning process facilitates the inclusion of the resident or resident
representative, includes an assessment of the resident's strengths and
needs, and incorporates the resident's personal and cultural
preferences in developing goals of care. We note that person-centered
planning involves providing those services and supports that assist
individuals to live with dignity and to support their goals (including,
but not limited to, goals to potentially return to a community
setting). The Department of Health and Human Services has issued
guidance for implementing person-centered planning and self-direction
in home and community-based services programs, as set forth in section
2402(a) of the Affordable Care Act. The principles in
[[Page 42185]]
that guidance regarding dignity and self-direction apply equally to
individuals who reside in a nursing facility. https://www.acl.gov/Programs/CDAP/OIP/docs/2402-a-Guidance.pdf. Our proposed requirements
support those principles.
We propose to re-designate Sec. 483.10(b)(9) as Sec. 483.11(c)(1)
and revise it to add other primary care providers to ensure that the
resident knows the name, specialty and means of contacting the
professionals officially responsible for his or her care, whether that
provider is a physician, nurse practitioner, physician assistant, or
clinical nurse specialist. We further propose to add a new Sec.
483.11(c)(2), consistent with our proposed Sec. 483.10(c)(1), (2) and
(3), to clarify that the facility has a responsibility to ensure that
the resident's attending physician has appropriate professional
credentials and meets the requirements of this subpart. If the
physician was not appropriately credentialed or was unwilling or unable
to meet the requirements of this subpart, the facility could seek an
alternate physician after informing and discussing this matter with the
resident. In order to ensure that the resident could seek out a
suitable alternative, we propose to add a new Sec. 483.11(c)(3) to
specify that if the resident subsequently finds a new physician who
meets the necessary requirements, the facility would be required to
honor that selection.
We propose a new Sec. 483.11(d) to address the facility's
responsibilities related to resident self-determination. We propose to
re-designate Sec. 483.10(j), regarding access to the resident, as
Sec. 483.11(d)(1), and revise it to include visitors as specified in
our ``Resident Rights'' provision, including immediate access to the
resident by the resident representative, and to update the languages
and references for the Office of the State long term care ombudsman and
the protection and advocacy system. This would be an addition to the
current requirement which provides a right of access to any entity or
individual that provides health, social, legal, or other services to
the resident, subject to the resident's right to deny or withdraw
consent at any time. This is consistent with our approach in other
settings such as acute care hospitals, and in keeping with the person-
centered focus of this proposed rule. In addition, we propose to add a
new Sec. 483.11(d)(2) to require that the facility have written
policies and procedures regarding visitation rights of residents. This
requirement would support resident self-determination, consistent with
the person-centered focus of this proposed rule, and would follow the
requirements established for inpatient hospitals. As noted in the
November 19, 2010 final rule (75 FR 70831 at 70832), regarding hospital
visitation rights, physicians, nurses, and other staff caring for the
resident might miss an opportunity to gain valuable information from
those who may know the resident best with respect to the resident's
medical history, conditions, medications, and allergies, particularly
if the resident had difficulties recalling or articulating, or is
totally unable to recall or articulate, this vital personal
information. Many times, these individuals who may know the resident
best can act as an intermediary for the resident, helping to
communicate the resident's needs to facility staff. As stated in that
November 19, 2010 final rule, we believe that restrictive visitation
policies can effectively eliminate these advocates for many residents,
potentially to the detriment of the resident's health and safety.
Further, given that the facility is often the resident's home, we
suggest that, as in hospitals, the hazards and challenges regarding
open visitation are manageable. In fact, we believe an open visitation
policy helps residents by providing a better support system and a more
homelike environment. Moreover, this policy may create more trust and a
better working relationship between facility staff, the resident, and
the resident's support system. Thus, we believe it is vital to
establish open visitation in SNFs and NFs.
We propose to re-designate Sec. 483.15(c)(5) as Sec.
483.11(d)(3)(ii) and revise it to clarify that the facility-designated
staff person who participates in a resident or family group must be
approved by the resident or family group and the facility. It is
important that the facility representative be an individual who the
group can work with and who does not have a chilling effect on the
function of the group. We further clarify that this provision does not
require a facility to implement every recommendation of a resident or
family group, but that the facility should be able to provide the
rationale for their response. We propose a new Sec. 483.11(d)(4),
which would incorporate requirements currently specified in Sec.
483.10(h) and would specify that the facility is responsible for
ensuring that a resident is not required to perform services for the
facility.
We propose a new Sec. 483.11(d)(5), which would incorporate
requirements from Sec. 483.10(c) that focus on the facility's
responsibility related to the protection of resident funds.
Specifically, we propose in Sec. 483.11(d)(5)(ii) to reflect the
different dollar threshold requirements of sections 1819(c)(6)(B)(i)
and 1919(c)(6)(B)(i) of the Act and establish the statutory requirement
for deposit of resident funds in excess of $100 in an interest-bearing
account for Medicare and other non-Medicaid SNF residents, consistent
with section 1819(c)(6)(B)(i) of the Act, and funds in excess of $50
for Medicaid beneficiaries, consistent with section 1919(c)(6)(B)(i) of
the Act. We propose in Sec. 483.11(d)(5)(v) to include the return of
funds to residents upon discharge or eviction, in accordance with state
law in addition to the already existing regulatory requirement for
conveyance to the estate upon death. We received suggestions to reduce
the time frame for these conveyances. We researched common time frames
for the return of security deposits and found that most states (at
least 33) allow 30-days, and sometimes longer for the return of
security deposits. Therefore, we determined the current time frame is
reasonable and we do not propose to make any changes to this section.
We propose to add a new Sec. 483.11(d)(6)(i)(G) to indicate that
the facility may not charge the resident for hospice services elected
by the resident and paid for under the Medicare Hospice Benefit or paid
for by Medicaid under a state plan, whether provided directly by the
SNF/NF or by a hospice provider under agreement with the SNF/NF.
We propose in Sec. 483.11(d)(6)(ii), re-designated from Sec.
483.10(c)(8)(ii), to add to the limitations on charges to residents'
funds. This provision currently provides general categories and
examples of items and services that the facility may charge to
residents' funds if the items are requested by a resident, and are not
required to achieve the goals stated in the resident's care plan. In
these instances, the resident is informed that there will be a charge
and that the items are not paid for by Medicare or under a state plan.
We propose to add new Sec. 483.11(d)(6)(ii)(L)(1) and (2) to clarify
that the facility may not charge for special food and meals ordered for
a resident by a physician, physician assistant, nurse practitioner,
clinical nurse specialist, dietitian or other clinically qualified
nutrition professional and to cross-reference to provisions regarding
the expectation that the foods and meals a facility generally prepares
should be developed taking into consideration residents' needs and
individual preferences in addition to the overall cultural and
religious make-up of the facility's population. Refer to our discussion
in
[[Page 42186]]
Section II. P. ``Food and Nutrition Services for additional
information. We propose a clarification in proposed Sec.
483.11(d)(6)(iii) by adding the term ``non-covered'' before ``item or
service,'' as this provision would only apply to non-covered items or
services.
We propose to establish a new Sec. 483.11(e) to incorporate
multiple provisions related to information and communication. With the
exception of medical records, we propose in Sec. 483.11(e)(1) to
specify that the facility is responsible for ensuring that information
provided to the resident is provided in a form and manner that the
resident can access and understand, including in a language that the
resident can understand. Medical records are addressed in proposed
Sec. 483.11(e)(2), As noted earlier, this proposal does not address
the creation or provision of summary reports of medical records.
Summary reports of medical records may be provided in accordance with
applicable law. The language requirement is already a requirement for
specific types of notices and information (see Sec. 483.10(b)(1),
Sec. 483.10(b)(3), and Sec. 483.12(a)(4)(i)). However, language is
not the only barrier to effective communication and it is important for
the resident to have the opportunity to understand all information that
is provided. We also hope to provide facilities with some flexibility
to implement this requirement. For example, in some cases, a resident
representative may prefer to access information on the internet rather
than receive a paper copy, or it may be more effective and efficient
for a resident who is blind or visually impaired to listen to an audio
file explaining resident rights. Some residents may require assistive
technology or alternative formats. The key to this provision is
ensuring that when there is a requirement to provide information, it is
provided in a way to ensure both resident access and understanding.
We propose in Sec. 483.11(e)(2) to revise facility requirements
currently in Sec. 483.10(b)(2)(i) through (ii), consistent with our
proposal at Sec. 483.10(f)(3). Proposed (e)(2)(i) would require that
facilities provide residents with access to his or her medical records
in the form and format requested by the individual, if it is readily
producible in such form and format (including in an electronic form or
format when such medical records are maintained electronically); or, if
it is not readily producible in such form and format, in a readable
hard copy form or other form and format as may be agreed to by the
facility and the individual. This provision would include the existing
requirement that access be provided upon oral or written request,
redesignated from Sec. 483.10(b)(2)(i), and that this access be
provided within 24 hours, excluding weekends and holidays, as required
by sections 1819(c)(1)(A)(iv) and 1919(c)(1)(A)(iv) of the Act. We
believe in some circumstances an electronic copy may be a preferable
and more efficient option for both the facility and the resident or
resident's representative, particularly where the record already exists
in an electronic format. We propose at (e)(2)(i) to require that the
facility allow the resident, after receipt of his or her medical
records for inspection, to purchase a copy of the medical records or
any portion thereof upon request and with 2 working days advance notice
to the facility. We further propose at Sec. 483.11(e)(2)(iii) to
revise the standard for the fee a facility may charge for the requested
information from a community standard to a cost-based standard under
which the fee includes only the cost of labor for copying the requested
health information, whether in paper or electronic form; the supplies
for creating the paper copy or electronic media if the individual
requests that the electronic copy be provided on portable media,
postage when the individual requested the copy be mailed. This is
consistent with the requirements of 45 CFR 164.524(c)(4).
We propose to add a new Sec. 483.11(e)(3), incorporating and re-
designating part of existing Sec. 483.10(g)(1), with revisions
required by section 6103(c) of the Affordable Care Act, which added new
sections 1819(d)(1)(C) and 1919(d)(1)(V). Those provisions require that
individuals have access to surveys of the facility conducted by federal
or state surveyors and any plan of correction in effect with respect to
the facility for the preceding 3 years. We note that this provision
does not require a specific format, but consistent with our proposed
Sec. 483.11(e)(1), it must be in a form and manner accessible to and
understandable by the resident.
We propose to add a new Sec. 483.11(e)(4)(i) and (ii) to require
the facility to post, in a form and manner easily accessible and
understandable to residents, resident representatives and support
persons, information that would allow individuals to contact pertinent
client advocacy groups, including the state survey and certification
agency, the state licensure office, the State Long-Term Care Ombudsman
Program, the Protection and Advocacy Network, and the Medicaid Fraud
Control Unit. We also propose to require that the facility post a
statement that a resident may file a complaint with the state survey
and certification agency. The facility is already required at existing
Sec. 483.10(b)(7), which would be re-designated at proposed Sec.
483.11(e)(12), to provide this information in the written description
of legal rights provided to the resident. However, we believe that
posting this information will ensure that resident representatives as
well as other support persons and residents continue to have access to
updated and readily understandable information.
We propose to add a new paragraph Sec. 483.11(e)(7)(i) to specify
that when a facility notifies a physician of a change in a resident's
status, the facility must ensure that certain pertinent information is
available and is provided to the physician upon request. The required
information would be the same information we propose to require under
new Sec. 483.15(b)(2) (information in transfer or discharge). This
requirement, in concert with proposals to improve transitions of care,
communications among and between practitioners, appropriate exchange of
information, and quality assessment activities, will help ensure that
the physician's decisions relating to treatment or transfer of a
resident to an acute care facility are made on the basis of the best
information available. Widely available methodologies and tools may
assist facilities in ensuring that effective information exchanges
occur. For example, Situation, Background, Assessment, Recommendation
(SBAR) is a common methodology for structured communication.
Information and tools relating to SBAR are widely available, including
but not limited to from sources such as the Agency for Healthcare
Research and Quality (www.innovations.ahrq.gov), The Joint Commission
(www.jointcommission.org), the Institute for Healthcare Improvement
(www.ihi.org), the INTERACT (Interventions to Reduce Acute Care
Transfers) project (https://interact2.net), and others.
We propose to revise the language of Sec. 483.10(b)(11)(i) and re-
designate it as new Sec. 483.11(e)(7)(i) to provide that the facility
would be required to notify the resident representatives, rather than
the current requirement that the facility notify ``. . . the resident's
legal representative or an interested family member . . .''. The
proposed language allows a guardian or other legal representative as
well as any other individuals the resident identifies, including family
members, other
[[Page 42187]]
relatives, close personal friends, or any other persons identified by
the resident, to receive the required notifications and thus remain
informed of important information about the resident.
We propose to re-designate Sec. 483.10(b)(1), which addresses the
facility requirement to provide a notice of rights and services, as
Sec. 483.11(e)(9)(i) through (iii). We propose one minor revision for
clarity in Sec. 483.11(e)(9)(ii) to state ``the State-developed notice
of Medicaid rights, if any'' instead of the current language ``notice
(if any) of the State developed under 1919(e) of the Act''.
We propose to revise Sec. 483.10(b)(5)(i) and (ii) and re-
designate them as Sec. 483.11(e)(10). The revised provision would
specify that the facility must inform each resident, in writing, at the
time of admission to a Medicaid-participating nursing facility and when
the resident becomes eligible for Medicaid--(1) Of the items and
services that are included in nursing facility services under the state
plan and for which the resident may not be charged; (2) of those items
for which the resident may be charged, and the amount of charges for
those services; and (3) inform Medicaid-eligible residents when changes
are made to the items and services in proposed paragraph (e)(11)(i) of
this section.
We propose to revise and re-designate Sec. 483.10(b)(6) as new
Sec. 483.11(e)(11). In addition, we propose to add new paragraphs (i)
through (v) to require the facility to provide notice to residents when
changes are made to the items and services covered by Medicare and/or
Medicaid or to the amount that the facility charges for items and
services. It is important that residents remain informed of these
issues in order to ensure their ability to make informed decisions,
both financial and health-care related.
To improve clarity, we propose to re-designate Sec. 483.10(b)(7)
as new Sec. 483.11(e)(12) and revise current paragraph (b)(7)(iii) to
require that the facility provide the resident with ``a list of names,
addresses (mailing and email), and telephone numbers of all pertinent
state regulatory and informational agencies, resident advocacy groups
such as the state survey and certification agency, the state licensure
office, the state long-term care ombudsman program, the protection and
advocacy agency, adult protective services, the state or local contact
agencies for information about returning to the community and the
Medicaid fraud control unit.'' Additionally, we propose to revise
current paragraph (b)(7)(iv) to require that the facility include in
the written description of legal rights ``a statement that the resident
may file a complaint with the state survey and certification agency
concerning any suspected violation of LTC requirements, including but
not limited to resident abuse, neglect, misappropriation of resident
property in the facility, non-compliance with the advance directives
requirements, and requests for information regarding returning to the
community.''
We propose a new Sec. 483.11(e)(13) that would establish that the
facility must protect and facilitate a resident's right to communicate
with individuals and entities both inside and external to the facility,
including at Sec. 483.11(e)(13)(ii) reasonable access to the internet,
to the extent it is available to the facility. Section
483.11(e)(13)((i) would revise and replace Sec. 483.10(k) and Sec.
483.11(e)(13)((iii) would revise and replace Sec. 483.10(i)(2) with
regard to reasonable access to a telephone, including TTY and TDD
services, and to stationery, postage, writing implements and the
ability to send mail, respectively.
We propose a new Sec. 483.11(f) to include provisions related to
privacy and confidentiality. Proposed Sec. 483.11(f)(1) would require
that the facility respect the resident's right to personal privacy.
Proposed (f)(1)(ii) would incorporate the definition of personal
privacy currently set out at Sec. 483.10(e)(1). We propose to replace
the requirements of existing Sec. 483.10(e)(2) with new Sec.
483.11(f)(2) which requires the facility to comply with the
requirements of proposed Sec. 483.10(g)(3). We propose to redesignate
existing Sec. 483.10(j)(3) as Sec. 483.11(f)(3) and revise it to
require that the facility allow representatives of the Office of the
State Long-Term Care Ombudsman to examine a resident's medical, social,
and administrative records in accordance with state law. This is
consistent with the requirements of section 712(b)(1) of the Older
Americans Act.
We propose a new Sec. 483.11(g) that would include provisions
related to a safe environment. Specifically, we propose to re-designate
Sec. 483.15(h)(1) through (7) as Sec. 483.11(g)(1) through (7) and
revise paragraph (g)(1) to include paragraphs (g)(1)(i) specifying that
the facility must ensure an environment where care and services can be
delivered safely, and (g)(1)(ii) specifying that the facility must
ensure that the physical layout of the facility maximizes independence
and does not pose a safety risk.
We are proposing a new Sec. 483.11(h) Grievances, which would
incorporate the facility responsibilities expressed in existing Sec.
483.10(f) and would also require that facilities ensure that residents
know how to file grievances. The proposed provision would also require
that the facility establish a grievance policy to ensure the prompt
resolution of grievances, and identify a Grievance Officer.
Additionally, the facility would be required to provide a copy of this
policy upon request, as well as make information about filing
grievances available to residents. Furthermore, the facility would be
required to take a number of actions in response to a grievance,
including:
1. Preventing further violations of resident rights during an
investigation,
2. Immediately reporting allegations of neglect, abuse (including
injuries of unknown source), and/or misappropriation of resident
property, by anyone furnishing services on behalf of the facility, to
the administrator of the facility and as required by state law,
3. Ensuring that all written grievance decisions include the date
the grievance was received, a summary statement of the resident's
grievance, the steps taken to investigate the grievance, a summary of
the pertinent findings or conclusions regarding the resident's
concerns, a statement as to whether the grievance was confirmed or not
confirmed, any corrective action taken or to be taken by the facility
as a result of the grievance, and the date the written decision was
issued,
4. Taking appropriate corrective action in accordance with state
law if the alleged violation of the residents' rights is confirmed by
the facility or if an outside entity having jurisdiction confirms a
violation of any of these residents' rights within its area of
responsibility; and
5. Maintain evidence demonstrating the resolution of complaints and
grievances for at least 3 years.
The right to file a grievance is an important protection for
residents and an important right of residents. The proposed revisions
are intended to ensure that grievances are taken seriously and
processed appropriately.
Finally, we propose a new Sec. 483.11(i) which would require that
a facility not prevent or discourage a resident from communicating with
Federal, State, or local officials, including but not limited to
Federal and State surveyors, other Federal or State health department
employees, including representatives of the Office of the State Long-
Term Care Ombudsman and of the protection and advocacy system.
Residents must have the ability to communicate freely with
representatives of these entities when
[[Page 42188]]
they have concerns about quality or care and quality of life.
E. Freedom From Abuse, Neglect, and Exploitation (Sec. 483.12)
Currently, Sec. 483.13 is titled ``Resident Behavior and Facility
Practices.'' The focus of this section is to ensure that residents of
SNFs and NFs are not subjected to abuse, neglect, misappropriate of
resident property, and exploitation when they reside in a facility, to
specify the facility responsibilities to prevent abuse, neglect and
exploitation, and to establish requirements for the facility response
to allegations that any of these has occurred. Thus, we propose to re-
designate and revise this section as Sec. 483.12, ``Freedom from
Abuse, Neglect and Exploitation,'' to more accurately reflect the
contents and intent. The term ``exploitation'' was not previously
included in this regulatory provision. However, in reviewing available
materials related to abuse such as The Joint Commission standards for
accreditation of long term care facilities and language relating to
``misappropriation of resident property,'' currently defined at Sec.
488.301, we believe it is appropriate and necessary to add this term
here as well to address circumstances that may not rise to the level of
abuse or neglect but nonetheless would be prohibited. Therefore, we
propose in our discussion of the definitions section of this regulation
to provide a definition of ``exploitation''. Although there have been
significant improvements in many areas of nursing home care, abuse
remains a serious issue. According to CMS Certification and Survey
Provider Enhanced Reports (CASPER) data, there were 474 noncompliance
deficiency citations related to freedom from abuse in Fiscal Year (FY)
2011, and 475 citations in FY 2012, affecting 2.5 percent of nursing
home providers. Our proposed updates and revisions to this section are
intended to both recognize that abuse continues to occur, and to
provide language that will build on progress to improve conditions in
nursing homes begun by the nursing home reforms of the Omnibus Budget
Reconciliation Act of 1987, Pub. L. 100-203 (OBRA '87).
Currently, paragraph Sec. 483.13(a) addresses the use of
restraints. We propose to address restraints in both the introductory
paragraph to proposed Sec. 483.12 and in proposed Sec. 483.25(d)(1).
In the introductory paragraph to proposed Sec. 483.12, we would
continue to prohibit the inappropriate use of restraints. Restraints
can be used abusively. There may be very limited circumstances where
restraints would be appropriate in a nursing facility. We propose to
further address restraints in proposed section Sec. 483.25(d)(1) on
Quality of Care and Quality of Life. The use of restraints has fallen
significantly in the last decade and CMS continues to promote reduction
in the use of physical restraints. (See CMS 2012 Nursing Home Action
Plan; https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Downloads/2012-Nursing-Home-Action-Plan.pdf). We note that many facilities have achieved a rate of
zero percent restraint use (see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/Downloads/QAPINewsBrief.pdf).
Existing paragraph Sec. 483.13(b) would also be included in the
new introductory paragraph to revised Sec. 483.12. The revised
introductory paragraph would set out the intent of this section. We
propose to re-designate existing Sec. 483.13(c)(1) as Sec.
483.12(a)(2) and modify the language to clarify that a facility must
not employ or otherwise engage individuals who have been found guilty
of abuse, neglect, or mistreatment of residents by a court of law; had
a finding of abuse, neglect, mistreatment of resident or
misappropriation of property reported into a state nurse aide registry,
or had a disciplinary action taken against a professional license by a
state licensure body as a result of a finding of abuse, neglect, or
mistreatment of residents or a finding of misappropriation of property.
The proposed revision makes clear that the facility is responsible for
protecting residents from abuse, neglect and exploitation by a person
providing services, whether the individual has an employee relationship
with the facility or is ``otherwise engaged'' by the facility--that is,
providing services under a different arrangement, such as a volunteer
or a contractor. Currently, the regulations require that a facility
must not employ an individual who has had a finding entered against
them into a state nurse aide registry concerning abuse, neglect,
mistreatment of residents or misappropriation of property. We propose
to add a new Sec. 483.12(a)(2)(iii) to expand this employment
prohibition to include licensed professionals who have had a
disciplinary action taken against them by a state licensure body as a
result of a finding of abuse, neglect, mistreatment of residents or
misappropriation of resident property. Although a licensure
disciplinary action would normally prevent a licensed professional from
further practice in the state of licensure for some specified period of
time, we believe inclusion in the federal standards is necessary to
ensure the safety of long term care facility residents. We believe that
disciplinary action information is available through state licensing
boards and that it is appropriate to explicitly hold licensed personnel
to the same standard as nurse aides.
We propose to re-designate existing Sec. 483.13(c) as Sec.
483.12(b) and to revise it to also require that the facility develop
and implement written policies and procedures that prohibit and prevent
abuse, neglect, exploitation of residents and misappropriation of
resident property. We propose to add a new Sec. 483.12 (b)(2) to
require that the facility establish policies and procedures to
investigate any allegations of abuse, neglect, exploitation, or
misappropriation of property, We also propose to add a new Sec.
483.12(b)(3) to require training, including training on resident's
rights, facility responsibilities, and recognition and reporting of
abuse neglect and exploitation, which we would require in proposed
Sec. 483.95. Our proposals related to training are discussed in
section X, ``Training requirements'' (Sec. 483.95) of this preamble.
We believe both the requirements in proposed new Sec. 483.12(b)(2) and
(b)(3) are necessary to ensure effective and consistent investigative
processes and to ensure that direct care/direct access workers are
trained to recognize when treatment is abusive or constitutes neglect
or exploitation. We are hopeful that training may reduce the frequency
of these incidents. Finally, we propose a new Sec. 483.12(b)(5) to
require that facilities establish policies and procedures to ensure
reporting of crimes in accordance with section 1150B of the Act. The
policies and procedures would have to include, at a minimum, annual
notification of covered individuals, posting a conspicuous notice of
employee rights, and prohibiting and preventing retaliation.
Annual notification of covered individuals, as defined at sec.
1150B(a)(3), includes notification of that individual's obligation, as
specified at 1150B(b)(1), to report to the State Agency and one or more
law enforcement entities for the political subdivision in which the
facility is located any reasonable suspicion of a crime against any
individual who is a resident of, or is receiving care from, the
facility. Reporting to the State Agency fulfills the statutory
directive to report to the Secretary. In accordance with 1150B(b)(2),
the reporting required by 1150B(b)(1) must occur not later than 2 hours
after forming the suspicion, if the
[[Page 42189]]
events that cause the suspicion result in serious bodily injury, or not
later than 24 hours if the events that cause the suspicion do not
result in serious bodily injury. A fuller discussion of these
requirements was provided in a June 17, 2011 Survey and Certification
Letter to State Survey Agency Directors and further addressed through a
question and answers document in January, 2012. These documents are
available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SCLetter11_30.pdf .
We propose that enforcement of these requirements would be based on the
terms of that guidance. We are specifically requesting comment on these
proposed provisions and our proposed implementation of Section 1150B of
the Act.
We propose to re-designate existing Sec. 483.13(c)(1)(iii) as
proposed Sec. 483.12(a)(3) and revise existing Sec. 483.13(c)(2), (3)
and (4) as proposed Sec. 483.12(c)(1), (2), (3) and (4). Specifically,
we propose to add the term ``exploitation'' in proposed paragraph
(c)(1) and add adult protective services where state law provides for
jurisdiction in long-term care facilities to the list of officials who
must be notified in accordance with state law; otherwise the language
would be unchanged from Sec. 483.12(c)(2). We propose to divide
existing Sec. 483.13(c)(3) into two paragraphs, Sec. 483.12(c)(2) and
(3), making the investigation of alleged violations distinct from the
facility's obligation to prevent further abuse of the allegedly abused
resident or other residents while the investigation is in progress.
F. Transitions of Care (Sec. 483.15)
We propose to re-designate current Sec. 483.12 ``Admission,
transfer, and discharge rights'' as new Sec. 483.15, and revise the
general title to ``Transitions of care'' in order to reflect current
terminology that applies to all instances where care of a resident is
transitioned between care settings. Extensive literature speaks to
quality of care concerns related to the transitions.
In proposed new paragraph (a) we would begin with requirements for
admissions policies, which would be moved to the beginning of the
section to reflect chronological order. We propose a new paragraph
(a)(1) to require that the facility establish an admissions policy.
Additionally, we would re-designate current Sec. 483.12(d)(1) as
Sec. 483.15(a)(2) to state that facilities cannot request or require
residents or potential residents to waive their rights to Medicare or
Medicaid benefits or to any rights conferred by applicable state,
federal and local licensing or certification laws. We propose to add a
new paragraph (a)(2)(iii) to prohibit facilities from requesting or
requiring residents or potential residents to waive any potential
facility liability for losses of personal property. We understand that
residents are sometimes asked to waive facility responsibility for the
loss of their personal property or are unable to use personal property
because it is only permitted in the facility if safeguarded by the
facility in a manner that makes the property usually inaccessible to
the resident. These policies effectively take away the residents' right
to use personal possessions and relieve facilities from their
responsibility to exercise due care with respect to residents' personal
property. We expect this requirement will encourage facilities to
develop policies and procedures to safeguard residents' personal
possessions without effectively prohibiting a resident's use of
personal possessions. We further propose to add a new paragraph (a)(6)
to specify that a nursing facility must disclose and provide to a
resident or potential resident, prior to time of admission, notice of
any special characteristics or service limitations of the facility. For
example, if a facility has a religious affiliation that guides its
practices, any resulting special characteristics, requirements, or
limitations would have to be communicated to potential residents at
admission. Similarly, if a facility did not have the capability to care
for residents requiring psychiatric care, potential residents would
have to be advised of this prior to admission. The potential resident
or resident representative could then make an informed initial decision
about admission, should the need for specific types of care or services
later become necessary, the need for an appropriate transfer will be
more predictable and understandable to the resident. We believe this
type of disclosure is current standard business practice, however, in
keeping with proposed provisions related to specifying reasons for
transfer or discharge as well as to ensure informed choices on the part
of the resident at the time of admission, we would add this requirement
explicitly.
We also propose to relocate existing Sec. 483.10(b)(12) to new
Sec. 483.15(a)(7). This section addresses admission disclosure
requirements for composite distinct part nursing facility, and is more
appropriately located in the section on admissions.
We propose to re-designate Sec. 483.12(a) as proposed Sec.
483.15(b) and address transfers and discharges. Sec.
483.15(b)(1)(ii)(C) would revise existing Sec. 483.12(a)(2)(iii) and
we would clarify that a resident could be discharged when the safety of
other individuals is endangered due to the clinical or behavioral
status of that resident. In proposed Sec. 483.15(b)(1)(ii)(E), we
would revise existing Sec. 483.12(a)(2)(v) and clarify that provisions
for discharge as a result of non-payment of facility charges would not
apply unless the resident did not submit the necessary paperwork for
third party payment or until the third party, including Medicare or
Medicaid, denied the claim and the resident refused to pay for his or
her stay. This is consistent with existing guidance and would help to
clarify the meaning of failure to pay. Finally, we propose a new Sec.
483.15(b)(1)(iii) to specify that the facility may not transfer or
discharge the resident while the appeal is pending, pursuant to 42 CFR
431.230 when a resident exercises his or her right to appeal a transfer
or discharge notice from the facility pursuant to 42 CFR 431.220(a)(3).
``Discharge/Eviction'' was the most frequent nursing facility complaint
category processed by the Long-Term Care Ombudsman Programs nationally
in FY 2013 (8,478 complaints) and has been the first or second most
frequent complaint category consistently since 2006. Involuntary
discharges are often traumatic for residents. Transfer or discharge
from a facility prior to an appeal determination can result in an
unnecessary transfer out of and back to a facility.
In the proposed revision to paragraph Sec. 483.15(b)(2), we would
make a number of revisions based on the importance of effective
communication between providers during transitions of care. First, we
propose to clarify that the transfer or discharge would be documented
in the resident's clinical record and that appropriate information
would be communicated to the receiving setting. While this type of
documentation is presently required for hospitals with which the
facility has a transfer agreement, such communication is important
regardless of the setting to which the resident is being transferred or
discharged. In addition, we propose to require that, when a facility
transfers or discharges a resident because the transfer or discharge is
necessary for the resident's safety and welfare, the facility would
include in its documentation the specific resident needs that it cannot
meet, facility attempts to meet the resident needs, and the service(s)
available at the receiving facility that
[[Page 42190]]
will meet the resident's needs. We believe this proposal will
discourage facilities from discharging residents inappropriately. We
note that facilities are obligated under the Americans with
Disabilities Act and the Rehabilitation Act not to discriminate against
residents based on the severity of their disability. Discharging or
transferring a resident without first implementing accommodations to
better meet the resident's needs may be in conflict with these laws.
We propose to add a new requirement at Sec. 483.15(b)(2)(i) that
the transferring facility provide necessary information to the
resident's receiving provider, whether it is an acute care hospital, a
LTC hospital, a psychiatric facility, another LTC facility, a hospice,
home health agency, or another community-based provider or
practitioner. We note that the exchange of information ``needed for
care and treatment of residents, and when the transferring facility
deems it appropriate, for determining whether such residents can be
safely and appropriately cared for in a less expensive setting than
either the facility or the hospital'' is already required under Sec.
483.75(n) as a component of the transfer agreement a facility must have
with one or more hospitals. However, that provision only applies to
hospitals with which the facility has a transfer agreement and it does
not require any minimum standards for the information to be exchanged.
To provide safe, effective care to residents, we believe it is critical
that timely and accurate clinical information follow the resident
across care settings and providers. Transitions of care represent a
period of increased risk for complications and adverse events for the
individual. One way to reduce this risk is to ensure effective
communication between care providers. In recognition of this, in August
of 2011, the State of New Jersey mandated the use of a universal
transfer form. Rhode Island and Massachusetts also require a universal
transfer form and the American Medical Directors Association has
developed and recommends the use of a universal transfer form.
Additionally, other tools and information are available from CMS (see
https://www.medicare.gov/Pubs/pdf/11376.pdf) and AHRQ (see https://www.innovations.ahrq.gov/content.aspx?id=3285) as well as through a
number of professional organizations, including but not limited to the
National Transitions of Care Coalition (www.ntocc.org). Examples of
resources include TeamSTEPPS[supreg] Long Term Care Version (https://www.ahrq.gov/professionals/education/curriculum-tools/teamstepps/longtermcare/) INTERACT (https://interact2.net/), and the On-Time
Quality Improvement Program (https://www.ahrq.gov/professionals/systems/long-term-care/resources/ontime/qualityimprov/). We expect
that new tools and information will be developed over time. Electronic
health records could simplify the process of extracting necessary
information when a resident is transferred from a nursing home and
electronic summary of care documents provide a standardized way to
exchange critical information between providers.
As noted earlier, HHS also has a number of initiatives designed to
encourage and support the adoption of health information technology and
to promote nationwide health information exchange to improve health
care. While current Medicare and Medicaid EHR Incentive programs have
focused on providers other than SNFs and NFs, certified health IT
possesses capabilities that can assist any health care provider to
improve the quality, safety and efficiency of the care they deliver.
For more information about how currently available certified health IT
systems can enable the electronic exchange of a summary care record,
providers should review ``Certification Guidance for EHR Technology
Developers Serving Health Care Providers Ineligible for Medicare and
Medicaid EHR Incentive Payments,'' which addresses use of the 2014
Edition of ONC certification criteria (available at https://www.healthit.gov/sites/default/files/generalcertexchangeguidance_final_9-9-13.pdf).
The 2015 Edition of certification criteria for health IT, published
on March 30, 2015 at 80 FR 16902, proposes to define a common clinical
data set. As discussed in the draft Interoperability Roadmap, HHS
believes a core priority for improving health and health care quality
through nationwide interoperability is the ability to electronically
send, receive, find and use a common clinical data set. By aligning the
data elements proposed below with this proposed common clinical data
set, we believe facilities will be well-positioned to engage in
electronic communication of information during the transfer process. In
addition, new standards supporting the exchange of a summary care
record include additional information directly applicable to SNF and NF
settings. The HL7 Clinical Document Architecture (CDA) Release 2.0, now
identified as the best available standard for exchange of a summary
care record (https://www.healthit.gov/standards-advisory) and proposed
for inclusion in the 2015 Edition of certification criteria for health
IT (80 FR 16804) makes new standards available for pressure ulcers,
functional and cognitive status, advanced directives, and other
clinical health information that could be used for exchange in summary
records, as well as a new dedicated Transfer Summary document that
could be used for exchange in summary records. These standards were
developed through a public-private collaboration including an ONC-
sponsored Standards and Interoperability Longitudinal Coordination of
Care Workgroup and HL7 (a private sector, American National Standards
Institute (ANSI)-accredited standards development organization) and
will support more robust interoperable health information exchange
across the care continuum, including with and by nursing homes.
We note that we are not proposing to require a specific form,
format, or methodology for this communication. Instead, we propose
specific data elements or a set of information that must be
communicated during the transfer process. We believe that existing
state-mandated forms would meet our proposed requirements. We have
reviewed literature related to transitions of care and re-
hospitalization as well as the available universal transfer forms and
work on the development of interoperability standards for EHRs and
propose to require specific information consistent with our research.
This includes demographic information, including but not limited to
name, sex, date of birth, race, ethnicity, and preferred language,
resident representative information including contact information,
advanced directive information, history of present illness/reason for
transfer, including primary care team contact information, past
medical/surgical history, including procedures, active diagnoses/
current problem list, laboratory tests and the results of pertinent
laboratory and other diagnostic testing, functional status,
psychosocial assessment including cognitive status, social supports,
behavioral health issues, medications, allergies including medication
allergies, immunizations, smoking status, vital signs, unique
identifier(s) for a resident's implantable device(s), if any,
comprehensive care plan including health concerns, assessment and plan,
goals, resident preferences, other interventions, efforts to meet
resident needs, and resident status. We have not established a time
frame for this
[[Page 42191]]
communication, as this may vary based on the circumstances surrounding
the transfer; however, we would expect communication to occur shortly
before or as close as possible to the actual time of transfer and that
the facility would document that communication has occurred. We
understand that limited information may initially be sent with a
resident in an emergency situation; however, we would expect that if an
initial communication does not include all of the required information,
a subsequent communication to fill-out the missing information would
occur in a timely manner. We are soliciting comment on both the
information elements we are requiring and the time frame for
transmission of the required information. While we are not proposing
any specific form, format, or methodology for the communication of this
information for all facilities, we strongly believe that those
facilities that are electronically capturing this information should be
doing so using certified health IT that will enable the real time
electronic exchange with the receiving provider. By utilizing certified
health IT, facilities can ensure that they are transmitting
interoperable data that can be used by other settings, supporting more
robust care coordination and higher quality care for patients.
In proposed paragraph (b)(3)(i), we would update the language
currently in Sec. 483.12(a)(4)(i) to reflect our ``resident
representative'' language and propose to require that the facility send
a copy of the notice of transfer or discharge to the State Long-Term
Care Ombudsman with the resident's consent. If a resident does not
agree to have the notice sent to the State Long-Term Care Ombudsman, we
would expect the refusal to be documented in the resident's medical
record. The requirement to send this notice the State Long-Term Care
Ombudsman is another provision related to concerns about inappropriate
discharges and was suggested by stakeholders to allow timely assistance
to the resident in cases where the discharge is involuntary. In
proposed paragraph (b)(3)(ii), we propose a minor revision to the
language currently in Sec. 483.12(a)(4)(ii) to clarify that the
facility records the reasons for the transfer or discharge, in
accordance with proposed Sec. 483.15(b)(2).
In paragraph Sec. 483.15(b)(5)(iii), we propose to modify language
currently in Sec. 483.12(a)(6)(iii) by adding the phrase ``expected to
be'' to reflect our understanding that when a notice of transfer or
discharge is issued 30 days prior to transfer, the transfer or
discharge destination may subsequently change. We also propose in
paragraph (b)(5)(iv) to require that the notice include the name,
address (mailing and email), and telephone number of the state entity
which receives discharge or transfer appeal requests; and information
on how to obtain an appeal form, how to obtain assistance in completing
the form, and how to submit the appeal request. We also propose to add
a new paragraph Sec. 483.15(b)(6) to require that when information in
the notice changes, the facility must update the recipients of the
notice as soon as practicable with the new information to ensure that
residents are aware of and can respond appropriately to discharge
information. We propose to re-designate Sec. 483.12(a)(7) as Sec.
483.15(b)(7) and revise it to require that the facility provide to the
resident an orientation regarding his or her transfer or discharge in a
form and manner that the resident can understand. The facility must
also document this orientation, including the resident's understanding
of the orientation (teach back or other methodology). To do otherwise
would negate the intent of this provision. Finally, in Sec.
483.15(b)(9), we propose to clarify that room changes in a composite
distinct part are subject to the requirements of proposed Sec.
483.10(d)(7).
Some states have requirements for facilities to reserve a
resident's bed when the resident is transferred to an acute care
facility. These requirements and individual facility policies may vary
widely and may impact the availability of the resident's original bed
or any bed when the resident is ready to return to the facility as well
as have payment implications for the resident. In paragraph Sec.
483.15(c) we propose to add language to require that the facility
provide information to the resident that informs the resident of and
distinguishes and explains the difference between the duration of the
state bed-hold policy, if any, as well as the reserve bed payment
policy in the state plan, required under 42 CFR 447.40, if any. In
Sec. 483.15(c)(1)(iv), we propose to add a new requirement that a
facility's notice of its bed-hold policy and readmission must also
include information on the facility's policy for readmission, as
required under proposed Sec. 483.15(c)(3), for a resident whose
hospitalization or therapeutic leave exceeds the bed-hold period under
the state plan. We are soliciting comments on state and facility bed-
hold policies and state reserve bed payment policies, including whether
the proposed notices have adequately differentiated these. Further, we
are interested in the impact, if any, of reserve bed arrangements
between some hospitals and some facilities. Finally, we propose to
redesignate existing Sec. 483.12(a)(3) as Sec. 483.15(c)(3) and
revise it to add a new requirement that a resident who is hospitalized
or placed on therapeutic leave with an expectation of returning to the
facility must be notified in writing by the facility when the facility
determines that the resident cannot be readmitted to the facility, the
reason the resident cannot be readmitted to the facility, and the
appeal and contact information specified in Sec. 483.15(b)(5)(iv)
through (vii). As noted earlier, discharge/eviction is the most common
category of complaint processed by the Long-Term Care Ombudsman
Program. Residents often do not realize that there are requirements
allowing them to return to a facility after a hospitalization or that
they may have appeal rights. This provision is intended to ensure that
residents have an opportunity to exercise an appeal right if they
choose to do so.
G. Resident Assessments (Sec. 483.20)
Current regulations at Sec. 483.20 require that a facility must
initially and periodically conduct a comprehensive, accurate,
standardized, reproducible assessment of each resident's functional
capacity and sets forth the requirements a facility must meet to be in
compliance. As part of the proposed restructuring of subpart B, current
Sec. 483.20(k) and Sec. 483.20(l), which set forth requirements for
care plans and discharge planning, would be removed and re-designated
to proposed Sec. 483.21(b) and Sec. 483.21(c), respectively.
Similarly Sec. 483.20(m) would be re-designated as proposed Sec.
483.20(k). The proposed removal and re-designation of paragraphs (k)
and (l) are discussed below in the section entitled, ``Sec. 483.21
Comprehensive Person-Centered Care Planning.''
Existing Sec. 483.20(b) sets forth the information that must be
included in a resident's comprehensive assessment using the resident
assessment instrument. Consistent with our goal of encouraging person-
centered care, we propose to revise this section to clarify that the
assessment is not merely for the purpose of understanding a resident
needs, but also to understand their strengths, goals, life history, and
preferences. We also revise the regulations to specify that CMS (not
the State) prescribes the resident assessment instrument. At Sec.
483.20(b)(1)(xvi) we propose to revise the text from ``discharge
potential'' to read, ``discharge planning'' in an effort to encourage
facilities to move the discussion of possible discharge away
[[Page 42192]]
from a facility's judgment and towards a resident's preference and
expectation.
Existing regulations at Sec. 483.20(e) require facilities to
coordinate assessments with the PASARR program under Medicaid in part
483, subpart C to the maximum extent practicable to avoid duplicative
testing and efforts. It is our understanding that many facilities are
unclear as to what this provision requires. Our goal is to clarify for
facilities what it means to coordinate resident assessments with
PASARR. Therefore, we propose to add new Sec. 483.20(e)(1) and Sec.
483.20(e)(2). In new Sec. 483.20(e)(1), we propose to clarify that
coordination with PASARR includes incorporating the recommendations
from the PASARR level II determination and the PASARR evaluation report
into a resident's assessment, care planning, and transitions of care.
In new Sec. 483.20(e)(2), we propose to clarify that PASARR
coordination also includes referring all level II residents and all
residents with newly evident or possible serious mental illness,
intellectual disability, or related conditions for level II resident
review upon a significant change in status assessment (that is, a
decline or improvement in a resident's status). Often facilities
overlook the PASARR recommendations during a resident's assessment and
the development of their care plan. The recommendations should be used
as a tool by facilities to make a complete and accurate assessment of a
resident with evident or possible mental illness. The addition of these
two requirements would promote better coordination of a resident's
assessment with the PASARR, allowing for a facility to better assess
their residents with mental illness.
As mentioned earlier in this section, we are proposing to re-
designate existing Sec. 483.20(m) as Sec. 483.20(k). In addition, we
propose to make a few technical corrections at proposed Sec.
483.20(k). First, we propose to re-designate existing Sec.
483.20(k)(2) as (k)(3), and add a new paragraph (k)(2). Sections
1919(e)(7)(A)(ii) and (iii) of the Act provide exceptions to the
preadmission screening for individuals with mental illness and
individuals with intellectual disability for admittance into a nursing
facility. Newly proposed Sec. 483.20(k)(2) would add to the regulation
these statutory exceptions that were inadvertently omitted when this
regulation was initially written. Second, we propose to add a new
paragraph at Sec. 482.20(k)(4). Section 1919(e)(7)(B)(iii) of the Act
requires a NF to notify the state mental health authority or state
intellectual disability authority when there has been a significant
change in the resident's physical or mental condition so that a
resident review can be conducted. Proposed Sec. 483.20(k)(4) would add
to the regulation this statutory requirement that was inadvertently
omitted. Lastly, we propose to replace ``mental retardation'' with the
term ``intellectual disability'' throughout Sec. 483.20(k), as
appropriate.
H. Comprehensive Person-Centered Care Planning (Sec. 483.21)
In accordance with the proposed reorganization of part 483, subpart
B, we propose to add a new Sec. 483.21 ``Comprehensive Person-Centered
Care Planning''. This section would retain certain existing provisions
of current Sec. 483.20 as well as other additions and revisions
discussed in detail below. Through the care planning process a facility
should establish and document the services that the facility will
provide to residents to assist them in attaining or maintaining their
highest quality of life. Care planning drives the type of care that a
resident receives and is essentially the framework for the quality of
care that a facility will provide. The diversity of the nursing home
population can create challenges for facilities in meeting care
planning requirements, and improper care planning or the lack of care
planning by a facility can negatively impact the quality of care that a
resident receives while in a nursing home.
OIG reports reveal some gaps in care planning within LTC
facilities. According to a July 2012 report, ``Nursing Facility
Assessments and Care Plans for Residents Receiving Atypical
Antipsychotic Drugs'' ((OEI-07-08-00151), https://oig.hhs.gov/oei/reports/oei-07-08-00151.asp), the OIG found that nearly all records (99
percent) reviewed in their study failed to meet one or more Medicare
requirements for beneficiary assessments and/or care plans.
Furthermore, 9 percent of records contained care plans that were not
developed or updated within the required 7 days from the completion of
the Minimum Data Set (MDS), while 6 percent of records did not include
care plans at all. The report also found that less than 5 percent of
the records actually contained care plans that were developed by the
required interdisciplinary team. Moreover, 91 percent of the records
did not contain evidence that the resident, resident's family, or the
resident's legal representative participated in the care planning
process. Nearly two-thirds of these records lacked documentation as to
why participation was not practicable.
Similarly, a February 2013 OIG report, ``Skilled Nursing Facilities
Often Fail to Meet Care Planning and Discharge Planning Requirements''
((OEI-02-09-00201), https://oig.hhs.gov/oei/reports/oei-02-09-00201.asp), studied the extent to which LTC facilities meet
requirements for care planning. The OIG report found that for 37
percent of the stays, facilities did not meet Medicare requirements for
care planning. The February 2013 OIG report also found that for 31
percent of nursing home stays, facilities did not meet requirements
specific to discharge planning. However, the report noted that despite
these deficiencies, Medicare paid approximately $4.5 billion for the
stays that did not meet quality of care requirements and approximately
$1.9 billion for those that did not meet the discharge planning
requirements.
Currently, the requirements for care plans and discharge planning
are set out at Sec. 483.20 along with the requirements for conducting
an assessment of each resident's health and completing the MDS. To
emphasize the level of importance for care planning and to increase the
visibility of the requirements, we propose to remove the requirements
for care plans from current Sec. 483.20(k) and discharge planning in
current Sec. 483.20(l) (collectively referred to here as care
planning) and relocate them to a new proposed Sec. 483.21, entitled
``Comprehensive Person-Centered Care Planning.'' This new section would
contain all of the existing requirements for care planning. We believe
that relocating the requirements to a new section dedicated solely to
care planning would emphasize the importance of care planning as well
as provide clarity to the regulations. In addition to relocating
existing provisions, we are also adding new requirements as discussed
in detail below.
Proposed Sec. 483.21(a)
Currently, Sec. 483.20(k)(2)(i) requires that a comprehensive care
plan be developed for each resident within 7 days after completion of
the comprehensive resident assessment. Section 1819(b)(3)(C)(i) of the
Act requires that the comprehensive resident assessment be completed
within 14 days after a resident is admitted. These timeframes allow a
facility up to 21 days to develop a comprehensive care plan for a new
resident. While we believe that most facilities are indeed developing
their care plans much sooner than required, the February 2013 OIG
report reveals that some facilities are not. During our dialogue with
stakeholders, concerns
[[Page 42193]]
were expressed about the ability of a facility to delay development of
a care plan for 21 days without consequence to residents. We recognize
that during these 21 days facilities could use admission orders to
determine a resident's care; however, we believe that there are common
health concerns found in the residents of LTC facilities that need to
be identified and addressed in a care plan to prevent resident decline
or injury. Some of these problems include behavioral intervention in
dementia care, dietary issues, fall risks, supervision, and the ability
to perform activities of daily living (ADLs). These areas need to be
assessed and issues identified quickly in order to prevent adverse
events such as injuries, unintended weight loss and dehydration, and
instances of wandering off. Without a proper interim care plan within
the initial period of residency, residents could receive poor quality
care simply due to the fact that staff does not receive the relevant
information they need to be effective and provide high quality care and
services to the resident. This could also place residents at a much
higher risk of hospital readmission. Therefore, we are proposing to add
a new Sec. 483.21(a)(1) to the current care planning regulations and
require that facilities complete a baseline interim care plan for each
resident upon their admission to the facility. This baseline interim
care plan would include the necessary instructions for the proper
professional care and services to meet the immediate needs of a new
resident. This proposal would increase resident safety and safeguard
against adverse events that are most likely to occur right after
admission.
We believe that residents are receiving initial services and care
based on physician's orders within the first 24 to 48 hours of
admission and therefore propose to require that the proposed baseline
care plan be completed within 48 hours of a resident's admission. It is
our expectation that facilities would continuously revise and update
this baseline care plan as needed until the comprehensive assessment
and care plan could be developed. We believe that most facilities are
assessing residents as soon as possible and establishing plans of care
earlier than the regulatory deadline; however this requirement would
eliminate the possibility that residents could reside in a facility for
21 days without any care planning. Also, requiring facilities to
complete this baseline interim care plan within 48 hours would promote
continuity of care across shift changes by improving communication
among nursing home staff during a period when residents are especially
vulnerable to adverse health events.
At Sec. 483.21(a)(1)(ii), we propose to list the information that
would, at a minimum, be necessary for inclusion in a baseline care
plan, but would not limit the contents of the care plan to only this
information. Information such as initial goals based on admission
orders, physician orders, dietary orders, therapy services, social
services, and PASARR recommendations as appropriate would be the type
of information that would be necessary to provide appropriate immediate
care for a resident. However, since care plans are developed
specifically for each resident, a facility could decide to include
additional information as appropriate.
Finally, at Sec. 483.21(a)(2), we propose to allow facilities to
complete a comprehensive care plan instead of completing both a
baseline care plan and then a comprehensive care plan. In this
circumstance, the comprehensive care plan would then have to be
completed within 48 hours of admission and comply with the requirements
for a comprehensive care plan at proposed Sec. 483.21(b). We discuss
those requirements below.
Proposed Sec. 483.21(b)
Current regulations at Sec. 483.20(k) set forth the requirements
for developing a comprehensive care plan. As mentioned above, we
propose to re-designate this section as a new Sec. 483.21(b). In
addition, we are also proposing revisions to this section that we
believe would provide clarity, promote resident safety, and encourage
person-centered care. First, we propose to add a new Sec.
483.21(b)(1)(iii), that would require any specialized services or
specialized rehabilitation services that a nursing facility provided
pursuant to a PASARR recommendation to be included in the resident's
care plan. This inclusion would improve coordination between the
nursing facilities and a resident's PASARR. In addition, we propose to
require that if a facility disagrees with the findings of the PASARR,
it must indicate this disagreement and the reasons for it in the
resident's medical record.
We also propose to add a new Sec. 483.21(b)(1)(iv) that would
require discharge assessment and planning to be a part of developing
the comprehensive care plan. We are proposing to require facilities to
assess a resident's potential for future discharge, as appropriate, as
early as upon admission, to ensure that residents are given every
opportunity to attain their highest quality of life. This proposal
seeks to improve resident satisfaction and encourage facilities to
operate in a person-centered fashion that addresses resident choice and
preferences. Upon a resident's request, this discharge assessment may
include referral to a community transition planning agency to explore
community living options, resources, and available supports and
services. We propose to require at Sec. 483.21(b)(1)(iv) that
facilities document whether a resident's desire for information
regarding returning to the community is assessed and any referrals that
are made for this purpose. Furthermore, we also acknowledge that
residents' preferences and goals of care may change throughout the
length of their stay in a facility, so we also want to emphasize that
there needs to be an ongoing discussion with the resident or their
representatives of the goals of care.
Also in the spirit of person-centered care, we are proposing to
specify additional mandatory members of the interdisciplinary team
(IDT). The IDT is responsible for developing a comprehensive care plan
for each resident at proposed Sec. 483.21(b)(2)(ii). Under current
Sec. 483.20(k)(2)(ii), the attending physician, a registered nurse
with responsibility for the resident, other appropriate staff in
disciplines as determined by the resident's needs, and to the extent
possible the resident or the resident's family/legal representative are
all required to participate in the IDT. We are proposing to add the
term ``other appropriate staff'', which should be determined based on
the specific needs of the resident or at the request of the resident.
For example, a qualified mental health professional should be involved
when residents are diagnosed with mental health conditions or
prescribed psychotropic drugs. Similarly, based on a resident's needs,
a chaplain or other spiritual care provider could be deemed appropriate
for inclusion in the development of a residents care plan. However, we
believe there would be other appropriate staff in specific disciplines
that all residents need to also be a part of the IDT. Therefore, we
propose to also explicitly require a NA with responsibility for the
resident, an appropriate member of the food and nutrition services
staff, and a social worker to be a part of the IDT. Including these
critical team members in the IDT and the care planning process would
ensure that the individual needs of a particular resident are being
assessed and appropriately addressed.
NAs spend much of their time interacting directly with the
residents providing them day-to-day care. Their
[[Page 42194]]
knowledge of a resident care plan and medical needs directly relates to
how well they can care for a resident. Dietary concerns and unplanned
weight loss are major concerns for the LTC population, especially for
the elderly population. Since nutrition is a fundamental part of a
resident's overall health and well-being, it is important that a member
of the food and nutrition services staff be knowledgeable of the
resident's needs and preferences to achieve their maximum practicable
well-being. Social workers serve as a critical link with families in
many ways, including arranging post-discharge services and addressing
mental and behavioral health care needs. The involvement of social
services and food and nutrition services would also promote and enhance
a resident's choice regarding their day-to-day activities and meals as
well as encourage facilities to take a more comprehensive approach to
providing individualized quality of care and quality of life specific
to each resident.
Additionally, we propose to revise Sec. 483.21(b)(2)(ii)(F), to
provide that to the extent practicable, the IDT must include the
participation of the resident and the resident representatives. We want
to ensure that residents have the ability to choose who they want to be
a part of making decisions about their care. This participation can
incorporate many forms of communication such as conference calls or
using electronic tools for video conferencing. Further, at Sec.
483.21(b)(2)(ii)(F) we propose to add the requirement that an
explanation must be included in a resident's medical record if the IDT
decides not to include the resident and/or their resident
representative in the development of the resident's care plan or if a
resident or their representative chooses not to participate. Residents
should be involved in making decisions about their care and facilities
should be held accountable for their attempts to involve the resident
when it is appropriate and provide an explanation when they determine
that it is not feasible or appropriate. We believe the addition of
these requirements would increase resident choice, but also seek to
improve the communication between the facilities and the residents
regarding the aspects of a resident's care, choice, and the services to
be provided by facility to maintain or improve a resident's care.
Lastly, we have added a new requirement at Sec. 483.21(b)(3)(iii)
to require that the services provided or arranged by the facility be
culturally-competent and trauma-informed. As discussed previously,
culturally-competent (including language, culture preferences and other
cultural concerns), trauma-informed approaches that help to minimize
triggers and re-traumatization, and that address the unique care needs
of Holocaust survivors and other trauma survivors, are an important
aspect of person-centered care for these individuals.
We note that certified health IT can support efforts by LTC
facilities to develop robust comprehensive care plans that can be
shared with other providers across the continuum of care. We strongly
believe that facilities that use certified health IT applications
should seek to generate comprehensive care plans using technology
solutions, in order to further improve access and communication among
staff. ONC has identified the HL7 Clinical Document Architecture (CDA)
Release 2.0: Consolidated CDA Templates for clinical notes as the best
available standard for care plans (see the Interoperability Standards
Advisory at https://www.healthit.gov/standards-advisory). The dedicated
care plan document contained within this standard is designed to help
providers reconcile and resolve conflicts between different plans of
care and to help the care team prioritize goals and interventions. As
part of the 2015 Edition of certification criteria for health IT, ONC
proposed to certify health IT systems to their ability to generate a
Care Plan document according to this standard (see 80 FR 16842).
Proposed Sec. 483.21(c)
Current regulations at Sec. 483.20(l) set forth the requirements
for discharge planning. As mentioned above, we propose to re-designate
this section as a new Sec. 483.21(c). Transitions between settings of
care are often complex for residents as well as for LTC facilities
given that each facility differs greatly in its organization, practices
and cultures. As mentioned earlier, the population receiving care and
service in LTC facilities is diverse and includes those who have
complex health and continuing care needs and rely on various services
to help meet these needs. Furthermore, these individuals may have
increased susceptibility to infections, malnutrition, dehydration,
comorbidities, or functional impairments. All of these factors
contribute to a person's increased vulnerability to receiving
suboptimal care during a period of transition from one care setting to
another. Older adults often receive healthcare in multiple settings
thus requiring multiple transitions of care. For example, an older
adult with an acute or chronic illness may receive healthcare at an
inpatient hospital setting, followed by treatment at a LTC facility,
possibly followed by discharge to their home to receive services from a
visiting nurse or a primary care physician in an outpatient setting.
The February 2013 OIG report found that for the current discharge
planning requirements (summary of a resident's stay and a post-
discharge plan of care), many SNF stays that did not meet the discharge
planning requirements did not have a post-discharge plan of care.
Results of the study also indicated that, in some instances, staff
provided only verbal instructions to the beneficiary and in one example
a resident did not receive specific instructions about medications.
Another study found that one in five Medicare beneficiaries are re-
hospitalized within 30 days, largely a result of medication errors,
resident confusion about and subsequent failure to follow up on care
instructions and the management of multiple chronic conditions (Parry,
C., & Coleman, E. A. (2010). Active Roles for Older Adults in
Navigating Care Transitions: Lessons Learned from the Care Transitions
Intervention. Open Longevity Science, 43-50).
Relevant literature indicates that different priorities and
organizational structures result in little coordination and lack of
understanding about what occurs across settings. (McCloskey R. A
Qualitative Study on the Transfer of Residents between a Nursing Home
and an Emergency Department. Journal of the American Geriatrics Society
[serial online]. April 2011; 59(4):717-724. Available from: Academic
Search Complete, Ipswich, MA. Accessed November 14, 2012.) For example,
staff in a LTC facility setting may decide that a resident's condition
requires acute care services and transfer the resident to the hospital
for an assessment. The physicians in the hospital setting may not
believe the resident's condition warrants acute care and thus may send
the resident back to the nursing home, or may admit the resident when a
hospital level of care is not indicated. Proper discharge planning
across all provider settings helps improve the communication regarding
a resident's needs and promotes safer care transitions.
Given the heightened need to ensure safe transitions of care across
all providers, we are proposing to strengthen the current LTC
requirements for discharge planning. These proposals would also support
CMS' initiative to safely reduce hospital readmissions and unnecessary
hospitalizations by improving communication and ensuring that
[[Page 42195]]
residents are being empowered and educated about their care. Our
proposals also emphasize that discharge planning should focus on the
necessary steps to achieve discharge consistent with a resident's goals
and preferences. In addition, the IMPACT Act amended title XVIII of the
Act by adding Section 1899B to require that post-acute care (PAC)
providers, home health agencies (HHAs), SNFs, inpatient rehabilitation
facilities (IRFs), and long-term care hospitals (LTCHs) report
standardized patient assessment data, data on quality measures, and
data on resource use and other measures. The IMPACT Act also requires
that this data be standardized and interoperable to allow for the
exchange of data among PAC providers and other providers. The IMPACT
Act requires the modification of PAC assessment instruments to allow
for the submission of standardized patient assessment data and enable
comparison of this assessment data across providers. Additionally, the
IMPACT Act requires that standardized patient data, quality measures,
and resource use measures along with patient treatment goals and
preferences be taken into account in discharge planning.
At Sec. 483.21(c)(1) we propose to improve the discharge planning
for LTC facilities by adding a requirement that facilities must develop
and implement an effective discharge planning process. The facility's
discharge planning process must ensure that the discharge goals and
needs of each resident are identified. This process should also result
in the development of a discharge plan for each resident and any
referrals to local contact agencies or other appropriate entities,
should the resident have a desire to receive information about
returning to the community. In addition, we propose to require that the
facility's discharge planning process require the regular re-evaluation
of residents to identify changes that require modification of the
discharge plan. The discharge plan must also be updated, as needed, to
reflect these changes. We also propose to require that the IDT
responsible for the developing a resident's comprehensive care plan be
involved in the ongoing process of developing the discharge plan.
Furthermore, we propose to require that the facility consider
caregiver/support person availability, and the resident's or caregiver
support persons' capacity and capability to perform the required care,
as part of the identification of discharge needs. In order to
incorporate residents and their families in the discharge planning
process, we also propose to require that the discharge plan address the
resident's goals of care and treatment preferences. Facilities would
have to document in the discharge plan that a resident has been asked
about their interest in receiving information regarding returning to
the community. If the resident indicated interest in returning to the
community, the facility must document any referrals to local contact
agencies or other appropriate entities made for this purpose and update
a resident's comprehensive care plan and discharge plan in response to
information received from such referrals. Likewise, if discharge to the
community were determined to not be feasible, the facility would
document who made the determination and why.
As required under section 1899B(i)(1) of the Act, to help inform
the discharge planning process, we propose to require LTC facilities to
take into account, consistent with the applicable reporting provisions,
standardized patient assessment data, quality measures and resource use
measures that pertain to the IMPACT Act domains, as well as other
relevant measures specified by the Secretary. For those residents who
are transferred to another LTC facility or who are discharged to a HHA,
IRF, or LTCH, we propose at Sec. 483.21(c)(1)(viii) to require that
the facility assist residents and their resident representatives in
selecting a post-acute care provider by using data that includes, but
is not limited to SNF, HHA, IRF, or LTCH standardized patient
assessment data, data on quality measures, and data on resource use to
the extent the data are available. Further, under the proposed
regulation, the facility would have to ensure that the post-acute care
standardized patient assessment data, data on quality measures, and
data on resource use are relevant and applicable to the resident's
goals of care and treatment preferences. In order to emphasize resident
preferences, we would expect that the facility would compile the
relevant data and present it to the resident and their resident
representative in an accessible and understandable format and with
useful content. For example, the facility could provide the
aforementioned quality data on other post-acute care providers that are
within the resident's desired geographic area. Facilities would then
need to assist residents and their resident representative as they seek
to understand the data and use it to help them choose a high quality
post-acute care provider, or other setting for discharge, as
appropriate.
Finally, at Sec. 483.21(c)(1)(viii), we propose that facilities
must document in the discharge plan whether a determination is made by
the resident, resident representative, or interdisciplinary team that
discharge to the community is not feasible. At Sec. 483.21(c)(1)(ix),
we propose to require that the evaluation of the resident's discharge
needs and discharge plan must be documented, completed on a timely
basis based on the resident's needs, and included in the clinical
record. The results of the evaluation must be discussed with the
resident or resident's representative. Furthermore, all relevant
resident information must be incorporated into the discharge plan to
facilitate its implementation and to avoid unnecessary delays in the
resident's discharge or transfer.
At Sec. 483.21(c)(2), we propose to set forth the existing
requirements for providing a resident with a discharge summary when
discharge from the facility is anticipated.
At Sec. 483.21(c)(2)(i) we propose to revise the current
requirements for the post-discharge plan of care to specify that a
recapitulation of a resident's stay would include, but not be limited
to, diagnoses, course of illness/treatment or therapy, and pertinent
lab, radiology, and consultation results. We also propose to explicitly
include a requirement for facilities to include what arrangements have
been made with other providers for the resident's follow-up care and
any post-discharge medical and non-medical services as needed. These
arrangements should include community care options, resources, and
available supports and services presented and arranged by the community
care provider as needed. Some local community transition agencies
include Area Agencies on Aging (AAAs), Aging and Disability Resource
Centers (ADRCs), or Centers for Independent Living (CILs), which can
provide information and assist the resident in arranging for available
community supports and services prior to discharge. Adding this
requirement would hold facilities accountable for their role in
preparing residents for care transitions from one setting to another
and assist in decreasing a resident's risk for complications and
hospitalization.
In addition, the discharge planning process should ensure that
residents receive adequate information that is understandable and
prepares them to be active partners and advocates for their healthcare
upon discharge. Yet residents and/or their representatives frequently
are unable to understand their diagnoses, list their medications and
describe their purpose and side effects, or explain their follow-up
plan of care instructions, all key factors of a resident's healthcare
needs. Therefore, at Sec. 483.21(c)(2)(iii) we propose to add
[[Page 42196]]
a new requirement that would require facilities to reconcile all pre-
discharge medications both prescribed and non-prescription, with the
resident's post discharge medications. This medication reconciliation
would be included as part of the discharge summary. The addition of
this requirement would ensure that residents avoid unnecessary
medications and prevent drug interactions. This proposal would also
improve transitions across varying care settings by avoiding
unnecessary situations, such as placing a resident on duplicate
prescriptions leading to an adverse event and unnecessary
hospitalization.
Lastly, in keeping with the theme of resident centered care, we
also propose at Sec. 483.21(c)(2)(iv) to require that the post-
discharge plan be developed along with the participation of the
resident and, with the resident's consent, his or her resident
representative. Furthermore, upon a resident's request, facilities
should also include the community transition planning agency to assist
the resident and facility with housing, personal care assistance,
assistive technology, and other resources.
We encourage facilities to explore how the use of certified health
IT can support their efforts to electronically develop and share
standardized discharge summaries. Information about how currently
available certified health IT systems can enable the electronic
exchange of a summary care record is available in ``Certification
Guidance for EHR Technology Developers Serving Health Care Providers
Ineligible for Medicare and Medicaid EHR Incentive Payments,'' which
addresses the use of the 2014 Edition of ONC certification criteria
(available at https://www.healthit.gov/sites/default/files/generalcertexchangeguidance_final_9-9-13.pdf). Facilities may also wish
to review the Discharge Summary document that is included in the HL7
Clinical Document Architecture (CDA) Release 2.0, now identified as the
best available standard for the summary care record (see the
Interoperability Standards Advisory at https://www.healthit.gov/standards-advisory).
I. Quality of Care and Quality of Life (Sec. 483.25)
Current regulations at Sec. 483.25 establish requirements for
numerous aspects of care and special needs of nursing home residents
under the general heading of ``Quality of Care.'' Quality of Care and
Quality of Life are two separate and overarching principles in the
delivery of care to residents of nursing homes. These principles apply
to every service provided by a SNF or NF. Sections 1819(b)(1)(A) and
1919(b)(1)(A) of the Act require that a SNF or NF care for its
residents in a manner and in an environment that will promote
maintenance or enhancement of the quality of life of each resident.
Services and care must be provided in accordance with established
standards of practice, in a manner intended to support achievement of a
resident's individualized goals for attaining or maintaining his or her
highest practicable physical, mental, and psychosocial well-being, as
set out in the plan of care. In addition, services and care must be
provided in a manner intended to support each resident's overall well-
being, as perceived by the resident, including emotional, social and
physical aspects of his or her life. We propose to comprehensively
revise and re-organize the current Sec. 483.25 to ensure person-
centered, quality care and quality of life for this vulnerable
population. In this proposed revised section, we would focus on a
limited set of concerns that do not clearly fit in other general
sections of the regulation but which are of significant importance for
each resident's health and safety and which contribute substantially to
their quality of care, quality of life and person-centered issues such
as dignity, respect, self-esteem and self-determination. These concerns
have both medical and psychosocial aspects and include activities of
daily living which are those self-care activities that an individual
performs daily, including everyday routines involving functional
mobility and personal care, such as bathing, dressing, toileting, and
meal preparation and consumption. Diminished ability or inability to
perform these activities renders an individual vulnerable and dependent
on others for assistance.
First, we propose to retitle this section ``Quality of Care and
Quality of Life'', reflecting the overarching application of these
principles. In our proposed revised introductory paragraph, we
reiterate the requirement that each resident must receive and the
facility must provide the necessary care and services to attain or
maintain the highest practicable physical, mental, and psychosocial
well-being, consistent with the resident's comprehensive assessment and
plan of care. We focus throughout this section, as we have in other
areas, on establishing person-centered requirements that acknowledge
both the resident's needs and the resident's right to make choices.
Second, in Sec. 483.25(a), we propose to address the residents'
ability to perform ADLs and establish that, based on the comprehensive
assessment of a resident and consistent with the resident's needs,
choices, and preferences, the facility must provide the necessary care
and services to maintain or improve, as practicable, the resident's
abilities to perform his or her activities of daily living and to
ensure that those abilities do not diminish unless the diminution is
unavoidable as a result of the individual's clinical condition. This
means that a resident is offered the appropriate treatment and services
to improve or maintain his or her ability to carry out ADLs and, if a
resident is unable to do so, he or she receives the necessary care and
services from qualified staff to maintain good nutrition, functional
mobility, grooming, and personal and oral hygiene. We propose to divide
the requirements of existing Sec. 483.25(a)(1) into proposed Sec.
483.25(a) and (b). Existing (a)(2) and (a)(3) would be re-designated as
Sec. 483.25(a)(1) and (a)(2), respectively. We propose a new Sec.
483.25(a)(3) to clarify that, in keeping with the requirement to
provide the necessary care and services to attain or maintain the
highest practicable physical, mental, and psychosocial well-being, a
facility must ensure that appropriate personnel provide basic life
support, including cardiopulmonary resuscitation (CPR) to a resident
requiring this emergency care prior to the arrival of emergency medical
personnel and subject to accepted professional guidelines and the
resident's advance directives. It has come to our attention that there
are nursing facilities that have implemented a facility-wide policy of
not initiating basic life support. They will, instead, call 911 and
wait for the arrival of emergency personnel, unless the resident does
not want CPR at all. We believe that the determination to provide or
not provide basic life support such as CPR should be made on an
individual resident basis rather than as a facility-wide policy. The
determination should be based on a resident's advance directives, the
presence or absence of do-not-resuscitate orders, and accepted
professional standards. Further, we believe that the provision of CPR
in applicable emergency situations and subject to an individual's
advance directives is a generally accepted expectation in healthcare
facilities.
In proposed Sec. 483.25(b), we would establish those activities
that we include as ADLs. These activities are currently listed in Sec.
483.25(a)(1)(i) through (v). We propose to update the language of that
list, although the underlying activities
[[Page 42197]]
remain unchanged. We would establish as ADLs (1) hygiene, such as
bathing, dressing, grooming, and oral care; (2) mobility, which
includes transfers and ambulation; (3) toileting and use of the
bathroom; (4) dining, including eating meals and snacks; and (5)
communication, including speech, language and other functional
communication systems. We note that communications are not considered
an ADL in standard instruments such as the Barthel Index of Activities
of Daily Living or the Index of Independence in Activities of Daily
Living (Katz, 1963). However, we believe that the ability to
communicate is a vital aspect of an individual's daily life and a
resident's ability to do so should continue to be included in our
provisions relating to ADLs. We also highlight the inclusion of oral
hygiene in this section. In the elderly population, periodontal disease
has been linked to a wide variety of systemic diseases, including
diabetes, cardiovascular disease, arthritis, neurodegenerative
diseases, respiratory diseases, and nutritional deficits. One study
suggests that maintaining optimal oral health may do more to reduce
healthcare expenditures in an elder's remaining lifespan than any other
public health measure. According to a 2000 report by HHS, 23 percent of
65- to 74-year olds have severe periodontal disease. Nursing home
residents in particular are recognized as receiving inadequate oral
care. Even if a resident enters a nursing facility with good oral
health, that oral health is likely to decline within 6 months. Thus, we
emphasize here that if a resident is unable to brush and floss his or
her teeth or otherwise maintain good oral hygiene, the facility must
ensure that he or she receives the necessary care and services from
qualified staff to maintain good oral hygiene.
In proposed Sec. 483.25(c), we propose to relocate the current
requirements related to an activities program as required in existing
Sec. 483.15(f). An ongoing individualized activities program that
incorporates an individual's interests and hobbies can and should be
integral to maintaining and improving a resident's physical, mental,
and psychosocial well-being and his or her independence. Thus, we
propose to revise the language to include a required consideration of
the comprehensive assessment, care plan and the preferences of the
resident as well as potential for independence and ability to interact
with the community. This reflects our focus on person-centered care as
well as our recognition of the development of support programs and
community resources in some areas that may allow for resident
involvement or reintegration into the community setting for some
nursing home residents. We received stakeholder input on the
requirements for the director of a facility activities program and
considered, but did not modify the requirements for the director of the
activities program. However, we are soliciting comments on the current
requirements to determine if they remain appropriate and, if not, what
the evidence is for changing the current requirements for this position
and what stakeholders would recommend as minimum requirements for this
position.
We propose a new Sec. 483.25(d), ``Special Care Issues,'' which we
revise, re-locate, and add requirements for specific special concerns,
including restraints; bed rails; vision and hearing; skin integrity;
mobility; incontinence; colostomy, ureterostomy, or ileostomy; assisted
nutrition and hydration; parenteral fluids, accidents, respiratory
care, prostheses, pain management, dialysis, and trauma-informed care.
Each of these special concerns is related to an ADL but has a
significant medical component or is an issue that could significantly
impact a resident's ability to perform or engage in ADLs. For example,
there are specific medical professional standards of practice that
affect when and how tube-feedings are initiated and performed. At the
same time, the resident's need for tube-feeding reflects the resident's
significantly diminished ability to perform or participate in ADLs
related to eating. Similarly, pain management is a medical issue, but
can significantly alter a resident's ability to engage in an activities
program of choice, perform transfers or ambulate, impairs quality of
life and can contribute to depression. As many of the concerns in this
section were previously included in Sec. 483.25, we discuss here only
the provisions we propose to add or modify.
Specifically, we propose to re-designate and revise Sec.
483.13(a), ``Restraints,'' as Sec. 483.25(d)(1). While we would
prohibit the use of any physical or chemical restraint not required to
treat the resident's medical symptoms in the introductory language to
proposed Sec. 483.12, in proposed Sec. 483.25(d)(1), we would require
that the facility ensure that residents are free from restraints that
are imposed for purposes of discipline or convenience, in addition to
ensuring that residents are free from restraints not required to treat
the resident's medical symptoms. In addition, we would add new
requirements to specify that, if used, restraints must be the least
restrictive alternative for the least amount of time. Further,
documentation of ongoing evaluation of the need for the restraints is
required. As noted in our discussion above regarding the proposed
requirement ``Freedom from Abuse, Neglect, and Exploitation'' (Sec.
483.12), there are very limited circumstances where restraints may be
appropriate in a nursing facility. However, many facilities have
achieved a rate of zero percent restraint use, and CMS continues to
promote reduction in the use of physical restraints. We considered
proposing requirements for the use of restraints and seclusion that
parallel the more extensive requirements for restraint and seclusion
currently set forth in the Conditions of Participation for Hospitals at
Sec. 483.13(e). However, given the progress towards zero restraint use
under existing guidance and taking into consideration the different
types of care provided in the two settings, we have chosen to pursue a
less burdensome approach and codify existing guidance. In addition, we
are proposing requirements for the use of psychotropic medications,
including the use of PRN orders, at Sec. 483.45(e), discussed below,
to ensure that these medications are only used to treat specific
conditions that are diagnosed and documented in the resident's clinical
record. We welcome comments on our approach as well as suggestions for
more extensive requirements.
We propose a new Sec. 483.25(d)(2) to establish specific
requirements when a facility uses bed rails on a resident's bed.
Specifically, we propose to require that the facility ensure correct
installation, use and maintenance of bed rails, including attempting to
use alternatives prior to installing a side or bed rail, assessing the
resident for risk of entrapment from bed rails prior to installation,
reviewing the risks and benefits of bed rails with the resident and
obtaining informed consent prior to installation, ensuring that the
resident's size and weight are appropriate for the bed's dimensions,
and following the manufacturers' recommendations and specifications for
installing and maintaining bed rails. Bed rails can pose a significant
safety risk to residents. Between January 1, 1985 and January 1, 2013,
FDA received 901 incidents of patients caught, trapped, entangled, or
strangled in hospital beds. The reports included 531 deaths, 151
nonfatal injuries, and 220 cases where staff needed to intervene to
prevent injuries. Most patients were frail, elderly or confused.
Additional information and resources regarding the use of bed rails
[[Page 42198]]
is available at https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/HospitalBeds/default.htm. We propose to revise existing language at
Sec. 483.25(c) and Sec. 483.25(k)(7) and re-designate them under a
new Sec. 483.25(d)(4), ``Skin Integrity.'' Here, we propose to revise
the language to include a statement that care must be consistent with
professional standards of practice and to clarify that foot care
includes care to prevent complications from the resident's medical
conditions such as diabetes, peripheral vascular disease, or
immobility, and also includes assistance in making and keeping
necessary appointments with qualified healthcare providers such as
podiatrists.
In Sec. 483.25(d)(5), we propose to address mobility both range of
motion and other limitations of mobility. We propose to retain,
unchanged, the provisions related to range of motion, but to add a new
provision to require that residents with limited mobility receive
appropriate services and equipment to maintain or improve mobility
unless reduced mobility is unavoidable based on the resident's clinical
condition.
In Sec. 483.25(d)(6), we propose to retain existing provisions on
urinary incontinence, add a new Sec. 483.25(d)(5)(B) to address
residents who are admitted with an indwelling urinary catheter, and add
a new Sec. 483.25(d)(6)(iii) to require that residents with fecal
incontinence receive the appropriate treatment and services to restore
as much normal bowel function as possible. Fecal or bowel incontinence
affects a substantial number of nursing home residents. Urinary and
fecal incontinence affect 50 percent or more of nursing home residents
and frequently occur together because immobility and dementia are
primary risk factors for both conditions (John F Schnelle, Felix W
Leung, Urinary and fecal incontinence in nursing homes,
Gastroenterology, Volume 126, Supplement 1, January 2004, Pages S41-
S47, ISSN 0016-5085, 10.1053/j.gastro.2003.10.017. (https://www.sciencedirect.com/science/article/pii/S0016508503015658)). In an
older study, 20 percent of nursing home study participants developed
fecal incontinence over a 10 month period (Chassagne P, Landrin I,
Neveu C, et al. Fecal incontinence in the institutionalized elderly:
incidence, risk factors, and prognosis. Am J Med 1999;106:185-90.), and
a 1998 survey of 18,000 Wisconsin nursing home residents found a
prevalence of up to 50 percent (Nelson RL, Furner S, Jesudason V. Fecal
incontinence in Wisconsin nursing homes. Dis Colon Rectum 1998;41:1226-
9). Fecal incontinence may be related to impaired skin integrity,
including pressure ulcers, as well as depression and anxiety. We
retain, unchanged, colostomy, ureterostomy, and ileostomy care in Sec.
483.25(d)(7).
In Sec. 483.25(d)(8), we propose to modify existing provisions on
nasogastric tubes to reflect current clinical practice and to include
enteral fluids. Other methods of providing assisted nutrition are now
common practice. Therefore, we propose to include gastrostomy tubes
with nasogastric tubes, both percutaneous endoscopic gastrostomy and
percutaneous endoscopic jejunostomy. We also propose to include in this
paragraph requirements regarding both assisted nutrition and hydration
and specify that the facility must ensure that the resident maintains
acceptable parameters of nutritional status, such as usual body weight
or desirable body weight range and protein levels, unless the
resident's clinical condition demonstrates that this is not possible
and that the resident receives sufficient fluid intake to maintain
proper hydration and health. Additionally, we propose to modify the
requirement for a therapeutic diet to require that the resident is
offered a therapeutic diet when appropriate, recognizing that the
resident has a right to choose to eat a therapeutic diet or not.
Finally, we propose to specify that based on the comprehensive
assessment of a resident, the facility must ensure that a resident who
has been able to eat enough on his or her own or with assistance is not
fed by enteral methods unless the resident's clinical condition
demonstrates that enteral feeding was clinically indicated and
consented to by the resident; and a resident who is fed by enteral
means receives the appropriate treatment and services to restore, if
possible, oral eating skills and to prevent complications of enteral
feeding. The American Geriatric Society (AGS), in their May 2013
position statement on feeding tubes in advanced dementia, states that
institutions such as hospitals, nursing homes and other care settings
should promote choice, endorse shared and informed
decision[hyphen]making, and honor patient preferences regarding tube
feeding. The statement further notes that enteral feeding is not
associated with better outcomes in older adults with advanced dementia,
but is associated with agitation, increased use of restraints, and
worsening pressure ulcers and is not recommended for older adults with
advanced dementia and recommends careful hand-feeding. (https://www.americangeriatrics.org/files/documents/feeding.tubes.advanced.dementia.pdf). Our proposed requirements are
consistent with the AGS position statement.
In Sec. 483.25(d)(9), we propose to address only parenteral
fluids. We would include enteral fluids in Sec. 483.25(d)(8), our
proposed provisions on assisted nutrition and hydration, as discussed
above.
We propose to add a new Sec. 483.25(d)(13) to ensure that
residents receive necessary and appropriate pain management. Pain that
impairs function affects 45 percent to 80 percent of nursing home
residents, with half of those experiencing daily pain (Davis, M., &
Srivastava, M. (2003). Demographics, assessment and management of pain
in the elderly. Drugs & Aging, 20(1), 23-57). Also, Thomas Cavalieri
noted that pain in the elderly is often unrecognized and undertreated.
He further recognized that ineffective pain management can have a
significant impact on the quality of life of older adults, including
contributing to depression, isolation, and loss of function. (J Am
Osteopath Assoc September 1, 2002 vol. 102 no. 9 481-485). Further,
Cheryl Phillips, MD, speaking to the United State Senate Special
Committee on Aging on behalf of the American Geriatrics Society,
reported that pain is common among nursing home residents and is
undertreated in an estimated 45 percent to 80 percent of residents with
substantial pain. According to Dr. Phillips untreated pain is
associated with multiple consequences, including poor oral intake and
weight loss, inability to sleep, depression, loss of mobility and
increased risk of falls, increased risk of pressure ulcers, depression,
anxiety, decreased socialization, sleep disturbance, increased
emergency room transfers and increased re-hospitalization rates
(Testimony of Cheryl Phillips, MD before the Special Committee on
Aging, United States Senate, March 24, 2010. https://www.americangeriatrics.org/files/documents/Adv_Resources/AGS.Testimony.Senate.Aging.Pain.Management.in.Nursing.Homes.pdf).
More recently, in 2011, the Institute of Medicine issued a
comprehensive report on pain entitled ``Relieving Pain in America: A
Blueprint for Transforming Prevention, Care, Education and Research''
(https://www.iom.edu/Reports/2011/Relieving-Pain-in-America-A-Blueprint-
for-Transforming-
[[Page 42199]]
Prevention-Care-Education-Research.aspx). This report identifies pain
as a national challenge, affecting more Americans than heart disease,
diabetes, and cancer combined, and as a factor that significantly
increases the cost of health care across all settings, including
nursing facilities.
Clearly, adequate pain management is critical to the health,
safety, and quality of life for nursing home residents. Therefore, we
propose to explicitly include oversight of pain management as a special
concern. We propose that the facility, based on the resident's
comprehensive assessment and choices, must ensure that residents
receive treatment and care for pain management in accordance with
professional standards of practice.
We also propose to add a new Sec. 483.25(d)(14) to ensure that
residents who require dialysis receive those services in accordance
with professional standards of practice and the residents choices.
We further propose to add a new Sec. 483.25(d)(15) to ensure that
trauma survivors, including Holocaust survivors, survivors of abuse,
military veterans with post-traumatic stress disorder, and survivors of
other trauma receive care that addresses the special needs of trauma
survivors. Specifically, we propose to require that facilities ensure
that residents who are trauma survivors receive care and treatment that
is trauma-informed, takes into consideration the resident's experiences
and preferences in order to avoid triggers that may cause re-
traumatization, and meet professional standards of practice.
Finally, we propose to revise and relocate to Sec. 483.45,
``Pharmacy services'', the provisions related to unnecessary drugs,
antipsychotic drugs, medication errors, and influenza and pneumococcal
immunizations. These provisions are further discussed below in our
section on pharmacy services.
J. Physician Services (Sec. 483.30)
Under the reorganization discussed above, requirements regarding
physician services currently located at Sec. 483.40 would be moved to
proposed Sec. 483.30. We would retain the current requirements but
propose a few additions as discussed below. In our review of the
requirements for LTC facilities, we have considered what, if any,
minimum health and safety standards are appropriate and necessary to
ensure that residents of SNFs and NFs are not unnecessarily
hospitalized. CMS has focused recently on reducing the number of
avoidable hospitalizations of nursing home residents. We believe that
many of our proposals will support this objective.
We propose to revise the introductory text of new Sec. 483.30 to
specify that, in addition to a physician's recommendation that the
individual be admitted to a facility, a physician, a physician
assistant, a nurse practitioner, or a clinical nurse specialist must
provide orders for the resident's immediate care and needs. This is
consistent with the current requirement at Sec. 483.20(a) that the
facility must have physician's orders for the resident's immediate care
and ensure that each resident receives care for his or her specific
needs until a comprehensive assessment and care planning can be
completed.
We also propose to add a new Sec. 483.30(e) to require that a
facility, prior to an unscheduled transfer of a resident to a hospital,
provide or arrange for an in-person evaluation of a resident, to be
conducted expeditiously, by a physician, a physician assistant, nurse
practitioner, or clinical nurse specialist prior to transferring the
resident to a hospital, unless the transfer is emergent and obtaining
the in-person evaluation would endanger the health or safety of the
individual or unreasonably delay the transfer. This requirement, in
concert with proposals to improve transitions of care, communications
among and between practitioners, appropriate exchange of information,
and quality assessment activities, will help ensure that the decision
to transfer a resident to an acute care facility is made on the basis
of a clinical assessment and the best evidence available. Physicians
are already required under Sec. 483.12(a)(3) to document in the
medical record when a resident is discharged or transferred as a result
of the facility's inability to meet the needs of the resident. However,
an evaluation of a resident by a physician, a physician assistant, a
nurse practitioner, or a clinical nurse specialist prior to a
resident's transfer may identify options that could allow for the
resident to be treated in place and avoid an unnecessary
hospitalization. Additionally, in the event the resident needs to be
transferred, the evaluation would provide valuable assessment
information for the receiving facility.
At Sec. 483.30(f)(2), we propose to provide the physician with the
flexibility to delegate to a qualified dietitian or other clinically
qualified nutrition professional the task of writing dietary orders, to
the extent the dietitian or other clinically qualified nutrition
professional is permitted to do so under state law. We believe this
flexibility is beneficial to both the physician and the resident and is
consistent with the training and experience of qualified dietitians and
other clinically qualified nutrition professionals, as discussed below
in section II. P. of this preamble, ``Food and Nutrition Services.''
Similarly, at Sec. 483.30(f)(3), we propose to provide the
physician with the flexibility to delegate to a qualified therapist
under proposed Sec. 483.65 below the task of writing therapy orders,
to the extent that the therapist is permitted to do so under state law.
We believe this flexibility is beneficial to both the physician and the
resident, allowing the physician to determine how to best use his or
her time and allowing the resident to have more frequent adjustments to
therapy as his or her condition or abilities change. Furthermore, we
believe this is consistent with the training and experience of
qualified therapists acting in accordance with their state scope of
practice acts. Moreover, we believe therapists already write therapy
orders that are routinely endorsed by a physician without change.
K. Nursing Services (Sec. 483.35)
Under the proposed reorganization, requirements for nursing
services currently located at Sec. 483.30 would be located at proposed
Sec. 483.35. The current regulations at Sec. 483.30 address certain
aspects of nursing home staffing but leave gaps related to a number of
areas such as the competencies of licensed nurses and the need to take
into account resident acuity. Since the promulgation of the original
regulations, state requirements and industry standards, as well as
research, literature and related policy in other healthcare settings
regarding nursing home staffing have all evolved. Issues such as
nursing home administrator standards, minimum nurse staffing standards,
requirements related to specialized personnel such as dietitians,
pharmacists, therapists and practitioners with behavioral health and/or
geriatric training/experience as well as utilization of nurse
practitioners, clinical nurse specialists, and physician assistants
have all been raised as concerns or options to address care and
services provided in the LTC setting.
We are aware of long-standing interest in increasing the required
hours of nurse staffing per day. We have heard suggestions that we
impose a minimum number of hours per resident day or require a RN to be
on site 24 hours a day 7 days a week. Existing regulations at Sec.
483.30 mirror the statutory language at sections 1819(b)(4)(C)(i) and
1919(b)(4)(C)(i) of the Act requiring
[[Page 42200]]
(with certain exceptions) an RN providing services in a facility 8
consecutive hours a day, 7 days a week, licensed nurses 24 hours a day
and ``sufficient staff'' to meet residents' needs. We may also waive
the nurse staffing requirements in specific circumstances.
There is abundant research that associates increased RN staffing
with improved quality of care. Rather than specify how many nurses must
be on duty, most focus on the number of hours of nursing care a
resident must receive to achieve certain quality objectives. A 2001
DHHS Report to Congress provides substantial information about
potential minimum requirements, although it stops short of making a
recommendation. A 2011 study by Zhao and Haley demonstrated that higher
RN staffing hours per resident day was associated with significantly
lower malpractice paid-losses and higher NA hours per resident day was
found to be related to higher malpractice paid-losses. At least one
study notes that the relationship is not necessarily linear--that is,
it takes more resources to achieve a certain level of improvement, but
beyond that the improvement slows. (Zhang, Unruh, Liu, and Wan, 2006.
``Minimum Nurse Staffing Ratios for Nursing Homes.''
CMS's own study reported that facilities with staffing levels below
4.1 hours per resident day (HRPD) for long stay residents may provide
care that results in harm and jeopardy to residents (Appropriateness of
Minimum Nurse Staffing Ratios in Nursing Homes, Phase II Final Report,
2001, Abt Associates). A study by Schnelle and colleagues (2004) also
supports a threshold level of 4.1 total nursing hours per resident day
to ensure that the processes of nursing care are adequate (Nursing
Facilities, Staffing, Residents, and Facility Deficiencies, 2005-2010.
Charlene Harrington, Ph.D.; Helen Carrillo, M.S.; Megan Dowdell, M.A.;
Paul P. Tang, B.S.; Brandee Woleslagle Blank, M.A.). A staffing level
of 4.1 hours per resident day is the most common number put forward as
a minimum standard. However, the conclusions in the 2001 Abt Associates
study previously cited were rejected by the then Secretary of HHS due
to ``serious reservations about the reliability of staffing data at the
nursing home level.'' Based on existing data, according to the Centers
for Disease Control's National Center for Health Statistics National
Study of Long-Term Care Providers (2013), the average hours of nursing
care per resident per day for nursing homes is 3.83 (.52 RN, .85 LPN or
LVN, and 2.46 Aide) plus an additional .08 hours of Social Worker time.
This does not include therapist time, although virtually all nursing
homes (99.3%) offer therapeutic services and therapeutic services are
critical to helping residents `attain or maintain the highest
practicable physical, mental, and psychosocial well-being'--in order
for a facility to achieve its statutory mandate that a nursing facility
provide services and activities to attain or maintain the highest
practicable physical, mental, and psychosocial well-being of each
resident.'' (see sections 1819(b)(2) and1919(b)(2) of the Act).
However, as a result of section 1128I of the Act, as added by the ACA,
CMS is currently developing systems to collect staffing information
that is auditable back to payroll data. Once implemented, this new
system is expected to increase accuracy and timeliness of data. When
this improved staffing data is collected at the nursing home level,
more accurate and reliable estimates of the care hours provided by
staff categories will be available, potentially leading to updated
research and reconsideration of HPRD requirements and recommendations.
An alternative approach to mandating a specific number of hours per
resident day is to mandate the presence of a registered nurse in a
nursing home for more hours per day than is currently required,
potentially 24 hours a day 7 days a week, subject to the statutory
waiver. We note that a number of states already require this. Increased
presence of RNs in nursing facilities would address several issues.
First, greater RN presence has been associated in research literature
with higher quality of care and fewer deficiencies. Second, it has been
reported in the literature that LPNs or LVNs may find themselves
practicing outside of their scope of practice because, at least in
part, there are not enough RNs providing direct patient care.
Increasing the number of hours a day that an LTC facility must have RNs
in the nursing home would alleviate this issue. While imposing a
mandate for more RNs raises concerns about the adequacy of the supply
of registered nurses, a December 2014 HRSA report on the future of the
nursing workforce suggests that growth in RN supply will actually
outpace demand in the period between 2012 and 2025 (U.S. Department of
Health and Human Services. ``The Future of the Nursing Workforce:
National- and State-Level Projections, 2012-2025.'' Health Resources
and Services Administration, Bureau of Health Workforce, National
Center for Health Workforce Analysis. (December 2014)). The study notes
that the national projections mask a distributional imbalance of RNs at
the state level and that there is considerable variation in the
geographic distribution of the growth in RN supply. Sixteen states are
projected to have a shortage by 2025, particularly Arizona, Colorado,
and North Carolina (https://bhpr.hrsa.gov/healthworkforce/supplydemand/nursing/workforceprojections/nursingprojections.pdf). In looking at the
employment of registered nurses in nursing homes, the BLS reported in
its May 2012 Occupational Employment Statistics (https://www.bls.gov/oes/2012/may/oes291141.htm) that 139,440 registered nurses were
employed in nursing care facilities (skilled nursing facilities); in
the May 2014 Occupational Employment Statistics (https://www.bls.gov/oes/current/oes291141.htm) that number has risen to 148,970. At the
same time, the number of nursing homes has decreased somewhat from
15,844 based on FY 2012 to 15,691 in 2015, based on CASPER data.
Perhaps somewhat contrary to much of the discussion and literature,
a 2011 review of the literature on nurse staffing and quality of care
raises questions about the direct cause and effect relationship between
the nursing workforce and quality of care. Specifically, the authors
conclude that ``A focus on numbers of nurses fails to address the
influence of other staffing factors (for example, turnover and agency
staff use), training and experience of staff, and care organization and
management.'' They note that the studies they reviewed presented 42
measures of quality and 52 ways of measuring staffing. They also note
that it is ``difficult to offer conclusions and recommendations about
nurse staffing based on the existing research evidence.'' (Spilsbury,
Hewitt, Stirk and Bowman ``The relationship between nurse staffing and
quality of care in nursing homes: a systematic review'' The
International Journal of Nursing Studies 48(2011)732-750.) An October
2011 research article by John R. Bowblis concludes that minimum direct
care staffing requirements for nursing homes ``change staffing levels
and skill mix, improve certain aspects of quality, but can lead to use
of care practices associated with lower quality'' (HSR: Health Services
Research 46:5 (2011) 1945). In short, there is concern that a facility
can have sufficient numbers of staff, but if those staff do not have
the skills and competencies to do the
[[Page 42201]]
necessary work, quality will not improve.
While we believe that existing requirements for sufficient staff
need further clarification, we do not believe that we have sufficient
information at this time to require a specific number of staff or hours
of nursing care per resident. Furthermore, we do not necessarily agree
that imposing such a requirement is the best way to clarify what is
``sufficient'' to the exclusion of other factors that are important in
improving the quality of care for each resident. The American Nurses
Association (ANA), in its 2012 Principles for Nurse Staffing, describe
appropriate nurse staffing as ``a match of registered nurse expertise
with the needs of the recipient of nursing care services in the context
of the practice setting and situation.'' The ANA further notes that
``staffing needs must be determined based on an analysis of healthcare
consumer status (for example, degree of stability, intensity, and
acuity), and the environment in which the care is provided. Other
considerations to be included are: professional characteristics, skill
set, and mix of the staff and previous staffing patterns that have been
shown to improve outcomes. The International Council of Nurses (ICN)
included similar considerations in its 2012 statement of principles of
safe staffing levels (https://www.icn.ch/images/stories/documents/pillars/sew/ICHRN/Policy_Statements/Policy_statement_Safe_staffing_levels.pdf). The ICN policy statement
includes as one of its key principles that ``safe staffing levels must
reflect the skills, experience and knowledge required to meet patient
care needs, taking acuity levels into account.'' A second key principle
states that safe staffing ``involves a range of factors including (but
not limited to) a sufficient number of staff available, an appropriate
level and mix of skills, a manageable workload of both teams and
individuals; . . .''. We agree. We believe that the focus should be on
the skill sets and specific competencies of assigned staff to provide
the nursing care a resident needs rather than a static number of staff
or hours of nursing care that does not consider resident
characteristics such as stability, intensity and acuity and staffing
abilities including professional characteristics, skill sets and staff
mix. We are concerned that establishing a specific number of staff or
hours of nursing care could result in staffing to that number rather
than to the needs of the resident population. A competency-based
staffing approach would require the facility to evaluate its population
and its resources in accordance with proposed Sec. 483.70(e),
including the number and acuity of the residents, the range of
diagnoses and resident needs and the training, experience, and skill
sets of staff, and base staffing plans and assignments on these
assessments. This would include, but not be limited to, allocating the
appropriate number of competent staff to a care situation. Based on
evolving demographic shifts and staffing patterns, we believe a
competency based approach will help to maintain flexibility in facility
staffing and capability. Our intent is to require facilities to make
thoughtful, informed staffing plans and decisions that are focused on
meeting resident needs, including maintaining or improving resident
function and quality of life. We maintain that such an approach is
essential to person-centered care. We considered combining this
approach with a minimum staffing requirement. Options included
establishing minimum nurse hours per resident day, establishing minimum
nurse to resident ratios, requiring that an RN be present in every
facility either 24 hours a day or 16 hours a day, and requiring that an
RN be on-call whenever an RN was not present in the facility. We also
considered multiple combinations of these option and note that states
have implemented a variety of these options. We welcome comment on all
of these options. In particular, we are aware that the IOM has
recommended in several reports that we require the presence of at least
one RN within every facility at all times. We specifically invite
comments on the costs of mandating a 24 hour RN presence. We also
invite comment on the benefits of a mandatory 24 hour RN presence,
including cost savings and improved resident outcomes, as well as any
unintended consequences of implementing this requirement. We further
welcome evidence of appropriate thresholds for minimum staffing
requirements (for both nurses and direct care workers) and evidence of
the actual cost of implementing recommended thresholds, including
taking into account current staffing levels as well as projected
savings from reduced hospitalizations and other adverse events.
As noted earlier, current regulations at Sec. 483.30 mirror the
statutory language at sections 1819(b)(4)(C)(i) and 1919(b)(4)(C)(i) of
the Act, requiring (with certain exceptions) an RN providing services
in a facility 8 consecutive hours a day, 7 days a week, licensed nurses
24 hours a day current regulations and requiring the facility to have
``sufficient'' nursing staff. This standard has been praised by some in
that it provides facilities with flexibility to determine the level of
staffing needed in order to meet the needs of each resident, based upon
individual assessments and plans of care. However, the current standard
has been criticized by others who have found it lacking sufficient
clarity to indicate to facilities what level of staffing is sufficient
to provide residents with even minimal standards of care and quality of
life. In this proposed rule, we have proposed an approach of a facility
assessment process, requiring facilities to determine adequate staffing
based on this assessment, which includes but is not limited to the
number of residents, resident acuity, range of diagnoses, and the
content of care plans. (proposed Sec. Sec. 483.35 and 483.70). We
solicit comments on whether this proposed approach can reasonably be
expected to enable facilities to determine and provide adequate levels
of staffing to meet the needs of each resident.
We recognize that many States have developed minimum staffing
levels of CNAs in their nursing facility licensure requirements. States
have implemented a variety of methods to address staffing levels to
best meet resident care and quality of life needs. Some States have
implemented a CNA hours-per-resident-day model (some include part or
all of the hours of licensed nurses into this calculation). For
example, Washington, DC requires a minimum daily average of 4.1 hours
of direct nursing care per resident per day (with opportunity to adjust
the requirements above or below this level, as determined by the
Director of Department of Health), an RN on site 24/7, plus additional
nursing and medical staffing requirements. https://doh.dc.gov/sites/default/files/dc/sites/doh/publication/attachments/Nursing_Facility_Regulations_Health_Care_Facilities_Improvement_2012.pdf
.
Some States have implemented a ratio of numbers of full-time
equivalent CNAs per resident. For example, Maine requires no fewer than
one direct care provider for every five residents during the day shift,
one per ten in the evening, and one per fifteen in the night. Arkansas
requires no less than one direct care provider for every six residents
during the day shift, one per nine in the evening, and one per fourteen
in the night, plus requirements for minimum numbers of licensed nurses
per residents per shift. We solicit comments on whether CMS should
consider adopting one of these or other approaches in determining
adequate direct care staffing. We invite information regarding research
on these
[[Page 42202]]
approaches which indicate an association of a particular approach or
approaches and the quality of care and/or quality of life outcomes
experienced by resident, as well as any efficiencies that might be
realized through such approaches.
States have found that requirements for increased staffing levels
resulted in improved resident care outcomes and decreased deficiencies.
For example, after increasing its nurse staffing levels, Florida found
``evidence that quality of care has substantially improved in Florida
nursing homes since the introduction of increased nurse staffing levels
and other quality standards since 2001. Average deficiencies per
facility have decreased. Importantly, the citations for the more
serious deficiencies have decreased dramatically and remain lower than
the national average. Measures of resident care outcomes have improved
in 2007 after the new staffing standards of 2.9 hours per resident day
were instituted.'' Hyer, K. et al, (2009) University of South Florida,
Analyses on Outcomes of Increased Nurse Staffing Policies in Florida
Nursing Homes: Staffing Levels, Quality and Costs (2002-2007); i. At
this time, we have deferred deciding on any potential specific
requirement pending evaluation of additional data that will be
collected on payroll based staffing data.
We are proposing to revise the section to incorporate language to
require that nursing service personnel have the competencies and skill
sets necessary to provide nursing and related services to assure the
safety of residents and help them to attain or maintain the highest
practicable physical, mental, and psychosocial well-being. The facility
would have to take into account its assessment of all residents as well
as the skill-sets of individual staff when making staffing decisions.
We also propose revisions to improve the logical order and readability
of these regulatory provisions.
We propose to include in the introductory language of proposed
Sec. 483.35 ``Nursing Services'' the requirement that, in addition to
having sufficient staff to provide nursing care to each resident in
accordance with his or her care plan and individual needs, the facility
ensure that staff have appropriate competencies and skill sets to
assure resident safety. We would also require that the determination of
what is sufficient staff as well as the determination of the necessary
competencies and skill sets take into account the number, acuity and
diagnoses of the facility's resident population.
We propose to clarify at Sec. 483.35(a)(1)(ii) that nurse aides
are included in the term ``other nursing personnel.'' Currently, a
number of provisions regarding nurse aides are included in the
regulatory provisions under Sec. 483.75 Administration. Nurse aides
provide much, if not most, of the direct care provided in nursing
facilities and as a practical matter are managed within most
organizations by the nursing services department in medical models of
care delivery. We include nurse aides in proposed Sec. 483.35 in
recognition of this fact and to ensure clarity of our intent.
We propose to add Sec. 483.35(a)(3) and (4) to specify that the
facility ensure that licensed nurses have the competencies and skill
sets necessary to care for residents' needs, as identified through
resident assessments, and as described in each resident's individual
plan of care. We further propose to specify that caring for a
resident's needs would include but not be limited to assessing,
evaluating, planning and implementing resident care plans and
responding to each resident's needs. This continues our focus on
ensuring that not only are there a sufficient number of staff in a
facility, but also that staff have the necessary abilities, knowledge
and competencies to be effective and efficient in carrying out the work
necessary to meet the needs of each resident receiving care in the
facility.
Consistent with our clarification that nurse aides are included in
the term ``other nursing personnel,'' we propose to move most of the
provisions relating to nurse aides previously located in Sec. 483.75
to proposed Sec. 483.35. Specifically, we propose to re-designate
Sec. 483.75(f) ``Proficiency of Nurse Aides'' as Sec. 483.35(c). We
propose to re-designate Sec. 483.75(e) as Sec. 483.35(d) and re-title
the provision as ``Requirements for Facility hiring and use of nursing
aides'' to reflect its contents more accurately. A proposed revision to
the definition of a nurse aide is included in our proposed revisions to
Sec. 483.5 and is included in our earlier discussion of that section.
The regulations at proposed Sec. 483.35(d)(2) are re-designated from
Sec. 483.75(e) and address non-permanent employees Non-permanent
caregivers are expected to meet competency, knowledge and skill
requirements to the same extent as permanent personnel. These
caregivers may have less familiarity than permanent staff with a
facility's residents and processes. Therefore, this must be considered
when using, orienting, and assigning non-permanent staff. We also
propose to add the term ``minimum'' to Sec. 483.35(c)(3) to clarify
that this paragraph identifies the minimum requirements for hiring a
nurse aide. Meeting this minimum standard does not automatically meet
the competency requirement specified in Sec. 483.35 that would be
specific to the needs of each individual resident.
L. Behavioral Health Services (Sec. 483.40)
Currently, Sec. 483.25 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, in accordance with the comprehensive assessment and plan of
care. We propose to add a new section Sec. 483.40 to address this
requirement as it relates to behavioral health services.
Serious mental illness and cognitive and/or functional impairment
are strong predictors of admission into a nursing home. Although
estimates vary, the industry literature indicates that a large number
of nursing home residents have a significant mental health disorder. In
2004, over 16 percent of nursing home residents received a primary
diagnosis of a mental disorder upon admission (Jones, Figure 7). By the
time residents were interviewed for the National Nursing Home Survey
that percentage increased to almost 22 percent. The 1999 estimate was
about 18 percent. In addition, nursing homes are caring for a
significant number of patients with dementia and depression. By 2012,
over 48 percent of nursing home residents had a diagnosis of
Alzheimer's disease or another dementia and/or depression (Harris-
Kojetin, p. 35, Figure 23).
In a 2003 report, the OIG concluded that not all residents of LTC
facilities receive the behavioral health services they need.
Additionally, there is evidence that there is not full compliance with
the requirement to provide medically-related social services to attain
or maintain the highest practicable physical, mental and psychosocial
well-being of each resident (``Psychosocial Services in Skilled Nursing
Facilities,'' Department of Health and Human Services, Office of the
Inspector General, OEI-02-01-00610, March 2003).
Given the prevalence of mental health disorders and other cognitive
impairments and in order to achieve the LTC requirements' goal of the
highest practicable mental and psychosocial well-being for each
resident, it is critical that LTC facilities ensure that behavioral
health issues are addressed. Therefore, we propose to add a new section
Sec. 483.40 to include requirements for both behavioral health
services and for social workers. These provisions
[[Page 42203]]
work in conjunction with other provisions we propose, including those
related to reducing the inappropriate use of psychotropic medications.
Currently, sections 1819(b)(7) and 1919(b)(7) of the Act require
that a facility with more than 120 beds employ at least one social
worker on a full-time basis or assure the provision of social services.
However, all facilities are required to provide the necessary care and
services to attain or maintain the highest practicable physical, mental
and psychosocial well-being, in accordance with the comprehensive
assessment and plan of care. Meeting one requirement does not negate
the need to meet other requirements. In keeping with our competency
focus, we propose to include in new Sec. 483.40 requirements to ensure
that there are sufficient direct care staff with the appropriate
competencies and skills to provide the necessary care to residents with
mental illness and cognitive impairment. The needed competencies and
skill sets include knowledge and training, including non-pharmacologic
interventions, necessary to provide the care for residents with mental
illnesses and psychosocial disorders. Thus, LTC facilities would be
required to have the staff, including social workers, necessary to
provide the social services needed by their residents.
We propose, in Sec. 483.40(a) to require that the facility have
sufficient direct care staff with the appropriate competencies and
skills sets to provide nursing and related services to assure resident
safety and attain or maintain the highest practicable physical, mental,
and psychosocial well-being of each resident, as determined by resident
assessments and individual plans of care and considering the number,
acuity and diagnoses of the facility's resident population in
accordance with the facility assessment required at proposed Sec.
483.70(e). Necessary competencies and skills include knowledge of and
appropriate training and supervision for caring for residents with the
mental illness and psychosocial or adjustment problems as well as
residents with a history of trauma and/or post-traumatic stress
disorder that have been identified in the facility assessment.
Furthermore, staff must be trained in implementing non-pharmacological
interventions. We propose to specify in new paragraph (b) that, based
on the comprehensive assessment of a resident, the facility must ensure
that a resident who displays or is diagnosed with mental or
psychosocial adjustment difficulty receives appropriate treatment and
services to correct the assessed problem or to attain the highest
practicable mental health and psychosocial well-being. In addition, we
propose to specify that a resident whose assessment does not reveal or
who does not have a diagnosis of a mental illness or psychosocial
adjustment difficulty will not display a pattern of decreased social
interaction and/or increased withdrawn, angry, or depressive behaviors,
unless the resident's clinical condition demonstrates that the pattern
was unavoidable. Furthermore, if rehabilitative services such as
physical therapy, speech-language pathology, occupational therapy, and
rehabilitative services for mental illness and intellectual disability
are required in the resident's comprehensive plan of care, the facility
must provide the required services, including specialized
rehabilitation services as required in Sec. 483.45; or obtain the
required services from an outside provider of specialized
rehabilitative services in accordance with proposed Sec. 483.75(g).
We encourage facilities to take advantage of the many tools and
resources available to them for free or at low cost. Facilities may
also contact CMS staff at dnh_behavioralhealth@cms.hhs.gov, to be put
in touch with state coalition leads and state-level resources.
M. Pharmacy Services (Sec. 483.45)
Currently, the LTC requirements require that each resident's drug
regimen be reviewed by a pharmacist at least once a month (Sec.
483.60(c)). Based on our experience with LTC facilities, some
pharmacists review the medical chart for each resident when they
perform the drug regimen review, and others simply review the
medication administration record (MAR).
We believe that there are specific circumstances under which the
pharmacist must at least periodically review the resident's medical
record concurrently with the drug regimen review. Those circumstances
include transitions in care, specifically when the resident is new to
the facility or is returning or being transferred from another
facility. We also believe it is critical when a resident is on a
psychotropic or antimicrobial medication. In addition, we propose
specific requirements related to the use of psychotropic drugs, Sec.
483.45(e), and antibiotics, Sec. 483.80(a)(2). We believe having the
pharmacist review residents' medical charts when these medications are
prescribed would not only assist the pharmacist in detecting
irregularities related to these drugs but also enhance or contribute to
the goal of ensuring that these medications are used only when
medically appropriate for the resident. We also believe that the
pharmacist's review could contribute to our proposed requirements for
infection control and antibiotic stewardship. By reviewing the
resident's medical chart, the pharmacist could review whether an
infection or communicable disease has been documented in the chart,
whether the antibiotic is usually prescribed for that condition, and
whether it has been prescribed for the recommended length of time. To
maximize the effectiveness of this review, we would recommend that the
pharmacist be familiar with the facility's antibiotic use protocols and
its system for monitoring antibiotic use. Thus, we propose that a
pharmacist be required to review the resident's medical record
coincident with the drug regimen review when--(1) the resident is new
to the facility; (2) a prior resident returns or is transferred from a
hospital or other facility; and (3) during each monthly drug regimen
review when the resident has been prescribed or is taking a
psychotropic drug, an antibiotic, or any drug the QAA Committee has
requested be included in the pharmacist's monthly drug review. We are
proposing the last criteria to give each facility's QAA Committee the
ability to request that certain drugs receive more scrutiny during the
monthly drug regiment review. For example, anticoagulants and
antidiabetic medications have been identified as being related to
adverse events related to medications in SNFs (Adverse Events in
Skilled Nursing Facilities: National Incidence Among Medicare
Beneficiaries. Office of Evaluations and Inspections, Report OEI-06-11-
00370. Office of Inspector General, Department of Health & Human
Services. (2014)). Our proposal would give the facility's QAA Committee
the ability to add specific drugs or drug categories that need
additional scrutiny so that those residents on those drugs would have
their medical record reviewed by a pharmacist as part of the monthly
drug review. In addition, we encourage the QAA Committee to collaborate
with the pharmacist to enhance the committee's understanding and
oversight of the facility's pharmaceutical practices, especially
concerning the use of psychotropic drugs and its antibiotic
stewardship, as well as their QAPI activities.
The current LTC requirements at Sec. 483.25(l)(2) also
specifically identify antipsychotic drugs and provide specific
safeguards for their use. Section 483.25(l)(2)(i) requires that
residents who have not previously been prescribed antipsychotics not be
given them unless the medication is necessary
[[Page 42204]]
to treat a specific condition as diagnosed and documented in the
clinical record. Also, Sec. 483.25(l)(2)(ii) requires that residents
taking antipsychotics should receive gradual dose reductions, and
behavioral interventions, unless clinically contraindicated, in an
effort to discontinue use of these drugs. In this proposed rule, we are
moving this requirement to Sec. 483.45(e).
Antipsychotics are a particular concern for residents. These drugs
have serious side effects and can be especially dangerous for the
elderly. Since the LTC requirements became effective in 1992, there has
been a reduction in the number of antipsychotics prescribed to
residents. However, we are concerned that as the use of antipsychotic
drugs has decreased, the use of other psychotropic medications has
increased. Therefore, we propose to expand the drugs to which proposed
Sec. 483.45(e) applies to include all psychotropic medications. In
conducting our research into a definition for psychotropic medications,
we discovered different definitions. We are proposing to use the
definition used in the November 2001 OIG report, ``Psychotropic Drug
Use in Nursing Homes'' (OEI-02-00-00490), which is that they are drugs
that affect brain activities associated with mental processes and
behavior. These drugs include, but are not limited to, drugs in the
following categories: (1) Anti-psychotic, (2) anti-depressant, (3)
anti-anxiety, (4) hypnotic, (5) opioid analgesic, and (6) any other
drug that results in effects similar to the drugs listed above. We are
proposing the last category, ``(6) any other drug that results in
effects similar to the drugs listed above,'' to address other
medications. We are also specifically soliciting comments on this
definition and the types of drugs that should be included.
In addition, we are concerned about the PRN use of psychotropic
medications. A PRN order is often used to titrate or adjust the dosage
of a psychotropic medication until an appropriate therapeutic dose is
determined for the resident. However, we have received reports that
some residents remain on PRN orders for psychotropic medications for
extended periods of time. Therefore, we are proposing that LTC
facilities ensure that residents do not receive psychotropic drugs
pursuant to a PRN order unless that medication is necessary to treat a
diagnosed specific condition that is documented in the clinical record.
In addition, every PRN order for a psychotropic drug is limited to 48
hours and cannot be continued beyond that time unless the resident's
primary care provider, for example, his or her physician, documents the
justification for this continuation in the resident's clinical record.
We would also appreciate comments on the use of PRN orders for these
medications and our proposal to limit PRN prescriptions for these drugs
to 48 hours unless the resident's primary care provider provides a
rationale for the continuation of the PRN order in the resident's
clinical record.
The current LTC requirements also require the pharmacist conducting
the monthly drug regimen review must report any irregularities to the
attending physician and the director of nursing. The term
``irregularities'' is not defined in the regulation and no examples are
given. We propose to define ``irregularities'' to include, but not be
limited to, the use of any drug that meets the criteria set forth in
proposed paragraph (d) for an unnecessary drug. In addition, we propose
to require that the pharmacist performing the monthly drug regimen
review must report any ``irregularities'' to the attending physician
and the facility's medical director and the director of nursing, and
that these reports must be acted upon (re-designated in proposed Sec.
483.45(c)(4)). However, it does not indicate how the pharmacist is to
notify these individuals or how to ascertain if the report was acted
upon. Based on our experience with facilities, this reporting of
irregularities has been communicated in different ways, including by
simply making a note in the resident's medical chart that the drug will
be continued as ordered. We are concerned that the pharmacist's report
of irregularities may not be given the appropriate review and
consideration that is merited. Therefore, we propose that the medical
director be added to the individuals who should be notified of
irregularities in residents' drug regimens. We also propose that the
pharmacist create a written report that is dated, and contains, at a
minimum, the resident's name, the relevant drug, and the irregularity
the pharmacist noted. We are not proposing the manner in which this
report is developed or transmitted because we want nursing homes to
have the flexibility to comply with this proposed requirement in the
most efficient manner considering their circumstances. For example, for
many nursing homes, the facility may develop an electronic form that
the pharmacist can fill out on-line as he or she is performing the
reviews and pre-populating the emails to which the form is to be sent
to include, at a minimum, the attending physician, medical director,
and director of nursing. Other nursing homes may need to develop a
paper form and ensure that copies are transmitted to the appropriate
individuals. To ensure that the reported irregularities are acted upon,
we are also proposing that the attending physician must document in the
resident's medical record that the identified irregularity has been
reviewed and what, if any, action has been taken to address it. If
there is to be no change in the medication, the attending physician
should document his or her rationale in the resident's medical record.
The current description of ``unnecessary drugs'' and the specific
requirements for antipsychotic drugs are set forth in Sec.
483.25(l)(1) and (2), respectively, under the ``Quality of Care''
condition of participation. Furthermore, the requirements for the
facility to maintain a medication error rate of no greater than 5
percent and to keep residents free of any significant medication errors
is set forth in current Sec. 483.25(m). After reviewing the existing
provisions, we believe that these requirements should be relocated from
Sec. 483.25 ``Quality of Care'' to proposed Sec. 483.45 ``Pharmacy
services.'' All of these requirements are concerned with medications
and medication errors. Although medication errors and unnecessary drugs
are clearly part of the quality of care that residents receive, we
believe it is more appropriate and logical to relocate these
requirements under the general section at proposed to Sec. 483.45,
``Pharmacy Services.'' This relocation should make it easier for
individuals to locate the requirements concerning medications since
they will all be set forth in the pharmacy services section.
We want to emphasize that the proposed requirements concerning
psychotropic medications are not intended to have a chilling effect or
in any manner discourage the prescription or use of any medication
intended for the benefit of a resident who has been diagnosed for a
specific condition that requires these medications. Our proposed
requirements are intended to protect nursing home residents from drugs
that are not being prescribed for their benefit. Our proposed
requirements for gradual drug reductions, if not clinically
contraindicated, and for behavioral interventions are intended to
reduce or, if possible, eliminate the need for these medications.
Likewise, our proposed requirement for a 48 hour limitation on PRN
orders for psychotropic medications is intended to safeguard the
resident's health. We are concerned about reports that PRN orders for
these
[[Page 42205]]
drugs may remain in effect for an extended time without being reviewed
by the resident's physician or primary care provider. These proposed
requirements are completely in alignment with the concepts and
requirements of person-center care and the requirement that residents
receive the necessary behavioral health care and services to attain or
maintain the highest practicable physical, mental, and psychosocial
well-being, in accordance with the comprehensive assessment and plan of
care (Proposed Sec. Sec. 483.21 and 483.40). Therefore, we do not
believe these proposed requirements should discourage the use of
psychotropic medications when these drugs are required for the
resident's benefit.
N. Laboratory, Radiology, and Other Diagnostic Services (Sec. 483.50)
Currently, Sec. 483.75(j) sets forth requirements regarding
laboratory services and Sec. 483.75(k) sets forth requirements for
radiology and other diagnostic services that a facility must provide or
obtain to meet the needs of its residents. These regulations are
currently located in Sec. 483.75 ``Administration,'' which largely
focuses on the manner in which a facility must operate to provide
quality care to its residents. In an effort to improve the readability
of our regulations and follow our proposed reorganization of subpart B,
we propose to relocate and re-designate both Sec. 483.75(j) and Sec.
483.75(k) to a new proposed Sec. 483.50 entitled, ``Laboratory,
Radiology, and Other Diagnostic Services.'' This proposed new section
would include all of the content from current Sec. 483.75(j) and Sec.
483.75(k) relocated to Sec. 483.50(a) and Sec. 483.50(b),
respectively. We propose to retain the existing requirements with some
revisions as discussed in detail below.
Current Sec. 483.75(j)(a)(2)(i) and Sec. 485.75(k)(2)(i), require
that a facility must provide or obtain laboratory and radiology and
other diagnostic services ``only when ordered by the attending
physician.'' We propose to clarify these requirements by removing the
phrase, ``the attending physician'' and replacing it with ``a
physician, a physician assistant, nurse practitioner, or clinical nurse
specialist.'' The revised requirements would be located at proposed
Sec. 483.50(a)(2)(i) and (b)(2)(i), respectively. Furthermore, we
would allow for these orders only if the practitioners are acting in
accordance with state law, including scope of practice laws and
facility policy. We believe that this proposal reflects current
practice models and recognizes the importance of non-physician
practitioners in LTC facilities. These revisions would also increase
access to care by avoiding possible delays in treatment of residents as
well as eliminate burden to attending physicians by clarifying the
services that non-physician practitioners can provide.
Additionally, current Sec. 483.75(j)(2)(ii) and (k)(2)(ii) require
that facilities ``promptly notify the attending physician of the
findings'' once laboratory results have been obtained. We are
sympathetic to stakeholder concerns regarding the potential for
disruption that notification of attending physicians for nonemergency
results or findings could cause. Therefore, we are proposing to allow
increased flexibility under this requirement to provide that other
practitioners have the ability to receive laboratory and radiology and
other diagnostic results if these practitioners ordered the tests.
Specifically, we propose to revise Sec. 483.50(a)(2)(ii) to permit
that the ordering physician, physician assistant, nurse practitioner,
or clinical nurse specialist to be notified of laboratory results. In
addition, we propose in Sec. 483.50(a)(2)(ii) to clarify that the
laboratory must promptly notify the ordering professional if results
fall outside of clinical reference or expected ``normal'' ranges,
unless the orders for the test or the facility's policies and
procedures require otherwise. While we want to ensure that the lab
notifies the appropriate professional, we also want to reduce
unnecessary notification of staff. We believe this revision would
improve the notification process, therefore saving time and reducing
burden, while still ensuring resident safety.
We received a comment from stakeholders requesting that we revise
the regulations to explicitly state that laboratory and diagnostic
services be provided or obtained from ``a certified or accredited
company.'' Current Sec. 483.75(j)(1)(i) (now re-designated in proposed
Sec. 483.50(a)(1)(i)), provides that laboratory services provided in a
facility are subject to the requirements set forth in 42 CFR part 493
under the Clinical Laboratory Improvement Amendment (CLIA). Part 493
sets forth the conditions that all laboratories must meet to be
certified to perform testing on human specimens. In addition, current
Sec. 483.75(k)(1)(i) specifies that if a facility provides its own
diagnostic services, the services must meet the requirements set forth
in Sec. 482.26. Section 482.26 sets forth the conditions of
participation that a hospital must meet to provide diagnostic
radiologic services including staff qualifications. Similarly, current
Sec. 483.75(k)(ii) specifies that if the facility does not provide its
own diagnostic services, it must have an agreement to obtain the
services from a provider or supplier that is approved to provide the
services under Medicare. We believe that the current requirements for
laboratory and diagnostic services to be furnished by qualified
laboratories and facilities are sufficient, and are proposing to retain
it without change.
O. Dental Services (Sec. 483.55)
Under the proposed reorganization, requirements regarding dental
services would remain at Sec. 483.55. Section 1862(a)(12) of the Act
states, in part, that Medicare will not cover dental services such as
the care, treatment, filling, removal, or replacement of teeth or
structures directly supporting teeth. State plans vary in their
coverage of dental services. However, both sections 1819(b)(4)(A)(vi)
and 1919(b)(4)(A)(vi) of the Act include requirements related to the
provision of dental services. We recognize that dental care supports
the overall well-being of all facility residents. Currently, Sec.
483.55 requires that facilities assist residents in obtaining
appropriate dental services at the resident's expense for SNF residents
and as covered under the state plan for NF residents.
We propose limited changes to update and clarify this section.
First, we propose to add a new Sec. 483.55(a)(3) to clarify that a
facility may not charge a resident for the loss of or damage to
dentures when the loss or damage is the responsibility of the facility.
We considered, but are not specifying in this proposed rule, the
circumstances under which a facility is responsible, believing that
facilities already make this determination, but we do specify that the
determination must be made pursuant to facility policy. We welcome
comment on this issue. Second, we propose to re-designate existing
Sec. 483.55(a)(3) as Sec. 483.55(a)(4) and revise Sec. 483.55(a)(4)
by adding the phrase ``or if requested'' to clarify that if a resident
asks for assistance in scheduling a dental appointment, the facility
would be required to provide the assistance. Third, we propose to
modify the section by adding language at new Sec. 483.55(a)(4)(ii) and
Sec. 483.55(a)(5) regarding transportation and referrals for dental
services. We note that facilities could comply with these provisions by
referring and transporting residents to a dental clinic or dental
school rather than a dentist's office. We also understand that in some
facilities, dental services are provided in the facility. In these
instances, the facility
[[Page 42206]]
would be in compliance with these provisions by assisting resident
access to the dental office within the facility. Finally, we propose to
re-designate Sec. 483.55(a)(4) as Sec. 483.55(a)(5) and would require
that referral for dental services occur in 3 business days or less from
the time the loss or damage to dentures is identified unless the
facility can provide documentation of extenuating circumstances that
resulted in the delay. We believe that it is imperative that the loss
or damage is addressed and corrected quickly to avoid adverse
consequences such as weight loss. We propose to make the same changes
at Sec. 483.55(b)(2) and Sec. 483.55(b)(3) to apply to nursing
facilities and add a new Sec. 483.55(b)(4) to require that facilities
assist residents to apply for reimbursement of dental services as an
incurred medical expense under the state plan as appropriate.
P. Food and Nutrition Services (Sec. 483.60)
Dietary standards for residents of LTC facilities are critical to
both quality of care and quality of life. An August 2011 report by the
Pioneer Network Food and Dining Clinical Standards Task Force notes
research by Simmons and others (Simmons SF, Lim B & Schnelle JF.
(2002). Accuracy of Minimum Data Set in identifying residents at risk
for undernutrition: Oral intake and food complaints. Journal of the
American Medical Directors' Association, 3(May/June):140[hyphen]145)
that 50 to 70 percent of residents leave 25 percent or more of their
food uneaten at most meals and that documentation by facility staff on
food consumption is inaccurate. A 2005 position paper by the American
Dietetic Association suggests that malnutrition is one of the most
serious problems in LTC and is associated with poor outcomes (https://www.journals.elsevierhealth.com/periodicals/yjada/article/S0002-8223(05)01742-6/fulltext). Malnutrition, protein-energy under nutrition
(PEU), and dehydration can have a deleterious cascade effect on
residents, resulting in a downward spiral of declining physical, mental
and psychosocial well-being. An earlier (2000) report sponsored by the
Commonwealth Fund stated that between 35 percent and 85 percent of
nursing home residents are malnourished and between 3 percent and 50
percent are substandard in bodyweight (https://www.commonwealthfund.org/
~/media/Files/Publications/Fund%20Report/2000/Jul/
Malnutrition%20and%20Dehydration%20in%20Nursing%20Homes%20%20Key%20Issue
s%20in%20Prevention%20and%20Treatment/burger_mal_386%20pdf.pdf). Thus,
in considering requirements for food and nutrition services in
facilities, we seek to establish minimum health and safety standards
that support the nutritional well-being of all nursing home residents
while respecting each resident's right to make informed choices about
his or her care, including decisions about diet. Given the diversity of
nursing home residents, it may be challenging for facilities to meet
every resident's individual preferences every time; however, we believe
by incorporating a facility assessment, along with individual
assessments, more can be done to ensure residents are offered
meaningful choices in diets that are nutritionally adequate and
satisfying to the individual. At the same time, we do not intend to
require a facility to provide on an ongoing basis a diet that would be
impractical or financially unreasonable. Therefore, we propose
revisions described below consistent with our goals to provide
flexibility for the facility while enhancing resident choice. We
believe that this will lead to overall improvement in the nutritional
status of nursing home residents.
It is not enough; however, to ensure that residents have choices in
what they eat. Many nursing home residents have other barriers to
eating, including dental issues, medical issues, medication-related
issues, physical limitations and the need for proper positioning and
assistance at mealtimes. With so many issues facing nursing home
residents, adequate nutrition requires both an understanding of the
facility's population as a whole and an interdisciplinary approach for
each resident. This includes ensuring that sufficient staff are
available and have the appropriate skill sets, competencies, and
training to assess and plan an overall facility dietary program as well
as assess and assist individual residents at meals and with snacks.
Some individual residents may require assistance to get to a dining
area or to sit up in a comfortable position conducive to eating. Other
residents may require the correct application and set up of assistive
devices or may need an individual to sit with them and actively assist
them throughout the meal. Thus, our proposed revisions include person-
centered requirements that are outcome focused and intended to ensure
each resident is provided, in a dignified manner, the nutritional and
dietary care and services needed to meet the statutory goal of
attaining or maintaining his or her highest practicable mental,
physical and psychosocial well-being. We propose to revise this section
as follows:
We propose to re-designate existing Sec. 483.35 ``Dietary
Services'' as new proposed Sec. 483.60 ``Food and Nutrition Services''
and revise the introductory language to include taking resident
preferences into consideration. We propose to revise Sec. 483.60(a) to
require that the facility employ sufficient staff with the appropriate
competencies and skills sets to carry out the functions of the food and
nutrition service, taking into consideration resident assessments,
individual plans of care and the number, acuity and diagnoses of the
facility's resident population.
In proposed Sec. 483.60(a)(1) we would retain the requirement that
a facility employ a qualified dietitian on a full-time, part-time or
consultant basis and update the requirements to be considered a
qualified dietitian. The role of the dietitian is critical in the
delivery of food and nutrition services. Dietitians are part of the
interdisciplinary team and play a significant role, working with other
clinicians, to treat wounds, weight-gain or -loss, protein
malnutrition, dehydration, and nutrition-related chronic diseases such
as diabetes, congestive heart failure and chronic obstructive pulmonary
disease. The dietitian is the subject-matter expert for making person-
centered recommendations to ensure the nutritional well-being of each
resident. In addition to individual evaluations, the dietitian plays a
vital role in developing the nursing home's overall menus. This means
the dietitian must understand the general and individual needs of the
population of the nursing home, encompassing not just minimum
nutritional needs, but also diversity and cultural variety of the
residents and work with the director of food service to craft menus to
serve the facility population. Finally, the dietitian plays a role in
managing and monitoring the dietary staff and food quality, including
nutritional standards, food service standards, and infection control
standards. In order to ensure the highest level of expertise to meet
these requirements, we are proposing to require minimum qualifications
for dietitians working in SNFs or NFs. We propose to require that a
qualified dietitian must either be registered by the Commission on
Dietetic Registration of the Academy of Nutrition and Dietetics, or be
recognized (licensed or certified) by the state in which the SNF or NF
operates as a dietitian or clinically qualified nutrition
professionals. Currently, five states (AZ, CA, CO, NJ, and VA) do not
license or certify
[[Page 42207]]
dietitians. We note that the California State Personnel Board requires
valid certificate of registration with the Commission on Dietetic
Registration of the American Dietetic Association to qualify for state
employment in various dietetic positions. We would allow for the
retention of dietitians hired or contracted prior to the effective
dates of the revised regulations, for a period of no longer than 5
years after the effective date of a finalized requirement. We propose
to change the requirement for employment of a dietitian on a full-time,
part-time or consultant basis to allow for employment of other
clinically qualified nutrition professionals who are recognized
(licensed or certified) by the state in which the SNF or NF operates.
Retaining the option to employ a dietitian or other clinically
qualified nutrition professional less than full-time would allow
flexibility for small facilities and alternative care delivery models.
We note that regardless of how the facility chooses to obtain the
services of a dietitian or other clinically qualified nutrition
professional, the facility must ensure it achieves the required
outcomes for food and nutrition services, both in terms of providing a
nourishing, palatable, balanced diet and in terms of ensuring that each
resident is provided the necessary services, both assessment and care
delivery, to achieve his or her highest practicable physical, mental,
and psychosocial well-being.
In re-designated Sec. 483.60(a)(2), we propose to continue to
require that, if a qualified dietitian or other clinically qualified
nutrition professional is not employed full-time, the facility must
designate a person to serve as the director of food and nutrition
services who receives frequently scheduled consultation from a
qualified dietitian. We do not currently establish any standards for a
director of food and nutrition services. However, we believe that this
position is responsible for critical aspects of food and nutrition
services and we believe this individual should have specialized
training to manage menus, food purchasing, and food preparation; to be
able to apply nutrition principles, document nutrition information,
ensure food safety and sanitary procedures, and to manage staff and
work teams. We propose to require that the director of food and
nutrition services, if hired or designated after the effective date of
these regulations, must be a certified dietary manager or certified
food service manager as evidenced by meeting national certification
standards for a certified dietary manager such as those by the
Association of Nutrition and Foodservice Professionals (ANFP), or for a
certified food manager such as those by the International Food Service
Executives Association or the Food Management Professional
certification through the National Restaurant Association. If already
serving as a director of food and nutrition service on the effective
date without one of these certifications, the individual must obtain a
certification no later than 5 years after the effective date of the
rule. Alternatively, the director of food and nutrition services may
also meet the proposed requirement through specialized education or
training in food service management and safety resulting in an
associate's or higher degree in hospitality or food service management.
Finally, the director of food and nutrition services would meet our
proposed requirement if he or she meets applicable state requirements
to be a food service manager or dietary manager. We do not suggest that
a the director of food and nutrition services replaces the specialized
expertise of qualified dietitians or other clinically qualified
nutrition professionals; however, with their expertise in managing
dietary operations in a facility, they may provide needed expertise and
assistance in combination with a qualified dietitian or other
clinically qualified nutrition professional to achieve the necessary
quality of food and nutrition services for residents.
In new Sec. 483.60(a)(4), we propose to require that the facility
provide sufficient support personnel with the appropriate competencies
and skills sets to carry out the functions of the food and nutrition
service, taking into consideration resident assessments, individual
plans of care and a facility assessment that includes the number,
acuity and diagnoses of the facility's resident population. The current
regulations require that the facility employ sufficient support
personnel to carry out the functions of the dietary service. Our
proposed revisions would clarify that those support personnel must have
the requisite skill sets that take into account an assessment of the
facility and considering the individual needs of residents. We believe
that most facilities already meet this requirement; however, because
nutrition and dining safety are critical to the well-being of
residents, we think it is important to be more explicit in our
expectations. In particular, we think it is imperative that facilities
consider not just the number of residents when making staffing
decisions, but the acuity and diagnoses of residents in order to
provide effective and appropriate food and nutrition services. SNF and
NF residents have become sicker and more complex over time and this
must be factored into staffing decisions, both in terms of how many
staff are present and the skill sets and competencies the staff need to
have.
We propose a new Sec. 483.60(b) to specify that a member of food
and nutrition services also participate in the IDT. The registered
dietitian or other clinically qualified nutrition professional is a
critical member of the IDT; however, in some cases another member of
food and nutrition services with the appropriate skill sets and
competencies may be an acceptable alternative. Nutrition is an integral
aspect of a resident's well-being, thus it is critical an individual
knowledgeable about the facility capabilities as well as the resident's
needs and preferences participate in the interdisciplinary team in
order to ensure that resident can achieve or maintain his or her
maximum practicable well-being.
In proposed Sec. 483.60(c)(1), we would change ``Recommended
Dietary Allowances'' to ``established national guidelines or industry
standards.'' For example, United States Department of Agriculture
provides an online, interactive tool for healthcare professions to
calculate daily nutrient recommendations for dietary planning based on
the Dietary Reference Intakes (DRIs) at https://fnic.nal.usda.gov/fnic/interactiveDRI/. The DRIs are the Food and Nutrition Board of the
Institute of Medicine's update to the Recommended Dietary Allowances,
developed in partnership with Health Canada. Since 1998, the Institute
of Medicine has issued a series of DRIs that offer quantitative
estimates of nutrient intakes to be used for planning and assessing
diets applicable to healthy individuals in the United States and
Canada. Additional information on the DRIs, including access to 14
nutrient specific reports and several summary charts, are available in
the USDA Food and Nutrition Information Center at https://fnic.nal.usda.gov/. We also propose to add a new Sec. 483.60(c)(4) to
require that menus reflect the religious, cultural, and ethnic needs of
the residents, as well as input received from residents or resident
groups. While we do not require that every resident be afforded every
possible choice at any time, we are cognizant of the importance of
appropriate choice availability. Utilizing information from a facility
assessment and from residents and resident groups should assist in
ensuring that appropriate options are
[[Page 42208]]
available to residents under most circumstances.
In proposed Sec. 483.60(d), we propose minor revisions to
incorporate the addition of drinks, to clarify that ``proper'' means
both safe and appetizing, to include consideration of allergies,
intolerances, and preferences in preparing food, and to ensure that
water and other dietary liquids are available to residents and
provided, consistent with resident needs and preferences. We believe it
is critical to specifically include dietary fluids in our regulations
pertaining to food and nutrition services. Hydration is a critical
aspect of nutrition and elderly people who do not receive adequate
fluids are more susceptible to urinary tract infections, pneumonia,
decubitus ulcers, and confusion and disorientation. Chidester, J.C.,
and Spangler, A.A., ``Fluid Intake in the Institutionalized Elderly,''
Journal of the American Dietetic Association 97 (1997):23-30.
Orthostasis, confusion and disorientation, function decline, recurrent
falls, pressure sores, urinary tract infections, pneumonia, and skin
infections are all common conditions associated with inadequate fluid
intake in frail, elderly long-term care residents. Feinsod, F.,
Levenson, S., Rapp, K., Rapp, M., Beechinor, E., & Liebmann, L. (2004).
``Dehydration in frail, older residents in long-term care facilities.''
Journal of The American Medical Directors Association, 5(2 Suppl), S35-
S41. Available from: MEDLINE with Full Text, Ipswich, MA. A 1999 study
by Gaspar revealed that only 8 of 99 nursing home residents observed
met their standard water requirement based on two 24 hour observation
periods. (Gasper, P.M. ``Water Intake of Nursing Home Residents.''
Journal of Gerontologic Nursing. 1999;25(4):22-29.)
In new Sec. 483.60(e) ``Therapeutic diets,'' we propose to retain
the requirement in current Sec. 483.35(e) that therapeutic diets be
prescribed by the attending physician. However, we propose to add a new
Sec. 483.60(e)(2) to allow the attending physician to delegate to a
qualified dietitian or other clinically qualified nutrition
professional the task of prescribing a resident's diet, including a
therapeutic diet, to the extent allowed by state law. While the statute
requires physician supervision of each resident's nursing home care, we
believe that the physician can delegate authority to a dietitian or
other clinically qualified nutrition professional to write dietary
orders, so long as the authority is consistent with dietitian or other
clinically qualified nutrition professional practice allowed under
state law. In this instance, the physician is responsible for making
the decision of whether or not to delegate this task and remains
responsible for the resident's care even if the task is delegated.
Further, if necessary, the physician would be able to modify a diet
order with a subsequent physician order. We believe this is consistent
with other tasks that the physician may delegate and may allow for more
efficient use of physician time and effort and more frequent assessment
and updating of diet orders by an on-site dietitian or other clinically
qualified nutrition professional. We believe qualified dietitians and
other clinically qualified nutrition professional are well qualified to
assess a resident's nutritional status and design and implement a
nutritional treatment plan in consultation with the resident's
interdisciplinary team. In order for residents to receive timely
nutritional care, the qualified dietitian or other clinically qualified
nutrition professional must be viewed as an integral member of the IDT
who, as the team's clinical nutrition expert, is responsible for a
resident's nutritional evaluation and treatment in light of the
resident's medical diagnosis. Without allowing for the delegation for
writing diet orders to qualified dietitians or other clinically
qualified nutrition professionals, nursing homes will not be able to
effectively realize the improved resident outcomes and overall cost
savings that we believe would be possible with these changes. However,
we note that because a few states elect not to use the regulatory term
``registered'' and choose instead to use the term ``licensed'' (or use
no modifying term at all), we are proposing to use the term ``qualified
dietitian.'' Our intention is to include all qualified dietitians,
regardless of the modifying term (or lack thereof), as long as each
qualified dietitian meets the requirements of his or her respective
state laws. We also recognize that there are other nutrition
professionals who are equally qualified to provide required services
and we are expressly including these or other clinically qualified
nutrition professionals to the extent they are authorized under state
law.
We propose to modify Sec. 483.35(f) in re-designated Sec.
483.60(f) regarding frequency of meals. Specifically, we propose to
modify the requirement that facilities provide and residents receive 3
meals per day at regular times by adding language to clarify that meals
should be served at times in accordance with resident needs,
preferences, requests and the plan of care. We further propose to
eliminate the requirement that there be no more than 14 hours between a
substantial evening meal and breakfast the following day, except when a
substantial bedtime snack is provided, and focus instead on when
residents prefer to eat and on ensuring that meal service is provided
to meet residents' clinical and nutritional needs. Rather, we propose
to require instead that the facility provide suitable, nourishing
alternative meals and snacks for each resident who want to eat at non-
traditional times or outside of the facility's scheduled meal service
times, in accordance with their respective plan of care. By suitable,
nourishing alternative meals, we mean that when a resident misses a
meal or snack, an alternative of comparable nutritive value to the
missed meal or snack should be provided. We do not intend to require a
24-hour-a-day full service food operation or an on-site chef. Suitable
alternatives may be meals prepared in advance that can be appropriately
served by appropriately trained facility staff at non-traditional
times. For example, staff may be trained to safely re-heat soup and
serve a sandwich as a reasonable alternative for a resident who prefers
to eat a late supper, so long as it meets the resident's nutritional
needs, takes into consideration the resident's preferences, and is
prepared using safe food handling techniques.
We propose to re-designate existing Sec. 483.35(g) as new Sec.
483.60(g) and revise it to require that the facility provide not only
adaptive eating equipment and utensils for residents who need these
devices but also provide the appropriate staff assistance to ensure
that these residents can use the assistive devices when consuming meals
and snacks.
We propose to re-designate existing Sec. 483.35(h) as new Sec.
483.60(h) and retain, with some revisions, provisions for paid feeding
assistants, as set out in the 2003 final rule (68 FR 55528). We believe
the use of paid feeding assistants provides a valuable flexibility to
nursing facilities and can serve to ensure that residents requiring
dining assistance are able to receive it. In Sec. 483.60(h)(2)(ii), we
propose to eliminate the reference to the resident call system. Section
483.35(h)(2)(ii) currently requires that, in an emergency, a paid
feeding assistant must call a supervisory nurse for help ``on the
resident call system.'' Paid feeding assistants should be able to call
for assistance in whatever manner is most efficient rather than be
limited to a specific call system. We focus on the outcome of getting
assistance rather than on the mechanism used to request it. We also
propose to have the IDT
[[Page 42209]]
make the determination if a resident is appropriate for assistance by a
paid feeding assistant which would be separate from a charge nurse's
ability and responsibility to make work assignments on a more immediate
basis reflecting the current situation.
In proposed Sec. 483.60(i), we clarify in new Sec.
483.60(i)(1)(i) that facilities may procure food directly from local
producers--farmers or growers, in accordance with state and local laws
or regulations. We further propose to clarify in new Sec.
483.60(i)(1)(ii) that this provision does not prohibit or prevent
facilities from using produce grown in facility gardens, subject to
compliance with applicable safe growing and handling practices, such as
using pesticides in accordance with manufacturers' instructions. We
note that facilities are required under proposed Sec. 483.70(b) and
(c) to be in compliance with applicable federal, state and local laws,
regulations and codes and professional standards as well as other HHS
regulations. We believe this includes food service requirements
applicable to facilities and note that most states and territories have
adopted some version of the FDA model food code (https://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FederalStateCooperativePrograms/ucm108156.htm). We expect that facilities comply with these
requirements as required by state law. Consistent with Sec. 483.70(b),
we propose to specify in Sec. 483.60(i)(2) that facilities would be
required to store, prepare, distribute, and serve food in accordance
with professional standards for food service safety. We considered
requiring a Hazard Analysis and Critical Control Points (HACCP) program
in facilities; however, we are concerned about the application of this
requirement in innovative and small health care delivery models. We
understand this may be a requirement under some state or local laws and
solicit comment on whether or not a HACCP program should be required in
all SNFs and NFs. We propose to add a new Sec. 483.60(i)(3) to require
a facility to have a policy in place regarding use and storage of foods
brought to residents by visitors to ensure safe and sanitary handling.
A resident has the right to make choices, including the right to decide
whether or not to accept food from family, friends, or other visitors
and guests. However, the facility has a responsibility to help family,
visitors, and residents understand safe food handling practices. If
facility staff is assisting with reheating or other preparation
activities for food brought by visitors, the facility staff must use
safe food handling practices and encourage visitors and residents who
are contributing to food preparation to also use these safe practices.
We believe having a policy in place to address use and storage of foods
brought to residents will help ensure consistent application of safe
and sanitary food handling practices by staff when these foods are
present in the facility.
Q. Specialized Rehabilitative Services (Sec. 483.65)
Current regulations at Sec. 483.45 set forth the services that a
facility must provide if a resident needs specialized rehabilitative
services including, but not limited to, physical therapy, speech-
language pathology, occupational therapy, and mental health
rehabilitative services for mental illness. Following our proposed
reorganization of part 483 subpart B, we propose to relocate these
existing provisions to proposed Sec. 483.65 with minor revisions.
Consistent with specialized rehabilitative services, the need for
respiratory therapy and respiratory illnesses are very common among
older adults; however, the current regulations do not discuss
respiratory therapy. According to data collected by the Centers for
Disease Control and Prevention (CDC), 6.7 percent of nursing home
residents have some form of disease of the respiratory system at the
time of their admission into a nursing home (The National Nursing Home
Survey. 2004 overview: National Center for health Statistics [on-line].
https://www.cdc.gov/nchs/about/major/nnhsd/nnhsd.htm. Accessed January
10, 2013). In addition to the occurrence of respiratory illnesses at
admission, outbreaks of respiratory tract infections are also common in
LTC facilities among older adults. In LTC facilities, rates of
pneumonia as high as 42 percent and case-fatality rates exceeding 70
percent have been reported in outbreaks due to the influenza virus
(Loeb M, McGeer A, McArthur, Peeling R, Petric M, Simor A. Surveillance
for outbreaks of respiratory tract infections in nursing homes (cover
story). CMAJ: Canadian Medical Association Journal [serial online].
April 18, 2000;162(8):1133-1137. Available from: Health Policy
Reference Center, Ipswich, MA. Accessed January 23, 2013).
Given these statistics and our prior knowledge about the need for
respiratory related treatment and therapy in facilities, we propose at
re-designated Sec. 483.65(a) to specifically add respiratory therapy
to the list of specialized rehabilitative services. Adding this service
to the regulations would reflect the more current needs of facility
residents. The addition of this service would also explicitly require
facilities to provide or obtain these services when necessary and meet
the needs of residents facing respiratory issues. However, this would
not change coverage policy regarding respiratory therapy. At Sec.
483.65(a)(2), we propose to clarify that when it is necessary for
facilities to obtain these services from an outside source, the
provider should be a certified Medicare and/or Medicaid provider.
Secondly, we propose to clarify the meaning of specialized
rehabilitative services in relation to PASARR. Current requirements do
not clarify what specialized rehabilitative services for mental illness
are and this has led to confusion among providers, states, and others.
Therefore, to eliminate confusion and provide clarification, we propose
to add in Sec. 483.65 a cross reference to the PASARR regulations at
Sec. 483.120(c) which define the mental health or intellectual
disability services a nursing facility must provide to all residents
who need these services. In addition, we would correct a typographical
error deleting the redundant ``mental health'' before ``rehabilitative
services for mental illness and intellectual disability''.
R. Outpatient Rehabilitative Services (Sec. 483.67)
We propose to add a new Sec. 483.67 ``Outpatient Rehabilitative
Services'' to address facilities that choose to provide outpatient
rehabilitative therapy services to individuals that do not reside in
the facility. Currently, the provision of outpatient rehabilitative
services for non-residents is not addressed by the requirements for LTC
care facilities. We note that Sec. 483.65 ``Specialized Rehabilitative
Services'' sets forth the requirements that a facility must meet when
providing rehabilitative therapy services to residents who reside in
their facility. We understand that some, and possible many, facilities
provide rehabilitative services on an outpatient basis and that these
services may be paid for under Medicare Part B (see section 1861(p) of
the Act, implementing regulations at 42 CFR 410.60(b), and the Medicare
Benefit Policy Manual, Pub. 100-02, Chapter 15, Sec. 220.1.4.)
Therefore, we believe it is necessary to ensure that services meet
health and safety standards. We propose to require facilities that
provide outpatient rehabilitative therapy services to meet requirements
similar to those already established for hospitals. Specifically, we
propose to require in
[[Page 42210]]
new Sec. 483.67 that if the facility provides outpatient
rehabilitation, physical therapy, occupational therapy, audiology, or
speech-language pathology services, the services must meet the needs of
the patients in accordance with acceptable standards of practice and
the facility must meet certain requirements. The requirements include
at proposed Sec. 483.67(a) that the organization of the service must
be appropriate to the scope of the services offered. In proposed Sec.
483.67(b), we are proposing to require that the facility assign one or
more individuals to be responsible for outpatient rehabilitative
services and that the individual responsible for the outpatient
rehabilitative services must have the necessary knowledge, experience,
and capabilities to properly supervise and administer the services. We
also propose to require that the facility must have appropriate
professional and nonprofessional personnel available at each location
where outpatient services are offered. In addition, we propose to
require that physical therapy, occupational therapy, speech-language
pathology or audiology services, if provided, must be provided by
qualified physical therapists, physical therapist assistants,
occupational therapists, occupational therapy assistants, speech-
language pathologists, or audiologists as defined in part 484 of this
chapter. In proposed Sec. 483.68(c) we would require that services
must only be provided under the orders of a qualified and licensed
practitioner who is responsible for the care of the patient, acting
within his or her scope of practice under state law and that all
rehabilitation services orders and progress notes must be documented in
the patient's clinical record in accordance with the requirements at
Sec. 483.70(i). Finally, we propose to require that the provision of
care and the personnel qualifications must be in accordance with
national acceptable standards of practice. We believe the addition of
these provisions is necessary to ensure that outpatient rehabilitative
services provided by facilities meet health and safety standards.
S. Administration (Sec. 483.70)
We propose to re-designate current Sec. 483.75 ``Administration''
as Sec. 483.70. In paragraph (c), we propose to replace the term
``handicap'' with the term ``disability''and to add a reference to the
HIPAA Privacy, Security, and Breach Notification Rules, 45 CFR parts
160 and 164. In addition, we would clarify that violations of other HHS
regulations, as determined by the agency or entity with enforcement
authority for those regulations, may result in a finding by CMS of non-
compliance with the requirements of Sec. 483.70(c). In proposed Sec.
483.70(d)(2)(i) we would delete the phrase ``where licensing is
required'' since all states participating in the Medicaid program are
required to license nursing home administrators under section 1908 of
the Act. We propose to add a new Sec. 483.70(d)(2)(iii) to specify
that the nursing home administrator would report to and be accountable
to the governing body. We are concerned that the governing body can
appoint the nursing home administrator but is not, on an ongoing basis,
required to remain cognizant of the operations and management of the
facility. Given that the governing body is responsible for implementing
the management and operations of the facility, we believe it is
important to ensure that it remains informed and knowledgeable
regarding those issues. We also propose to add a new Sec. 483.70(d)(3)
to specify that the governing body is responsible and accountable for
the QAPI program, in accordance with proposed Sec. 483.75(f). We
propose to re-designate and revise existing Sec. 483.75(e) and (f),
provisions regarding nurse aides, to our proposed section on Nursing
Services at Sec. 483.35 or our proposed new section on Training at
Sec. 483.95. We refer readers to see the separate discussions under
those sections.
We propose to create new section Sec. 483.50 ``Laboratory,
radiology, and other diagnostic services'' and relocate and revise
existing paragraphs, Sec. 483.75(j) laboratory services and Sec.
483.75(k) radiology and other diagnostic services, to the new section.
Please see our separate discussions of the new section.
We are proposing a new Sec. 483.70(e) which would establish a new
requirement for an annual facility assessment. This new requirement
would be a central feature of our revisions to subpart B and is
intended to be used by the facility for multiple purposes, including
but not limited to activities such as determining staffing
requirements, establishing a QAPI program, and conducting emergency
preparedness planning. This is similar to existing common business
practices for strategic planning and capital budget planning and we
believe that facilities will find this assessment useful beyond what is
required to meet our requirements. This facility-wide assessment would
determine what resources a facility would need to care for its
residents competently during both day-to-day operations and
emergencies. This assessment would have to be facility and community-
based, utilizing an all-hazards approach. The facility would have to
review and update the assessment as necessary, but at least annually
and whenever there was, or the facility planned for, any change that
would require a substantial modification to any part of the assessment.
We propose to require that the facility assessment address or include:
The facility's resident population, including the number
of residents, the facility's resident capacity, the care required by
the resident population considering the types of diseases, conditions,
physical and cognitive disabilities, overall acuity that are present
within that population.
The staff competencies that are necessary to provide the
level and types of care needed for the resident population.
The physical environment, equipment, and services that are
necessary to care for this population.
Any ethnic, cultural, or religious factors that may
potentially affect the care provided by the facility, including, but
not limited to, activities and food and nutrition services.
The facility's resources, including but not limited to
buildings and other physical structures and vehicles; medical and non-
medical equipment.
The services provided, such as physical therapy, pharmacy,
and specific rehabilitation therapies.
Personnel, including managers, employed and contracted
staff, and volunteers, as well as their education and/or training and
any competencies related to resident care.
Contracts, memorandums of understanding, or other
agreements with third parties to provide services or equipment to the
facility both during normal operations and emergencies.
Health information technology resources, such as systems
for electronically managing patient medical records and electronically
sharing information with other organizations.
In conducting the facility assessment, we did not propose that the
facility include any input from either the resident or any other
individuals who have a personal interest in the resident. We believe
the facility should have the flexibility to determine when and from
whom a facility would seek input and how to incorporate that
information into their assessment. However, we encourage facilities to
determine when it would be appropriate to seek input from the resident,
the resident's representative or any of the resident's family or
friends and consider that
[[Page 42211]]
information in formulating their assessment.
We propose to retain the provisions in existing Sec. 483.75(g),
(h) and (i) unchanged and re-designate them as proposed Sec. 483.70
(f), (g), and (h). We propose to re-designate existing Sec. 483.75(l)
as proposed Sec. 483.70(i) and to amend it to better conform to the
requirements of the HIPAA Privacy, Security, and Breach Notification
rules at 45 CFR parts 160 and 164. We also propose minor revisions in
it to clarify that the clinical record must contain the resident's
comprehensive plan of care and physician's and other licensed
professional's progress notes. It is important that the clinical record
reflect the services provided across disciplines to ensure information
is readily available when needed and to facilitate communication among
the interdisciplinary team. Existing paragraph (m) would be removed and
revised pursuant to a separate proposed rule, ``Medicare and Medicaid
Programs: Emergency Preparedness Requirements for Medicare and Medicaid
Participating Providers and Suppliers'' (78 FR 79081, December 27,
2013).
In proposed Sec. 483.70(j), ``Transfer Agreement, ''we propose to
modify the current language at Sec. 483.75(n) to allow a practitioner
other than the attending physician to determine that a hospital
transfer is medically appropriate in an emergency situation and
consistent with state law and facility policy. We believe this is both
appropriate and necessary to promote prompt treatment and protect
resident safety. We further propose to specify here that the
information exchange required by existing paragraph Sec. 483.75(n)(ii)
be modified to require that the exchanged information include, at a
minimum, the information we propose to require under new paragraph
Sec. 483.15(b)(2)(iii)(B). As discussed earlier, the effective
exchange of information can reduce the risk inherent to transitions of
care and promote improved resident outcomes.
We propose to incorporate existing Sec. 483.75(o), assessment and
quality assurance, into proposed Sec. 483.75(c). New Sec. 483.75 will
also include requirements established under section 6102 of the
Affordable Care Act for a QAPI program. We refer readers to the
separate discussion on QAPI, in Section II.S. of this proposed rule.
Provisions on Disclosure of Ownership, Facility Closure-
Administrator, Facility Closure, and Hospice services are re-designated
as paragraphs Sec. 483.75(k), (l), (m), and (o) respectively, and the
cross-reference in proposed (m) updated, but otherwise unchanged. We
propose to address training of paid feeding assistants in our proposed
new Sec. 483.95--Training requirements.
We propose in Sec. 483.70(n) to require facilities that ask
residents to accept binding arbitration to resolve disputes between the
facility and the resident to meet certain criteria. Alternative dispute
resolution (ADR), including binding arbitration, has become
increasingly popular in recent years. However, unlike other forms of
ADR, binding arbitration requires that both parties waive the right to
any type of judicial review or relief. While this can be a valid
agreement when entered into by individuals with equal bargaining power,
we are concerned that the facilities' superior bargaining power could
result in a resident feeling coerced into signing the agreement. Also,
if the agreement is not explained to the resident, he or she may be
waiving an important right, the right to judicial relief, without fully
understanding what he or she is waiving. Also, the increasing
prevalence of these agreements could be detrimental to residents'
health and safety and may create barriers for surveyors and other
responsible parties to obtain information related to serious quality of
care issues. This results not only from the residents' waiver of
judicial review, but also from the possible inclusion of
confidentiality clauses that prohibit the resident and others from
discussing any incidents with individuals outside the facility, such as
surveyors and representatives of the Office of the State Long-Term Care
Ombudsman.
We propose that the facility be required to explain the agreement
to the resident in a form, manner and language that he or she
understands and have the resident acknowledge that he or she
understands the agreement. The agreement must not contain any language
that prohibits or discourages the resident or any other person from
communicating with federal, state, or local officials, including, but
not limited to, federal and state surveyors, other federal or state
health department employees, or representatives of the Office of the
State Long-Term Care Ombudsman, regarding any matter, whether or not
subject to arbitration or any other type of judicial or regulatory
action, in accordance with proposed Sec. 483.11(i). The explanation
must state, at a minimum, that the resident is waiving his or her right
to judicial relief for any potential cause of action covered by the
agreement. The agreement must be entered into by the resident
voluntarily and provide for the selection of a neutral arbitrator and a
venue convenient to both parties, the resident and the facility. An
agreement will not be considered to have been entered into voluntarily
by the resident if the facility makes it a condition of admission,
readmission, or the continuation of his or her residence at the
facility. Thus, we believe that any agreement for binding arbitration
should not be contained within any other agreement or paperwork
addressing any other issues. It should be a separate agreement in which
the resident must make an affirmative choice to either accept or reject
binding arbitration for disputes between the resident and the facility.
Finally, in order to address concerns about conflict of interest when
the resident has a guardian that is affiliated with the facility, we
propose to specify that the guardians or representatives cannot consent
to an agreement for binding arbitration on the resident's behalf unless
that individual is allowed to do so under state law, all of the other
requirements in this section is met, and the individual has no interest
in the facility. We are also aware that there are concerns that these
agreements should be prohibited in the case of nursing home residents.
Therefore, we are also soliciting comments on whether binding
arbitration agreements should be prohibited.
We propose to relocate the requirement for and qualifications of a
social worker from the current Sec. 483.15(g)(3) to proposed Sec.
483.70(p). In addition, there is a list of human services fields from
which a bachelors degree could provide the minimum educational
requirement for a social worker. We propose to add ``gerontology'' to
that list of human services fields. We would also welcome comments
related to qualifications for the social worker, especially whether
state licensure should remain the threshold requirement or if
additional requirements are appropriate.
Finally, in our proposed rule ``Medicare and Medicaid Programs;
Prospective Payment System and Consolidated Billing for Skilled Nursing
Facilities (SNFs) for FY 2016, SNF Value-Based Purchasing Program, SNF
Quality Reporting Program, and Staffing Data Collection'' (CMS-1622-P)
(80 FR 22044), published on April 20, 2015, at Sec. 483.75(u), we
proposed to require that facilities submit staffing information based
on payroll data in a uniform format. Section 6106 of the Affordable
Care Act of 2010 (Pub. L. 111-148, March 23, 2010) added a new section
1128I to the Act that requires a facility to electronically submit to
the Secretary direct care staffing information, including information
for agency and
[[Page 42212]]
contract staff, based on payroll and other verifiable and auditable
data in a uniform format according to specifications established by the
Secretary. In this proposed regulation, we are proposing to redesignate
Sec. 483.75(u) (as set out in the April 20, 2015 proposed rule at 80
FR 22044) to Sec. 483.70(q).
T. Quality Assurance and Performance Improvement (QAPI) (Sec. 483.75)
Section 6102 of the Affordable Care Act amended the Act by adding
new section 1128I. Subsection (c) of section 1128I of the Act requires
that the Secretary establish and implement a QAPI program requirement
for SNFs and NFs, including those that are part of a multi-unit chain
of facilities. Under the QAPI provision, the Secretary must establish
standards relating to facilities' QAPI program and provide technical
assistance to facilities on the development of best practices in order
to meet these standards. No later than 1 year after the date on which
the regulations are promulgated, a facility must submit to the
Secretary a plan for the facility to meet these standards and implement
the best practices, including a description of how it would coordinate
the implementation of the plan with quality assessment and assurance
activities currently conducted under sections 1819(b)(1)(B) and
1919(b)(1)(B) of the Act. This proposed rule would establish these
programmatic standards.
Current regulations at Sec. 483.75(o) require a facility to
maintain a quality assessment and assurance (QAA) committee, consisting
of the director of nursing services, a physician designated by the
facility, and at least three other members of the facility staff. The
QAA committee must meet at least quarterly and identify quality
deficiencies and develop and implement plans of action to correct the
deficiencies. The facility is only required to disclose records of the
QAA committee if the disclosure is related to the compliance of the
committee with the regulatory requirements. While our proposal retains
the existing QAA requirements at Sec. 483.75(o), these requirements
alone do not conform to the current health care industry standards that
proactively design quality improvement into each program at the outset,
monitor data (indicators, measures and reports of staff/residents/
families), determine root causes of problems, design and use
performance improvement projects (PIPs) to promote continuous
improvement, develop and implement plans that effect system
improvement, and monitor the success of this systematic approach to
improving quality. The focus of a QAPI approach is to optimize quality
improvement activities and programs comprehensively and proactively,
even in areas where no specific deficiencies are noted. The QAPI
program should include standards for quality assurance, active feedback
systems to monitor performance, and continuous efforts to optimize
program design through quality improvement activities and proactive
strategies. The QAPI requirements we propose would not replace the QAA
committee requirements but would enhance and be coordinated with these
requirements.
The QAPI program utilizes objective data to study and continually
make improvements to all aspects of an organization's operations and
services. It enables facilities to take a systematic approach to
reviewing its operating systems and processes of care and identifying
and implementing opportunities for improvement. QAPI has significant
potential to be an efficient and effective method for improving the
quality of care and performance of health care providers.
In 2001, the Institute of Medicine released a pivotal report,
``Crossing the Quality Chasm'' in which it stated that ``the American
healthcare delivery system is in need of fundamental change'' and
recognized that ``quality problems are everywhere affecting many
patients (https://www.iom.edu/Reports/2001/Crossing-the-Quality-Chasm-A-New-Health-System-for-the-21st-Century.aspx). In a 2004 educational
publication co-sponsored by the Office of Inspector General (OIG) of
the U.S. Department of Health and Human Services and the American
Health Lawyers Association (AHLA), ``Corporate Responsibility and
Health Care Quality: A Resource for Health Care Boards of Directors,
(https://oig.hhs.gov/fraud/docs/complianceguidance/CorporateResponsibilityFinal%209-4-07.pdf), the authors discuss the IOM
report and state that the oversight of quality and patient safety is
becoming clearly recognized as a core fiduciary responsibility of
health care organizations. They further note that promoting quality of
care and preserving patient safety are at the core of the health care
industry and the reputation of each health care organization and
suggest that ``contemporary health care quality, patient safety and
cost efficiency initiatives provide an opportunity for health care
organizations to make a positive difference to society while promoting
their missions and enhancing their financial success.'' Therefore,
pursuant to the requirements of the Affordable Care Act and as
discussed in detail below, we are proposing to add a new Sec. 483.75
entitled, ``Quality Assurance and Performance Improvement.''
At proposed Sec. 483.75(a), we would require that a facility
develop, implement, and maintain an effective, comprehensive, data-
driven QAPI program, reflected in its QAPI plan, that focuses on
systems of care, outcomes and services for residents and staff. The
QAPI program would be designed to monitor and evaluate performance of
all services and programs of the facility, including services provided
under contract or arrangement. We propose that the facility's governing
body, or designated persons functioning as a governing body, ensure
that the QAPI program is defined, implemented, and maintained and
addresses identified priorities. As discussed above, facilities are
required to submit the QAPI plan to the Secretary. Therefore, we
propose in new Sec. 483.75(a)(1) that the facility would maintain
documentation and demonstrate evidence of its QAPI program. This
includes but is not limited to the QAPI plan. We propose in new Sec.
483.75(a)(2) that the facility must submit the QAPI plan to the State
Agency or federal surveyor, as the agent of the Secretary, at the first
annual recertification survey that occurs at least 1 year after the
effective date of these regulations. In addition, we propose in new
Sec. 483.75(a)(3), based on the Secretary's authority at sections
1819(d)(4)(B) and 1919(d)(4)(B) of the Act to establish other
requirements relating to the health and safety of residents, to require
that the facility present the QAPI plan to the State Agency surveyor at
each annual recertification survey and upon request to the State Agency
or federal surveyor at any other survey and to CMS upon request. In
addition, we propose in new Sec. 483.75(a)(4), to require the facility
to present its documentation and evidence of an ongoing QAPI program
upon request of a State Agency, federal surveyor, or CMS. The State
Agency, pursuant to its agreement with the Secretary under section 1864
(a) of the Act, will consider such plan in making its certification
recommendation and providing evidence to the CMS Regional Office for a
compliance determination. We propose this recurring requirement to
ensure that the QAPI program is ongoing and that the facility meets the
standards established in this section.
At Sec. 483.75(b), we establish requirements for the design and
scope of the QAPI program. We propose to
[[Page 42213]]
require that the facility design its QAPI program to be ongoing,
comprehensive and address the full range of care and services provided
by the facility. When implemented, the QAPI program would be required
to address all systems of care and management practices and would
always include clinical care, quality of life, and resident choice. It
would have to utilize the best available evidence to define and measure
indicators of quality and facility goals that reflect processes of care
and facility operations that have been shown to be predictive of
desired outcomes for residents of a facility and reflect the
complexities, unique care, and services that the facility provides.
We propose in new Sec. 483.75(c) to establish requirements for
QAPI program feedback, data systems and monitoring. We propose at new
Sec. 483.75(c)(1) that, as part of its QAPI process, the facility
would have to maintain effective systems to obtain and use feedback and
input from direct care/direct access workers, other staff, and
residents, resident representatives and families to identify
opportunities for improvement. In new Sec. 483.75(c)(2), we propose to
require that the systems, governed by appropriate policies and
procedures, also include how the facility would identify, collect, and
use data from all departments, including how the information would be
used to identify high risk, high volume or problem-prone areas. In new
Sec. 483.75(c)(3), we would require that the policies and procedures
include a description of the methodology and frequency for developing,
monitoring, and evaluating performance indicators. Finally, in new
Sec. 483.75(c)(4), we propose to require that the system, policies and
procedures include the process for identification, reporting, analysis,
and prevention of adverse events and potential adverse events or near
misses. This would include methods by which the facility would obtain
information on adverse events and potential adverse events from
residents, family and direct care/direct access staff, and how the
facility would address and investigate the adverse event or potential
adverse event and provide feedback to those same individuals. Adverse
events remain a serious problem in LTC facilities. A recent OIG report
estimated that 22 percent of Medicare beneficiaries experienced adverse
events during a skilled nursing facility stay. Many of those adverse
events were preventable. (Adverse Events in Skilled Nursing Facilities:
National Incidence Among Medicare Beneficiaries. Office of Evaluations
and Inspections, Report OEI-06-11-00370. Office of Inspector General,
Department of Health & Human Services. (2014)). According to the World
Health Organization (WHO), an adverse event is an injury related to
medical management, in contrast to complications of disease. Medical
management includes all aspects of care, including diagnosis and
treatment, failure to diagnose or treat, and the systems and equipment
used to deliver care. Adverse events may be preventable or non-
preventable. A near miss is a serious error or mishap that has the
potential to cause an adverse event but fails to do so because of
chance or because it is intercepted; it is also called a potential
adverse event. (WHO Draft Guidelines for Ad verse Event Reporting and
Learning Systems. 2005 https://www.who.int/patientsafety/events/05/Reporting_Guidelines.pdf). Examples of situations that would qualify as
an adverse event for a facility include, but are not limited to,
medication errors, resident injury due to falls, resident injury due to
abuse or neglect by care-givers or other residents, failure to identify
acute change in condition, pressure ulcers due to inappropriate care
and the spread of disease due to errors in infection prevention and
control. Near misses in any of these situations would be considered
potential adverse events. As discussed in section II.B. of this
preamble, we propose to define an adverse event as an untoward,
undesirable, and usually unanticipated event that cause death or
serious injury, or the risk thereof, consistent with the definition
currently established at 42 CFR 482.70 and already in use for
transplant centers. However, we are aware that there are other
definitions and welcome comments on this definition.
We propose to establish a new Sec. 483.75(d) to address QAPI
program systematic analysis and action. We propose in Sec.
483.75(d)(1) to require that the facility take actions aimed at
performance improvement and, after implementing those actions, to
measure the success of those actions and to track performance to ensure
that the improvements are sustained. We further propose to require in
Sec. 483.75(d)(2), that the facility develop policies describing how
they would use a systematic approach (such as, root cause analysis,
reverse tracer methodology, and health care failure and effects
analysis, for example) to determine underlying causes of problems
impacting larger systems. These policies would address the development
of corrective actions that would be designed to affect change at the
systems level, and how the facility would monitor the effectiveness of
its performance improvement activities to ensure that improvements were
sustained.
In Sec. 483.75(e), we propose to establish requirements for
program activities. Specifically, we would require at new Sec.
483.75(e)(1) through(3) that the facility establish priorities for
performance improvement activities that focus on patient safety;
coordination of care; autonomy; choice; and high risk, high volume,
and/or problem-prone areas identified as a result of the facility
assessment as specified in Sec. 483.70(e). We propose to require that
performance improvement activities track medical errors and adverse
resident events, analyze their causes, and implement preventative
actions and mechanisms that include feedback and learning throughout
the facility. Finally, QAPI program activities would be required to
include Performance Improvement Projects (PIPs). Under our proposal,
the facility would be required to conduct distinct performance
improvement projects. The number and frequency of improvement projects
conducted by the facility would have to reflect the scope and
complexity of the facility's services and available resources. We
propose that each facility would be required to implement at least one
project annually that focused on a high risk or problem prone area
identified through the required data collection and analysis. We
considered not establishing a minimum requirement or establishing a
requirement based on facility size and welcome comment on whether or
not there should be a specific number of PIPS and what that number
should be. We also considered establishing mandatory PIPs and requiring
facilities to implement at least one PIP selected from the mandatory
PIPs. We solicit comment on establishing mandatory PIPS, specifically
regarding the feasibility for and impact on facilities.
Finally, in new Sec. 483.75(f), we propose to require that the
facility ensure, through the governing body or executive leadership,
that an ongoing QAPI program is defined, implemented, and sustained
during transitions in leadership and staffing and that the QAPI program
is adequately resourced, including ensuring staff time, equipment, and
technical training as needed. Furthermore, the governing body or
executive leadership would have to ensure that the QAPI program
identified and prioritized problems and opportunities based on
performance indicator data; resident and staff input that reflected
organizational processes, functions, and services provided to
[[Page 42214]]
residents; that corrective actions addressed gaps in systems, and were
evaluated for effectiveness; and that clear expectations were set
around safety, quality, rights, choice, and respect.
These proposed requirements for the QAPI program are an outgrowth
of the QAPI demonstration project conducted by CMS working with
stakeholders, providers and experts. Our proposed requirements directly
reflect five elements that were identified through this process as
critical to the success of a QAPI program. We discuss this project
below under ``Technical Assistance for facilities.''
We propose to re-designate Sec. 483.75(o) as Sec. 483.75(g). In
Sec. 483.75(g)(1) we propose to revise the language to clarify that
the QAA committee membership requirements are a minimum requirement.
Facilities may, at their discretion, include additional individuals on
their QAA committee. For example, some facilities may wish to include a
pharmacist on the QAA committee to coordinate QAPI activities related
to reducing the inappropriate use of psychotropic medications. The QAA
committee may also benefit from including individuals such as a
resident council president, the director of social services or the
activities director. We also propose to add the requirement that the
Infection Control and Prevention Officer (ICPO) participate in the
quality assessment and assurance committee. We consider the ICPO's
coordination with the quality assurance committee and with QAPI
activities important to the success of the infection control and
prevention program and discuss the need for this further in our section
on infection control.
In Sec. 483.75(g)(2), we propose to specify that the quality
assessment and assurance committee report to the facility's governing
body, or designated persons functioning as a governing body, regarding
its activities, including implementation of the QAPI program required
under new Sec. 483.75(a) through (f). We further propose to specify
that the committee coordinate and evaluate activities under the QAPI
program, including performance improvement projects, and that the
committee review and analyze data collected under the QAPI program as
well as data from pharmacists resulting from monthly drug regimen
reviews and the resulting reports as specified in Sec. 483.45(c)(4).
Section 6102(c)(1) of the Affordable Care Act specifically requires
that the implementation of the QAPI plan be coordinated with the
quality assessment and assurance activities conducted under sections
1819(b)(1)(B) and 1919(b)(1)(B) of the Act. As there is significant
overlap in the expectations for the QAPI program and the quality
assessment and assurance committee, we believe that the existing
committee is the appropriate resource to coordinate the QAPI program.
We propose to add a new Sec. 483.75(h) to address disclosure of
information. We propose to re-designate existing Sec. 483.75(o)(3) as
Sec. 483.75(h)(1) and add a new Sec. 483.75(h)(2) to clarify that
facilities, in order to demonstrate compliance with the requirements of
this section, may be required to disclose or provide access to certain
QAPI information. Specifically, we would require, to the extent
necessary to demonstrate compliance with the requirements of this
section, access to systems and reports demonstrating systematic
identification, reporting, investigation, analysis, and prevention of
adverse events; documentation demonstrating the development,
implementation, and evaluation of corrective actions or process
improvement activities; and other documentation considered necessary by
a state or federal surveyor in assessing compliance. We further propose
to re-designate Sec. 483.75(o)(4) as Sec. 483.75(i).
In sum, we believe these proposed requirements would ensure that
facilities establish and implement QAPI plans that result in continuous
quality improvement throughout the facility and enhanced quality of
care, quality of life and resident and staff satisfaction, while
providing facilities with the flexibility to design, monitor, and
maintain QAPI approaches best suited to the type and complexity of
services they provide and the needs of their residents.
Technical Assistance for Facilities
In addition to establishing the standards for a QAPI program in
this proposed rule, we would provide technical assistance to nursing
homes on the development of best practices relating to QAPI. Since
2011, we have worked with stakeholders, providers and experts to
develop tools, resources and technical assistance to implement a QAPI
program. A demonstration project tested implementation strategies and
effectiveness of QAPI tools, resources and technical assistance.
Through this process, five critical elements, which are reflected in
our proposed requirements, have been identified for a successful QAPI
program. The five elements are as follows:
Design and Scope.
Governance and Leadership.
Feedback, Data Systems and Monitoring.
Performance Improvement Projects.
Systematic Analysis and Systemic Action.
QAPI materials developed through this process are available at no
cost to all facilities at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/QAPI.html. In
addition, facilities may choose from a wide variety of existing
professionally recognized quality assurance and performance improvement
resources. We discuss a non-exhaustive list of some of these resources
below.
Under the direction of CMS, the Medicare Quality Improvement
Organization (QIO) Program (www.cms.hhs.gov/QualityImprovementOrgs)
consists of a national network of 53 QIOs--one in each state, plus the
District of Columbia, Puerto Rico, and the Virgin Islands. QIOs work
with beneficiaries, healthcare providers, consumers and stakeholder to
achieve national priorities focused on three broad aims of--(1) better
care; (2) improved health; and (3) lower costs. QIOs work with nursing
homes (among other providers) to focus on a number of quality
improvement measures, such as decreasing healthcare associated
conditions, providing direct technical assistance and engaging with
nursing homes and other long term care providers participating in the
National Nursing Home Quality Care Collaborative.
Advancing Excellence in America's Nursing Homes (https://www.nhqualitycampaign.org) is a national campaign to encourage, assist
and empower nursing homes to improve the quality of care and life for
residents. It is composed of LTC providers, medical professionals,
consumers, employees, and is an ongoing, coalition-based campaign
focused on improvements in care and services for the elderly,
chronically ill and disabled, as well as those recuperating in a
nursing home environment. The mission of the Advancing Excellence in
America's Nursing Homes Campaign is to help nursing homes achieve
excellence in the quality of care and quality of life for the more than
1.5 million residents in America's nursing homes by improving clinical
and organizational outcomes, among other goals. The Campaign works to
achieve its mission by providing free practical and evidence-based
resources to support quality improvement efforts in America's nursing
homes.
[[Page 42215]]
The State Medicaid Agencies (SMAs) and HHS's Administration for
Community Living (ACL) provide online information resources for
community care and transition programs, options, supports and services,
community care transition planning entities, and contacts and links:
www.medicaid.gov; www.mfp-tac.com; and www.acl.gov. Finally, CMS
provides links to resources in its existing Interpretive Guidelines
that provide information on how to develop and enhance quality
improvement programs.
U. Infection Control (Sec. 483.80)
Healthcare-associated infections (HAIs) often result in
considerable suffering for residents in LTC facilities as well as
increased costs for the healthcare system. Although estimates vary
widely, there are between 1.6 and 3.8 million HAIs in nursing homes
every year. Annually, these infections result in an estimated 150,000
hospitalizations, 388,000 deaths, and between $673 million to $2
billion dollars in additional healthcare costs (Castle, et al. Nursing
home deficiency citations for infection control, American Journal of
Infection Control, May 2011; 39, 4). Individuals receiving care in a
nursing home may have increased susceptibility to infections as a
result of malnutrition, dehydration, comorbidities, or functional
impairments, such as urinary and fecal incontinence, or medications
that diminish immunity, or immobility. In addition, residents may have
a higher risk of exposure to infectious agents in the facility due to
socialization among residents, staff, and visitors. The National Action
Plan to Prevent Health Care Associated Infections includes a chapter
focused on long term care settings that pertains to nursing facilities:
https://www.hhs.gov/ash/initiatives/hai/actionplan/hai-action-plan-ltcf.pdf. According to the Plan, the most common HAIs in nursing
facilities are urinary tract infections, lower respiratory tract
infections, skin and soft tissue infections, and gastroenteritis.
Since 1992, our requirements for LTC facilities currently set out
at Sec. 483.65 have required these facilities to establish and
maintain infection control programs designed to provide a safe,
sanitary, and comfortable environment and to help prevent the
development and transmission of disease and infection. The program must
investigate, control, and prevent infections in the facility; issue and
maintain protocols to guide decisions about what procedures, such as
isolation, should be applied to an individual resident, and maintain a
record of incidents and corrective actions related to infections. Under
Sec. 483.65(b)(1), when the infection control protocol recommends that
a resident be isolated to prevent the spread of infection, the facility
must isolate the resident. Under Sec. 483.65(b)(2) of our regulations,
the facility must prohibit employees with a communicable disease or
infected skin lesions from direct contact with residents or their food
if direct contact will transmit the disease. Under Sec. 483.65(b)(3),
the facility must require staff to wash their hands after each direct
resident contact. Section 483.65(c) requires LTC facilities to handle,
store, process, and transport linens so as to prevent the spread of
infection.
Each of these requirements remains important; however, as a result
of advances in the study and practice of infection prevention and
control and given the impact of HAIs, we find that the current
requirements for infection control in our requirements warrant updating
and strengthening. In developing our proposals, we reviewed the
existing requirements for SNFs and NFs, as well as the current
requirements for other Medicare providers and suppliers related to
infection control. We also reviewed available research and literature
related to infection prevention and control in nursing homes and
published infection control guidelines for long term care facilities
from the Society for Healthcare Epidemiology of America (SHEA) and the
Association for Professionals in Infection Control (APIC) (Smith, P.W.,
et al., SHEA/APIC Guideline: Infection Prevention and Control in the
Long-Term Care Facility, Infection Control and Hospital Epidemiology,
Vol. 29, No. 9 (September 2008), pp. 785-814).
We especially want to emphasize the importance of infection
prevention and surveillance. As discussed below, we propose that each
facility's infection prevention and control program (IPCP) include an
antibiotic stewardship program, which includes antibiotic use protocols
and antibiotic monitoring. Antibiotic resistance has emerged as a
national healthcare concern and even the appropriate use of antibiotics
can contribute to antibiotic resistance. Nursing homes are the next
frontier where new antibiotic resistant organisms may emerge and
flourish. Organisms such as Clostridium difficile (C-diff) and
methicillin-resistant Staphylococcus aureus (MRSA) are known concerns.
Nursing homes need to have the tools to participate in surveillance,
learn and use infection control and containment practices, and adopt a
proactive approach to preventing spread while being good stewards of
antibiotics to preserve effectiveness of the agents we have today.
While avoiding the inappropriate use of antibiotics is critical, one of
the best mechanisms to combat the rise in antibiotic resistance is to
prevent infections and, when they do occur, prevent the spread of the
infection to others (Spellberg, Brad, et al., The Future of Antibiotics
and Resistance, The New England Journal of Medicine, 368:4 (January 24,
2013), pp. 299-302). In addition, the Centers for Disease Control and
Prevention (CDC) has identified four core actions to prevent antibiotic
resistance (Frieden, Tom, et al., Antibiotic Resistance Threats in the
United States, 2013, Centers for Disease Control and Prevention
(2013)). Those four core actions are preventing infections and the
spread of those infections, tracking or monitoring, improving
antibiotic prescribing and stewardship, and developing new medications
and tests. The first three actions are within the control of the
nursing home. Thus, we propose to require that the IPCP incorporate
preventing and controlling infections and communicable diseases, and an
antibiotic stewardship program, which includes both antibiotic use
protocols and a system to monitor antibiotic use. We believe these
requirements will improve antibiotic use by ensuring that the residents
who require antibiotics are prescribed the appropriate antibiotics for
the medically necessary time. This should reduce unnecessary antibiotic
use and the risk to residents from being prescribed an unnecessary
antibiotic or an inappropriate antibiotic for an inappropriate time.
The surveillance and prevention aspects of the LTC facilities' IPCP are
crucial to the health of the residents, as well as for individuals who
work or visit the facility.
Based on our research, we propose to revise the regulatory
description of the infection control program to: include infection
prevention, identification, surveillance, and antibiotic stewardship;
require each facility to periodically review and update its program;
require performance of an analysis of their resident population and
facility; designate an infection prevention and control officer(s)
(IPCO); integrate the IPCO with the facility's quality assurance and
performance improvement (QAPI) program; establish written policies and
procedures for the IPCP; and provide the IPCO and facility staff with
education or training related to the IPCP.
[[Page 42216]]
Specifically, as part of our overall reorganization of these
regulations to improve clarity, we propose to re-designate the
provisions under existing Sec. 483.65 as Sec. 483.80. We propose to
modify the introductory language to include infection prevention as
well as control and to clarify that the program must help prevent the
development and transmission of communicable diseases as well as
infections. We propose to revise paragraph (a) to read ``Infection
prevention and control program'' and add new Sec. 483.80(a)(1), (2)
and (3) to specify the elements of the IPCP. We propose to require that
the program must follow accepted national standards, be based upon the
facility assessment conducted according to proposed Sec. 483.70(e) and
include, at a minimum, a system for preventing, identifying, reporting,
investigating, and controlling infections and communicable diseases for
all residents, staff, volunteers, visitors, and other individuals
providing services under a contractual arrangement. We would require
the facility to have written standards, policies, and procedures for
the IPCP, including but not limited to, a system of surveillance
designed to identify possible communicable disease or infections before
it can spread to other persons in the facility; reporting requirements
for possible incidents of communicable disease or infections; standard
and transmission-based precautions to be followed to prevent spread of
infections; circumstances in which generally, isolation should be used
for a resident; the circumstances under which the facility must
prohibit employees with a communicable disease or infected skin lesions
from direct contact with residents or their food, if the contact is
likely to transmit the disease; and the hand hygiene procedures to be
followed by all staff as indicated by accepted professional practice.
The facility would be required to train staff related to the IPCP as
specified below in proposed Sec. 483.95.
We are not proposing specific requirements for the standard and
transmission-based precautions to be followed to prevent the spread of
infections and isolation. Medical science and our knowledge of
infectious agents are constantly improving. In addition, we can expect
that new infectious agents will be identified in the future. Facilities
need the flexibility to determine the appropriate care for their
residents who have infectious agents, including whether isolation is
appropriate and the circumstances of that isolation.
Antibiotics are one of the most frequently prescribed medications
in nursing homes. Antibiotics may account for approximately 40 percent
of the drugs given in nursing homes (NAP, p. 216). It has been
estimated that between 25 and 75 percent of antibiotic prescriptions in
nursing homes may be inappropriate. This extensive use of antibiotics
results in the risk of not only adverse drug reactions, but also the
development of antibiotic-resistant or even multidrug resistant
organisms (MDROs). Thus, the inappropriate use of antibiotics poses a
significant risk to the resident population (Smith, 2008). In order to
effectively address the problem of healthcare-associated infections, a
LTC facility must have an effective IPCP that includes antibiotic
stewardship. Therefore, we are proposing that the facility's IPCP must
also include an antibiotic stewardship program that includes antibiotic
use protocols and systems for monitoring antibiotic use and recording
incidents identified under the facility's IPCP and the corrective
actions taken by the facility.
We further propose to add a new paragraph (b) to require that the
facility designate an IPCO who is responsible for the IPCP and who has
received specialized training in infection prevention and control.
While all staff members should be responsible for infection prevention
and control, we agree with the SHEA/APIC guidelines that establish that
an effective IPCP should have a designated IPCO for whom implementation
and management of the IPCP is a major responsibility. We understand
that infection control is often assigned to a nurse who may have other
administrative or patient care responsibilities. We want to allow
sufficient flexibility for facilities to determine the qualifications
of and the time needed for an IPCO to devote to the IPCP based on the
facility assessment but also ensure that an IPCO has the time and other
resources necessary to properly develop, implement, monitor and
maintain the IPCP for the facility. Thus we require that the IPCP be a
major responsibility for the individual assigned as the facility's
IPCO. In addition, while nurses and other healthcare professionals may
be likely candidates for the IPCO role, many of these professionals may
have only received training in basic infection control practices in
their core professional preparation for licensure. The responsibility
and necessary knowledge for an IPCP likely goes well beyond basic
infection control training. Therefore, we propose to require that the
IPCO be a healthcare professional with specialized training in
infection prevention and control beyond their initial professional
degree. Considering the diverse nature of the resident population and
of the healthcare delivery model, the qualifications, training, and
time needed by an IPCO at each facility would vary widely, thus we are
not at this time proposing more specific requirements. We do, however,
solicit comment on the issue of IPCO qualifications as well as the
requirements for an effective IPCP.
In new Sec. 483.80(c), we propose to require that the IPCO be a
member of the facility's Quality Assessment and Assurance (QAA)
committee. While the literature suggests and we agree that an infection
control committee is a good idea, we are also mindful that many nursing
homes have limited staff and that requiring an infection control
committee could be overly burdensome, especially for small facilities.
We believe that requiring that the IPCO work with the facility's QAA
committee, which is responsible for implementing the facility's QAPI
plan, as well as coordinating and evaluating activities under the QAPI
plan, as discussed in section II.S. of this preamble, would achieve
many of the same benefits. Thus we do not propose to require that a
facility have an infection control committee, only that the IPCO be a
member of the facility's QAA committee to ensure that the IPCO is an
active participant in the facility's QAPI plan. If a facility does have
an infection control committee, we would still expect the IPCO to be a
member of the QAA committee.
We are also proposing to eliminate the exception that is currently
located at Sec. 483.25(v), which provides that, based on an assessment
and practitioner recommendation, a second pneumococcal immunization
could be given after 5 years following the first pneumococcal
immunization, unless medically contraindicated or the resident or the
resident's legal representative refuses the second immunization. We are
proposing to remove this exception because it is no longer the standard
of care.
We also propose to add a new Sec. 483.80(f) to require that the
facility review its IPCP annually and update the program as necessary.
Due to changes in the issues and practice of infection prevention and
control and changes in the facility itself, an annual update is
important to ensuring the effectiveness of the IPCP.
We are proposing to relocate the requirements for influenza and
pneumococcal immunizations from the current Sec. 483.25(n) to Sec.
483.80(d). The language in Sec. 483.80(d) is identical to the current
Sec. 483.25(n), except that we
[[Page 42217]]
propose using the term ``resident representative'' instead of ``legal
representative.'' We believe this is a broader term and encompasses
individuals whom the resident has personally identified as their
representative. A more detailed discussion of this change is set forth
in Section II. ``Provisions of the Proposed Rule'', B. Definitions.
Finally, we propose moving the requirement concerning linens from
the current Sec. 483.65(c) to the proposed Sec. 483.80(e). Otherwise,
the language is identical.
V. Compliance and Ethics Program (Sec. 483.85)
As noted previously, section 6102 of the Affordable Care Act
amended the Act by adding new section 1128I. Subsection 1128I(b)
requires the operating organizations for SNFs and NFs to have in
operation a compliance and ethics program that is effective in
preventing and detecting criminal, civil, and administrative violations
under the Act and in promoting quality of care consistent with
regulations developed by the Secretary. The current regulations
governing SNFs and NFs at Sec. 483.75(b) require these facilities to
be ``in compliance with all applicable Federal, State, and local laws,
regulations, and codes, and with accepted professional standards and
principles that apply to professionals providing services in such a
facility.'' In addition, according to Sec. 483.75(c), SNFs and NFs
must be in compliance with ``the applicable provisions of other HHS
regulations, including but not limited to those pertaining to . . .
fraud and abuse (42 CFR part 455).'' However, the current regulations
do not require that SNFs and NFs have in place compliance and ethics
programs as required by the Affordable Care Act.
In this proposed rule, we seek to address how nursing facilities
can best establish internal controls, prevent fraudulent activities,
and promote quality of care through these elements as implementing
written procedures and standards of conduct, designating a compliance
officer, and other specific requirements. This proposed rule would
require SNFs, NFs, and dually-participating SNF/NFs to have in place an
effective compliance and ethics program that would require facilities
to use internal controls to more efficiently monitor adherence to
applicable statutes, regulations, and program requirements to deter,
reduce, and detect violations and promote quality of care for nursing
home residents. SNFs and NFs must meet the requirements in part 483 to
participate in the Medicare and Medicaid programs and therefore, we are
proposing that the requirements for effective compliance and ethics
programs as set forth in section 1128I of the Act be incorporated into
the SNF and NF Requirements in Part 483. Specifically, we are proposing
to add a new Sec. 483.85 entitled, ``Compliance and ethics program''.
Prior OIG Guidance
The DHHS Office of the Inspector General (OIG) has issued several
industry-specific guidance documents on compliance. In the March 16,
2000, Federal Register (65 FR 14289), the OIG published its ``Final
Compliance Program Guidance for Nursing Facilities'' (herein after
referred to as the 2000 OIG Guidance). In this guidance, the OIG uses
the term ``nursing facility'' to include SNFs and NFs that meet the
requirements of sections 1819 and 1919 of the Act, respectively. The
OIG guidance was intended to assist SNFs and NFs in the development of
comprehensive compliance programs that would promote facilities'
adherence to applicable statutes and regulations in the federal health
care programs, as well as meet private insurance program requirements.
It indicated that the guidance was voluntary for nursing homes and did
not establish any mandatory requirements. The OIG also noted that
compliance programs promote a nursing home's goals of providing quality
care to its residents and enhancing operation functions, as well as
strengthen the government's efforts in preventing and reducing fraud
and abuse. The 2000 OIG Guidance listed the following seven basic
elements that, at a minimum, should be included in any effective
comprehensive compliance program:
The development and distribution of written standards of
conduct, as well as written policies, procedures and protocols that
promote the nursing facility's commitment to compliance (for example,
including adherence to the compliance program as an element in
evaluating managers and employees) and address specific areas of
potential fraud and abuse, such as claims development and submission
processes, quality of care issues, and financial arrangements with
physicians and outside contractors.
The designation of a compliance officer and other
appropriate bodies (for example, a corporate compliance committee)
charged with the responsibility for developing, operating and
monitoring the compliance program. The officers and committees, report
directly to the owner(s), governing body, and or chief executive
officers.
The development and implementation of regular, effective
education and training programs for all affected employees.
The creation and maintenance of an effective line of
communication between the compliance officer and all employees,
including a process, such as a hotline or other reporting system, to
receive complaints, and the adoption of procedures to protect the
anonymity of complainants and protect whistle-blowers from retaliation.
The use of audits and other risk evaluation techniques to
monitor compliance, identify problem areas, and assist in the reduction
of identified problems.
The development of policies and procedures addressing the
non-employment or retention of excluded individuals or entities and the
enforcement of appropriate disciplinary action against employees or
contractors who have violated corporate or compliance policies and
procedures, applicable statutes, regulations, or federal, state, or
private payer health care program requirements.
The development of policies and procedures with respect to
the investigation of identified systemic problems, which include
direction regarding the prompt and proper response to detected
offenses, such as the initiation of appropriate corrective action,
repayments, and preventive measures (see 65 FR 14291).
In the September 30, 2008 Federal Register (73 FR 56832), the OIG
published additional guidance entitled, ``OIG Supplemental Compliance
Program Guidance for Nursing Facilities'' (hereinafter referred to as
the ``2008 OIG Guidance''). In this supplemental guidance, the OIG
again indicated that the guidance was only a recommendation and
provided voluntary guidelines to assist SNFs and NFs. It noted that
facilities should regularly conduct periodic reviews of the
implementation and execution of their compliance programs, such as on
an annual basis (73 FR 56848). It also reiterated that the basic
elements of a compliance program include all of the following:
Designation of a compliance officer and compliance
committee.
Development of compliance policies and procedures,
including standards of conduct.
Development of open lines of communication.
Appropriate training and teaching.
Internal monitoring and auditing.
Response to detected deficiencies.
[[Page 42218]]
Enforcement of disciplinary standards.
Although the basic elements of an effective compliance program
listed in the 2008 OIG guidance are more concise, they appear to be
essentially the same as those provided in the original 2000 OIG
guidance to which the supplemental guidance directs facilities to
review for further details on the elements.
Comments Solicited in the September 23, 2010 Proposed Rule
Section 6401(a)(3) of the Affordable Care Act, as amended by
subsection 1304(1) of HCERA, established a new paragraph 1866(j)(8) of
the Act. This paragraph requires that all providers of medical or other
items or services or suppliers shall, as a condition of enrollment in
Medicare, Medicaid, or the Children's Health Insurance Program (CHIP),
establish a compliance program that contains core elements to be
established by ``the Secretary in consultation with the Inspector
General [of DHHS].'' SNFs and NFs are subject to the compliance program
requirements under both section 6102 and section 6401(a) of the
Affordable Care Act since section 6401(a) of the Affordable Care Act
applies to all providers and suppliers enrolling into the Medicare and
Medicaid programs, and CHIP.
In order to consider the view of the industry stakeholders, on
September 23, 2010, we published a proposed rule entitled, ``Medicare,
Medicaid, and Children's Health Insurance Programs; Additional
Screening Requirements, Application Fees, Temporary Enrollment
Moratoria, Payment Suspensions and Compliance Plans for Providers and
Suppliers,'' in the Federal Register (75 FR 58204). In section II.E. of
that proposed rule, we solicited public comments on compliance program
requirements that are required by both sections 6102 and 6401(a) of the
Affordable Care Act. We listed the seven basic elements of an effective
compliance and ethics program that were taken from Chapter 8 of the
U.S. Federal Sentencing Guidelines Manual (75 FR 58228) and
specifically sought comments on those elements. Some of the commenters
were supportive of using those elements as a basis for the core
elements of any required compliance program for Medicare, Medicaid, and
CHIP. In addition, a few commenters from the healthcare industry
indicated that they had already incorporated at least some of those
elements into their existing compliance programs. Only one of those
commenters appeared to be from the nursing home industry. Some
commenters expressed concerns about, among other things, the use of
those elements, how compliance would be evaluated, and how long they
would be given to get their compliance and ethics programs in
compliance with our requirements.
The 2010 proposed rule was published as a final rule with comment
period in the February 2, 2011 Federal Register (76 FR 5862). In that
final rule with a comment period, we stated that we did not intend to
finalize any of the compliance and ethics plan requirements of sections
6102 and 7401(a) of the Affordable Care Act in that final rule at that
time. Rather, we intended to propose both compliance plan requirements
in future rulemaking (76 FR 5942). This proposed rule only implements
section 6102 of the Affordable Care Act, which applies only to SNFs and
NFs. The requirements under section 6401(a) of the Affordable Care Act,
which apply to all providers and suppliers including SNFs and NFs, will
be addressed in separate rulemaking at a later time. We will consider
this proposed and subsequent final rule as we are developing the rule
for section 6401(a) of the Affordable Care Act to ensure consistency.
We would like to express our appreciation to all of the individuals
and groups that submitted comments in response to our solicitation,
which greatly assisted us in developing this proposed rule regarding
the requirements of section 6102 of the Affordable Care Act. In
addition to reviewing the public comments received, we have met with
and will continue to work with the OIG to discuss the statutory
provisions for sections 6102 and 6401(a) of the Affordable Care Act and
the lessons the OIG has learned about establishing effective and
comprehensive compliance programs in general.
Proposed Sec. 483.85(a) and Sec. 483.85(b)
At proposed Sec. 483.85(a), we would define the terms ``compliance
and ethics program,'' ``high-level personnel'', and ``operating
organization.'' We are proposing to define ``compliance and ethics
program'' to mean with respect to a facility, a program of the
operating organization that has been reasonably designed, implemented,
and enforced so that it is effective in preventing and detecting
criminal, civil, and administrative violations under the Act, and in
promoting quality of care; and includes, at a minimum, the required
components specified in proposed Sec. 483.85(c). We are proposing to
define ``high-level personnel'' as individuals who have substantial
control over the operating organization or who have a substantial role
in the making of policy within the operating organization. The
individuals considered ``high-level personnel'' will differ according
to each operating organization's structure. However, some examples
include, but are not limited to, the following: (1) A director; (2) an
executive officer; (3) an individual in charge of a major business or
functional unit; and (4) an individual with a substantial ownership
interest as defined in section 1124(a)(3) of the Act in the operating
organization.
We do not propose using the term ``managing employee'' that is
contained in the current nursing home requirements. Section 1126(b) of
the Act defines a managing employee as, ``with respect to an entity, an
individual, including a general manager, business manager,
administrator, and director who exercises operational or managerial
control over the entity, or who directly or indirectly conducts the
day-to-day operations of the entity.'' In describing the required
components for the compliance and ethics program in section 1128I(b)(4)
of the Act, the Congress specifically used the term ``high-level
personnel.'' The term ``high-level personnel'' was also used in the
September 23, 2010 proposed rule that solicited comments on, among
other things, the compliance and ethics program requirements that are
required by section 6102 of the Affordable Care Act. While the
definition of ``managing employee'' refers to an individual with either
operational or managerial control over the entity or who directly or
indirectly conducts the day-to-day operations of the entity, the
proposed definition of ``high-level personnel'' includes the term
``substantial'' and adds someone who has ``a substantial role in the
making of policy within the operating organization.'' We believe the
differences in these two terms clearly convey our intention that only
individuals who exercise the greatest control over the operating
organization are to have the overall responsibility and oversee its
compliance and ethics program. Therefore, we propose to retain the
terminology used in the Affordable Care Act and the former proposed
rule.
We are also proposing to define ``operating organization'' to mean
the individual(s) or entity that operates a facility. Section
1128I(b)(1) of the Act defines an ``operating organization'' as ``the
entity that operates the facility.'' Although many nursing homes are
part of corporate chains, there are still some nursing homes that are
owned by an individual or a small group of individuals. Therefore, we
added
[[Page 42219]]
``individual(s)'' to the definition to make it clear that all nursing
homes, regardless of their legal structure, are required to comply with
these requirements.
In Sec. 483.85(b), we propose that the operating organization for
each facility must have in operation a compliance and ethics program
(as defined in proposed Sec. 483.85(a)) that meets the requirements of
this section beginning on the date that is one year after the rule's
effective date.
Proposed Sec. 483.85(c)
In Sec. 483.85(c), we propose that the operating organization for
each facility be required to develop, implement, and maintain an
effective compliance and ethics program that contains, at a minimum,
several components, which we discuss below.
The operating organization would have to establish written
compliance and ethics standards, policies, and procedures to follow
that are reasonably capable of reducing the prospect of criminal,
civil, and administrative violations under the Act and which include,
but are not limited to, the designation of an appropriate compliance
and ethics program contact to which individuals may report suspected
violations, as well as an alternate method of reporting suspected
violations anonymously without fear of retribution; and disciplinary
standards that set out the consequences for committing violations for
the operating organization's entire staff; individuals providing
services under a contractual arrangement; and volunteers, consistent
with the volunteers' expected roles (proposed Sec. 483.85(c)(1)).
We expect that each operating organization would establish its own
written compliance and ethics standards, policies, and procedures. We
also expect that each operating organization's standards, policies, and
procedures would include, among other things, financial disclosure
obligations, conflicts of interest standards, and requirements for
promptly reporting any abuse or neglect of a resident. Additionally,
within their program, each operating organizations should designate an
appropriate compliance and ethics program contact to which individuals
may report suspected violations, as well as an alternate method of
reporting suspected violations anonymously without fear of retribution;
and establish disciplinary standards so that the operating
organization's entire staff, individuals providing services under a
contractual arrangement, and volunteers, consistent with the
volunteers' expected roles, are clearly aware of the consequences of
program violations. We also expect that these disciplinary standards
would promote consistent enforcement of the operating organization's
program through disciplinary mechanisms, as required in proposed Sec.
483.85(c)(7). We acknowledge that there may be instances when an
individual who chooses to report a suspected violation anonymously may
subsequently be subject to discipline for not reporting the suspected
violation. Each operating organization should be aware of this
possibility and address how it would be handled in their program.
The operating organization would assign specific individuals within
the high-level personnel of the operating organization with the overall
responsibility to oversee compliance with the operating organization's
compliance and ethics program's standards, policies, and procedures,
such as, but not limited to, the chief executive officer (CEO), members
of the board of directors, or directors of major divisions in the
operating organization (proposed Sec. 483.85(c)(2)).
The program would include provisions ensuring that the specific
individuals designated with oversight responsibility in proposed Sec.
483.85(c)(2) have sufficient resources and authority to assure
compliance with these standards, policies, and procedures (proposed
Sec. 483.85(c)(3)). The resources devoted should include both human
and financial resources.
The operating organization would be required to use due care not to
delegate discretionary authority to individuals whom the operating
organization knew, or should have known through the exercise of due
diligence, had a propensity to engage in criminal, civil, or
administrative violations under the Act. (Proposed Sec. 483.85(c)(4)).
``Due care'' generally means the care that a reasonable person would
use under the same or similar circumstances (see, e.g., https://thelawdictionary.org/due-care/ (accessed on April 17, 2015)). While the
degree of due care would vary depending upon the circumstances, we
would expect that the operating organization would apply the degree of
scrutiny commensurate with the level of discretion being delegated to
the individual. For example, the level of scrutiny applied to the
compliance officer should be much higher than the level given to an
employee who has minimal discretionary authority over the residents'
activities.
The operating organization would be required to effectively
communicate the standards, policies, and procedures in the operating
organization's compliance and ethics program to the operating
organization's entire staff including individuals providing services
under a contractual arrangement, and volunteers, consistent with the
volunteers' expected roles. Requirements would include, but not be
limited to, mandatory participation in training or orientation
programs, and/or dissemination of information that explained in a
practical manner what was required under the program (proposed Sec.
483.85(c)(5)).
The compliance program would need to ensure that reasonable steps
were being taken to achieve compliance with the program's standards,
policies, and procedures, such as utilizing monitoring and auditing
systems reasonably designed to detect criminal, civil, and
administrative violations under the Social Security Act by any of the
operating organization's staff, individuals providing services under a
contractual arrangement, or volunteers, having in place and publicizing
a reporting system whereby any of these individuals could report
violations by others anonymously within the operating organization
without fear of retaliation, and having a process for ensuring the
integrity of any reported data (proposed Sec. 483.85(c)(6)).
The operating organization would be required to enforce
consistently the operating organization's standards, policies, and
procedures through appropriate disciplinary mechanisms, including, as
appropriate, discipline of individuals responsible for the failure to
detect and report a violation to the appropriate party identified in
the operating organization's compliance and ethics program. An
operating organization would be required to consistently enforce its
standards and procedures through appropriate disciplinary mechanisms
(proposed Sec. 483.85(c)(7)).
After an operating organization detected a violation, it would have
to ensure that all reasonable steps identified in its program were
taken to respond appropriately to the violation and, to prevent further
similar violations, including any necessary modification to the
operating organization's program to prevent and detect criminal, civil,
and administrative violations under the Act (proposed Sec.
483.85(c)(8)).
The ``reasonable steps'' that should be taken when a violation is
detected should be clearly identified in the operating organization's
program. We expect that the steps would differ depending upon the size
of the operating organization, the position of the individual reporting
the violation,
[[Page 42220]]
and possibly the type of violation. For example, an operating
organization's program may state that a staff member should immediately
notify their immediate superior when he or she detects a violation.
However, if it is the immediate superior or the operating
organization's management whom the staff member believes is committing
the violation, the staff member should have an alternative process to
report the violation, such as, the Office of the State Long-Term Care
Ombudsman or other appropriate agency or law enforcement authority. In
addition, the operating organization's program should include those
steps that are necessary to comply with any mandatory reporting
requirements, such as those concerning suspected resident neglect or
abuse. Under those circumstances, reporting to an immediate supervisor
or manager may not be sufficient and the program should clearly
indicate how any suspected neglect or abuse is to be reported. We also
expect that ethics compliance would be a strong component of each
operating organization's program.
In sections 1128I(b)(3)(F) and (G) of the Act, which correspond to
proposed Sec. 483.85(c)(7) and (8), the term ``offense,'' is used
instead of ``violation.'' We believe that the terms are used
interchangeably. We have used ``violations'' throughout the proposed
regulatory text. The eight previously described components would be
mandatory for all of the SNF and NF operating organizations' compliance
and ethics programs.
Proposed Sec. 483.85(d)
In proposed Sec. 483.85(d), we would require operating
organizations that operate five or more facilities to designate a
compliance officer, and require that such individuals be designated as
high-level personnel of the operating organizations with the overall
responsibility to oversee the compliance and ethics program. In
addition, the designated compliance officer should report directly to
the governing body for the operating organization. We believe this is
necessary to ensure that the compliance officer is not unduly
influenced by other managers or executive officers, such as the general
counsel, chief financial officer or chief operating officer. Thus, we
are proposing the compliance officer should not be subordinate to the
general counsel, chief financial officer or the chief operating
officer. We considered requiring all operating organizations to
designate a compliance officer. However, some smaller operating
organizations may not have the staff to have one individual to whom the
compliance and ethics program could be a major responsibility. However,
it is very important that there be an individual that staff, as well as
others, may contact for questions or concerns and to whom they could
report suspected violations. Therefore, we are proposing that all
operating organizations designate a compliance and ethics program
contact. We welcome comments on this issue.
In Sec. 483.85(d), in addition to all of the other requirements in
proposed Sec. 483.85(a), (b), and (c), we propose that operating
organizations that operate five or more facilities must also include,
at a minimum, the following components in their compliance and ethics
program:
A mandatory annual training program on the operating
organization's compliance and ethics program (Sec. 483.85(d)(1)).
A designated compliance officer for whom the operating
organization's compliance and ethics program is a major responsibility
(Sec. 483.85(d)(2)).
Designated compliance liaisons located at each of the
operating organization's facilities (Sec. 483.95(d)(3)).
The compliance officer should be among those individuals designated
as high-level personnel of the operating organization with the overall
responsibility to oversee the operating organization's compliance and
ethics program as required by proposed Sec. 483.85(c)(2). We also
believe that the compliance officer must have the authority to raise
compliance and ethics issues directly with the Board of Directors,
President, CEO, and General Counsel or their equivalents in the
operating organization. We have not defined ``major responsibility'' in
this rule because we believe that operating organizations must have
flexibility in designating their compliance officers. The category of
``five or more operating organizations'' encompasses small chains of
facilities with as few as five nursing homes up to very large nursing
home chains with hundreds of nursing homes. For some operating
organizations to have an effective compliance and ethics program, they
will need a compliance officer who can devote all of her or his time to
the program. However, some operating organizations will have the
resources to have a dedicated individual whose sole responsibility is
the compliance and ethics program and others will not. For operating
organizations that have insufficient resources to appoint a compliance
officer whose sole responsibility is the operating organization's
program, we would expect that the operating organization would ensure
that the assigned compliance officer has sufficient time and other
resources to fulfill all of his or her responsibilities under the
operating organization's compliance and ethics program.
In selecting their designated compliance officers, we also expect
that operating organizations would consider potential conflicts of
interest. For example, if the compliance officer was also the director
of accounting, he or she might have a conflict of interest if there
were an allegation of deliberate billing errors. In addition, if the
compliance officer was also related to other high-level personnel in
the operating organization, staff members might be hesitant to report
certain violations that might involve the compliance officer's family
members. Therefore, we expect that operating organizations would take
appropriate action concerning any actual or potential conflicts of
interest when selecting their compliance officers. In addition, we
believe that the compliance officer should report directly to the
governing body.
The facility would be required to designate compliance liaisons at
each of the operating organization's facilities (proposed Sec.
483.85(d)(3)). We have not provided a specific definition for a
``designated compliance liaison'' in this rule. We believe that
operating organizations need to have flexibility in defining these
positions and their responsibilities. We would expect that operating
organizations would develop a description for these positions and the
duties and responsibilities these individuals would have in the
operating organization's compliance and ethics program. At a minimum,
these liaisons should be responsible for assisting the compliance
officer with his or her duties under the operating organization's
program at their individual facilities.
In addition to the additional elements for operating organizations
that operate five or more facilities, as set out previously in proposed
paragraph (d), we also anticipate that their programs would be more
formal. However, the formality of these programs will be addressed in
other guidance, including the interpretative guidelines, which will be
developed to provide more instruction on how this rule should be
implemented after it is finalized.
We welcome comments on the proposed additional requirements for
operating organizations with five or more facilities and how to address
the formalizing of these programs. In addition to the auditing and
monitoring systems described in proposed Sec. 483.85(c), we also
considered
[[Page 42221]]
requiring periodic external audits specifically focusing on financial
records and quality of care issues. We would welcome comments on a
requirement for these types of audits or any other additional
requirements for operating organizations that operate five or more
facilities.
Proposed Sec. 483.85(e)
Lastly, at Sec. 483.85(e), we propose that the operating
organization for each facility must review its compliance and ethics
program annually, and revise its program, as needed to reflect changes
in all applicable laws or regulations and within its organization and
facilities to improve its performance in deterring, reducing, and
detecting criminal, civil, and administrative violations under the Act
and in promoting quality of care.
Laws, regulations, and administrative requirements are subject to
change. Without an annual review, an operating organization's
compliance and ethics program could easily become out of date. As an
operating organization becomes aware of changes in these requirements,
it should modify its program to ensure it is current with these
requirements. Importantly, the operating organization's performance in
prior years should also be used to improve its program. In addition, as
an operating organization revises its program, it should ensure that
those changes are communicated to all of the individuals identified in
proposed Sec. 483.85(c)(5).
In proposed Sec. 483.85(a), we use the term ``reasonable'' or
``reasonably'' in the definition of a compliance and ethics program and
in three of the proposed required components of the program in proposed
Sec. 483.85(c)(1), (6) and (8). These terms are used in the Affordable
Care Act legislation. We would appreciate comments on how to evaluate
the reasonableness of the design, implementation, and enforcement of an
operating organization's compliance and ethics program and how to
determine the reasonableness of the steps an operating organization has
taken to achieve compliance with its standards and the steps an
operating organization should take in response to offenses and prevent
similar occurrences.
W. Physical Environment (Sec. 483.90)
The physical environment of a nursing facility is integral to the
resident's health and safety. Therefore, the facility must be designed,
constructed, equipped, and maintained to protect the health and safety
of residents, personnel and the public. Many of these provisions relate
to Life Safety Code (LSC) requirements. We have recently published a
proposed rule which would adopt many provisions of the 2012 LSC
``Medicare and Medicaid Programs; Fire Safety Requirements for Certain
Health Care Facilities,'' 79 FR 21552, April 16, 2014. Those
requirements have been or are being addressed in separate rule-making
and we are not proposing any substantial changes or revisions. As part
of our comprehensive review and restructuring, we propose to re-
designate the existing provisions of Sec. 483.70 as new Sec. 483.90;
however, the language in existing Sec. 483.70(a) ``Life safety from
fire'' and Sec. 483.70(b) ``Emergency power'' would be unchanged,
including new provisions related to the requirement that long term care
facilities have automatic sprinkler systems added by the final rule
``Medicare and Medicaid Programs; Regulatory Provisions to Promote
Program Efficiency, Transparency, and Burden Reduction, Part II''
published in the Federal Register on May 12, 2014 (79 FR 27106). In new
Sec. 483.90(c) ``Space and equipment'', we propose to add the
resident's individual assessment, including preferences and choices, as
an element to consider in addition to the resident's plan of care when
considering the space and equipment requirements of the facility. While
this assessment is considered in developing the resident's plan of
care, we believe including it separately for consideration will help
avoid any gaps in the facility's ability to provide required services
based on space and equipment needs and help ensure person-centeredness.
We propose to eliminate the word ``essential'' from new Sec.
483.90(c)(2) (re-designated from Sec. 483.70(c)(2)), as we believe
that all equipment the resident may be exposed to, whether it is deemed
essential or not, must be maintained in safe operating condition in
order to ensure resident safety. In addition, we propose to add a new
Sec. 483.90(c)(3) to specifically require that facilities conduct
regular inspections of all bed frames, mattresses, and bed rails and to
ensure that bed rails are compatible with the bed frame and mattress.
As noted earlier, bed rails can pose a significant entrapment hazard,
so ensuring that they are used safely warrants explicit reference here.
Currently, in existing Sec. 483.70(d), the regulations allow for
bedrooms that accommodate up to four residents. We believe that this
number of residents per room is inconsistent with current common
practice, is not person-centered nor supportive of achieving the
resident's highest practicable mental, physical and psychosocial well-
being and is not an environment that promotes maintenance or
enhancement of each resident's quality of life. Therefore, we propose
to require in new Sec. 483.90(d)(1)(i) that, bedrooms in facilities
accommodate not more than two residents unless the facility is
currently certified to participate in Medicare and/or Medicaid or has
received approval of construction or reconstruction plans by state and
local authorities prior to the effective date of this regulation.
Reconstruction means that the facility undergoes reconfiguration of the
space such that the space is not permitted to be occupied, or the
entire building or an entire occupancy within the building, such as a
wing of the building, is modified. We believe that semi-private rooms
are far more supportive of privacy and dignity. While a facility is not
a permanent home for all of its residents, this provision is
particularly critical for those residents whose only home is the
nursing facility. We considered, but did not propose to require private
rooms. We note that many states have physical environment requirements
that exceed our requirements. These requirements vary widely, but many
include a requirement for no more than two beds per resident room or
establish a minimum percentage of rooms that must be private or semi-
private. Proposed Sec. 483.90(d) also would require that the bed size
and height be not only convenient for the resident's needs, but also
safe. The Food and Drug Administration (FDA) reports that between Jan
1, 1985 and January 1, 2013, it received 901 incidents of patients
caught, trapped, entangled, or strangled in hospital beds. Most
patients were frail, elderly or confused. (see https://www.fda.gov/
medicaldevices/productsandmedicalprocedures/
generalhospitaldevicesandsupplies/hospitalbeds/default.htm). Therefore,
we believe that bed safety should be an explicit consideration for
facilities. Guidance for facilities as well as other information
related to bed safety is available from FDA, which issued, on March 10,
2006, its ``Hospital Bed System Dimensional and Assessment Guidance to
Reduce Entrapment.'' (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072662.htm). Section
483.70(e) currently requires that each bedroom be equipped with or
located near toilet and bathing facilities. We propose in new Sec.
483.90(e) to add the requirement that, for facilities that receive
approval of construction or
[[Page 42222]]
reconstruction plans by State and local authorities or are newly
certified to participate in Medicare and/or Medicaid after the
effective date of this rule, each resident room must have its own
bathroom equipped with at least a toilet, sink and shower. In addition,
we propose that if a facility undergoes reconstruction, each resident
room in the reconstructed space must have its own bathroom equipped
with at least a toilet, sink and shower. Reconstruction means that the
facility undergoes reconfiguration of the space such that the space is
not permitted to be occupied, or the entire building or an entire
occupancy within the building, such as a wing of the building, is
modified. We understand that this is common in new construction, and we
believe it is important to ensure that residents can achieve their
highest practicable mental, physical and psychosocial well-being and
maintain self-respect and dignity. Further, we expect that this will
ease care delivery. Ensuring facilities in each room may minimize staff
time and effort to assist residents to and from the bathroom, reduce
the likelihood of avoidable incontinence episodes, and enhance the
facility's ability to effectively implement toileting protocols for
residents who are good candidates for these interventions.
Proposed Sec. 483.90(f), re-designated from Sec. 483.70(f),
requires a resident call system. The intent of this provision is to
ensure that a resident can easily call for assistance in his or her
room or bathroom. This is a critical safety issue. The existing
language refers to a ``nurse's station.'' This language may, in many
cases, be outdated. Therefore, we propose to require that the facility
must be adequately equipped to allow residents to call for staff
assistance through a communication system which relays the call
directly to a staff member or to a centralized staff work area from the
resident's bedside, toilet and bathing facilities. This provides
flexibility that will be supportive of innovation in care delivery and
still provide the elements necessary for resident needs and safety.
Proposed Sec. 483.90(g), re-designated from Sec. 483.70(g)
addresses dining and activity rooms and includes a requirement to
designate non-smoking areas. We propose to eliminate the language
``with non-smoking areas identified'', as it is inconsistent with
current practice. Many, if not all, states have specific requirements
related to the permissibility of smoking in healthcare facilities and
related issues. In current practice, facilities are likely to be non-
smoking facilities or may have designated smoking areas. Therefore, we
propose to add a new paragraph (h)(5) to new Sec. 483.90(h) that would
require facilities to establish policies, in accordance with applicable
federal, state and local laws and regulations, regarding smoking,
including tobacco cessation, smoking areas and safety, including but
not limited to non-smoking residents. The inclusion of a tobacco
cessation policy is consistent with the recommendations of the U.S.
Preventive Services Task Force (https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryDraft/tobacco-use-in-adults-and-pregnant-women-counseling-and-interventions1?ds=1&s=Smoking) as well as the National Strategy for
Quality Improvement in Health Care (https://www.ahrq.gov/workingforquality/about.htm). Smoking cessation, even among older,
frail adults, produces significant health and quality of life benefits
(Cataldo, JK. J Gerontol Nurs, 2007 Aug; 33(8):32-41). While we would
expect that, when appropriate, tobacco cessation would be a matter to
be discussed between a resident and his or her primary care provider
and to be addressed in a resident's care plan, based on the
individual's preferences and goals of care, we believe that including
the overarching policy within the facility policy related to smoking
would be beneficial.
X. Training Requirements (Sec. 483.95)
We are proposing to add a new Sec. 483.95 to subpart B that would
set forth training requirements. We propose that a facility must
develop, implement, and maintain an effective training program for all
new and existing staff; individuals providing services under a
contractual arrangement; and volunteers, consistent with their expected
roles. We also propose that a facility be required to determine the
amount and types of training necessary based on a facility assessment
as specified at Sec. 483.70(e). We encourage facilities to take
advantage of the many free or low cost resources available to them.
Various resources and training materials are available at https://www.nhqualitycampaign.org.
Communication Training
We propose at Sec. 483.95(a) to include effective communications
as a required training topic for direct care personnel. Effective
communication has been identified as important in reducing unnecessary
hospitalizations as well as for improving a nursing home resident's
overall quality of life and quality of care. Breakdowns in
communications are a known contributor to adverse events of all types.
CMS noted in its 2012 Nursing Home Action Plan that critical
information often is not communicated from one set of providers to
another during a care transition. According to the Agency for Health
Research and Quality, detecting and promptly reporting changes in a
nursing home resident's condition are critical for ensuring the
resident's well-being and safety. These changes may represent a patient
safety problem, and they can be a signal that the resident is at
increased risk for falling, medication errors, and other complications.
Training all nursing home staff, particularly direct care staff, to be
on the lookout for changes in a resident's condition and to effectively
communicate those changes is one tool LTC facilities can employ to
improve patient safety, create a more person-centered environment, and
reduce the number of adverse events or other resident complications.
AHRQ offers training materials to train front line personnel in nursing
homes in effective communications (Improving Patient Safety in Long-
Term Care Facilities: Training Modules. AHRQ Publication No. 12-0001.
July 2012. Agency for Healthcare Research and Quality, Rockville, MD.
https://www.ahrq.gov/qual/ptsafetyltc/). AHRQ's
TeamSTEPPS[supreg] Long Term Care Version is a training program to
enhance communication for front line staff in nursing homes. (https://www.ahrq.gov/professionals/education/curriculum-tools/teamstepps/longtermcare). AHRQ's On-Time Pressure Ulcer Prevention program
provides training for nursing homes with an EHR to use the EHR to
improve communications of changes in residents' pressure ulcer risk
factors to help staff intervene earlier. (www.ahrq.gov/professionals/systems/long-term-care/resources/on-time/qualityimprov/). An
evaluation of nursing homes in New York State showed a reduction of 59%
in the incidence of pressure ulcers that integrated 3 EHR pressure
ulcer risk reports into day-to-day workflow. (Olsho, L., Spector, W.,
Williams, C. et al. Evaluation of AHRQ's On-Time Pressure Ulcer
Prevention Program: A Facilitator-assisted Clinical Decision Support
Intervention for Nursing Homes. Medical Care 2014 Mar;52(3):258-66.) In
an analysis of interviews of direct care workers, communication and
teamwork were also identified as important in delirium prevention and
appropriate management (Peacock, R., Hopton, A., Featherstone, I., &
Edwards, J. (2012). Care home staff can detect the difference between
delirium, dementia and depression. Nursing Older People, 24(1),
[[Page 42223]]
26-30.) Finally, enhanced communication skills can have a positive
impact on job satisfaction and turnover, factors that can also impact
resident care (Rubin, G., Balaji, R. V., & Barcikowski, R. (2009).
Barriers to nurse/nursing aide communication: the search for
collegiality in a southeast Ohio nursing home. Journal of Nursing
Management, 17(7), 822-832. doi:10.1111/j.1365-2834.2008.00913.x)
We are not proposing to require a specific amount of time, specific
communications topics, or specific training mechanisms to meet this
requirement. While we believe communications training is vital, we also
believe that each facility should have the flexibility to determine,
based on its internal facility assessment and competencies and skill
sets needed for employees, how to structure training to meet its
specific needs. We also recognize that training needs are likely to
change over time. The specific communications training may even vary
within the facility, based on its aspects of care and service. We also
note that states may have their own requirements, at the facility or
professional levels that already require training. We have, therefore,
only proposed this as a training topic that must be incorporated into a
facility's ongoing training expectations for all employees. We welcome
comments on whether or not more specific requirements are necessary.
Resident's Rights Training
We propose at Sec. 483.95(b) to require that facilities train
staff members on the rights of the resident and the responsibilities of
a LTC facility to properly care for its residents as set forth at Sec.
483.10 and Sec. 483.11, respectively. We believe that it is necessary
to ensure that direct care workers are trained to recognize when
treatment is abusive or constitutes neglect or exploitation. We also
believe that training in these areas is likely to reduce incidents. In
addition, the effective training of staff on the requirements for
participation is likely to have a positive effect on the operation of a
facility.
Abuse, Neglect, and Exploitation Training
At Sec. 483.95(c) we propose to require that a facility provide
training to its staff on the freedom from abuse, neglect, and
exploitation requirements found in Sec. 483.12. We propose to specify
that facilities must provide training to their staff that at a minimum
educates staff on activities that constitute abuse, neglect,
exploitation, and misappropriation of resident property and procedures
for reporting incidents of abuse, neglect, exploitation, or the
misappropriation of resident property. We believe that in order for
staff to be proactive and prevent these types of incidents, they must
first be educated on what they are and how to report them. We believe
that requiring this training would not only educate a facilities staff,
but would also improve operations and increase the level of
accountability for staff members.
Quality Assurance and Performance Improvement Training
At Sec. 485.95(d), we propose to require that a facility must
provide mandatory QAPI training to its staff. This training would
outline the elements and goals of the facility's QAPI program. All
facility staff should be aware of what a QAPI program entails and how
the facility intends to implement and monitor their program. Given that
a facility's QAPI program is meant to encompass input from facility
staff, it is imperative that staff members are adequately trained on
the elements of the facility's QAPI program.
Infection Control Training
As discussed earlier, HAIs result in considerable suffering to
nursing home residents and considerable costs to the healthcare system.
Therefore, at Sec. 483.95(e) we propose to require LTC facilities to
include staff training as part of their efforts to prevent and control
infection. It would be the facility's responsibility to ensure that
their staff was effectively educated on the facility's infection
control policies and procedures.
Compliance and Ethics Training
At Sec. 483.95(f)(1), we propose that the operating organization
for each facility must include as part of their compliance and ethics
program training for staff that outlines the standards, policies, and
procedures. We do not specify how a facility should develop this
training; however the training must explain in a practical manner the
requirements under the compliance and ethics program. In addition, at
Sec. 483.95(f)(2) we propose to require that if the operating
organization operates five or more facilities, it must include
mandatory training annually.
Required In-Service Training for Nurse Aides
The Need for Nurse Aide Training in Dementia Management
Dementia among nursing home residents is prevalent and increasing.
According to the Certification and Survey Provider Enhanced Reports
(CASPER) data, in June 2009, 47 percent of all nursing home residents
had a diagnosis of Alzheimer's or other dementia in their nursing home
record. The Alzheimer's Association noted in a report entitled, ``2010-
Alzheimer's Disease Facts and Figures,'' at https://www.alz.org/documents_custom/report_alzfactsfigures2010.pdf that the number of
Americans surviving into their 80s and 90s and beyond is expected to
grow dramatically due to advances in medicine and medical technology,
as well as social and environmental conditions. Since the incidence and
prevalence of Alzheimer's disease and other dementias increase with
age, the number of people with these conditions will also grow rapidly.
The Alzheimer's Association also noted in the report that two-thirds of
those dying with dementia die in nursing homes, compared with 20
percent of cancer patients and 28 percent of residents dying from all
other conditions in nursing homes.
According to the OIG in a 2002 report entitled, ``Nurse Aide
Training,'' (OEI-05-01-00030), 63 percent of the nursing home
supervisors interviewed said that training has not kept pace with the
care demands imposed by current resident diagnoses. Many of these
supervisors pointed out that they are seeing more combative and violent
residents. Many supervisors and nurse aides stated that nurse aides
need more training in caring for residents with behavioral and
cognitive disorders, such as Alzheimer's disease. Also, six state Nurse
Aide Training Competency Evaluation Program (NATCEP) directors
specifically emphasized the need for more training in caring for
residents with cognitive disorders.
According to a September, 2008 report prepared for CMS entitled,
``Improving Nurse Aide Training,'' by Abt Associates, Inc. (Contract
#500-95-0062/TO#3), studies have shown that educational programs are
more likely to be successful when the education is ongoing. Students
are also more receptive to new information that is relevant to their
current work environment, rather than information that is presented
during the initial training. This report suggests that ongoing training
in dementia management and abuse prevention, in addition to the
already-required initial training, would be valuable.
Based on the information included in these reports, we believe that
ongoing training in dementia management and abuse prevention for NAs is
necessary and could enhance the overall quality of care that residents
receive in LTC facilities.
[[Page 42224]]
The Need for Nurse Aide Training in Abuse Prevention
Based on CASPER data for 2007-2009, nursing homes received 3,124
citations for abuse and mistreatment of residents. In 2003, State Long-
Term Care Ombudsman programs nationally investigated 20,673 complaints
of abuse, gross neglect, and exploitation on behalf of nursing home and
board and care residents. Among the types of abuse categories, physical
abuse was the most common type reported.
A GAO report entitled, ``More Can Be Done to Protect Residents from
Abuse,'' ((GAO-02-312) March 1,2002 https://www.gao.gov/newitems/do2312.pdf) revealed that experts who have conducted studies on the
issue of physical and sexual abuse of nursing home residents have
reported that abuse is a serious problem with potentially devastating
consequences. Nursing home residents have suffered serious injuries or,
in some cases, have died as a result of abuse.
A report by the National Association of State Units on Aging,
published in 2005, entitled, ``Nursing Home Abuse Risk Prevention
Profile and Checklist'' concluded that understaffing and inadequate
training of NAs are major causes of abuse, especially for individuals
with dementia.
The Center for Advocacy Rights and Interests (CARIE) reports on
their Web site (https://www.carie.org/programs-services/for-provider-professionals/abuse-prevention/) the results of a research study
conducted by Beth Hudson Keller, Director of Education and Training at
the Philadelphia CARIE, and Dr. Karl Pillemer, Associate Professor at
Cornell University, on nursing home abuse. The research showed that
nursing assistants in 10 Philadelphia-area nursing homes self-reported
abusive behaviors over a one-month period. During this period,
51 percent reported yelling at a resident in anger;
23 percent insulted or swore at a resident;
8 percent threatened to hit or throw something at a
resident;
17 percent excessively restrained a resident;
2 percent had slapped a resident; and
1 percent had kicked or hit a resident with a fist
CARIE believes that training helps to increase staff awareness of
abuse and neglect and potentially abusive situations. In addition,
training equips workers with appropriate conflict intervention
strategies and reduces incidents of abuse and neglect in LTC settings,
thus improving the quality of life for residents.
According to the National Center on Elder Abuse (NCEA), training
can, among other things, enable NAs to build confidence and develop
skills in defusing volatile situations, alert them to the penalties for
abuse, and help NAs cope with the stresses that are associated with
care giving. Also, as stated above, the 2008 Abt Report suggested that
ongoing NA training in abuse prevention should result in fewer
instances of resident abuse.
Section 6121 of the Affordable Care Act added sections
1819(f)(2)(A)(i)(1) and 1919(f)(2)(A)(i)(1) of the Act. These sections
require all NAs to receive on-going training in both dementia
management and patient abuse prevention training, ``if the Secretary
determines appropriate.'' While all NAs currently receive initial
training by the states in dementia management and abuse prevention, the
regulation does not require that training be provided by LTC facilities
to all NAs during their annual 12 hours of in-service training.
However, since NAs are the primary caregivers in LTC facilities, we
believe ongoing training of NAs is critical to prevent abuse of
patients and to ensure NAs can provide appropriate care for residents
particularly those individuals suffering from dementia. As discussed
previously, various studies and reports have indicated that these areas
need improvement.
We are proposing to amend the LTC requirements by requiring the
current mandatory on-going training requirements for NAs include
dementia management and resident abuse training. LTC facilities are
required at existing Sec. 483.75(e)(8) to complete a performance
review of every NA at least once every 12 months, and facilities must
provide regular in-service education based on the outcome of these
reviews. The in-service training must be sufficient to ensure the
continuing competence of NAs, and must be no less than 12 hours per
year. The training must address areas of weakness, as determined in the
NA's performance reviews and may address the special needs of residents
as determined by the facility staff. The existing requirement at Sec.
483.75(e)(8)(iii) requires NAs that provide services to individuals
with cognitive impairments to receive in-service training to address
the care of the cognitively impaired.
We propose to relocate these training requirements for CNAs at
Sec. 483.75(e)(8) to proposed Sec. 483.95(g). Specifically, we
propose to re-designate existing Sec. 483.75(e)(8)(i), (ii), and (iii)
to Sec. 483.95(g)(1), (3), and (4), respectively. At Sec.
483.95(g)(2), we propose to add the new requirement that the 12 hours
of annual in-service training for NAs must include dementia management
and abuse prevention training. Also, at newly redesignated Sec.
483.95(g)(3), we propose to add to the existing requirement that the
in-service training address areas of weakness as determined by a
facility's assessment at Sec. 483.70(e). We note that states have the
option of requiring additional hours of in-service training, as they
deem appropriate. According to the 2008 Abt report, ``Improving Nurse
Aide Training'', with regard to ongoing training, only four states
required more than 12 annual in-service hours. Florida required 18
hours and Alaska, California, and Oklahoma required 24 hours.
Since we are proposing that these four additional topics be
addressed within the current in-service training requirement, we would
like to solicit comments on whether it would be beneficial to require
additional ongoing hours to accommodate this training. As discussed in
the 2008 report by the Abt Associates, ``Improving Nurse Aide
Training,'' based on analyses of surveys of NAs, NATCEP directors, and
nursing home administrators, the report concluded, that there was no
evidence that additional hours resulted in better quality care or
outcomes for residents. The report also concluded that simply adding
more training hours without evaluating the efficacy of the training
would yield very little return on investment. Therefore, we are
requesting public comment, including the results of any additional
studies that would support an increase in the required hours for in-
service training above the currently required 12 hours.
Training for Feeding Assistants
Current regulations at Sec. 483.75(q) require facilities to only
employ as a paid feeding assistant those individuals who have
successfully completed a state approved training program, as specified
in Sec. 483.160. We propose to relocate this provision without change
to proposed Sec. 483.95(h).
Behavioral Health Training
We propose at Sec. 483.95(i) to require that facilities provide
behavioral health training to its entire staff, based on the facility
assessment at Sec. 483.70(e). As required at Sec. 483.70(e), the
facility would be responsible for using their facility assessment to
determine the behavioral health related needs of their residents. Then
the facility would ensure that their staff is provided with
[[Page 42225]]
behavioral health training that correlates with the needs of their
residents.
III. Long-Term Care Facilities Crosswalk
The table below shows the cross-references between the current
sections to the proposed. We also note that we have made conforming
changes that would revise any cross-references to part 483 in title 42
that would change due to the reorganization of subpart B in this
proposed rule.
Table A--Title 42 Cross-References to Part 483 Subpart B
----------------------------------------------------------------------------------------------------------------
Existing CFR Section Title Action New CFR section
----------------------------------------------------------------------------------------------------------------
Sec. 483.1.................. Basis and Scope.. Revised.......... Sec. 483.1.
(a)..............
Sec. 483.5(a)-(c)........... (a) Facility Re-designated.... Sec. 483.5 in alphabetical order.
defined.
(b) Distinct
part..
(c) Composite
distinct part..
Sec. 483.5 (d).............. (d) Common area.. Re-designated & Sec. 483.5 in alphabetical order.
revised.
Sec. 483.5(e)............... (e) Fully Re-designated.... Sec. 483.5 in alphabetical order.
sprinklered.
(f) Major
modification..
Sec. 483.10................. Resident rights.. Revised.......... Sec. 483.10.
Sec. 483.10(a)(1)........... (a) Exercise of No change........ Sec. 483.10(a)(2).
rights.
Sec. 483.10(a)(2)........... (a) Exercise of Revised.......... Sec. 483.10(a)(2).
rights.
Sec. 483.10 (a)(3).......... ................. Re-designated and Sec. 483.10(a)(4).
revised.
Sec. 483.10 (a)(4).......... ................. Re-designated and Sec. 483.10(a)(3).
revised.
Sec. 483.10 (b)(1).......... (b) Notice of Re-designated & Sec. 483.11(e)(9).
rights and revised.
services.
Sec. 483.10(b)(2)........... ................. Re-designated & Sec. 483.10(f)(3).
revised.
Sec. 483.10(b)(3)........... ................. Re-designated.... Sec. 483.10(b)(1).
Sec. 483.10 (b)(4).......... ................. Revised.......... Sec. 483.10(b)(4).
Sec. 483.10(b)(5)........... ................. Re-designated & Sec. 483.11(e)(10).
revised.
Sec. 483.10 (b)(6).......... ................. Re-designated & 483.11(e)(11).
revised.
Sec. 483.10(b)(7)........... ................. Re-designated & 483.11(e)(12).
revised.
Sec. 483.10(b)(8)........... ................. Re-designated & Sec. 483.11(e)(5)(i)-(v).
revised.
Sec. 483.10(b)(9)........... ................. Re-designated & Sec. 483.11(c)(1).
revised.
Sec. 483.10(b)(10).......... ................. Re-designated & Sec. 483.11(e)(6).
revised.
Sec. 483.10(b)(11).......... ................. Re-designated & Sec. 483.11(e)(7).
revised.
Sec. 483.10(b)(12).......... ................. Re-designated.... Sec. 483.11(e)(8).
Sec. 483.10(c)(1)........... (c) Protection of Re-designated & Sec. 483.10(e)(9), Sec. 483.11(d)(5).
resident funds. revised.
Sec. 483.10(c)(2)........... ................. Re-designated.... Sec. 483.11(d)(5)(i).
Sec. 483.10(c)(3)........... ................. Re-designated & Sec. 483.11(d)(5)(ii).
revised.
Sec. 483.10(c)(4)........... ................. Re-designated.... Sec. 483.11(d)(5)(iii).
Sec. 483.10(c)(5)........... ................. Re-designated.... Sec. 483.11(d)(5)(iv).
Sec. 483.10(c)(6)........... ................. Re-designated & Sec. 483.11(d)(5)(v).
revised.
Sec. 483.10(c)(7)........... ................. Re-designated.... Sec. 483.11(d)(5)(vi).
Sec. 483.10(c)(8)........... ................. Re-designated & Sec. 483.11(d)(6).
revised.
Sec. 483.10(d).............. (d) Free choice.. Re-designated & Sec. 483.10(c).
revised.
Sec. 483.10(d)(1)........... ................. Re-designated & Sec. 483.10(c).
revised.
Sec. 483.10(d)(2)........... ................. Re-designated & Sec. 483.10(b).
revised.
Sec. 483.10(d)(3)........... ................. Re-designated & Sec. 483.10(a)(4)(iv), Sec.
revised. 483.10(b)(5).
Sec. 483.10(e).............. (e) Privacy and Re-designated & Sec. 483.10(g).
confidentiality. revised.
Sec. 483.10(e)(1)........... ................. Re-designated.... Sec. 483.10(g)(2).
Sec. 483.10(e)(2)........... ................. Re-designated & Sec. 483.10(g)(4).
revised.
Sec. 483.10(e)(3)........... ................. Re-designated & Sec. 483.10(g)(4).
revised.
Sec. 483.10(e)(3)(i)........ ................. Re-designated & Sec. 483.10(g)(4).
revised.
Sec. 483.10(e)(3)(ii)....... ................. Re-designated & Sec. 483.10(g)(4).
revised.
Sec. 483.10(f).............. (f) Grievances... Re-designated & Sec. 483.10(j).
revised.
Sec. 483.10(f)(1)........... ................. Re-designated & Sec. 483.10(j)(1).
revised.
Sec. 483.10(f)(2)........... ................. Re-designated & Sec. 483.10(j)(2).
revised.
Sec. 483.10(g).............. (g) Examination Re-designated.... Sec. 483.10(f)(4).
of survey
results.
Sec. 483.10(g)(1)........... ................. Re-designated & Sec. 483.10(f)(4)(i), Sec.
revised. 483.11(e)(3).
Sec. 483.10(g)(2)........... ................. Re-designated.... Sec. 483.10(f)(4)(ii).
Sec. 483.10(h).............. (h) Work......... Re-designated & Sec. 483.10(e)(8).
revised.
Sec. 483.10(h)(1)........... ................. Re-designated & Sec. 483.10(e)(8).
revised.
Sec. 483.10(h)(2)........... ................. Re-designated & Sec. 483.10(e)(8), Sec. 483.11(d)(4).
revised.
Sec. 483.10(h)(2)(i)-(iv)... ................. Re-designated.... Sec. 483.11(d)(4)(i)-(iv).
Sec. 483.10(i).............. (i) Mail......... Re-designated & Sec. 483.10(g)(1) & (h)(3).
revised.
Sec. 483.10(i)(1)........... ................. Re-designated & Sec. 483.10(g)(1), Sec.
revised. 483.11(f)(1)(i).
Sec. 483.10(i)(2)........... ................. Re-designated & Sec. 483.10(h)(3)(ii), Sec.
revised. 483.11(e)(14)(iii).
Sec. 483.10(j)(1)........... (j) Access and Re-designated & Sec. 483.10(e)(3), Sec. 483.11(d)(1).
visitation revised.
rights.
Sec. 483.10(j)(1)(i)-(vi)... ................. Re-designated & Sec. 483.11(d)(1)(i)(A)-(F).
revised.
Sec. 483.10(j)(1)(vii)...... ................. Re-designated & Sec. 483.11(d)(1)(ii).
revised.
Sec. 483.10(j)(1)(viii)..... ................. Re-designated & Sec. 483.11(d)(1)(iii).
revised.
Sec. 483.10(j)(2)........... ................. Re-designated.... Sec. 483.11(d)(1)(iv).
Sec. 483.10(j)(3)........... ................. Re-designated & Sec. 483.11(f)(3).
revised.
Sec. 483.10(k).............. (k) Telephone.... Re-designated & Sec. 483.10(h)(1).
revised.
Sec. 483.10(l).............. (l) Personal Re-designated & Sec. 483.10(d)(2).
property. revised.
[[Page 42226]]
Sec. 483.10(m).............. (m) Married Re-designated.... Sec. 483.10(d)(4).
couples.
Sec. 483.10(n).............. (n) Self- Re-designated & Sec. 483.10(b)(6).
Administration revised.
of Drugs.
Sec. 483.10(o)(1)-(2)....... (o) Refusal of Re-designated & Sec. 483.10(d)(7)(i)-(ii), 483.11(d)(8).
certain revised.
transfers.
Sec. 483.12(a).............. Admission, Re-designated & Sec. 483.15(b).
transfer and revised.
discharge rights
(a) Transfer and
discharge.
Sec. 483.12(a)(1)........... (1) Definition:.. Re-designated.... Sec. 483.5.
Sec. 483.12(a)(2)........... ................. Re-designated & Sec. 483.15(b)(1)(ii).
revised.
Sec. 483.12(a)(2)(i)-(vi)... ................. Re-designated & Sec. 483.15(b)(1)(ii)(A)-(F).
revised.
Sec. 483.12(a)(3)........... ................. Re-designated & Sec. 483.15(b)(2).
revised.
Sec. 483.12(a)(3)(i)........ ................. Re-designated & Sec. 483.15(b)(2)(ii)(A).
revised.
Sec. 483.12(a)(3)(ii)....... ................. Re-designated & Sec. 483.15(b)(2)(ii)(B).
revised.
Sec. 483.12(a)(4)(i)-(iii).. ................. Re-designated & Sec. 483.15(b)(3)(i)-(iii).
revised.
Sec. 483.12(a)(5)(i)........ ................. Re-designated & Sec. 483.15(b)(4).
revised.
Sec. 483.12(a)(5)(ii)(A)-(E) ................. Re-designated & Sec. 483.15(b)(4)(ii)(A)-(E).
revised.
Sec. 483.12(a)(6)(i)-(vii).. ................. Re-designated & Sec. 483.15(b)(5)(i)-(vii).
revised.
Sec. 483.12(a)(7)........... ................. Re-designated & Sec. 483.15(b)(7).
revised.
Sec. 483.12(a)(8)........... ................. Re-designated & Sec. 483.15(b)(8).
revised.
Sec. 483.12(a)(9)........... ................. Re-designated & Sec. 483.15(b)(9).
revised.
Sec. 483.12(b)(1)(i)-(ii)... (b) Notice of bed- Re-designated & Sec. 483.15(c)(1)(i)-(iii).
hold policy and revised.
readmission.
Sec. 483.12(b)(2)........... ................. Re-designated & Sec. 483.15(c)(2).
revised.
Sec. 483.12(b)(3)(i)-(ii)... ................. Re-designated.... Sec. 483.15(c)(3)(i)-(ii).
Sec. 483.12(b)(4)........... ................. Re-designated & Sec. 483.15(c)(4).
revised.
Sec. 483.12(c)(1)........... (c) Equal access Re-designated & Sec. 483.15(b)(1)(i)(A).
to quality care. revised.
Sec. 483.12(c)(2)........... ................. Re-designated & Sec. 483.15(b)(1)(i)(B).
revised.
Sec. 483.12(c)(3)........... ................. Re-designated.... Sec. 483.15(b)(1)(i)(C).
Sec. 483.12(d)(1) (i)-(ii).. (d) Admissions Re-designated & S483.15(a)(2)(i)-(ii).
policy. revised.
Sec. 483.12(d)(2)........... ................. Re-designated & S483.15(a)(3).
revised.
Sec. 483.12(d)(3) (i)-(ii).. ................. Re-designated.... S483.15(a)(4)(i)-(ii).
Sec. 483.12(d)(4)........... ................. Re-designated.... Sec. 483.15(a)(5).
Sec. 483.13(a).............. Resident behavior Re-designated & Sec. 483.10(d)(1), Sec. 483.12, Sec.
and facility revised. 483.25(d)(1).
practices. (a)
Restraints.
Sec. 483.13(b).............. (b) Abuse........ Re-designated & Sec. 483.12.
revised.
Sec. 483.13(c).............. (c) Staff Re-designated & Sec. 483.12(b).
treatment of revised.
residents.
Sec. 483.13(c)(1)........... ................. Re-designated.... Sec. 483.12(a).
Sec. 483.13(c)(1)(i)........ ................. Re-designated.... Sec. 483.12(a)(1).
Sec. 483.13(c)(1)(ii)....... ................. Re-designated & Sec. 483.12(a)(2).
revised.
Sec. 483.13(c)(1)(ii)(A).... ................. Re-designated & Sec. 483.12(a)(2)(i).
revised.
Sec. 483.13(c)(1)(ii)(B).... ................. Re-designated & Sec. 483.12(a)(2)(ii).
revised.
Sec. 483.13(c)(1)(iii)...... ................. Re-designated & Sec. 483.12(a)(3).
revised.
Sec. 483.13(c)(2)........... ................. Re-designated & Sec. 483.12(c)(1).
revised.
Sec. 483.13(c)(3)........... ................. Re-designated & Sec. 483.12(c)(2)-(3).
revised.
Sec. 483.13(c)(4)........... ................. Re-designated & Sec. 483.12(c)(4).
revised.
Sec. 483.15................. Quality of life.. Re-designated & Sec. 483.11.
revised.
Sec. 483.15(a).............. (a) Dignity...... Re-designated & Sec. 483.11.
revised.
Sec. 483.15(b).............. (b) Self- Re-designated & Sec. 483.10(e), Sec. 483.11(d).
determination revised.
and
participation.
Sec. 483.15(b)(1)........... ................. Re-designated & Sec. 483.10(e)(1).
revised.
Sec. 483.15(b)(2)........... ................. Re-designated & Sec. 483.10(e)(2).
revised.
Sec. 483.15(b)(3)........... ................. Re-designated.... Sec. 483.10(e)(10).
Sec. 483.15(c)(1)........... (c) Participation Re-designated & Sec. 483.10(e)(4).
in resident and revised.
family groups
groups.
Sec. 483.15(c)(2)........... ................. Re-designated & Sec. 483.10(e)(5)-(6).
revised.
Sec. 483.15(c)(3)........... ................. Re-designated.... Sec. 483.11(d)(3).
Sec. 483.15(c)(4)-(6)....... ................. Re-designated & Sec. 483.11(d)(3)(i)-(iii).
revised.
Sec. 483.15(d).............. (d) Participation Re-designated& Sec. 483.10(e)(7).
in other revised.
activities.
Sec. 483.15(e).............. (e) Accommodation Re-designated & Sec. 483.10(d).
of needs. revised.
Sec. 483.15(e)(1)........... ................. Re-designated & Sec. 483.10(d)(3).
revised.
Sec. 483.15(e)(2)........... ................. Re-designated & Sec. 483.10(d)(6).
revised.
Sec. 483.15(f)(1)........... (f) Activities... Re-designated & Sec. 483.25(c)(1).
revised.
Sec. 483.15(f)(2)........... ................. Re-designated & Sec. 483.25(c)(2).
revised.
Sec. 483.15(f)(2)(i)........ ................. Re-designated & Sec. 483.25(c)(2).
revised.
Sec. 483.15(f)(2)(i)(A)..... ................. Re-designated.... Sec. 483.25(c)(2)(i).
Sec. 483.15(f)(2)(i)(B)..... ................. Re-designated & Sec. 483.25(c)(2)(ii)(A).
revised.
Sec. 483.15 (f)(2)(ii)-(iv). ................. Re-designated & Sec. 483.25(c)(2)(ii)(B)-(D).
revised.
Sec. 483.15(g)(1)........... (g) Social Re-designated & Sec. 483.40(d).
Services. revised.
Sec. 483.15(g)(2)........... ................. Re-designated & Sec. 483.70(p).
revised.
Sec. 483.15(g)(3)(i)-(ii)... (3) Re-designated & Sec. 483.70(p)(1)-(2).
Qualifications revised.
of social worker.
Sec. 483.15(h).............. (h) Environment.. Re-designated & Sec. 483.11(g).
revised.
Sec. 483.15(h)(1)........... ................. Re-designated & Sec. 483.11(g)(1).
revised.
Sec. 483.15(h)(2)........... ................. Re-designated.... Sec. 483.11(g)(2).
[[Page 42227]]
Sec. 483.15(h)(3)........... ................. Re-designated.... Sec. 483.11(g)(3).
Sec. 483.15(h)(4)........... ................. Re-designated & Sec. 483.11(g)(4).
revised.
Sec. 483.15(h)(5)........... ................. Re-designated.... Sec. 483.11(g)(5).
Sec. 483.15(h)(6)........... ................. Re-designated.... Sec. 483.11(g)(6).
Sec. 483.15(h)(7)........... ................. Re-designated.... Sec. 483.11(g)(7).
Sec. 483.20................. Resident No change........ Sec. 483.20.
Assessment.
Sec. 483.20(a).............. (a) Admission No change........ Sec. 483.20(a).
orders.
Sec. 483.20(b).............. (b) Comprehensive Revised.......... Sec. 483.20(b).
assessments--(1)
Resident
assessment
instrument.
Sec. 483.20(c)-(d).......... (c) Quarterly No change........ Sec. 483.20(c)-(d).
review
assessment.
(d) Use..........
Sec. 483.20(e).............. (e) Coordination. Revised.......... Sec. 483.20(e).
Sec. 483.20(f)-(j).......... (f) Automated
data processing
requirement.
(g) Accuracy of
assessments.
(h) Coordination.
(i) Certification
(j) Penalty for No change........ Sec. 483.20(f)-(j).
falsification.
Sec. 483.20(k)(1)........... (k) Comprehensive Re-designated & Sec. 483.21(b)(1).
care plans. revised.
Sec. 483.20(k)(2)........... ................. Re-designated.... Sec. 483.21(b)(2).
Sec. 483.20(k)(2)(i)........ ................. Re-designated.... Sec. 483.21(b)(2)(i).
Sec. 483.20(k)(2)(ii)....... ................. Re-designated & Sec. 483.21(b)(2)(ii)(A)-(G).
revised.
Sec. 483.20(k)(2)(iii)...... ................. Re-designated & Sec. 483.21(b)(2)(iii).
revised.
Sec. 483.20(k)(3)(i)-(ii)... ................. Re-designated.... Sec. 483.21(b)(3)(i)-(ii).
Sec. 483.20(l).............. (l) Discharge Re-designated & Sec. 483.21(c)(2).
summary. revised.
Sec. 483.20(l)(1)........... ................. Re-designated & Sec. 483.21(c)(2)(i).
revised.
Sec. 483.20(l)(2)........... ................. Re-designated & Sec. 483.21(c)(2)(ii).
revised.
Sec. 483.20(l)(3)........... ................. Re-designated & Sec. 483.21(c)(2)(iv).
revised.
Sec. 483.20(m).............. (m) Preadmission Re-designated.... Sec. 483.20(k)(1).
screening for
mentally ill
individuals and
individuals with
mental
retardation.
Sec. 483.20(m)(1)(i)-(ii)... ................. Re-designated.... Sec. 483.20(k)(1)(i)-(ii).
Sec. 483.20(m)(2)(i)-(ii)... (2) Definition Re-designated & Sec. 483.20(k)(3)(i)-(ii).
For purposes of revised.
this section--.
Sec. 483.25................. Quality of care.. Revised.......... Sec. 483.25.
Sec. 483.25(a).............. (a) Activities of Re-designated & Sec. 483.25(a).
daily living. revised.
Sec. 483.25(a)(1)........... ................. Re-designated and Sec. 483.25(a),(b).
revised.
Sec. 483.25(a)(1)(i)........ ................. Re-designated and Sec. 483.25(b)(1).
revised.
Sec. 483.25(a)(1)(ii)....... ................. Re-designated and Sec. 483.25(b)(2).
revised.
Sec. 483.25(a)(1)(iii)...... ................. Re-designated and Sec. 483.25(b)(3).
revised.
Sec. 483.25(a)(1)(iv)....... ................. Re-designated and Sec. 483.25(b)(4).
revised.
Sec. 483.25(a)(1)(v)........ ................. Re-designated and Sec. 483.25(b)(5).
revised.
Sec. 483.25(a)(2)........... ................. Re-designated and Sec. 483.25(a)(1).
revised.
Sec. 483.25(a)(3)........... ................. Re-designated.... Sec. 483.25(a)(2).
Sec. 483.25(b).............. (b) Vision and Re-designated.... Sec. 483.25(d)(3).
hearing.
Sec. 483.25(b)(1)........... ................. Re-designated.... Sec. 483.25(d)(3)(i).
Sec. 483.25(b)(2)........... ................. Re-designated.... Sec. 483.25(d)(3)(ii).
Sec. 483.25(c).............. (c) Pressure Re-designated & Sec. 483.25(d)(4)(i).
sores. revised.
Sec. 483.25(c)(1)........... ................. Re-designated & Sec. 483.25(d)(4)(i)(A).
revised.
Sec. 483.25(c)(2)........... ................. Re-designated & Sec. 483.25(d)(4)(i)(B).
revised.
Sec. 483.25(d).............. (d) Urinary Re-designated & Sec. 483.25(d)(6)(ii).
Incontinence. revised.
Sec. 483.25(d)(1)........... ................. Re-designated.... Sec. 483.25(d)(6)(ii)(A).
Sec. 483.25(d)(2)........... ................. Re-designated.... Sec. 483.25(d)(6)(i)(C).
Sec. 483.25(e).............. (e) Range of Re-designated & Sec. 483.25(d)(5).
motion. revised.
Sec. 483.25(e)(1)........... ................. Re-designated.... Sec. 483.25(d)(5)(i).
Sec. 483.25(e)(2)........... ................. Re-designated.... Sec. 483.25(d)(5)(ii).
Sec. 483.25(f).............. (f) Mental and Re-designated & Sec. 483.40(b).
Psychosocial revised.
functioning.
Sec. 483.25(f)(1)........... ................. Re-designated & Sec. 483.40(b)(1).
revised.
Sec. 483.25(f)(2)........... ................. Re-designated & Sec. 483.40(b)(2).
revised.
Sec. 483.25(g).............. (g) Naso-gastric Re-designated & Sec. 483.25(d)(8)(iv).
tubes. revised.
Sec. 483.25(g)(1)........... ................. Re-designated & Sec. 483.25(d)(8)(iv).
revised.
Sec. 483.25(g)(2)........... ................. Re-designated & Sec. 483.25(d)(8)(v).
revised.
Sec. 483.25(h).............. (h) Accidents.... Re-designated.... Sec. 483.25(d)(10).
Sec. 483.25(h)(1)........... ................. Re-designated.... Sec. 483.25(d)(10)(i).
Sec. 483.25(h)(2)........... ................. Re-designated.... Sec. 483.25(d)(10)(ii).
Sec. 483.25(i).............. (i) Nutrition.... Re-designated & Sec. 483.25(d)(8).
revised.
Sec. 483.25(i)(1)........... ................. Re-designated & Sec. 483.25(d)(8)(i).
revised.
Sec. 483.25(i)(2)........... ................. Re-designated & Sec. 483.25(d)(8)(iii).
revised.
Sec. 483.25(j).............. (j) Hydration.... Re-designated & Sec. 483.25(d)(8)(ii).
revised.
Sec. 483.25(k).............. (k) Special needs Re-designated & Sec. 483.25(d).
revised.
[[Page 42228]]
Sec. 483.25(k)(1)........... (1) Injections;.. Deleted. ..........................................
Sec. 483.25(k)(2)........... (2) Parenteral Re-designated & Sec. 483.25(d)(9).
and enteral revised.
fluids;.
Sec. 483.25(k)(3)........... (3) Colostomy, Re-designated.... Sec. 483.25(d)(7).
ureterostomy, or
ileostomy care;.
Sec. 483.25(k)(4)........... (4) Tracheostomy Re-designated & Sec. 483.25(d)(11).
care;. revised.
Sec. 483.25(k)(5)........... (5) Tracheal Re-designated & Sec. 483.25(d)(11).
suctioning;. revised.
Sec. 483.25(k)(6)........... (6) Respiratory Re-designated & Sec. 483.25(d)(11).
care;. revised.
Sec. 483.25(k)(7)........... (7) Foot care; Re-designated & Sec. 483.25(d)(4)(ii).
and. revised.
Sec. 483.25(k)(8)........... (8) Prostheses... Re-designated.... Sec. 483.25(d)(12).
Sec. 483.25(l).............. (l) Unnecessary Re-designated.... Sec. 483.45(d).
drugs.
Sec. 483.25(l)(1)(i)-(vi)... ................. Re-designated.... Sec. 483.45(d)(1)-(6).
Sec. 483.25(l)(2)(i)-(ii)... (2) Antipsychotic Re-designated & Sec. 483.45(e)(1)-(2).
Drugs. revised.
Sec. 483.25(m)(1)-(2)....... (m) Medication Re-designated & Sec. 483.45(f)(1)-(2).
Errors. revised.
Sec. 483.25(n).............. (n) Influenza and Re-designated.... Sec. 483.80(d)(1).
pneumococcal
immunizations.
Sec. 483.25(n)(1)(i)-(iv)... ................. Re-designated & Sec. 483.80(d)(1)(i)-(iv).
revised.
Sec. 483.25(n)(2)........... (2) Pneumococcal Re-designated.... Sec. 483.80(d)(2).
disease.
Sec. 483.25(n)(2)(i)-(iv)... ................. Re-designated & Sec. 483.80(d)(2)(i)-(iv).
revised.
Sec. 483.25(n)(2)(v)........ Exception........ Deleted. ..........................................
Sec. 483.30................. Nursing services. Re-designated & Sec. 483.35.
revised.
Sec. 483.30(a).............. (a) Sufficient Re-designated.... Sec. 483.35(a).
staff.
Sec. 483.30(a)(1)(ii)....... ................. Re-designated & Sec. 483.35(a)(1)(ii).
revised.
Sec. 483.30(a)(2)........... ................. Re-designated.... Sec. 483.35(a)(2).
Sec. 483.30(b)(1)........... (b) Registered Re-designated.... Sec. 483.35(b)(1).
nurse.
Sec. 483.30(b)(2)........... ................. Re-designated.... Sec. 483.35(b)(2).
Sec. 483.30(b)(3)........... ................. Re-designated.... Sec. 483.35(b)(3).
Sec. 483.30(c).............. (c) Nursing Re-designated.... Sec. 483.35(e).
facilities:
Waiver of
requirement to
provide licensed
nurses on a 24-
hour basis.
Sec. 483.30(c)(1)-(5)....... ................. Re-designated.... Sec. 483.35(e)(1)-(5).
Sec. 483.30(c)(6)........... ................. Re-designated & Sec. 483.35(e)(6).
revised.
Sec. 483.30(c)(7)........... ................. Re-designated & Sec. 483.35(e)(7).
revised.
Sec. 483.30(d)(1)........... (d) SNFs: Waiver Re-designated.... Sec. 483.35(f)(1).
of the
requirement to
provide services
of a registered
nurse for more
than 40 hours a
week.
Sec. 483.30(d)(1)(i)........ ................. Re-designated.... Sec. 483.35(f)(1)(i).
Sec. 483.30(d)(1)(ii)....... ................. Re-designated.... Sec. 483.35(f)(1)(ii).
Sec. 483.30(d)(1)(iii)...... ................. Re-designated.... Sec. 483.35(f)(1)(iii).
Sec. 483.30(d)(1)(iii)(A)... ................. Re-designated.... Sec. 483.35(f)(1)(iii)(A).
Sec. 483.30(d)(1)(iii)(B)... ................. Re-designated.... Sec. 483.35(f)(1)(iii)(B).
Sec. 483.30(d)(1)(iv)....... ................. Re-designated & Sec. 483.35(f)(1)(iv).
revised.
Sec. 483.30(d)(1)(v)........ ................. Re-designated & Sec. 483.35(f)(1)(v).
revised.
Sec. 483.30(d)(2)........... ................. Re-designated.... Sec. 483.35(f)(2).
Sec. 483.30(e)(1)(i)-(iv)... (e) Nurse Re-designated.... Sec. 483.35(g)(1)(i)-(iv).
staffing
information.
Sec. 483.30(e)(2)(i)-(ii)... ................. Re-designated.... Sec. 483.35(g)(2)(i)-(ii).
Sec. 483.30(e)(3)........... ................. Re-designated.... Sec. 483.35(g)(3).
Sec. 483.30(e)(4)........... ................. Re-designated.... Sec. 483.35(g)(4).
Sec. 483.35................. Dietary services. Re-designated & Sec. 483.60.
revised.
Sec. 483.35(a).............. (a) Staffing..... Re-designated & Sec. 483.60(a)(1).
revised.
Sec. 483.35(a)(1)........... ................. Re-designated & Sec. 483.60(a)(2).
revised.
Sec. 483.35(a)(2)........... ................. Re-designated & Sec. 483.60(a)(1)(i)-(iii).
revised.
Sec. 483.35(b).............. (b) Sufficient Re-designated & Sec. 483.60(a)(3).
staff. revised.
Sec. 483.35(c).............. (c) Menus and Re-designated.... Sec. 483.60(c).
nutritional
adequacy.
Sec. 483.35(c)(1)-(3)....... ................. Re-designated & Sec. 483.60(c)(1)-(3).
revised.
Sec. 483.35(d).............. (d) Food......... Re-designated.... Sec. 483.60(d).
Sec. 483.35(d)(1)........... ................. Re-designated.... Sec. 483.60(d)(1).
Sec. 483.35(d)(2)........... ................. Re-designated & Sec. 483.60(d)(2).
revised.
Sec. 483.35(d)(3)........... ................. Re-designated.... Sec. 483.60(d)(3).
Sec. 483.35(d)(4)........... ................. Re-designated & Sec. 483.60(d)(5).
revised.
Sec. 483.35(e).............. (e) Therapeutic Re-designated & Sec. 483.60(e).
diets. revised.
Sec. 483.35(f)(1)........... (f) Frequency of Re-designated & Sec. 483.60(f)(1).
meals. revised.
Sec. 483.35(f)(2)........... ................. Deleted. ..........................................
Sec. 483.35(f)(3)........... ................. Re-designated.... Sec. 483.60(f)(3).
Sec. 483.35(f)(4)........... ................. Deleted. ..........................................
Sec. 483.35(g).............. (g) Assistive Re-designated & Sec. 483.60(g).
devices. revised.
Sec. 483.35(h)(1)........... (h) Paid feeding Re-designated.... Sec. 483.60(h)(1).
assistants.
Sec. 483.35(h)(1)(i)-(ii)... ................. Re-designated.... Sec. 483.60(h)(1)(i)-(ii).
Sec. 483.35(h)(2)(i)........ ................. Re-designated.... Sec. 483.60(h)(2)(i).
Sec. 483.35 (h)(2)(ii)...... ................. Re-designated & Sec. 483.60(h)(2)(ii).
revised.
Sec. 483.35(h)(3)(i)-(ii)... ................. Re-designated & Sec. 483.60(h)(3)(i)-(ii).
revised.
[[Page 42229]]
Sec. 483.35(h)(3)(iii)...... ................. Re-designated & Sec. 483.60(h)(3)(iii).
revised.
Sec. 483.35(i).............. (i) Sanitary Re-designated & Sec. 483.60(i).
conditions. revised.
Sec. 483.35(i)(1)........... ................. Re-designated & Sec. 483.60(i)(1).
revised.
Sec. 483.35(i)(2)........... ................. Re-designated & Sec. 483.60(i)(2).
revised.
Sec. 483.35(i)(3)........... ................. Re-designated.... Sec. 483.60(i)(4).
Sec. 483.40................. Physician Re-designated & Sec. 483.30.
services. revised.
Sec. 483.40(a).............. (a) Physician Re-designated.... Sec. 483.30(a).
supervision.
Sec. 483.40(a)(1)-(2)....... ................. Re-designated.... Sec. 483.30(a)(1)-(2).
Sec. 483.40(b).............. (b) Physician Re-designated.... Sec. 483.30(b).
visits.
Sec. 483.40(b)(1)........... ................. Re-designated.... Sec. 483.30(b)(1).
Sec. 483.40(b)(2)........... ................. Re-designated.... Sec. 483.30(b)(2).
Sec. 483.40(b)(3)........... ................. Re-designated & Sec. 483.30(b)(3).
revised.
Sec. 483.40(c)(1)-(4)....... (c) Frequency of Re-designated.... Sec. 483.30(c)(1)-(4).
physician visits.
Sec. 483.40(d).............. (d) Availability Re-designated.... Sec. 483.30(d).
of physicians
for emergency
care.
Sec. 483.40(e)(1)........... (e) Physician Re-designated.... Sec. 483.30(f)(1).
delegation of
tasks in SNFs.
Sec. 483.40(e)(1)(i)-(iii).. ................. Re-designated.... Sec. 483.30(f)(1)(i)-(iii).
Sec. 483.40(e)(2)........... ................. Re-designated.... Sec. 483.30(f)(4).
Sec. 483.40(f).............. (f) Performance Re-designated.... Sec. 483.30(g).
of physician
tasks in NFs.
Sec. 483.45................. Specialized Re-designated & Sec. 483.65(a).
rehabilitative revised.
services.
(a) Provision of
services.
Sec. 483.45(a)(1)-(2)....... ................. Re-designated & Sec. 483.65(a)(1)-(2).
revised.
Sec. 483.45(b).............. (b) Re-designated.... Sec. 483.65(b).
Qualifications.
Sec. 483.55................. Dental services.. No change........ Sec. 483.55.
Sec. 483.55(a)(1)........... (a) Skilled Re-designated.... Sec. 483.55(a)(1).
nursing
facilities.
Sec. 483.55(a)(2)........... ................. Re-designated.... Sec. 483.55(a)(2).
Sec. 483.55(a)(3)........... ................. Re-designated.... Sec. 483.55(a)(4).
Sec. 483.55(a)(3)(i)........ ................. Re-designated.... Sec. 483.55(a)(4)(i).
Sec. 483.55(a)(3)(ii)....... ................. Re-designated & Sec. 483.55(a)(4)(ii).
revised.
Sec. 483.55(a)(4)........... ................. Re-designated & Sec. 483.55(a)(5).
revised.
Sec. 483.55(b).............. (b) Nursing Re-designated.... Sec. 483.55(b).
facilities.
Sec. 483.55(b)(1)(i)-(ii)... ................. Re-designated& Sec. 483.55(b)(1)(i)-(ii).
revised.
Sec. 483.55(b)(2)........... ................. Re-designated & Sec. 483.55(b).
revised.
Sec. 483.55(b)(2)(i)-(ii)... ................. Re-designated & Sec. 483.55(b)(2)(i)-(ii).
revised.
Sec. 483.55(b)(3)........... ................. Re-designated & Sec. 483.55(b)(3).
revised.
Sec. 483.60................. Pharmacy services Re-designated & Sec. 483.45.
revised.
Sec. 483.60(a).............. (a) Procedures... Re-designated.... Sec. 483.45(a).
Sec. 483.60(b).............. (b) Service Re-designated.... Sec. 483.45(b).
consultation.
Sec. 483.60(b)(1)-(3)....... ................. Re-designated.... Sec. 483.45(b)(1)-(3).
Sec. 483.60(c)(1)........... (c) Drug regimen Re-designated.... Sec. 483.45(c)(1).
review.
Sec. 483.60(c)(2)........... ................. Re-designated & Sec. 483.45(c)(4).
revised.
Sec. 483.60(d).............. (d) Labeling of Re-designated.... Sec. 483.45(g).
drugs and
biologicals.
Sec. 483.60(e)(1)-(2)....... (e) Storage of Re-designated.... Sec. 483.45(h)(1)-(2).
drugs and
biologicals.
Sec. 483.65................. Infection control Re-designated & Sec. 483.80.
revised.
Sec. 483.65(a)(1)-(3)....... (a) Infection Re-designated & Sec. 483.80(a)(1)-(3).
control program. revised.
Sec. 483.65(b)(1)........... (b) Preventing Re-designated & Sec. 483.80(a)(2)(iv).
spread of revised.
infection.
Sec. 483.65(b)(2)........... ................. Re-designated & Sec. 483.80(a)(2)(v).
revised.
Sec. 483.65(b)(3)........... ................. Re-designated & Sec. 483.80(a)(2)(vi).
revised.
Sec. 483.65(c).............. (c) Linens....... Re-designated.... Sec. 483.80(e).
Sec. 483.70................. Physical Re-designated.... Sec. 483.90.
environment.
Sec. 483.70(a)(1)-(8)....... (a) Life safety Re-designated.... Sec. 483.90(a)(1)-(8).
from fire.
Sec. 483.70(b)(1)-(2)....... (b) Emergency Re-designated.... Sec. 483.90(b)(1)-(2).
power.
Sec. 483.70(c)(1)-(2)....... (c) Space and Re-designated & Sec. 483.90(c)(1)-(2).
equipment. revised.
Sec. 483.70(d).............. (d) Resident Re-designated.... Sec. 483.90(d).
rooms.
Sec. 483.70(d)(1)........... ................. Re-designated.... Sec. 483.90(d)(1).
Sec. 483.70(d)(1)(i)........ ................. Re-designated & Sec. 483.90(d)(1)(i).
revised.
Sec. 483.70(d)(1)(ii)-(vii). ................. Re-designated.... Sec. 483.90(d)(1)(ii)-(vii).
Sec. 483.70(d)(2)........... ................. Re-designated.... Sec. 483.90(d)(2).
Sec. 483.70(d)(2)(i)........ ................. Re-designated & Sec. 483.90(d)(2)(i).
revised.
Sec. 483.70(d)(2)(ii)-(iv).. ................. Re-designated.... Sec. 483.90(d)(2)(ii)-(iv).
Sec. 483.70(d)(3)(i)-(ii)... ................. Re-designated.... Sec. 483.90(d)(3)(i)-(ii).
Sec. 483.70(e).............. (e) Toilet Re-designated & Sec. 483.90(e).
facilities. revised.
Sec. 483.70(f)(1)........... (f) Resident call Re-designated & Sec. 483.90(f)(1).
system. revised.
Sec. 483.70(f)(2)........... (f) Resident call Re-designated.... Sec. 483.90(f)(2).
system..
Sec. 483.70(g)(1)).......... (g) Dining and Re-designated.... Sec. 483.90(g)(1).
resident
activities.
Sec. 483.70(g)(2)........... ................. Re-designated & Sec. 483.90(g)(2).
revised.
Sec. 483.70(g)(3)-(4)....... ................. Re-designated.... Sec. 483.90(g)(3)-(4).
[[Page 42230]]
Sec. 483.70(h)(1)-(4)....... (h) Other Re-designated.... Sec. 483.90(h)(1)-(4).
environmental
conditions.
Sec. 483.75................. Administration... Re-designated.... Sec. 483.70.
Sec. 483.75(a).............. (a) Licensure.... Re-designated.... Sec. 483.70(a).
Sec. 483.75(b).............. (b) Compliance Re-designated.... Sec. 483.70(b).
with Federal,
State, and local
laws and
professional
standards.
Sec. 483.75(c).............. (c) Relationship Re-designated & Sec. 483.70(c).
to other HHS revised.
regulations.
Sec. 483.75(d)(1)........... (d) Governing Re-designated.... Sec. 483.70(d)(1).
body.
Sec. 483.75(d)(2)(i)-(ii)... ................. Re-designated & Sec. 483.70(d)(2)(i)-(ii).
revised.
Sec. 483.75(e).............. (e) Required Re-designated & 483.95(g).
training of revised.
nursing aides.
Sec. 483.75(e)(1)........... (1) Definitions. Re-designated & 483.5.
Licensed health revised.
professional.
Sec. 483.75(e)(1)........... Nurse aide....... Re-designated & 483.5.
revised.
Sec. 483.75(e)(2)(i)-(ii)... (2) General rule. Re-designated & Sec. 483.35(d)(1)(i)-(ii).
revised.
Sec. 483.75(e)(3)........... (3) Non-permanent Re-designated & Sec. 483.35(d)(2).
employees. revised.
Sec. 483.75(e)(4)(i)-(iii).. (4) Competency... Re-designated.... Sec. 483.35(d)(3)(i)-(iii).
Sec. 483.75(e)(5)(i)-(ii)... (5) Registry Re-designated.... Sec. 483.35(d)(4)(i)-(ii).
verification.
Sec. 483.75(e)(6)........... (6) Multi-State Re-designated & Sec. 483.35(d)(5).
registry revised.
verification.
Sec. 483.75(e)(7)........... (7) Required Re-designated.... Sec. 483.35(d)(6).
retraining.
Sec. 483.75(e)(8)(i)-(iii).. (8) Regular in- Re-designated & Sec. 483.35(d)(7), Sec. 483.95(g).
service revised.
education.
Sec. 483.75(f).............. (f) Proficiency Re-designated.... Sec. 483.35(c).
of Nurse aides.
Sec. 483.75(g)(1)........... (g) Staff Re-designated.... Sec. 483.70(f)(1).
qualifications.
Sec. 483.75(g)(2)........... ................. Re-designated.... Sec. 483.70(f)(2).
Sec. 483.75(h)(1)........... (h) Use of Re-designated.... Sec. 483.70(g)(1).
outside
resources.
Sec. 483.75(h)(2)(i)-(ii)... ................. Re-designated.... Sec. 483.70(g)(2)(i)-(ii).
Sec. 483.75(i)(1)........... (i) Medical Re-designated.... Sec. 483.70(h)(1).
director.
Sec. 483.75(i)(2)(i-ii)..... ................. Re-designated.... Sec. 483.70(h)(2)(i)-(ii).
Sec. 483.75(j)(1)(i)-(iv)... (j) Laboratory Re-designated.... Sec. 483.50(a)(1)(i)-(iv).
services.
Sec. 483.75(j)(2)........... ................. Re-designated.... Sec. 483.50(a)(2).
Sec. 483.75(j)(2)(i)-(iv)... ................. Re-designated & Sec. 483.50(a)(2)(i)-(iv).
Revised.
Sec. 483.75(k).............. (k) Radiology and Re-designated.... Sec. 483.50(b).
other diagnostic
services.
Sec. 483.75(k)(1)........... ................. Re-designated.... Sec. 483.50(b)(1).
Sec. 483.75(k)(2)........... ................. Re-designated & Sec. 483.50(b)(2).
revised.
Sec. 483.75(l)(1)........... (l) Clinical Re-designated & Sec. 483.70(i)(1).
records. revised.
Sec. 483.75(l)(1)(i)-(iv)... ................. Re-designated & Sec. 483.70(i)(1)(i)-(iv).
revised.
Sec. 483.75(l)(2)........... ................. Re-designated & Sec. 483.70(i)(4).
revised.
Sec. 483.75(l)(2)(i)........ ................. Re-designated.... Sec. 483.70(i)(4)(i).
Sec. 483.75(l)(2)(ii)....... ................. Re-designated.... Sec. 483.70(i)(4)(ii).
Sec. 483.75(l)(2)(iii)...... ................. Re-designated.... Sec. 483.70(i)(4)(iii).
Sec. 483.75(l)(3)........... ................. Re-designated & Sec. 483.70(i)(3).
revised.
Sec. 483.75(l)(4)(i)-(iv)... ................. Re-designated & Sec. 483.70(i)(2).
revised.
Sec. 483.75(l)(5)(i)-(v).... ................. Re-designated & Sec. 483.70(i)(5)(i)-(v).
revised.
Sec. 483.75(m)(1)........... (m) Disaster and See Proposed See 78 FR 79081.
emergency Rule: Emergency
preparedness. Preparedness
Requirements for
Medicare and
Medicaid
Participating
Providers and
Suppliers (78 FR
79081, December
27, 2013).
Sec. 483.75(m)(2)........... ................. See Proposed See 78 FR 79081.
Rule: Emergency
Preparedness
Requirements for
Medicare and
Medicaid
Participating
Providers and
Suppliers (78 FR
79081, December
27, 2013).
Sec. 483.75(n)(1)(i)-(ii)... (n) Transfer Re-designated & Sec. 483.70(j)(1)(i)-(ii).
agreement. revised.
Sec. 483.75(n)(2)........... ................. Re-designated.... Sec. 483.70(j)(2).
Sec. 483.75(o)(1)(i)-(iii).. (o) Quality Re-designated & Sec. 483.75(g)(1)(i)-(iv).
assessment and revised.
assurance.
Sec. 483.75(o)(2)(i)-(ii)... ................. Re-designated & Sec. 483.75(g)(2)(i)-(iii).
revised.
Sec. 483.75(o)(3)........... ................. Re-designated & Sec. 483.75(h)(1).
revised.
Sec. 483.75(o)(4)........... ................. Re-designated.... Sec. 483.75(i).
Sec. 483.75(p)(1)........... (p) Disclosure of Re-designated.... Sec. 483.70(k)(1).
ownership.
Sec. 483.75(p)(2)(i)-(iv)... ................. Re-designated.... Sec. 483.70(k)(2)(i)-(iv).
Sec. 483.75(p)(3)........... ................. Re-designated.... Sec. 483.70(k)(3).
Sec. 483.75(q).............. (q) Required Re-designated & Sec. 483.95(h).
training of revised.
feeding
assistants.
Sec. 483.75(r)(1)-(3)....... (r) Facility Re-designated.... Sec. 483.70(l)(1)-(3).
closure-
Administrator.
Sec. 483.75(s).............. (s) Facility Re-designated & Sec. 483.70(m).
closure. revised.
[[Page 42231]]
Sec. 483.75(t).............. (t)Hospice Re-designated.... Sec. 483.70(o)
services.
----------------------------------------------------------------------------------------------------------------
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information (COI) requirement is
submitted to the Office of Management and Budget (OMB) for review and
approval. In order to fairly evaluate whether an information collection
should be approved by OMB, section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires that we solicit comment on the following
issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
We are soliciting public comment on each of these issues for the
following sections of this document that contain information collection
requirements (ICRs).
Omnibus Budget Reconciliation Act of 1987 Waiver
Ordinarily, we would be required to estimate the public reporting
burden for information collection requirements for these regulations in
accordance with chapter 35 of title 44, United States Code. However,
sections 4204(b) and 4214(d) of Omnibus Budget Reconciliation Act of
1987, Public Law 100-203 (OBRA '87) provide for a waiver of Paperwork
Reduction Act (PRA) requirements for these regulations. We believe that
this waiver still applies to those revisions and updates we made to
existing requirements in part 483 subpart B. However, we provide burden
estimates for the new information collection requirements proposed in
this rule, specifically those requirements implemented as a result of
the Affordable Care Act.
Sources of Data Used in Estimates of Burden Hours and Cost Estimates
We obtained the data used in this discussion on the number of the
various Medicare and Medicaid nursing facilities from Medicare's
Certification and Survey Provider Enhanced Reporting (CASPER) as of
April 1, 2015. We have not included data for nursing facilities that
are not Medicare and/or Medicaid certified. According to our CASPER
database, there are 15,691 SNFs and NFs participating in the Medicare
and Medicaid programs. Since the individual States periodically update
the CASPER system, the number of SNFs and NFs may vary depending upon
the date of the report. Thus, while this number is accurate as of the
date of the report, the actual number of facilities may be different as
of the date of this proposed rule's publication.
Unless otherwise indicated, we obtained all salary information for
the different positions identified in the following assessments from
the US Bureau of Labor Statistics at https://www.bls.gov/oes. We used
the data from this Web site because it identifies many different
healthcare industry occupations and specialties and updates that data
monthly. We calculated the estimated hourly rates based upon the
national median salary for that particular position, including fringe
benefits and overhead worth 48 percent of the base salary. Where we
were able to identify positions linked to specific positions, we used
that compensation information. However, in some instances, we used a
general position description or we used information for comparable
positions. For example, we were not able to locate specific information
for nursing home administrators and directors of nursing, so we used
the average hourly wage for a medical and health services manager for
these positions. We welcome any comments on the accuracy of our
compensation estimates.
In estimating the burden associated with this proposed rule, we
also took into consideration the many free or low cost resources
nursing facilities have available to them. Following is a non-
exhaustive list of some of the available resources:
https://www.nhqualitycampaign.org
https://www.ascp.com
https://www.amda.com
https://www.ahcancal.org
https://www.leadingage.org
https://www.americangeriatrics.org
https://www.ntocc.org
We will discuss the burden for each provision included in this
proposed rule in the order in which they appear in the CFR.
A. ICRs Regarding Quality Assurance and Performance Improvement (Sec.
483.75)
Each facility is currently required to maintain a QAA committee
consisting of the director of nursing services, a physician designated
by the facility and at least three other members of the facility's
staff. The committee must meet at least quarterly to identify issues
with respect to which quality assessment and assurance activities are
necessary. The committee is required to develop and implement
appropriate plans of action to correct identified quality deficiencies.
Based on our experience with facilities' compliance with QAA
requirements, we anticipate that they already have some of the
resources needed to develop and implement a proactive QAPI program. In
addition, some ICRs will be met through the technical assistance
provided to facilities by CMS on the development of best practices, as
required by the Affordable Care Act.
We propose at Sec. 483.75 that a facility have a QAPI program. The
burden associated with these proposed requirements would be the time
and effort necessary to develop, implement, and maintain a
comprehensive, data-driven QAPI program designed to monitor and
evaluate the ongoing performance of the facility. The facility would
have to establish a program to address the key components of the
proposed standards (program measures, program scope, and program
activities). The existing regulations require that QAA committees
identify and correct specific deficiencies. We believe facilities would
use some of the resources they have to comply with the QAA requirements
(such as collecting data), in the development of a QAPI-based,
proactive approach to assessing services they provide (including those
services furnished under contract or arrangement) and to improve the
quality of care and quality of life provided to their residents.
Since the existing Interpretative Guidelines for facilities to
comply with the Medicare regulations provide information on how to
conduct quality improvement programs, we anticipate that some
facilities are already utilizing the QAPI model. We also anticipate
that facilities would use their existing
[[Page 42232]]
resources to meet the requirements in this proposed rule. To the extent
that facilities are utilizing a QAPI quality model and are proactively
collecting data, evaluating their performance, and making and
monitoring program improvements, they would be better prepared to
comply with the QAPI requirements. However, for the purpose of this
burden analysis, we assume that all facilities would need to develop a
QAPI program.
Based on our experience with other Medicare providers that have
developed QAPI programs, we estimate that, on average, it would take 56
hours for the facility to develop and document a comprehensive, data-
driven QAPI program designed to monitor and evaluate performance of all
services and programs of the facility, including services provided
under contract or arrangement.
We estimate that the facility administrator/coordinator would be
largely responsible for developing the overall QAPI program and would
spend approximately 30 hours on this activity; the director of nursing
and a registered nurse would each spend approximately 10 hours each to
review and provide input on clinical services activities; a physician
would spend approximately 4 hours to review the program plan and
provide medical direction and input; and one office assistant would
spend approximately 2 hours to prepare and distribute draft and final
program plans. We estimate that this would require a total of 878,696
burden hours for all 15,691 facilities (56 hours x 15,691 facilities)
to develop a QAPI program.
We estimate that the cost for the administrator/coordinator would
be $2,400 ($80 x 30 hours). We estimate the cost for the director of
nursing would be $800 ($80 x 10 hours). We estimate that the cost for
an RN would be $580 ($58 per hour x 10 hours). We estimate that the
cost for the physician would be $688 ($172 x 4 hours). We estimate that
the cost for an office assistant would be $58 ($29 x 2 hours). The
estimated one-time cost for each facility would total $4,526. The total
one-time cost for all 15,691 facilities would be $71,017,466.
We anticipate that the ongoing, annual burden for each facility to
collect and analyze data for QAPI activities would be 20 hours. We
anticipate that to document the improvement activities would require 20
hours. We estimate the total annual burden hours for all facilities
would be 627,640 (40 hours x 15,691 facilities). We anticipate that the
staff time would be distributed as follows:
Administrator/Coordinator to collect and analyze data: 10 hours x
$80 an hour = $800; to implement and document improvement projects: 4
hours x $80 = $320. (Total cost of $1,120)
Director of Nursing: 4 hours to collect and analyze data x $80 an
hour = $320; to implement and document improvement projects: 10 hours x
$80 an hour = $800. (Total cost of $1,120)
RN: 4 hours to collect and analyze data and 6 hours to implement
and document improvement projects; 10 hours x $58 an hour = $580.
Physician: 1 hour to analyze data x $172 an hour = $172
Office Assistant: 1 hour collect and analyze data x $29 an hour =
$29
We estimate that the annual cost for each facility would be $3,021.
The total annual cost for all facilities would be $47,402,511 ($3,021 x
15,691).
B. ICRs Regarding Compliance and Ethics Program (Sec. 483.85)
Proposed Sec. 483.85 would require the operating organization for
each SNF and NF to have in operation a compliance and ethics program
that would be effective in preventing and detecting criminal, civil,
and administrative violations under the Act and promoting quality of
care no later than 1 year after the effective date of the final rule.
Each compliance and ethics program must contain at least the eight
required elements in proposed Sec. 483.85(c). The operating
organization for each facility must also review its compliance and
ethics program annually, and revise its program, as needed.
Furthermore, proposed Sec. 483.85(d) has additional requirements for
operating organizations that operate five or more facilities.
For the purpose of determining a burden for this proposed rule, we
have estimated a burden based on the number of SNF and NF operating
organizations. Once this rule is finalized and becomes effective, it
would be enforced through the survey process. We expect that the
operating organization would develop the compliance and ethics program
in collaboration with staff at their facilities and then share the
implementation of the program with its operating facilities. Since it
would be the individual facilities that would be surveyed and not the
operating organization, operating organizations would need to ensure
that the appropriate documentation is available at all of their
individual facilities in order to demonstrate compliance with all of
the relevant requirements in this proposed rule. Therefore, the burden
we have assessed for the operating organization would encompass their
working with staff at their individual facilities.
The current regulations for SNFs and NFs do not contain any
requirements for a compliance and ethics program. However, SNFs and
NFs, as well as all other health care facilities, must comply with all
applicable statutes, regulations, and other mandatory guidance or face
criminal, civil, or administrative sanctions. In addition, as discussed
previously, the OIG had issued voluntary guidance about compliance and
ethics programs for SNFs and NFs in 2000 and 2008. We also believe that
it is standard practice for SNFs and NFs to have high-level personnel,
such as the administrator, director of nursing, or the facilities
director be responsible for ensuring that the facility is in compliance
with all of the applicable federal, state, and local laws. We believe
that many, if not all, of the operating organizations for SNFs and NFs
already have some type of compliance program in operation. Furthermore,
since many of the proposed required components for the compliance and
ethics programs are very similar to many of the listed elements for the
programs in the OIG's voluntary guidance documents published in 2000
and 2008, we believe the compliance and ethics programs that are
already being used by many nursing homes include many, if not all, of
the components proposed in this rule. However, since adherence to the
OIG's guidance was voluntary and did not impose mandatory obligations,
we also believe that some of these existing programs may not have all,
or perhaps any, of the required components or may not be documented or
included in the facility's standards, policies, or procedures.
Therefore, we believe that all of the operating organizations for the
SNFs and NFs would need to review their current programs and possibly
revise or, in some cases, develop new sections for their programs in
order to comply with the requirements in this proposed rule.
According to the Medicare Provider Enrollment, Chain, and Ownership
System (PECOS) as of March 2015, there are 9,023 SNFs and NFs that are
part of a multi-facility operating organization (an operating
organization with 2 or more facilities). Furthermore based on PECOS
data, for purposes of this regulation, we estimate that there are 7,445
total operating organizations (387 operating organizations with 5 or
more facilities, 437 operating organizations with 2 to 4 facilities,
and 6,621 operating organizations with single facilities). Based on our
experience with SNFs and NFs, we expect that the administrator and the
director of nursing would primarily be involved in
[[Page 42233]]
developing the operating organization's compliance and ethics program.
Thus, in determining the burden for all of the requirements in proposed
Sec. 483.85, except for Sec. 483.85(d), we will analyze the burden
based on an administrator and the director of nursing performing the
necessary tasks and activities. If the operating organization has a
designated compliance officer, we expect that he or she would take the
lead in developing the entire program with the assistance of the
administrator and the director of nursing as needed or when required.
Since we have estimated that the compliance officer and the director of
nursing would receive about the same amount of compensation, $80 an
hour, and that the necessary activities would require about the same
numbers of hours, we believe our estimates would be about the same
regardless of whether these tasks and activities were performed by the
administrator and the director of nursing or by the compliance officer
with the assistance of the administrator and the director of nursing.
As described previously, nursing homes must already ``be in
compliance with all applicable Federal, State, and local laws,
regulations, and codes, and with accepted professional standards and
principles that apply to professionals providing services in such a
facility'' (proposed Sec. 483.85(b)). Thus, we expect that nursing
homes are already performing many of the tasks and activities necessary
to a compliance program and spending hours of their time on compliance
issues, especially the nursing homes in multi-facility operating
organizations. However, we are not certain that most nursing homes have
formal programs that comply with the requirements in this proposed
rule. Thus, we believe that nursing homes would sustain a burden
associated with the requirement to develop a program that complied with
this proposed rule from the resources needed for each facility to
review, revise, and, if needed, develop new sections for the operating
organization's compliance and ethics program.
We estimate that complying with this requirement would require 10
burden hours from the administrator and 10 burden hours from the
director of nursing for a total of 20 burden hours from these
individuals at an estimated cost of $1,600 (20 hours x $80 hourly
wage). In addition, since we are proposing that compliance and ethics
programs should now be mandatory, we expect that facilities would have
an attorney review their programs to ensure they are in compliance with
the requirements in this rule. The cost of having an attorney review
the operating organization's program will vary depending on whether the
operating organization has in-house counsel or has to hire an attorney
at a law firm. For the purposes of determining the burden, we will
assume that each operating organization has in-house counsel. We expect
that an attorney would need to review the facility's compliance and
ethics program, make recommendations, and approve the final program. We
estimate this would require 4 burden hours at an estimated cost of $492
($123 hourly wage x 4 hours).
Based on this data, we estimate it would require a total of 24
burden hours (10 hours for an administrator + 10 hours for the director
of nursing + 4 hours for an attorney) for each operating organization
to develop a compliance and ethics program that complied with the
requirements in this proposed rule at a cost of $2,092 ($1,600 for the
administrator and director of nursing + $492 for an attorney).
Therefore, we estimate it would require 178,680 annual burden hours (24
burden hours for each operating organization x 7,445 operating
organizations) at a cost of $15,574,940 ($2,092 for each operating
organization x 7,445 operating organizations) for all facilities to
comply with this requirement.
Each operating organization would also need to develop the policies
and procedures necessary to implement the operating organization's
compliance and ethics program. The burden associated with this
requirement would be the resources needed to review and revise any
existing policies and procedures and, if needed, develop new policies
and procedures. Based on our experience with SNFs and NFs, we expect
that the administrator, director of nursing, or perhaps both of these
individuals would develop these policies and procedures. We estimate
that it would require 10 burden hours for each operating organization
to comply with this requirement at a cost of $800 ($80 hourly wage for
a health services manager x 10 hours). Therefore, we estimate that for
all 7,445 operating organizations to comply with this requirement, it
would require 74,450 burden hours (10 burden hours for each operating
organization x 7,445 operating organizations) at a cost of $5,956,000
($800 per operating organization x 7,445 operating organizations).
In addition to developing the compliance and ethics program, each
operating organization would be required to develop training materials
and/or other publications to disseminate information about the program
to its entire staff, individuals providing services under a contractual
arrangement, and volunteers, consistent with their expected roles. As
stated previously, we believe that nursing homes are already performing
many of the tasks necessary for a compliance program and spending many
hours on compliance issues. Thus, we expect that many operating
organizations already have some of the materials and/or other
publications that would be needed to comply with this requirement. The
burden associated with this requirement would be the resources needed
to review and revise any existing materials and, if needed, develop new
materials to comply with this requirement. Based on our experience with
operating organizations, we expect that the compliance liaison (nursing
staffs) would be involved in these activities.
We believe that the compliance liaison would need 8 hours to
develop these materials. Thus, we estimate it would require 8 burden
hours for each operating organization to comply with this requirement
at a cost of $464 ($58 hourly wage x 8 hours). Therefore, based on the
previous estimate, for all 7,445 operating organizations to comply with
this requirement it would require 59,560 burden hours (8 hours x 7,445
operating organizations) at a cost of $3,454,480 ($464 per operating
organization x 7,445 operating organizations).
We also propose in Sec. 483.85(e) that the operating organization
for each facility must review its compliance and ethics program
annually, and revise its program, as needed. Thus, after nursing homes
develop their compliance and ethics programs, these facilities would
need to review and revise their programs, as needed, in the subsequent
years. Based on our experience with other healthcare facilities, we
expect that most facilities are already periodically reviewing their
programs, policies, and procedures. However, since an effective
compliance and ethics program requires that a facility stay up-to-date
with all SNF and NF requirements to reduce the prospect of criminal,
civil, and administrative violations and promote quality of care, we
believe that the facility would require more time to review this
program as compared to its other programs, policies, and procedures
that it must periodically review. In addition, since it is common for
there to be changes in laws, regulations, and other requirements, we
expect that most SNFs and NFs would need to make at least some
revisions annually. Even if there are no changes in the applicable
laws, regulations, or other requirements, SNFs and NFs may need to make
changes in
[[Page 42234]]
their training materials or other publications.
We expect that the administrator or the director of nursing, or
perhaps both, would be responsible for reviewing this program annually
to ensure it was up-to-date and in compliance with all of the relevant
federal and state laws, regulations, and other guidance. We expect that
to comply with this requirement would require 5 hours from the
administrator and 5 hours from the director of nursing for 10 burden
hours at a cost of $800 ($80 hourly wage for administrator and director
of nursing x 10 hours). Therefore, based on the previous estimate, for
all 7,445 facilities to comply with this requirement would require
74,450 burden hours (10 hours x 7,445 operating organizations) at a
cost of $5,956,000 ($800 per facility x 7,445 operating organizations).
Based upon the previous estimates, for the first year that this
requirement is in effect, it would require 42 burden hours (24 hours
for developing the program + 10 hours for developing policies and
procedures + 8 hours for developing training materials, publication or
both) at a cost of $3,356 ($2,092 for developing the program + $800 for
developing policies and procedures + $464 for developing training
materials, publication or both) for each operating organization to
comply with this requirement. Based on the estimates shown previously
in this section, for all 7,445 operating organizations to comply with
these requirements it would require 312,690 burden hours (42 hours per
operating organization x 7,445 operating organizations) at an estimated
cost of $24,985,420 ($3,356 per operating organization x 7,445
operating organizations). For all subsequent years, we estimate to
comply with the information collection would annually require 10 burden
hours at a cost of $800. For all 7,445 operating organizations, it
would require 74,450 (10 hours x 7,445 facilities) burden hours at an
estimated cost of $5,956,000 ($800 per operating organization x 7,445
operating organizations).
C. ICRs Regarding Training Requirements (Sec. 483.95)
Each facility is already required to complete a performance review
of every NA at least once every 12 months, and must provide in-service
education based on the outcome of these reviews. The proposed
requirement at Sec. 483.95(f)(1) would require a facility to include
dementia management and abuse prevention in their regular in-service
education for all NAs.
Section Sec. 483.75(e)(8)(iii) of the current regulations already
requires that NAs who provide services to individuals with cognitive
impairments receive in-service training to address the care of the
cognitively impaired. Based on the existing requirements, facilities
already conduct training for some NAs on caring for residents who are
cognitively impaired. Additionally, the current requirement at Sec.
483.75(e)(8)(ii) states that NAs must receive in-service training that
addresses areas of weakness as determined in their performance reviews
and may address the special needs of residents, as determined by the
facility staff. Thus NAs receive annual training in dementia management
and abuse prevention only if the training is indicated by their
performance reviews.
Because this proposed rule would specifically require facilities to
provide dementia management and abuse prevention training to all NAs,
each facility would need to review their training procedures and
materials to ensure that they are complying with the new requirements.
For example, facilities may currently provide the in-service training
(as identified from the performance review) utilizing an individual,
targeted approach. In this proposed rule, all NAs would be required to
receive this training annually, and the facility would need to evaluate
whether another format might be more appropriate.
Since we are not proposing to increase the time needed to provide
this training, we are not adding additional burden for the staff to
train the NAs, since the existing requirements for facilities require
them to provide in-service training to all NAs at least once every 12
months. We estimate that the burden associated with complying with this
requirement would be a one-time burden due to the resources required to
review and, if necessary, modify the existing training materials to
apply to all NAs, regardless of identified performance weaknesses. We
expect that these activities would require the involvement of a RN or a
LPN. Based on our experience with facilities, we anticipate that it
would take each facility 4 hours to review and modify their existing
training materials. Based on an hourly rate of $58 for an RN that
includes fringe benefits, we estimate that this would require 62,764
burden hours (4 hours x 15,691 facilities) at a cost of $3,640,312
($232 per facility x 15,691 facilities).
Table 1 below summarizes the estimated annual reporting and
recordkeeping burdens for this proposed rule.
Table 1--Estimated Annual Reporting and Recordkeeping Burdens
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Total labor Total
OMB Control Number of Number of Burden per Total annual Hourly labor cost of capital/ Total cost
Regulation section(s) No. respondents responses response burden cost of reporting maintenance ($)
(hours) (hours) reporting ($) ($) costs ($)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 483.75(a)................................................ 0938--New 15,691 15,691 56 878,696 ** 71,017,466 0 71,017,466
Sec. 483.75(b)(2)............................................. 0938--New 15,691 15,691 40 627,640 ** 47,402,511 0 47,402,511
Sec. 483.85(b)................................................ 0938--New 7,445 7,445 24 178,680 ** 15,574,940 0 15,574,940
Sec. 483.85(c)................................................ 0938--New 7,445 7,445 10 74,450 ** 5,956,000 0 5,956,000
Sec. 483.85(d)(1)............................................. 0938--New 7,445 7,445 8 59,560 ** 3,454,480 0 3,454,480
Sec. 483.85(e)................................................ 0938--New 7,445 7,445 10 74,450 ** 5,956,000 0 5,956,000
Sec. 483.95................................................... 0938--New 15,691 15,691 4 62,764 ** 3,640,312 0 3,640,312
-----------------------------------------------------------------------------------------------------------------
Totals...................................................... ............ 23,136 76,853 ............ 1,956,240 .............. ............ ............ 106,001,709
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
** The hourly labor wages are discussed in detail earlier in this section.
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 1.
If you comment on these information collection and recordkeeping
requirements, please submit your comments electronically as specified
in the ADDRESSES section of this proposed rule.
Comments must be received on or by September 14, 2015.
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not
[[Page 42235]]
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and, when we proceed with a subsequent
document, we will respond to the comments in the preamble to that
document.
VI. Regulatory Impact Analysis (RIA)
A. Introduction
We have examined the impacts of this rule as required by Executive
Order 12866 on Regulatory Planning and Review (September 30, 1993),
Executive Order 13563 on Improving Regulation and Regulatory Review
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19,
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act,
section 202 of the Unfunded Mandates Reform Act of 1995 (March 22,
1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4,
1999) and the Congressional Review Act (5 U.S.C. 804(2).
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Section
3(f) of Executive Order 12866 defines a ``significant regulatory
action'' as an action that is likely to result in a rule: (1) Having an
annual effect on the economy of $100 million or more in any 1 year, or
adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules
with economically significant effects ($100 million or more in any 1
year). We estimate that this rulemaking is ``economically significant''
as measured by the $100 million threshold, and hence also a major rule
under the Congressional Review Act. We estimate the total projected
cost of this rule would be $729,495,614 million in the first year. This
results in an estimated first-year cost of approximately $ 46,491 per
facility and a subsequent-year cost of $40,685 per facility on 15,691
LTC facilities. Accordingly, we have prepared a Regulatory Impact
Analysis that to the best of our ability presents the costs and
benefits of the rulemaking.
B. Statement of Need
CMS had not comprehensively reviewed the entire set of requirements
for participation it imposes on LTC facilities in many years. CMS staff
as well as stakeholders identified problematic requirements over the
years. Accordingly, we decided to conduct a review of the requirements
in an effort to improve the quality of life, care, and services in
facilities, optimize resident safety, reflect current professional
standards, and improve the logical flow of the regulations. Based on
our analysis, we decided to pursue those regulatory revisions that
would reflect the advances that have been made in healthcare delivery
and that would improve resident safety.
C. Anticipated Impacts on SNFs and NFs
There are about 15,691 SNFs and NFs that are certified by Medicare
and Medicaid. We use these figures to estimate the potential impacts of
the proposed rule. In addition, we have used the same data source for
the RIA that we used to develop the PRA burden estimates. As stated in
the COI section, we obtained all salary information from the May 2014
National Occupational Employment and Wage Estimates, United States by
the BLS at https://www.bls.gov/oes/current/oes_nat.htm and all salary
estimates include benefits and overhead package worth 48 percent of the
base salary. The analysis below overlaps with the COI section for some
requirements and much of the economic impact of the rule would be due
to the cost for facilities to comply with the information collection
requirements. The COI section contains more technical and legal detail,
therefore readers may wish to consult both sections on some topics.
This proposed rule would require facilities to review their current
practices and make changes to be in compliance with the health and
safety standards as set forth in this proposed rule. Many of the
proposals in this rule are current and standard medical or business
practices and as a result do not pose an additional burden or new cost
to facilities. We have made several assumptions and estimates in order
to assess the time that it would take for a facility to comply with the
proposed provisions and the associated costs of compliance.
Resident Rights Sec. 483.10
Notification of Changes to Care Plan (Sec. 483.10(b)(5)(F))
As noted above, current requirements already require that a
resident, to the extent practicable, participate in the development of
his or her care plan and be informed of the need to significantly alter
treatment. We believe that the involvement and notification would
include an opportunity to see the care plan. Periodic review after
development of the care plan is also already required. However, we
propose a new right for the resident, the right to sign the care plan.
The intent is to ensure that the resident, to the extent practicable
and consistent with the resident's choices, demonstrates his or her
participation in and review of his or her care planning and that
participation is evident to care-givers, surveyors, and other
interested parties. We estimate that it should take a caregiver,
probably a nurse, no more than an additional 2 minutes per resident, to
obtain a resident signature. We estimate that this may occur up to four
times per year per resident. Based on an estimated 1,382,201 residents
per year, the resulting burden would be $9,620,119 for all nursing
homes. ($58 hourly wage for a nurse x .03 hour per occurrence x
1,382,201 residents x 4 occurrences per year = $9,620,119).
Notification of a Need To Select a New Physician (Sec. 483.10(c)(3)
and Sec. 483.11(c)(2))
The facility would have to inform the resident if the facility
determines that the physician chosen by the resident is unable or
unwilling to comply with regulatory requirements, discuss alternatives,
and honor the resident's preferences. Under current requirements, the
facility must already ensure that the resident is informed of the name,
specialty, and way of contacting the physician responsible for his or
her care. We have no basis upon which we can quantify how often this
occurs or how often a facility would need to obtain an alternate
provider. We believe that these conversations will be accomplished, and
in most cases already occur, in the course of routine communication
between a resident and caregivers. Thus, we do not believe this creates
any new burden.
If a resident requests an item or service for which the facility
will charge, the facility must inform the resident both orally and in
writing of
[[Page 42236]]
the charge. This requirement is modified to specify orally and in
writing; the previous requirement was just `to inform.' We expect that
``informing' has typically been accomplished orally; therefore the
burden would be in providing the written information at the time the
oral information is given. We anticipate that this written information
would most often be in the form of a list of standard charges for
frequently requested items and the cost would be the cost of
photocopying or printing the list. In infrequent cases, an
individualized cost page may be needed. We estimate that a facility
would spend no more than $50 per year on average to print the notices.
We estimate the cost of a notice to be $0.10/page (based on the per
page photocopying cost established at 45 CFR 5.43(c) for FOIA requests)
with no more than 500 notices required per facility per year for a
total estimated cost of $784,550 ($50 printing cost x 15,691
facilities) annually for all facilities.
Internet Access (Sec. 483.10(h)(2))
Proposed 483.10(h)(2) proposes to require that a resident has the
right to reasonable access and privacy for electronic communications
such as email and video communications and internet research. This
requirement is proposed in a way that the facility is not required to
provide internet access to any greater extent than the facility already
has internet access (that is, a facility that has no internet access
due to logistical deterrents is not required to overcome those
obstacles based on this requirement) and the facility is allowed to
transfer any additional expense to the resident if any additional
expense is incurred. The facility is not obligated to provide each
resident an individual means of access (that is, a personal computer or
tablet). A community computer with associated rules for sharing, such
as is commonly done in public libraries, may be an appropriate model.
While we allow the facility to pass additional costs to the resident,
we anticipate that some facilities may incur an initial hardware cost
that is not attributable to an individual resident. In addition, we
expect there will be minimal ongoing maintenance/replacement costs for
the shared devices. Finally, we do not believe this will add to the
supervision burden for facility staff, as appropriate resident
supervision is already required, but it may require a Director of
Nursing (DON) or Nursing Home Administrator (NHA) to establish rules
for use. We estimate this would require quarter of an hour of DON or
NHA time to develop in those facilities that do not already have a
policy established. We believe that up to ten percent of facilities
will need to develop an internet policy in the first year, at a total
cost of $31,382 (($80 hourly wage for a DON or NHA x .25 hours) x (0.10
x 15,691 facilities) = $31,382).
Facility Obligations (Sec. 483.11)
Mutually Agreeable Facility Representative (Sec. 483.11(d)(3)(iii))
Facilities are currently required to provide a facility
representative to participate in resident and family groups. Any added
burden is in establishing an individual who is mutually agreed to. We
believe it is most likely that the DON will select a representative and
obtain group agreement by providing a name or names to the group and
the group will respond. We estimate that this should generally consume
no more than an additional 15 minutes of the DONs time in most cases.
We believe some, and perhaps many, facilities already have such
mutually agreed upon representatives; however, for estimation purposes,
we estimate an additional 15 minutes of DON time at a cost of $80 per
hour for 15,691 facilities, resulting in a total cost of $313,820.
Visitation Related Notices (Sec. 483.11(d)(2))
We believe that--(1) these notices are periodically reviewed and
updated as a standard business practice, (2) the DON and Nursing Home
Administrator will develop the associated policy, and (3) visitation is
already addressed in the notice of rights and services. While we
believe that the notice of rights and services is or should be
periodically reviewed by each nursing facility as a standard practice,
we expect that the notice will need to be updated on a one-time basis
specifically to include the new visitation policy. We estimate that an
office clerk will require no more than 30 minutes to update the notice
and that will cost each facility approximately $14.50 ($29 hourly wage
for an office clerk x .5 hour = $14.50) or a total of $227,520 for all
facilities ($10.50 x 15,691 = $227,520).
Posting of Contact Information (Sec. 483.11(e)(5))
The facility must post a list of names and contact information.
This information must already be gathered for the notice of legal
rights, so the new burden is limited to the posting. This means
printing out and placing the notice in an appropriate location and/or
on an accessible Web site and perhaps updating the information
annually. Based on other current requirements, the location for this
information should already be identified and an office clerk should be
able to update, print and post a listing in 10 minutes. We estimate
this will cost each facility approximately $4.93 or a total of $77,357
for all facilities. ($29 hourly wage for an office clerk x .17 of an
hour x 15,691 facilities = $77,357).
Medicaid Eligibility (Sec. 483.11(e)(11)(i))
The facility must provide notice to each Medicaid-eligible
resident, in writing, at the time of admission and when the resident
becomes eligible for Medicaid. This means some residents will require a
second notice. As the notice is already required once, the burden is in
providing the notice an additional time. We anticipate that this will
affect only a subset of residents (those eligible but not yet receiving
Medicaid) and that the notice will be unchanged from the admission
notice. Thus the burden is in identifying eligible residents and
delivering the second notice. We anticipate that this will require a
social worker no more than 3 minutes per eligible resident. Based on a
data analysis by AHCA, approximately 64 percent of nursing home
residents are already Medicaid recipients (that is, Medicaid is the
payor of record); 14 percent are covered by Medicare and 22 percent
have another payor. Of those, only the 36 percent who are not receiving
Medicaid may require the second notice of Medicaid eligibility. We
assume that a portion of those will require ongoing care and become
eligible for Medicaid. We also assume that some of those residents will
apply for Medicaid at or shortly after admission or as a result of the
first notice and not require the second notice. For burden calculation
purposes, we estimate that 20 percent of nursing home residents
(slightly more than half of those not already receiving Medicaid) will
require a second notice of Medicaid eligibility. The per facility cost
will vary significantly according to facility size and resident mix and
will be about $2.20 per resident who requires notification, or $608,168
for all such residents across all 15,691 facilities. (($44 hourly wage
for social worker x .05 of an hour) x (.20 estimate percent of all
nursing home residents who will require a second notice x 1,382,201
nursing home residents) = $608,168).
Update the Description of Legal Rights (Sec. 483.11(e)(13))
Our proposed changes will require that facilities review and
possibly update their description of legal rights to include additional
names and contact information as well as some additional
[[Page 42237]]
language to meet the requirements of the revised regulatory language.
Collecting and verifying some of this information may require some
additional research. We anticipate that a social worker would need 45
minutes to review information and conduct the necessary research and an
office clerk would need an additional 15 minutes to update the notice.
The cost per facility is estimated at $30 per facility or a total of
$631,563 for all facilities. (($44 hourly wage for a social worker x
.75 of an hour) + ($29 hourly wage for an office clerk x .25 of an
hour) x 15,691 facilities = $631,563).
Grievances (Sec. 483.11(h)(1))
A facility must make information regarding the grievance process
and how to file a grievance available to residents. We believe this
information is already included in the notice of legal rights, but it
may need reviewed and updated. It would take an office clerk
approximately 10 minutes to review and update the notice. This would
cost each facility $4.93 or a total of $77,357 for all facilities. ($29
hourly wage for an office clerk x .17 of an hour x 15,691 facilities =
$77,357).
Transitions of Care (Sec. 483.15)
Notice of Transfer (Sec. 483.15(b)(4))
The notice is already created for the resident; this requirement
poses an additional burden of printing a copy of the notice and sending
it to the Office of the State Long-Term Care Ombudsman or, if a secure
means of electronic transmission is available, sending a notice
electronically. We estimate the burden of this requirement to be $.10
per notice to make a copy, and $.58 for a single pre-stamped first
class envelope (USPS retail) plus 5 minutes for an office clerk to
address and mail the notice. This will apply primarily to residents who
are involuntarily discharged from the facility and does not include
residents who request the transfer or who are transferred on an
emergency basis to an acute care facility. We estimate this notice may
need to be sent to the Office of the State Long-Term Care Ombudsman for
one third of all nursing home residents, resulting in a cost of
$1,243,981 for all facilities. The per-facility cost will vary
significantly according to facility size and number of transfers out of
each facility. (($.10 + $.58 + ($29 hourly wage for an office clerk x
.08 of an hour)) x (.3 percentage of nursing home residents for whom a
copy of a transfer notice needs sent to the Office of the State Long-
Term Care Ombudsman x 1,382,201 nursing home residents) = $1,243,981).
Update Transfer Notices (Sec. 483.15(b)(7))
The proposed requirement requires the facility to update transfer
notices if information in the notice changes and to provide the updated
information to the resident. We believe that the updates already occur
informally and estimate that updating the notice and providing it to
the resident will require a social worker an additional 5 minutes per
notice. As discussed above, this requirement will apply primarily to
residents who are involuntarily discharged from the facility and does
not include resident who request the transfer or who are transferred on
an emergency basis to an acute care facility. We estimate this notice
may need to be updated once for up to one third of nursing home
residents who are transferred. The resulting cost is $1,459,604 for all
facilities. (($44 hourly wage for a social worker x .08 of an hour) x
(.3 percent of nursing facility residents x 1,382,201 nursing facility
residents) = $1,459,604). The per-facility cost will vary significantly
according to facility size and number of transfers out of each
facility.
We believe the DON or administrator would perform a comprehensive
review of all required notices after all the cumulative changes noted
above are made and that this cumulative review would require
approximately 30 minutes at a cost of $40 per facility or $627,640 for
all facilities ($80 hourly wage for a NHA or DON x .5 of an hour x
15,691 facilities = $627,640).
Comprehensive Resident Centered Care Planning (Sec. 483.21)
Additional Members of the IDT (Sec. 483.21(b)(2)(ii))
We would require that a NA, member of nutrition services, and
social worker participate on the IDT. We believe that this requirement
would add to the current duties of each of these staff members and
therefore would be a new economic cost to each facility. Communications
about the status of a resident are a part of standard job duties. We
envision that these staff members are already regularly discussing
resident's needs and their plans of care. When assessing the amount of
burden associated with this requirement, we believe that this
requirement would only produce an incremental increase in the staff
time necessary to participate on the IDT. In addition, we do not
specify the type of communication the IDT must use. IDT members may use
electronic communication as well as informal discussions to participate
in IDT meetings. We estimate that participation on the IDT would add an
additional one hour of staff time to the duties of a NA, member of food
services, and social worker. While we do not require that a dietitian
participate on the IDT, for purposes of estimating the cost we use the
salary of a dietitian to represent the participation of a member of
food services. We estimate that this requirement would cost $97,911,840
($120 hourly wage ($23 NA hourly wage +$53 dietitian hourly wage +$44
social worker hourly wage = $120) x 52 hours (1hour per week x 52
weeks) x 15,691 facilities).
Discharge Planning (Sec. 483.21(c)(1)(vii))
We would require that, for residents who are transferred to another
SNF or who are discharged to a HHA, IRF, or LTCH, facilities assist
residents and their resident representatives in selecting a post-acute
care provider by using data that includes, but is not limited to SNF,
HHA, IRF, or LTCH standardized patient assessment data, data on quality
measures, and data on resource use. The facility also must ensure that
the post-acute care standardized patient assessment data, data on
quality measures, and data on resource use is relevant and applicable
to the resident's goals of care and treatment preferences. We believe
that a social worker would be responsible for compiling the
standardized data, reviewing the resident's preferences/goals, and
pulling data that applies to these preferences/goals. We estimate that
it would take a social worker approximately one hour of staff time to
compile and review the data in order to align the data with each
resident's preferences/goals. This staff time would only be required
for those residents who are transferred to another SNF or discharged
from the nursing home. We are unable to determine the average number of
residents who are transferred to another SNF or discharged from a
nursing home annually. We believe that a conservative estimate would be
that if there are an estimated 1,382,201 residents per year in nursing
homes, possibly a third of these residents are discharged or
transferred to another SNF on an annual basis. Therefore, we estimate
that this requirement would cost $20,272,252 ($44 social worker hourly
wage x 1 hour staff time x 460,733 residents discharged or transferred
to another SNF annually).
Physician Services (Sec. 483.30)
Practitioner Evaluation of a Resident (Sec. 483.30(e))
We believe that a physician, NP, CNS or PA often evaluate in person
a
[[Page 42238]]
resident prior to hospital transfer unless a delay in transfer places
the resident at risk. However, we also believe that there are instances
when an evaluation does not occur and could prevent an avoidable
hospital transfer. We estimate that it will require a physician, NP,
CNS, or PA 30 minutes to evaluate a resident prior to transfer. For
purposes of estimating this cost we will use the hourly wage of a
physician. Research shows that more than 15 percent of long-term
nursing home residents are hospitalized in any given 6 month period and
approximately 40 percent of nursing home to hospital transfers are
considered inappropriate (David C. Grabowski, A. James O'Malley and
Nancy R. Barhydt, The Costs And Potential Savings Associated With
Nursing Home Hospitalizations, Health Affairs, 26, no.6 (2007):1753-
1761). If we use 30 percent to estimate the number of in-person
evaluations required per year (15 percent per 6 months), the resulting
calculation provides a lower bound estimate of $35,660,786 (($172
hourly wage for a physician x .5 of an hour) x (30 percent of facility
residents who require an in-person evaluation prior to transfer x
1,382,201 facility residents) = $35,660,786).\1\
---------------------------------------------------------------------------
\1\ We refer to this estimate as a lower bound because the input
that is available--residents who are hospitalized--may be lower (due
to repeat admissions) than the input that would be most appropriate
for this calculation--the number of hospitalizations.
---------------------------------------------------------------------------
Nursing Services (Sec. 483.35)
Competency Requirements (Sec. 483.35, Sec. 483.60)
Our focus on competency requirements requires identification of and
documentation of training, certification, and similar records in an
existing personnel file or training record for direct care personnel.
This specifically includes nursing services and food and nutrition
services but may apply to any direct care provider. Initial competency
requirements would be identified via facility assessment with
documentation of individual accomplishments managed by an
administrative position, likely an office clerk, as an addition to
existing documentation. We estimate the incremental burden of adding
the additional information to existing files (paper or electronic) at 8
hours per year per facility, or $232. The cost for all facilities is
estimated at $3,640,312. ($29 office clerk hourly wage x 8 hours per
facility x 15,691 facilities = $3,640,312)
Food and Nutrition (Sec. 483.60)
Requirements for Food Service Directors (Sec. 483.60(a)(2))
The proposed provision establishes requirements for directors of
food and nutrition services hired after the effective date of these
requirements or, for current directors of food and nutrition services,
within 5 years of the effective date of these requirements. We would
require that the director of food and nutrition services be certified
as a certified dietary manager, certified food service manager or
similar national certification for food service management and safety
from a national certifying body; or has an associate's or higher degree
in food service management or hospitality from an accredited
institution of higher learning, or meets established state
requirements. Many states already establish additional staff
qualifications for food service directors and we expect that most
facilities already hire food service directors that meet the proposed
requirements. We anticipate that some hiring officials may spend some
additional time recruiting appropriate candidates for the food service
manager position and verifying credentials, although we believe this is
a small percentage of facilities. When necessary, we estimate this will
require an extra hour of the NHA's time. The burden is imposed only on
those facilities needing to hire a food service manager after the
effective date of the regulation. We anticipate that this will affect
less than 10 percent of all facilities during the five-year time
horizon we are analyzing in this regulatory impact analysis. The cost
per affected facility is approximately $80 and the total cost for all
affected facilities is estimated to be $125,528. (($80 NHA hourly wage
x 1 hour) x (.1 percentage of affected facilities x 15,691 facilities)
= $125,528).
Menu Options (Sec. 483.60(c))
We expect that our proposed requirement for menus to reflect the
cultural and ethnic needs of residents would require that menus be
updated by a qualified dietitian or other clinically qualified
nutrition professional in the course of routine reviews and updates.
Additional time would include the dietitian or other clinically
qualified nutrition professional reviewing the facility assessment for
pertinent factors and reviewing and updating the menus. We anticipate
this would require 1 to 4 hours, on average 2 hours, depending on the
size of the facility and complexity of resident needs. While we believe
that some facilities already meet this requirement, for estimation
purposes, we multiply the $53 hourly wage of a qualified dietitian or
other clinically qualified nutrition professional for 2 hours for
15,691 facilities, for a total cost of $1,663,246.
Facility Assessment (Sec. 483.70(e))
The proposed provision establishes requirements for each LTC
facility to conduct and document a facility-wide assessment to
determine what resources are necessary to care for its residents
competently during both day-to-day operations and emergencies. LTC
facilities must already determine and plan for what staffing they will
need, as well as the other resources that will be required to care for
their residents and operate their facilities. Thus, we believe that
conducting and documenting a facility assessment is a standard business
practice and will not include a burden for this requirement in the
impact analysis.
QAPI (Sec. 483.75)
We have proposed to require that each facility develop a QAPI
program. In addition to the QAPI requirement related ICR costs
discussed in the COI section, we expect that facilities would incur
additional costs that would be dependent upon the projects they
selected for their quality improvement activities. In turn, the
projects would be dependent upon resident needs, and the type,
complexity, and quality of services already provided by the facility.
Facilities would have the flexibility to determine their quality
performance improvement activities based on their assessment of needs
of their residents and their prioritized performance improvement
projects. For example, a facility that chose, as one of its projects,
to improve residents' nutritional status and satisfaction with the
facility's food services could incur costs for higher quality, more
palatable food. A facility that chose, as one of its projects, to
improve nurse aides' interactions with residents suffering from
dementia could incur costs for nurse aide training and/or additional
nurse aide staffing. A facility that chose, as one of its projects, to
improve residents' psychosocial well-being could incur costs for
conversion of double rooms to single rooms, and additional social
worker, and/or increased social activities for residents. Because the
number, degree, and costs of these activities are difficult, if not
impossible, to quantify, we have calculated only the cost of the QAPI
ICRs ($118,419,977 upfront) that would be associated with the QAPI
requirements (discussed in the COI section of the preamble). However,
we encourage the public to comment on the
[[Page 42239]]
potential costs for facilities of their quality improvement projects.
We estimate that the ongoing annual cost for each facility to comply
with the QAPI requirements would be $3,021 for each facility and for
all facilities would be $47,402,511 ($3,021 x 15,691). (This discussion
is detailed in the COI section.)
Infection Control (Sec. 483.80)
Infection Prevention and Control Officer (Sec. 483.80(b))
Facilities and their staffs are currently required to have an
infection control program (Sec. 483.65). In this rule, we are
proposing that each facility must also designate one individual as the
infection prevention and control officer (IPCO) for whom the infection
prevention and control program (IPCP) is a major responsibility. The
IPCO would be responsible for assessing the current program, making any
changes to the IPCP necessary to comply with the program's
requirements, and implementing and managing the IPCP. This individual
would also be required to be a member of the facility's QAA committee.
The percentage of the RN FTE that would be required at each facility
will vary greatly. We believe that each facility would have to
determine the appropriate percentage based upon it facility assessment,
especially its assessment of the acuity of its resident population. A
facility with a generally healthy population of elderly individuals
would likely require many fewer hours than a facility with a large
percentage of subacute residents or residents that are on ventilators.
For the purposes of determining an estimate, we believe that the
average facility would designate a registered nurse (RN) to be the IPCO
and that individual would need to commit about 15 percent of a full
time equivalent position (FTE) to his or her responsibilities under the
IPCP. We estimate that this would require 15 percent of one RN FTE for
each of the 15,691 facilities for a total cost of $283,944,336 (15% of
an RN FTE x $58 average hourly wage for an RN x 2,080 hours (40 hours a
week x 52 weeks = 2,080 hours) x 15,691 facilities = $283,944,336). We
request comment on the time and other costs that would be associated
with rule-induced improvements in infection control procedures if any,
put into practice by facility personnel other than the IPCO.
Compliance and Ethics Program (Sec. 483.85)
Compliance Officer and Compliance Liaison Activities (Sec. 483.85)
We propose to require facilities to develop a compliance and ethics
program. As discussed in the COI section, we estimate the ICR burden
associated with developing this program to be $24,985,420. We estimate
that in carrying out this program the compliance officer (similar to an
administrator) in each of the 387 organizations operating 5 or more
facilities would commit 30 percent of an full time equivalent (FTE) in
the compliance program operation, for a total cost of $19,319,040 (30%
of FTE x 2080 x $80 x 387). We also estimate that in carrying out this
program the compliance liaison (nursing staffs) in each of 7,879
facilities would commit 10 percent of an FTE, at a total cost of
$95,052,256 (10% of FTE x 2080 x $58 x 7879).
Annual Review of Program (483.85(e))
As detailed in the COI section, we propose to require each facility
to review their compliance and ethics program annually. Therefore, for
subsequent years we estimate to comply with the ICR requirement to
review and, if necessary, revise the operating organization's program
annually would cost an estimated $5,956,000.
Physical Environment (Sec. 483.90)
Resident Rooms (Sec. 483.90(d)(1)(i))
For facilities that receive approval of construction or
reconstruction plans by State and local authorities or are newly
certified or undergoing reconstruction, we would require that resident
rooms accommodate no more than two residents. A review of CASPER data
on the number of new providers per fiscal year from 2008 to 2013
reveals an annually declining number of new facilities, down from 225
new providers in 2008 to 172 in 2012, with only 144 new providers as of
August 2013. Of those, the majority were for-profit facilities of 99
beds or less. We further note the overall number of facilities has also
declined slightly (by less than 2 percent) but steadily over the same
period. A number of states already have requirements similar to those
proposed and represent an average of 7 percent of new providers for the
years we reviewed. Therefore, we expect that these requirements will
affect fewer than 140 facilities annually. We do not have statistics on
the number of providers per year who undertake reconstruction. Although
we know that semi-private rooms will increase constructions costs, we
were unable to find data regarding the incremental increased cost to
the facility of semi-private rooms versus configurations that
accommodate up to four residents. We welcome data on this issue and on
the question of whether this provision of the rule creates an incentive
for facilities to avoid or delay otherwise beneficial renovations.
Toilet Facilities (Sec. 483.90(e))
For resident rooms newly constructed or undergoing reconstruction,
we would require that each room have its own bathroom equipped with at
least a toilet, sink and shower. A review of CASPER data on the number
of new providers per fiscal year from 2008 to 2013 reveals an annually
declining number of new facilities, down from 225 new providers in 2008
to 172 in 2012, with only 144 new providers as of August 2013. Of
those, the majority were for-profit facilities of 99 beds or less. We
further note the overall number of facilities has also declined
slightly (by less than 2 percent) but steadily over the same period. In
addition, several states require direct access and limit the number of
rooms or residents who may be served by a toilet, lavatory (sink), and/
or shower or bath. Given the decline in new facilities and the impact
of state regulation, we estimate that this provision will impact fewer
than 150 providers per year. We do not have statistics on the number of
providers per year who undertake reconstruction. Although we are aware
that ensuring each resident bedroom has an adjacent bathroom may
increase construction costs, we were unable to find data regarding
neither the number of facilities that do not currently have bathrooms
adjacent to each resident room nor the incremental cost of adding
bathrooms adjacent to each resident room in new or reconstruction. We
welcome data on this issue and on the question of whether this
provision of the rule creates an incentive for facilities to avoid or
delay otherwise beneficial renovations.
Training Requirements (Sec. 483.95)
General Training Topics (Sec. 483.95a)
We are proposing that facilities develop and/or update training
materials to include topics on communication, resident rights, facility
obligations, abuse, neglect, exploitation, infection control, and its
QAPI program. We would require that these training topics be provided
for all new and existing staff; individuals providing services under a
contractual arrangement; and volunteers, consistent
[[Page 42240]]
with their expected roles and that they be able to demonstrate
competency in these topic areas. We would also expect each facility to
keep a record of these trainings. To reduce regulatory burden and
create a reasonable requirement we have not specified the amount or
types of training that a facility must provide. There are various free
online training tools and resources that facilities can use to assist
them in complying with this requirement. For example, the Agency for
Healthcare Research and Quality (AHRQ) released a set of training
modules to help educate nursing home staff on key patient safety
concepts to improve the safety of nursing home residents (https://www.ahrq.gov/professionals/systems/long-term-care/resources/facilities/ptsafety/). In addition to the web based materials, instructor and
student handbooks can be sent to facilities at no additional cost.
Therefore, we believe that the cost associated with this requirement
would be limited to the staff time required to review and update their
current training materials.
Based on our experience with facilities, we expect that all
facilities have some type of training program. However, we expect that
each facility would need to compare their training programs to their
facilities assessments as required at proposed Sec. 483.70(e) and
ensure they cover the above training topics. We expect that complying
with this requirement would require the involvement of a RN and the
infection control and prevention officer (ICPO). We expect that a RN
would spend more time reviewing, revising and/or developing new
sections for the training program. The ICPO would need to weigh in on
the infection control training related topics. We estimate that it
would require 8 (6 for the RN ($58/hr) and 2 for the ICPO ($58/hr))
burden hours for each facility to develop a training program at a cost
of $464. Thus, for all facilities to comply, it would cost an estimated
$7,280,624 ($464 estimated cost for each facility x 15,691 facilities).
We believe that the training would be considered part of regular on-
ongoing training for the staff of each facility.
Compliance and Ethics Program Training (Sec. 483.95(f))
We require that SNF and NF operating organizations include as part
of their compliance and ethics program an effective way to communicate
their program's standards, policies, and procedures. We believe that
all operating organizations would need to develop training materials
and/or other publications to comply with the training requirement. Our
rule proposes, higher standards for organizations operating 5 or more
facilities, therefore for the purposes of the RIA our cost estimates
differentiate by organization size. We estimate that training staff in
organizations operating 1 to 4 facilities would mainly require the
duties of a RN at a cost of $900,740 for all 7,765 facilities (6,621
single facilities operating organizations + 1,144 facilities in
operating organizations with 2 to 4 facilities = 7,765 facilities) x 2
hours x $58 average hourly wage for a RN = $900,740). For the training
in operating organizations with 1 to 4 facilities, we expect that
operating organizations would be able to minimize these training costs
by including the training on their compliance and ethics program with
any current trainings or in-services that they already conduct for
their staff. In addition, these facilities could also include this
information in publication, print or electronic, that are available to
their staff.
We estimate that training staff in organizations operating 5 or
more facilities would require 2 hours of time of a compliance officer
(similar to an administrator) conducting the training at the
organizational level (387 organizations) at a cost of $61,920 (387 x 2
x $80 = $61,920) and 2 hours of time of a compliance liaison (similar
to an RN) at the facility level (7,879 facilities x 2 x $58 =
$913,964), for a total cost of $975,884 ($61,920 + $913,964 =
$975,884).
Dementia Management and Abuse Prevention Training Sec. 483.95(g)
This proposed rule would implement section 6121 of the Affordable
Care Act which requires dementia management and abuse prevention
training to be included in the current mandatory on-going training
requirements for nurse aides. Facilities would have the flexibility to
determine the length of the training and the format of the training.
Since we have not increased the minimum hours for training, we
anticipate that facilitates would maximize their on-going training
efforts to improve outcomes through a more efficient training program
by modifying their current training program to ensure that all NAs
receive annual training in dementia management and abuse prevention. In
addition, we believe that the majority of facilities would need to
acquire training materials to either update or supplement what they are
currently using to train NAs. There are numerous online tools available
to facilities at no cost. For the sole purpose of complying with
section 6121 of the Affordable Care Act and ensuring that nurse aides
receive regular training on caring for residents with dementia and on
preventing abuse. CMS has published an online hand in hand tool kit
that provides a detailed training series for nursing homes on dementia
education and abuse prevention (https://www.cms-handinhandtoolkit.info/
). CMS, supported by a team of training developers and subject matter
experts, created this training to address the need for nurse aides'
annual in-service training on these important topics. The mission of
the hand in hand training is to provide nursing homes with a high-
quality training program that emphasizes person-centered care in the
care of persons with dementia and the prevention of abuse. Given the
availability of these materials, we have not assessed a cost burden
associated with acquiring training materials for this requirement,
however, as discussed in the COI section, we estimate that it would
cost facilities an estimated $3,640,312 to review and update their
current in-service training material.
D. Summary of Impacts
Table 2 below presents a summary of the section by section
estimated costs to comply with the requirements of this proposed rule.
Table 2--Section by Section Summary of Estimated Cost From ICR and RIA To Comply With the Requirements Contained
in This Proposed Rule
----------------------------------------------------------------------------------------------------------------
Total cost in
Regulatory area Section First year total year 2 and
cost thereafter
----------------------------------------------------------------------------------------------------------------
Resident Rights........................................ 483.10 $10,436,051 $10,436,051
Facility Obligations................................... 483.11 1,935,785 999,345
Transitions of Care.................................... 483.15 3,331,225 3,331,225
Comprehensive Resident Centered Care Planning.......... 483.21 118,184,092 118,184,092
Physician Services..................................... 483.30 35,660,786 35,660,786
[[Page 42241]]
Nursing Services....................................... 483.35 3,640,312 3,640,312
Food and Nutrition Services............................ 483.60 1,788,774 1,663,246
QAPI................................................... 483.75 118,419,977 47,402,511
Infection Control...................................... 483.80 283,944,336 283,944,336
Compliance and Ethics Program.......................... 483.85 139,356,716 120,327,296
Training............................................... 483.95
General Training Topics................................ 483.95(a) 7,280,624 7,280,624
Compliance and Ethics Training......................... 483.95(f) 1,876,624 1,876,624
Dementia Management and Abuse Training................. 483.95(g) 3,640,312 3,640,312
-------------------------------------
Total.............................................. ................. 729,495,614 638,386,760
----------------------------------------------------------------------------------------------------------------
E. Alternatives Considered
The requirements for long-term care facilities have not been
comprehensively updated in many years. The effective and efficient
delivery of health care services has changed substantially in that
time. We believe the changes we have proposed are necessary to ensure
the requirements are consistent with current standards of practice and
continue to meet statutory obligations and ensure that residents
receive care that maintains or enhances each resident's quality of life
and attains or maintains the resident's highest practicable physical,
mental, and psychosocial well-being. Below we discuss the alternatives
that we considered when developing this proposed rule.
1. Scope of Proposed Revisions
We considered only proposing those requirements that are required
by statute. Specifically, the Affordable Care Act included provisions
regarding dementia and abuse training, QAPI program, and compliance and
ethics program, and the IMPACT Act requires that we issue regulations
regarding discharge planning. Taking this approach would be less
burdensome on the LTC community overall. However despite the many
changes in the delivery of health care services, the requirements for
LTC care facilities have not been comprehensively updated in many
years. Our proposed revisions address several issues, such as avoidable
hospitalizations, staffing concerns, infection control, and behavioral
health. In addition, we believed that it was necessary to modernize the
regulations to reflect advances such as electronic communications and
health information technology. Overall, we believe that a general
reorganization and comprehensive revision would ensure the requirements
are consistent with current standards of practice and continue to meet
statutory obligations, while also assisting individuals who are less
familiar with these regulations to find information within the
requirements. We believe the changes we have proposed are necessary to
ensure that residents receive care that maintains or enhances each
resident's quality of life and attains or maintains the resident's
highest practicable physical, mental, and psychosocial well-being.
Therefore, we determined it would be most effective to make
comprehensive changes at this time.
2. Psychotropic Drugs
We considered not proposing to revise the existing requirements
that apply to antipsychotic drugs to psychotropic drugs. This approach
would be less burdensome for nursing homes. However, we are concerned
that the current requirements are insufficient to protect the health
and safety of nursing home residents. We learned that while some
residents are being taken off of anti-psychotics, they are then
prescribed other medications that are continuing to affect their mental
processes and behavior. We are also concerned that drugs, other than
anti-psychotics, that affect mental processes or behavior can be
prescribed in ways that benefit of the staff and not necessarily the
resident's health. In addition, in cases where medication is originally
prescribed for the resident's benefit, we are concerned that the
resident could remain on these types of medications even after non-
pharmacological interventions or gradual reductions in the medication
could have either eliminated the reason for the medication or at least
reduced the amount of medication required by the resident. Thus, we
believe that all psychotropic medications should be subject to the
proposed requirements to protect the health and safety of nursing home
residents.
We also considered various definitions for psychotropic drugs. The
definition would determine the types of medications that specific
requirements in this proposed rule would apply to and the burden they
would place on the LTC facilities and health care providers. After
reviewing different definitions, we are proposing to define a
psychotropic drug as any drug that affects brain activities associated
with mental processes and behavior. We have included a list of drug
categories that are typically considered psychotropic drugs in the
literature, that is, anti-psychotic, anti-depressant, anti-anxiety,
hypnotic, and opioid analgesics. We have also included any other drugs
that have effects similar to those drugs in these categories. We
believe that this provision is necessary so that drugs used for ``off-
label'' use would be subject to the regulatory requirements. We
acknowledge that this is a broad definition and may result in
additional burden for the facilities. However, we also believe this
definition encompasses all of the drugs that could be used to control a
resident's mental processes and behavior. We are specifically
requesting comments on the scope of our proposal.
3. Binding Arbitration
We considered not proposing any requirements concerning binding
arbitration agreements. Taking this approach would certainly be less
burdensome to the facilities. However, stakeholders raised specific
concerns about nursing homes either requiring or pressuring nursing
home residents to sign these agreements and, therefore, waiving the
right to pursue resolution of a dispute with the nursing home in court.
We share the stakeholders' concern that some nursing homes may be
requiring residents to sign agreements for binding arbitration as a
requirement for admission into the facility. In addition, if the
nursing home
[[Page 42242]]
is not requiring the agreement as a condition of admission, some
facilities may be requesting the resident to sign the agreement without
fully explaining the rights the resident is waiving and the
consequences of that waiver. We believe that nursing home residents
need to be fully aware of the right they are waiving (the right to seek
relief in a court for a dispute between the resident and the facility)
if a nursing home requests they sign an agreement for binding
arbitration. Thus, we have proposed specific requirements if a nursing
home chooses to request that a resident sign an agreement for binding
arbitration. These requirements include, among other things, that the
nursing home must explain the agreement to the resident in a form and
manner that he or she understands, and that the resident acknowledge
that they understand the agreement. We have also proposed specific
requirements for the agreement, including that admission to the
facility cannot be contingent upon the resident signing the agreement,
the agreement must be entered into voluntarily, and the arbitration
must be conducted by a neutral arbitrator in a venue convenient to both
parties. In addition, we have also proposed that the agreement not
contain any language that prohibits or discourages the resident or
anyone else from communicating with Federal, State, or local officials,
including but not limited to surveyors, health department employees,
and representatives of the Office of the State Long-Term Care
Ombudsman. We believe this requirement is essential so that residents
and others who have knowledge of their care are not discouraged from
speaking with surveyors and others from whom the resident can seek
assistance. In addition, another individual can sign the agreement for
the resident only if allowed by state law and the individual has no
interest in the facility. Thus, we believe these comprehensive
requirements are needed so that residents understand the right they are
waiving by signing an agreement for binding arbitration and that the
arbitration will be conducted in a neutral and fair manner.
We also considered prohibiting binding arbitration agreements. This
would be more burdensome to the LTC facilities. However, it would
remove the choice to agree to binding arbitration from the resident.
Alternative dispute resolution, which includes arbitration, is favored
by the courts and provides both parties, the resident and the nursing
home, with advantages. Arbitration can result in disputes being
resolved faster and in a less burdensome manner for both parties. There
have also been court decisions that have upheld these agreements in
cases involving nursing home residents. However, we are concerned that
despite the protections we have proposed in this rule, some nursing
home residents and potential residents may feel pressured to sign these
agreements. For example, in cases where a potential resident or their
family have the time to do research and visit multiple homes, a
resident may feel he or she can more easily refuse to sign an agreement
for binding arbitration. However, if the resident is hospitalized and
needs to locate a facility quickly, they may feel more pressure to
accept such an agreement. Thus, we have also requested comments on
whether agreements for binding arbitration should be prohibited.
4. In-Person Physician Evaluation Before Transfer
We considered not proposing to require an in-person evaluation of a
resident prior to an unscheduled, non-emergency transfer of a resident
to a hospital. However, in concert with improved communication
requirements, an evaluation of a resident by a physician, a physician
assistant, a nurse practitioner, or a clinical nurse specialist prior
to a resident's transfer may identify options that could allow some
residents to be treated in place and avoid unnecessary
hospitalizations.
5. Additional Changes
We also considered proposing additional changes. In some cases, we
determined that an issue was not adequately developed for us to make an
evidenced-based proposal. In several of these cases, we have
specifically solicited comments so that we are better informed. For
example, we considered requiring all facilities to implement a hazard
analysis and critical control point program for food and nutrition
services, but instead chose to request comments so that we better
understand the potential benefits and impact, particularly on small
facilities. We may consider these topics in future rule-making.
We also considered more prescriptive changes in several areas.
Throughout this rule, we focused on supporting person-centered
approaches and innovative care delivery models. This requires that we
allow flexibility in the regulatory language. Where possible, we chose
a more flexible option to ensure that proposed regulatory requirements
could be accommodated across the spectrum of facility sizes and
resident populations. This particularly applied in our consideration of
options to address nurse staffing. In that area, we specifically
considered establishing minimum nurse hours per resident day,
establishing minimum nurse to resident ratios, requiring that an RN be
present in every facility either 24 hours a day or 16 hours a day, and
requiring that an RN be on-call whenever an RN is not present in the
facility instead of or in addition to imposing a competency-based
staffing requirement that takes into consideration the acuity,
diagnoses, and number of residents in the facility. All of the options
not chosen had high associated burdens, with options for RN staffing
changes ranging from in excess of $1,000,000,000 to over $5,000,000,000
total to implement across likely affected facilities, based on the
current statutory minimum staffing requirements. Earlier in this
preamble, we specifically invited comments on the costs of mandating a
24 hour RN presence, the benefits of a mandatory 24 hour RN presence,
including cost savings and improved resident outcomes, as well as any
unintended consequences of implementing this requirement. We will
reconsider these options in light of future research, recommendations,
and the availability of more valid and reliable payroll-based staffing
data.
We also considered adding more requirements to the qualifications
for a social worker in Sec. 483.70(p). We considered requiring a
masters of social work (MSW) for the social worker. We also considered
requiring that the social worker also have a certification related to
clinical work or gerontology. We did not propose these requirements
because we are concerned that increasing the qualifications for social
workers in nursing homes may result in access issues. We have received
input that some nursing homes already have difficulty in hiring
qualified social workers. We would welcome comments related to
qualification for the social worker, especially whether state licensure
should remain the threshold requirement or if additional requirements
are appropriate.
F. Benefits of Proposed Rule
This proposed rule would implement comprehensive changes intended
to update the current requirements for long-term care facilities and
create new efficiencies and flexibilities for facilities. In addition,
these changes will support improved resident quality of life and
quality of care. Quality of life in particular can be difficult to
translate into dollars saved. However, there is a body of evidence
suggesting the factors that improve quality of life may also
[[Page 42243]]
increase the rate of improvement in quality and can have positive
business benefits for facilities. Many of the quality of life
improvements we propose are grounded in the concepts of person-centered
care and culture change. These changes not only result in improved
quality of life for the resident, they can result in improvements in
the caregiver's quality of work life and in savings to the facility.
Savings can be accrued through reduced turnover, decreased use of
agency labor and decreased worker compensation costs. Although these
savings are difficult to quantify, we believe that they must be lower
in magnitude than the costs borne by facilities; otherwise, facilities
would change their policies even in the absence of this rulemaking.
In addition to proposing changes that are likely to have long-term
positive impacts on quality of life and quality of care, we have
proposed several changes that may mitigate the costs associated with
implementing some of our proposed requirements. For example, including
the use of electronic health records in these regulations may reduce
the burden on facilities when providing a resident with a copy of his
or her clinical record. We believe that the option to provide an
electronic copy of the record may reduce the amount of time a staff
person is taken away from other duties to copy the medical records. We
do not have data on how many medical records requests are made each
year, nor do we have empirical data on the time difference, thus we
have no way to estimate the magnitude of these savings. However, to
understand the possible magnitude of the savings, let us assume that 2
percent of residents request their record each year (27,644). We
further assume that, on average, it takes an office clerk 15 minutes to
make a page by page copy of a medical record. If twenty-five percent of
residents (6,911) requesting a copy of their medical record accept an
electronic copy in lieu of a paper record or if the paper copy can be
printed from an electronic record rather than copied page by page and
it takes an office clerk 5 minutes to make an electronic copy, the
facility saves 10 minutes of clerk time per record. The annual savings
would be $24,189. We believe this is likely a conservative estimate.
Another area that may produce substantial savings is our proposal
to allow physicians to delegate to a qualified dietitian or other
clinically qualified nutrition professional the task of prescribing
diet, including therapeutic diets, to the extent allowed by state law.
We further believe that dietitians or other clinically qualified
nutrition professional are already performing resident dietary
assessments and making dietary recommendations to the physician who
then evaluates the recommendations and writes orders to implement them.
We do not currently have data to estimate the savings that this could
produce in SNFs and NFs. However, we believe that it will allow for
better use of both physician and dietitian time.
We also propose to allow physicians to delegate to qualified
therapists the task of prescribing physical, occupational, speech
language, or respiratory therapies, but as with dietitians, we have no
empirical evidence with which to quantify a cost savings. Again,
however, we believe that this allows better use of both physician and
therapist time.
With respect to dental services, we propose to modify the language
relating to dental services to remove references to a dentist's office
and replace these references to `dental services location.' This more
explicitly accommodates options for dental care such as dental schools
or provision of dental hygiene services on site at a facility. Based on
the literature we reviewed, improved dental health as a result of
improved access to dental care is highly likely to result in improved
health and well-being of facility residents, including potentially
fewer hospitalizations and less unanticipated weight loss. We have no
definitive data on the direct reduction in hospitalizations and other
complications stemming from or exacerbated by poor dental care and poor
dental hygiene, but given the relationship of poor dental care and poor
dental hygiene to other illnesses, savings are quite possible.
Furthermore, reducing the number of hospitalization through these
preventative actions would also reduce our estimated burden for
requiring practitioner evaluation of a resident prior to a hospital
transfer. Finally, improved dental care and oral hygiene would likely
result in improved quality of life. However, we have no basis on which
to calculate these savings and therefore do not quantify them.
We have also made a number of changes in the area of food and
nutrition services. These changes are expected to have multiple
impacts, ranging from the improved nutritional status of residents to
reduced food waste by the facility, to reductions in the incidence of
food-borne illness. In FY 2012, there were over 9,000 deficiency
citations associated with food and nutrition services. The most
commonly cited deficiency in this grouping was, by far, associated with
food sanitation. Out of 6,828 surveys, there were 5,490 citations for
deficiencies in food procurement, storage, preparation, and service-
sanitary, affecting 31.80 percent of providers. Proposed improvements
in food and nutrition services have the potential to improve resident
quality of life. They may also result in a reduced incidence of food-
borne illness, which could result in substantial savings. We invite
comment, data and analysis on this issue, including the related
question of whether the activities for which costs were estimated in
the cost section, above, are sufficient to generate the benefits
discussed here.\2\
---------------------------------------------------------------------------
\2\ It is logical to assume that the requirement for nursing,
food service and other competency either necessitates hiring more
competent staff who command a higher wage--the cost of which would
be included in the cost section--or the competency provision is
essentially unnecessary because staff are already competent--in
which case, there would be no benefits to facilities or their
residents. As regards the menu options provision, the cost section
mentions two hours of effort per facility. It might be plausible
that a two-hour review would be sufficient to confirm that there is
nothing in need of revision (in which case there are no benefits).
However, if a review uncovers that there is potential for benefits
due to menu revisions, then there will be further costs, such as
training for food service workers or higher costs of raw
ingredients.
---------------------------------------------------------------------------
We are concurrently proposing to strengthen requirements related to
infection control. While a reduction in the incidence of healthcare
associated infections would likely impact hospitalization of residents,
as discussed below, it will also impact the care required for residents
who remain in the facility. An effective infection prevention and
control program can, among other benefits, identify infections early
and prevent their spread. Several illness-causing organisms are of
particular concern in nursing homes. For example, Norovirus may cause
illness following a very low infection dose. The illness is
characterized by nausea, sudden onset of projectile vomiting
(particularly in children), watery, non-bloody diarrhea, abdominal
cramping, chills, body aches and fatigue. Dehydration is a common
complication, especially in the elderly. The illness usually lasts two
to three days. Outbreaks can impact residents and/or staff and cause
significant inconvenience and cost. (Overview of the management of
norovirus outbreaks in hospitals and nursing homes, compiled by the
Wisconsin Division of Public Health, Bureau of Communicable Diseases,
Communicable Disease Epidemiology Section, February 2004. Retrieved
from https://www.publichealthmdc.com/environmental/food/documents/
ManagementofNorovirusInfectionOutbreaksinHospitalsand
[[Page 42244]]
NursingHomes.pdf). These illnesses can result in higher acuity of
residents and increased care needs as well as increased use of either
overtime or temporary staff to replace ill staff. Improved prevention,
detection, and mitigation of illnesses can result in substantial
savings to a facility. Unfortunately, specific rates of infection and
the associated cost to treat residents or to replace absent staff have
not been clearly quantified in available literature or data. We invite
comment, data and analysis on this issue, including on the question of
how actions of a facility's infection prevention and control officer
affect the practices of other facility personnel, and whether such
effects are sufficient to yield infection control benefits.
We note that we made several changes that target reducing avoidable
or unnecessary hospitalizations. We make proposals regarding improved
communication of critical information, in-person evaluation or
residents prior to transfer, competency-based care assignments,
training, and systemic quality improvement. We believe that even a
small reduction in the number of unnecessary hospitalizations could
result in substantial savings, however, we have not quantified
potential savings.
Currently, the regulations require that the nurse's station be
equipped to receive resident calls. Our proposal to require a
communications system that allows residents to call for assistance
through a communications system that relays the call directly to a
staff person or centralized staff area from each bedside and from
toilet and bathing facilities provides added flexibility and
efficiency. Eliminating the requirement for a ``nurses' station''
better accommodates a decentralized care model, better reflects current
practice, and may improve response times. However, we have no basis
upon which to calculate specific cost savings that this flexibility
would provide.
This does not take into account dollar amounts from improved
resident quality of life or improved staff work life. Reduced costs
from improved staff satisfaction resulting in reduced turnover,
decreased use of agency labor and decreased worker compensation costs
could be substantial. The cost of turnover among nurse aides was
estimated at $2,500 per occurrence in 2008 (Frampton, Susan, et al.
``Making the Case for Change'' Long-Term Care Improvement Guide 2010,
retrieved from https://www.residentcenteredcare.org/Pages/About%20the%20guide.html). According to 2014 BLS statistics, there are
over 1.4 million nurse aides employed in the United States; over
616,000 are employed in nursing facilities. AHCA reported in 2010 that
the national turnover rate for certified nurse assistants (nurse aides)
was 43 percent.
According to the American Nurses Association, the cost of
recruiting and replacing an RN is 1.1 to 1.6 times an annual nurse's
salary (https://www.nursingworld.org/SafeStaffingFactsheet.aspx).
According to a 2009 survey by the American Health Care Association
(https://www.ahcancal.org/research_data/staffing/Documents/staffsurvey_2009_full_report.pdf), the turnover rate for staff RNs was
46.7 percent and for administrative RNs was 36.3 percent. 2014 BLS data
shows that over 140,000 RNs are employed in nursing care facilities at
an annual mean wage of $62,440. Additional savings would accrue as a
result of reduced turnover of other personnel such as licensed
practical or vocational nurses, reduced use of agency staff and
decreased worker compensation costs. One 2012 study found that over 60
percent of all nurse aides working in the United States reported being
injured once in the study year. Further, the report found that certain
workers were more likely to have a workplace injury, including those
who were new, changed jobs more frequently, reported poor job
preparation, and who had inadequate time to provide personal care.
Khatutsky, G., Wiener, J. M., Anderson, W. L., & Porell, F.W. (2012).
Work-related injuries among certified nursing assistants working in
U.S. nursing homes. RTI Press publication No. RR-0017-1204. Research
Triangle Park, NC: RTI Press. Retrieved from www.rti.org/rtipress).
Some of our proposals, such as nurse aide training and competency
requirements, would address some of these issues. However, the savings
are not easily estimated. Cumulative, modest impacts from proposed
changes could result in savings, in addition to the improvements in
quality of life for residents. In addition to the more specific
requests related to food service and infection control, we invite
general comment, data and analysis on whether the actions whose costs
are estimated elsewhere in the regulatory impact analysis are
sufficient to yield the benefits discussed in this section.
G. Cost to the Federal Government
If these requirements are finalized, CMS will update the
interpretive guidance, update the survey process, and make IT systems
changes. In order to implement these new standards, we anticipate
initial federal start-up costs between $15 to20 million. Once
implemented, improved surveys to review the new requirements will
require an estimated $15 to20 million annually in federal costs. CMS
will continue to examine and seeks comment on the potential impacts to
both Medicare and Medicaid.
H. Accounting Statement
As required by OMB Circular A-4 (available at https://www.whitehouse.gov/omb/circular/a004/a-4.pdf), we have prepared an
accounting statement.
Table 3--Accounting Statement
----------------------------------------------------------------------------------------------------------------
Units
-----------------------------------------------
Category Estimates Period
Year dollar Discount rate covered
----------------------------------------------------------------------------------------------------------------
Benefits........................................................................................................
----------------------------------------------------------------------------------------------------------------
Qualitative..................................... Improve in quality of life and quality of care
----------------------------------------------------------------------------------------------------------------
Costs...........................................................................................................
----------------------------------------------------------------------------------------------------------------
Annualized Monetized ($million/year)............ 659 2015 7% 2016-2020
658 2015 3% 2016-2020
---------------------------------------------------------------
Qualitative..................................... Unquantified possible cost associated with the toilet
requirement
----------------------------------------------------------------------------------------------------------------
[[Page 42245]]
Regulatory Flexibility Act (RFA)
The RFA requires agencies to analyze options for regulatory relief
of small entities, if a rule has a significant impact on a substantial
number of small entities. For purposes of the RFA, we estimate that
most nursing homes are small entities as that term is used in the RFA
(include small businesses, nonprofit organizations, and small
governmental jurisdictions). The great majority of nursing and
residential care facilities are small entities; either by being
nonprofit organizations or by meeting the Small Business
Administration's (SBA) definition of a small business having revenues
of less than $25.5 million in any 1 year (see the SBA's Web site at
https://www.sba.gov/content/small-business-size-standards). Therefore,
the Secretary has determined that this proposed rule will have a
significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis if a rule may have a significant impact on
the operations of a substantial number of small rural hospitals. This
analysis must conform to the provisions of section 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a metropolitan
statistical area and has fewer than 100 beds. This proposed rule
pertains solely to SNFs and NFs. Therefore, the Secretary has
determined that this proposed rule will not have a significant impact
on the operations of a substantial number of small rural hospitals.
Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also
requires that agencies assess anticipated costs and benefits before
issuing any rule whose mandates require spending in any 1 year of $100
million in 1995 dollars, updated annually for inflation. In 2014, that
is approximately $141 million. This proposed rule contains mandates
that would impose a one-time net cost of approximately $766,822,783
(after including savings of $24,189). Thus, we have assessed the
various costs and benefits of this proposed rule. This proposed rule
would not mandate any new requirements for state, local or tribal
governments. For the private sector facilities, the regulatory impact
section, together with the remainder of the preamble, constitutes the
analysis required under UMRA.
Federalism
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a proposed rule (and subsequent
final rule) that imposes substantial direct requirement costs on state
and local governments, preempts state law, or otherwise has Federalism
implications. We have determined that this proposed rule does not
contain policies that have substantial direct effects on the states, on
the relationship between the National Government and the states, or on
the distribution of power and responsibilities among the various levels
of government. Accordingly, we have concluded that the rule does not
contain policies that have Federalism implications as defined in the
Executive Order 13132 and, consequently, a Federalism summary impact
statement is not required.
Congressional Review Act
This proposed regulation is subject to the Congressional Review Act
provisions of the Small Business Regulatory Enforcement Fairness Act of
1996 (5 U.S.C. 801 et seq.) and has been transmitted to the Congress
and the Comptroller General for review.
I. Conclusion
The proposed requirements in this proposed rule would update the
existing requirements for long-term care facilities to reflect current
standards of practice. In addition, proposed changes would provide
added flexibility to providers, potentially improve efficiency and
effectiveness, potentially enhance resident quality of care and quality
of life, and potentially improve clinical outcomes. The analysis above,
together with the remainder of this preamble, provides a Regulatory
Impact Analysis.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.
42 CFR Part 431
Grant programs-health, Health facilities, Medicaid, Privacy,
Reporting and recordkeeping requirements.
42 CFR Part 447
Accounting, Administrative practice and procedure, Drugs, Grant
programs-health, Health facilities, Health professions, Medicaid,
Reporting and recordkeeping requirements, Rural areas.
42 CFR Part 482
Grant programs-health, Hospitals, Medicaid, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 483
Grant programs-health, Health facilities, Health professions,
Health records, Medicaid, Medicare, Nursing homes, Nutrition, Reporting
and recordkeeping requirements, Safety.
42 CFR Part 485
Grant programs-health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements.
42 CFR Part 488
Administrative practice and procedure, Health facilities, Medicare,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
0
1. The authority citation for part 405 continues to read as follows:
Authority: Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874,
1881, and 1886(k) of the Social Security Act (42 U.S.C. 405(a),
1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and
1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C.
263a).
Sec. 405.926 [Amended]
0
2. In Sec. 405.926, amend paragraph (f) by removing the reference
``Sec. 483.12'' and add in its place, the reference ``Sec. Sec.
483.5(n) and 483.15''.
PART 431--STATE ORGANIZATION AND GENERAL ADMINISTRATION
0
3. The authority citation for part 431 continues to read as follows:
Authority: Sec. 1102 of the Social Security Act, (42 U.S.C.
1302).
Sec. 431.206 [Amended]
0
4. In Sec. 431.206, amend paragraph (c)(3) by removing the reference
``Sec. 483.12'' and adding in its place the reference ``Sec.
483.15''.
[[Page 42246]]
Sec. 431.213 [Amended]
0
5. In Sec. 431.213, amend paragraph (h) by removing reference ``Sec.
483.12 (a)(5)(ii)'' and adding in its place the reference ``Sec.
483.15(b)(4)(ii) and (b)(8)'' and by removing the reference ``Sec.
483.12 (a)(5)(i)'' and adding in its place the reference ``Sec.
483.15(b)(4)(i) of this chapter''.
PART 447--PAYMENTS FOR SERVICES
0
6. The authority citation for part 447 continues to read as follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302).
Sec. 447.253 [Amended]
0
7. In Sec. 447.253, amend paragraph (b)(1)(iii)(B) by removing the
reference ``Sec. 483.30(c)'' and adding in its place the reference
``Sec. 483.35(e)''.
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
0
8. The authority citation for part 482 continues to read as follows:
Authority: Secs. 1102, 1871 and 1881 of the Social Security Act
(42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.
0
9. In Sec. 482.58, paragraphs (b)(1) through (8) are revised and
paragraph (b)(9) is added to read as follows:
Sec. 482.58 Special requirements for hospital providers of long-term
care services (``swing-beds'').
* * * * *
(b) * * *
(1) Resident rights (Sec. 483.10(a)(4)(iv), (b), (c), (d)(1),
(d)(3), (e)(8), (g), and (h)(3)).
(2) Facility responsibilities (Sec. 483.11(d)(1)(i), (d)(1)(iii),
(d)(4), (e)(11), (e)(12), (e)(14)(iii), and (f)(1)(i)).
(3) Transitions of care (Sec. 483.5(n), Sec. 483.15(b)(1),
(b)(2), (b)(3)(i) through(iii), (b)(4), (b)(5)(i) through (vii), and
(b)(7)).
(4) Freedom from abuse, neglect and exploitation (Sec. 483.12).
(5) Patient activities (Sec. 483.25(c)).
(6) Social services (Sec. 483.40(d) and Sec. 483.75(p)).
(7) Discharge planning (Sec. 483.20(e)).
(8) Specialized rehabilitative services (Sec. 483.65).
(9) Dental services (Sec. 483.55).
PART 483--REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
0
10. The authority citation for part 483 continues to read as follows:
Authority: Secs. 1102, 1128I and 1871 of the Social Security
Act (42 U.S.C. 1302, 1320a-7j, and 1395hh.
0
11. Section 483.1 is amended by revising paragraphs (a)(1) introductory
text, (a)(3), and (b) and adding paragraphs (a)(4) and (a)(5) to read
as follows:
Sec. 483.1 Basis and scope.
(a) * * *
(1) Sections 1819(a), (b), (c), (d), and (f) of the Act provide
that--
* * * * *
(3) Sections 1919(a), (b), (c), (d), and (f) of the Act provide
that nursing facilities participating in Medicaid must meet certain
specific requirements.
(4) Sections 1128I(b) and (c) require that--
(i) Skilled nursing facilities or nursing facility have in
operation a compliance and ethics program that is effective in
preventing and detecting criminal, civil, and administrative
violations.
(ii) The Secretary establish and implement a quality assurance and
performance improvement program for facilities, including multi-unit
chains of facilities.
(5) Section 1150B establishes requirements for reporting to law
enforcement crimes occurring in federally funded LTC facilities.
(b) Scope. The provisions of this part contain the requirements
that an institution must meet in order to qualify to participate as a
Skilled Nursing Facility in the Medicare program, and as a nursing
facility in the Medicaid program. They serve as the basis for survey
activities for the purpose of determining whether a facility meets the
requirements for participation in Medicare and Medicaid.
0
12. Section 483.5 is amended by--
0
a. Removing the paragraph designations for paragraphs (a), (b), (c),
(d), (e), and (f) and placing the definitions in alphabetical order.
0
b. Adding introductory text.
0
c. Revising the definition of ``common area''.
0
d. Amending the definition of ``composite distinct part'' by adding
paragraph (2)(v).
0
e. Amending the definition of ``Facility'' by removing the italicized
word ``defined''.
0
f. Adding the new definitions of ``abuse'', ``adverse event'',
``exploitation'', ``licensed health professional'', ``misappropriation
of resident property'', ``neglect'', ``nurse aide'', ``person-centered
care'', ``resident representative'', ``sexual abuse'', and ``transfer
and discharge'' in alphabetical order.
The revisions and additions read as follows:
Sec. 483.5 Definitions.
As used in this subpart, the following definitions apply:
Abuse. Abuse is the willful infliction of injury, unreasonable
confinement, intimidation, or punishment with resulting physical harm,
pain or mental anguish. Abuse also includes the deprivation by an
individual, including a caretaker, of goods or services that are
necessary to attain or maintain physical, mental, and psychosocial
well-being. This presumes that instances of abuse of all residents,
irrespective of any mental or physical condition, cause physical harm,
pain or mental anguish. It includes verbal abuse, sexual abuse,
physical abuse, and mental abuse including abuse facilitated or enabled
through the use of technology. Willful, as used in this definition of
abuse, means the individual must have acted deliberately, not that the
individual must have intended to inflict injury or harm.
Adverse event. An adverse event is an untoward, undesirable, and
usually unanticipated event that causes death or serious injury, or the
risk thereof.
Common area. Common areas are areas in the facility where residents
may gather together with other residents, visitors, and staff or engage
in individual pursuits, apart from their residential rooms. This
includes but is not limited to living rooms, dining rooms, activity
rooms, outdoor areas, and meeting rooms where residents are located on
a regular basis.
Composite distinct part. * * *
(2) * * *
(v) Use of composite distinct parts to segregate residents by
payment source or on a basis other than care needs is prohibited.
* * * * *
Exploitation. Means the unfair treatment or use of a resident or
the taking of a selfish or unfair advantage of a resident for personal
gain, through manipulation, intimidation, threats, or coercion.
* * * * *
Licensed health professional. A licensed health professional is a
physician; physician assistant; nurse practitioner; physical, speech,
or occupational therapist; physical or occupational therapy assistant;
registered professional nurse; licensed practical nurse; or licensed or
certified social worker.
* * * * *
Misappropriation of resident property means the deliberate
misplacement, exploitation, or wrongful, temporary, or permanent use of
a resident's belongings
[[Page 42247]]
or money without the resident's consent.
Neglect is the failure of the facility, its employees or service
providers to provide goods and services to a resident that are
necessary to avoid physical harm, pain, mental anguish or mental
illness.
Nurse aide. A nurse aide is 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 Sec. 488.301 of this chapter.
Person-centered care. For purposes of this subpart, person-centered
care means to focus on the resident as the locus of control and support
the resident in making their own choices and having control over their
daily lives.
Resident representative. For purposes of this subpart, the term
resident representative means an individual of the resident's choice
who has access to information and participates in healthcare
discussions or a personal representative with legal standing, such as a
power of attorney, legal guardian, or health care surrogate appointed
or designated in accordance with state law. If selected as the resident
representative, the same-sex spouse of a resident must be afforded
treatment equal to that afforded to an opposite-sex spouse if the
marriage was valid in the jurisdiction in which it was celebrated.
Sexual abuse is non-consensual sexual contact of any type with a
resident.
Transfer and discharge includes movement of a resident to a bed
outside of the certified facility whether that bed is in the same
physical plant or not. Transfer and discharge does not refer to
movement of a resident to a bed within the same certified facility.
0
13. Section 483.10 is revised to read as follows:
Sec. 483.10 Resident rights.
The resident has a right to a dignified existence, self-
determination, and communication with and access to persons and
services inside and outside the facility, including those specified in
this section.
(a) Exercise of rights. (1) The resident has the right to exercise
his or her rights as a resident of the facility and as a citizen or
resident of the United States.
(2) The resident has the right to be free of interference,
coercion, discrimination, and reprisal from the facility in exercising
his or her rights and to be supported by the facility in the exercise
of his or her rights as required under this subpart.
(3) A resident has the right to designate a representative, in
accordance with State law.
(i) The resident representative has the right to exercise the
resident's rights to the extent those rights are delegated to the
resident representative.
(ii) The resident retains the right to exercise those rights not
delegated to a resident representative, including the right to revoke a
delegation of rights, except as limited by State law.
(4) In the case of a resident adjudged incompetent under the laws
of a State by a court of competent jurisdiction, the rights of the
resident devolve to and are exercised by the resident representative
appointed under State law to act on the resident's behalf.
(i) The resident may exercise his or her rights to the extent not
prohibited by court order.
(ii) The court-appointed resident representative exercises the
resident's rights to the extent judged necessary by a court of
competent jurisdiction, in accordance with State law.
(iii) The resident's wishes and preferences must be considered in
the exercise of rights by the representative.
(iv) To the extent practicable, the resident must be provided with
opportunities to participate in the care planning process.
(5) In the case of a resident who has not been adjudged incompetent
by the state court, any legal surrogate designated in accordance with
state law may exercise the resident's rights to the extent provided by
state law. The same-sex spouse of a resident must be afforded treatment
equal to that afforded to an opposite-sex spouse if the marriage was
valid in the jurisdiction in which it was celebrated.
(b) Planning and implementing care. The resident has the right to
be informed of, and participate in, his or her treatment, including:
(1) The right to be fully informed in language that he or she can
understand of his or her total health status, including but not limited
to, his or her medical condition.
(2) The right to be informed, in advance, of the care to be
furnished and the disciplines that will furnish care.
(3) The right to be informed in advance of the risks and benefits
of proposed care, of treatment and treatment alternatives or treatment
options and to choose the alternative or option he or she prefers.
(4) The right to request, refuse, and/or discontinue treatment, to
participate in or refuse to participate in experimental research, and
to formulate an advance directive as specified in Sec. 483.11(e)(6).
(5) The right to participate in the development and implementation
of his or her person-centered plan of care, including but not limited
to:
(i) The right to participate in the planning process, including the
right to identify individuals or roles to be included in the planning
process, the right to request meetings and the right to request
revisions to the person-centered plan of care.
(ii) The right to participate in establishing the expected goals
and outcomes of care, the type, amount, frequency, and duration of
care, and any other factors related to the effectiveness of the plan of
care.
(iii) The right to be informed, in advance, of changes to the plan
of care.
(iv) The right to receive the services and/or items included in the
plan of care.
(v) The right to see the care plan, including the right to sign
after changes to the plan of care.
(6) The right to self-administer medications if the
interdisciplinary team has determined that this practice is clinically
appropriate in accordance with Sec. 483.11(b)(2).
(7) Nothing in this paragraph should be construed as the right of
the resident to receive the provision of medical treatment or medical
services deemed medically unnecessary or inappropriate.
(c) Choice of attending physician. The resident has the right to
choose his or her attending physician.
(1) The physician must be licensed to practice, and
(2) The physician must meet the professional credentialing
requirements of the facility.
(3) If the physician chosen by the resident refuses to or does not
meet requirements specified in this part, the facility may seek
alternate physician participation as specified in Sec. 483.11(c) to
assure provision of appropriate and adequate care and treatment.
(d) Respect and dignity. The resident has a right to be treated
with respect and dignity, including:
(1) The right to be free from any physical or chemical restraints
imposed for purposes of discipline or convenience, and not required to
treat the resident's medical symptoms.
(2) The right to retain and use personal possessions, including
furnishings, and clothing, as space
[[Page 42248]]
permits, unless to do so would infringe upon the rights or health and
safety of other residents.
(3) The right to reside and receive services in the facility with
reasonable accommodation of resident needs and preferences except when
to do so would endanger the health or safety of the resident or other
residents.
(4) The right to share a room with his or her spouse when married
residents live in the same facility and both spouses consent to the
arrangement.
(5) The right to share a room with his or her roommate of choice
when practicable, when both residents live in the same facility and
both residents consent to the arrangement.
(6) The right to receive notice before the resident's room or
roommate in the facility is changed.
(7) The right to refuse to transfer to another room in the
facility, if the purpose of the transfer is to relocate:
(i) A resident of a SNF from the distinct part of the institution
that is a SNF to a part of the institution that is not a SNF, or
(ii) A resident of a NF from the distinct part of the institution
that is a NF to a distinct part of the institution that is a SNF.
(8) A resident's exercise of the right to refuse transfer does not
affect the resident's eligibility or entitlement to Medicare or
Medicaid benefits.
(e) Self-determination. The resident has the right to self-
determination, including but not limited to the right to--
(1) Choose activities, schedules (including sleeping and waking
times), health care and providers of health care services consistent
with his or her interests, assessments, and plan of care;
(2) Interact with members of the community and participate in
community activities both inside and outside the facility;
(3) Receive visitors of his or her choosing at the time of his or
her choosing, subject to the resident's right to deny visitation, and
in a manner that does not impose on the rights of another resident,
including the individuals specified in Sec. 483.11(d);
(4) Organize and participate in resident groups in the facility;
(5) Participate in family groups;
(6) Have family member(s) or other resident representative(s) meet
in the facility with the families or resident representative(s) of
other residents in the facility;
(7) Participate in other activities, including social, religious,
and community activities that do not interfere with the rights of other
residents in the facility;
(8) Choose to or refuse to perform services for the facility
subject to the facility requirements in Sec. 483.11(d)(4);
(9) Manage his or her financial affairs. This includes the right to
know, in advance, what charges a facility may impose against a
resident's personal funds as specified in Sec. 483.11(d)(6)(ii);
(10) Make choices about aspects of his or her life in the facility
that are significant to the resident.
(f) Access to information. (1) The resident has the right to be
informed of his or her rights and of all rules and regulations
governing resident conduct and responsibilities during his or her stay
in the facility.
(2) The resident has the right to receive notices verbally (meaning
spoken) and in writing (including Braille) in a format and a language
he or she understands, including
(i) Required notices as specified in Sec. 483.11(e);
(ii) Information and contact information for State and local
advocacy organizations, including but not limited to the State Long-
Term Care Ombudsman program (established under section 712 of the Older
Americans Act of 1965, as amended 2006 (42 U.S.C. 3001 et seq) and the
protection and advocacy system (as designated by the state, and as
established under the Developmental Disabilities Assistance and Bill of
Rights Act of 2000 (42 U.S.C. 15001 et seq.);
(iii) Information regarding Medicare and Medicaid eligibility and
coverage;
(iv) Contact information for the Aging and Disability Resource
Center (established under Section 202(a)(20)(B)(iii) of the Older
Americans Act); or other No Wrong Door Program
(v) Contact information for the Medicaid fraud control unit; and
(vi) Information and contact information for filing grievances or
complaints about abuse, neglect, misappropriation of resident property
in the facility, and non-compliance with Sec. 489.102 of this chapter.
(3) The resident has the right to access medical records pertaining
to him or herself,--
(i) Upon an oral or written request, in the form and format
requested by the individual, if it is readily producible in such form
and format (including in an electronic form or format when such medical
records are maintained electronically); or, if not, in a readable hard
copy form or such other form and format as agreed to by the facility
and the individual, including current medical records, within 24 hours
(excluding weekends and holidays); and
(ii) After receipt of his or her medical records for inspection, to
purchase, a copy of the medical records or any portions thereof
(including in an electronic form or format when such medical records
are maintained electronically) upon request and 2 working days advance
notice to the facility. The facility may impose a reasonable, cost-
based fee on the provision of copies, provided that the fee includes
only the cost of:
(A) Labor for copying the medical records requested by the
individual, whether in paper or electronic form;
(B) Supplies for creating the paper copy or electronic media if the
individual requests that the electronic copy be provided on portable
media; and
(C) Postage, when the individual has requested the copy be mailed.
(4) The resident has the right to--
(i) Examine the results of the most recent survey of the facility
conducted by Federal or State surveyors and any plan of correction in
effect with respect to the facility; and
(ii) Receive information from agencies acting as client advocates,
and be afforded the opportunity to contact these agencies.
(g) Privacy and confidentiality. The resident has a right to
personal privacy and confidentiality of his or her personal and medical
records.
(1) This includes the right to privacy in his or her verbal (that
is, spoken), written, and electronic communications, including the
right to send and promptly receive unopened mail and other letters,
packages and other materials delivered to the facility for the
resident, including those delivered through a means other than a postal
service.
(2) Personal privacy includes accommodations, medical treatment,
written and telephone communications, personal care, visits, and
meetings of family and resident groups, but this does not require the
facility to provide a private room for each resident;
(3) The resident has a right to a secure and confidential medical
record.
(4) The resident has the right to refuse the release of personal
and medical records except as provided at Sec. 483.70(i)(2) or other
applicable federal or state laws.
(h) Communication. (1) The resident has the right to have
reasonable access to the use of a telephone, including TTY and TDD
services, and a place in the facility where calls can be made without
being overheard. This includes the right to retain and use a cellular
phone at the resident's own expense.
(2) The resident has the right to have reasonable access to and
privacy in their use of electronic communications such
[[Page 42249]]
as email and video communications and for internet research.
(i) If the access is available to the facility.
(ii) At the resident's expense, if any additional expense is
incurred by the facility to provide such access to the resident.
(3) The resident has the right to send and receive mail, and to
receive letters, packages and other materials delivered to the facility
for the resident through a means other than a postal service, including
the right to:
(i) Privacy of such communications consistent with paragraph (g)(1)
of this section; and
(ii) Access to stationery, postage, and writing implements at the
resident's own expense.
(i) Safe environment. The resident has a right to a safe, clean,
comfortable and homelike environment in accordance with Sec.
483.11(g), including but not limited to receiving treatment and
supports for daily living safely.
(j) Grievances. (1) The resident has the right to voice grievances
to the facility or other agency or entity that hears grievances without
discrimination or reprisal and without fear of discrimination or
reprisal. Such grievances include those with respect to care and
treatment which has been furnished as well as that which has not been
furnished.
(2) The resident has the right to prompt efforts by the facility to
resolve grievances in accordance with Sec. 483.11(h).
0
14. Section 483.11 is added to subpart B to read as follows:
Sec. 483.11 Facility responsibilities.
A facility must treat each resident with respect and dignity and
care for each resident in a manner and in an environment that promotes
maintenance or enhancement of his or her quality of life, recognizing
each resident's individuality. The facility must protect and promote
the rights of the resident as specified in Sec. 483.10, including, but
not limited to the following obligations:
(a) Exercise of rights. (1) The facility must ensure that the
resident can exercise his or her rights without interference, coercion,
discrimination, or reprisal from the facility.
(2) The facility must provide equal access to quality care
regardless of diagnosis, severity of condition, or payment source. A
facility must establish and maintain identical policies and practices
regarding transfer, discharge, and the provision of services under the
State plan for all residents regardless of payment source.
(3) The facility must treat the decisions of a resident
representative as the decisions of the resident to the extent required
by the court or delegated by the resident, in accordance with
applicable law.
(4) The facility shall not extend the resident representative the
right to make decisions on behalf of the resident beyond the extent
required by the court or delegated by the resident, in accordance with
applicable law.
(5) If the facility has reason to believe that a resident
representative is making decisions or taking actions that are not in
the best interests of a resident, the facility may report such concerns
as permitted and shall report such concerns when and in the manner
required under State law.
(b) Planning and implementing care. (1) The facility shall inform
the resident of the right to participate in his or her treatment and
shall support the resident in this right, consistent with Sec.
483.10(b). The planning process must:
(i) Facilitate the inclusion of the resident or resident
representative.
(ii) Include an assessment of the resident's strengths and needs.
(iii) Incorporate the resident's personal and cultural preferences
in developing goals of care.
(2) The interdisciplinary team, as defined by Sec.
483.21(b)(2)(ii), is responsible for determining if resident self-
administration of medications is clinically appropriate.
(c) Attending physician. (1) The facility must ensure that each
resident remains informed of the name, specialty, and way of contacting
the physician and other primary care professionals responsible for his
or her care.
(2) The facility must inform the resident if the facility
determines that the physician chosen by the resident is unable or
unwilling to meet requirements specified in this part and the facility
seeks alternate physician participation to assure provision of
appropriate and adequate care and treatment. The facility must discuss
the alternative physician participation with the resident and honor the
resident's preferences, if any, among options.
(3) If the resident subsequently selects another attending
physician who meets the requirements specified in this part, the
facility must honor that choice.
(d) Self-determination. The facility must promote and facilitate
resident self-determination through support of resident choice as
specified in Sec. 483.10(e) and as follows:
(1) The facility must:
(i) Provide immediate access to any resident by:
(A) Any representative of the Secretary,
(B) Any representative of the State,
(C) Any representative of the Office of the State long term care
ombudsman, (established under section 712 of the Older Americans Act of
1965, as amended 2006 (42 U.S.C. 3001 et seq.);
(D) The resident's individual physician,
(E) Any representative of the protection and advocacy systems, as
designated by the state, and as established under the Developmental
Disabilities Assistance and Bill of Rights Act of 2000 (42 U.S.C. 15001
et seq.),
(F) Any representative of the agency responsible for the protection
and advocacy system for individuals with mental illness (established
under the Protection and Advocacy for Mentally Ill Individuals Act of
2000 (42 U.S.C. 10802); and
(G) The resident representative.
(ii) Provide immediate access to a resident by immediate family and
other relatives of the resident, subject to the resident's right to
deny or withdraw consent at any time;
(iii) Provide immediate access to a resident by others who are
visiting with the consent of the resident, subject to reasonable
clinical and safety restrictions and the resident's right to deny or
withdraw consent at any time;
(iv) Provide reasonable access to a resident by any entity or
individual that provides health, social, legal, or other services to
the resident, subject to the resident's right to deny or withdraw
consent at any time; and
(2) The facility must have written policies and procedures
regarding the visitation rights of residents, including those setting
forth any clinically necessary or reasonable restriction or limitation
or safety restriction or limitation that the facility may need to place
on such rights and the reasons for the clinical or safety restriction
or limitation. A facility must meet the following requirements:
(i) Inform each resident (or resident representative, where
appropriate) of his or her visitation rights, including any clinical or
safety restriction or limitation on such rights, when he or she is
informed of his or her other rights under this section.
(ii) Inform each resident of the right, subject to his or her
consent, to receive the visitors whom he or she designates, including,
but not limited to, a spouse (including a same-sex spouse), a domestic
partner (including a same-sex domestic partner), another family member,
or a friend, and his or her right to withdraw or deny such consent at
any time.
(iii) Not restrict, limit, or otherwise deny visitation privileges
on the basis of
[[Page 42250]]
race, color, national origin, religion, sex, gender identity, sexual
orientation, or disability.
(iv) Ensure that all visitors enjoy full and equal visitation
privileges consistent with resident preferences.
(3) The facility must provide a resident or family group, if one
exists, with private space; and
(i) Staff or visitors may attend meetings only at the group's
invitation;
(ii) The facility must provide a designated staff person who is
approved by the resident or family group and the facility and who is
responsible for providing assistance and responding to written requests
that result from group meetings;
(iii) The facility must consider the views of a resident or family
group and act upon the grievances and recommendations of such groups
concerning issues of resident care and life in the facility.
(A) This should not be construed to mean that the facility must
implement as recommended every request of the resident or family group.
(B) The facility must be able to demonstrate their response and
rationale for such response.
(4) The facility must not require a resident to perform services
for the facility. The resident may perform services for the facility,
if he or she chooses, when--
(i) The facility has documented the resident's need or desire for
work in the plan of care;
(ii) The plan specifies the nature of the services performed and
whether the services are voluntary or paid;
(iii) Compensation for paid services is at or above prevailing
rates; and
(iv) The resident agrees to the work arrangement described in the
plan of care.
(5) The facility must not require residents to deposit their
personal funds with the facility. If a resident chooses to deposit
personal funds with the facility, the facility must adhere to the
following requirements.
(i) Management of personal funds. Upon written authorization of a
resident, the facility must hold, safeguard, manage, and account for
the personal funds of the resident deposited with the facility, as
specified in this section.
(ii) Deposit of funds.
(A) In general:
(1) Except as set out in paragraph (d)(5)(ii)(B)(1) of this
section, the facility must deposit any residents' personal funds in
excess of $100 in an interest bearing account (or accounts) that is
separate from any of the facility's operating accounts, and that
credits all interest earned on resident's funds to that account. (In
pooled accounts, there must be a separate accounting for each
resident's share.)
(2) The facility must maintain a resident's personal funds that do
not exceed $100 in a non-interest bearing account, interest-bearing
account, or petty cash fund.
(B) Residents whose care is funded by Medicaid:
(1) The facility must deposit the residents' personal funds in
excess of $50 in an interest bearing account (or accounts) that is
separate from any of the facility's operating accounts, and that
credits all interest earned on resident's funds to that account. (In
pooled accounts, there must be a separate accounting for each
resident's share.)
(2) The facility must maintain personal funds that do not exceed
$50 in a non-interest bearing account, interest-bearing account, or
petty cash fund.
(iii) Accounting and records. (A) The facility must establish and
maintain a system that assures a full and complete and separate
accounting, according to generally accepted accounting principles, of
each resident's personal funds entrusted to the facility on the
resident's behalf. (B) The system must preclude any commingling of
resident funds with facility funds or with the funds of any person
other than another resident.
(C) The individual financial record must be available to the
resident through quarterly statements and upon request.
(iv) Notice of certain balances. The facility must notify each
resident that receives Medicaid benefits--
(A) When the amount in the resident's account reaches $200 less
than the SSI resource limit for one person, specified in section
1611(a)(3)(B) of the Act; and
(B) That, if the amount in the account, in addition to the value of
the resident's other nonexempt resources, reaches the SSI resource
limit for one person, the resident may lose eligibility for Medicaid or
SSI.
(v) Conveyance upon discharge, eviction, or death. Upon the
discharge, eviction, or death of a resident with a personal fund
deposited with the facility, the facility must convey within 30 days
the resident's funds, and a final accounting of those funds, to the
resident, or in the case of death, the individual or probate
jurisdiction administering the resident's estate, in accordance with
State law.
(vi) Assurance of financial security. The facility must purchase a
surety bond, or otherwise provide assurance satisfactory to the
Secretary, to assure the security of all personal funds of residents
deposited with the facility.
(6) The facility must not impose a charge against the personal
funds of a resident for any item or service for which payment is made
under Medicaid or Medicare (except for applicable deductible and
coinsurance amounts). The facility may charge the resident for
requested services that are more expensive than or in excess of covered
services in accordance with Sec. 489.32 of this chapter. (This does
not affect the prohibition on facility charges for items and services
for which Medicaid has paid. See Sec. 447.15 of this chapter, which
limits participation in the Medicaid program to providers who accept,
as payment in full, Medicaid payment plus any deductible, coinsurance,
or copayment required by the plan to be paid by the individual.)
(i) Services included in Medicare or Medicaid payment. During the
course of a covered Medicare or Medicaid stay, facilities may not
charge a resident for the following categories of items and services:
(A) Nursing services as required at Sec. 483.35.
(B) Food and Nutrition services as required at Sec. 483.60.
(C) An activities program as required at Sec. 483.25(c).
(D) Room/bed maintenance services.
(E) Routine personal hygiene items and services as required to meet
the needs of residents, including, but not limited to, hair hygiene
supplies, comb, brush, bath soap, disinfecting soaps or specialized
cleansing agents when indicated to treat special skin problems or to
fight infection, razor, shaving cream, toothbrush, toothpaste, denture
adhesive, denture cleaner, dental floss, moisturizing lotion, tissues,
cotton balls, cotton swabs, deodorant, incontinence care and supplies,
sanitary napkins and related supplies, towels, washcloths, hospital
gowns, over the counter drugs, hair and nail hygiene services, bathing
assistance, and basic personal laundry.
(F) Medically-related social services as required at Sec.
483.40(d).
(G) Hospice services elected by the resident and paid for under the
Medicare Hospice Benefit or paid for by Medicaid under a state plan.
(ii) Items and services that may be charged to residents' funds.
Listed below in paragraphs (d)(6)(ii)(A) through (L) of this section
are general categories and examples of items and services that the
facility may charge to residents' funds if they are requested by a
resident, if they are not required to achieve the goals stated in the
resident's care plan, if the facility informs the
[[Page 42251]]
resident that there will be a charge, and if payment is not made by
Medicare or Medicaid:
(A) Telephone, including a cellular phone.
(B) Television/radio, personal computer or other electronic device
for personal use.
(C) Personal comfort items, including smoking materials, notions
and novelties, and confections.
(D) Cosmetic and grooming items and services in excess of those for
which payment is made under Medicaid or Medicare.
(E) Personal clothing.
(F) Personal reading matter.
(G) Gifts purchased on behalf of a resident.
(H) Flowers and plants.
(I) Cost to participate in social events and entertainment outside
the scope of the activities program, provided under Sec. 483.25(c).
(J) Noncovered special care services such as privately hired nurses
or aides.
(K) Private room, except when therapeutically required (for
example, isolation for infection control).
(L) Except as provided below, specially prepared or alternative
food requested instead of the food and meals generally prepared by the
facility, as required by Sec. 483.60.
(1) The facility may not charge for special foods and meals,
including medically prescribed dietary supplements, ordered by the
resident's health care provider, as these are included per Sec.
483.60.
(2) In accordance with Sec. 483.60(c) through (f), when preparing
foods and meals, a facility must take into consideration residents'
needs and preferences and the overall cultural and religious make-up of
the facility's population.
(iii) Requests for items and services. (A) The facility can only
charge a resident for any noncovered item or service if such item or
service is specifically requested by the resident.
(B) The facility must not require a resident to request any item or
service as a condition of admission or continued stay.
(C) The facility must inform, orally and in writing, the resident
requesting an item or service for which a charge will be made that
there will be a charge for the item or service and what the charge will
be.
(e) Information and communication. (1) With the exception of
information described in paragraph (e)(2) of this section, the facility
must ensure that information is provided to each resident in a form and
manner the resident can access and understand, including in an
alternative format or in a language that the resident can understand.
Summaries that translate information described in paragraph (e)(2) of
this section may be made available to the patient at their request and
expense in accordance with applicable law.
(2) The facility must:
(i) Provide the resident with access to medical records pertaining
to him or herself, upon an oral or written request, in the form and
format requested by the individual, if it is readily producible in such
form and format (including in an electronic form or format when such
medical records are maintained electronically); or, if not, in a
readable hard copy form or such other form and format as agreed to by
the facility and the individual, within 24 hours (excluding weekends
and holidays); and
(ii) Allow the resident to purchase, after receipt of his or her
medical records for inspection, a copy of the medical records or any
portions thereof (including in an electronic form or format when such
medical records are maintained electronically) upon request and 2
working days advance notice to the facility.
(iii) The facility may impose a reasonable, cost-based fee,
provided that the fee includes only the cost of:
(A) Labor for copying the medical records requested by the
individual, whether in paper or electronic form;
(B) Supplies for creating the paper copy or electronic media if the
individual requests that the electronic copy be provided on portable
media; and
(C) Postage, when the individual has requested the copy be mailed.
(3) The facility must make reports with respect to any surveys,
certifications, and complaint investigations conducted by Federal or
State surveyors during the 3 preceding years available for any
individual to review upon request and any plan of correction in effect
with respect to the facility available for examination in a place
readily accessible to and in a form understandable by residents, and
must post a notice of its availability.
(4) The facility must post, in a form and manner accessible and
understandable to residents, resident representatives and support
person:
(i) A list of names, addresses (mailing and email), and telephone
numbers of all pertinent State agencies and advocacy groups, such as
the State survey and certification agency, the State licensure office,
adult protective services where state law provides for jurisdiction in
long-term care facilities, the Office of the State Long-Term Care
Ombudsman program, the protection and advocacy network, home and
community based service programs, and the Medicaid fraud control unit;
and
(ii) A statement that the resident may file a complaint with the
State survey and certification agency concerning resident abuse,
neglect, misappropriation of resident property in the facility, and
non-compliance with the requirements specified in 42 CFR part 489
subpart I (Advance Directives).
(5) The facility must comply with the requirements specified in 42
CFR part 489, subpart I (Advance Directives).
(i) These requirements include provisions to inform and provide
written information to all adult residents concerning the right to
accept or refuse medical or surgical treatment and, at the resident's
option, formulate an advance directive.
(ii) This includes a written description of the facility's policies
to implement advance directives and applicable State law.
(iii) Facilities are permitted to contract with other entities to
furnish this information but are still legally responsible for ensuring
that the requirements of this section are met.
(iv) If an adult individual is incapacitated at the time of
admission and is unable to receive information or articulate whether or
not he or she has executed an advance directive, the facility may give
advance directive information to the individual's resident
representative in accordance with State law.
(v) The facility is not relieved of its obligation to provide this
information to the individual once he or she is able to receive such
information. Follow-up procedures must be in place to provide the
information to the individual directly at the appropriate time.
(6) The facility must display in the facility written information,
and provide to residents and applicants for admission, oral and written
information about how to apply for and use Medicare and Medicaid
benefits, and how to receive refunds for previous payments covered by
such benefits.
(7) Notification of changes. (i) A facility must immediately inform
the resident; consult with the resident's physician; and notify the
resident representative(s) when there is--
(A) An accident involving the resident which results in injury and
has the potential for requiring physician intervention;
(B) A significant change in the resident's physical, mental, or
psychosocial status (that is, a deterioration in health, mental, or
psychosocial status in either life-
[[Page 42252]]
threatening conditions or clinical complications);
(C) A need to alter treatment significantly (that is, a need to
discontinue an existing form of treatment due to adverse consequences,
or to commence a new form of treatment); or
(D) A decision to transfer or discharge the resident from the
facility as specified in Sec. 483.15(b)(1)(ii).
(ii) When making notification under paragraph (e)(7)(i) of this
section, the facility must ensure that all pertinent information
specified in Sec. 483.15(b)(2) is available and provided upon request
to the physician.
(iii) The facility must also promptly notify the resident and the
resident representative, if any, when there is--
(A) A change in room or roommate assignment as specified in Sec.
483.10(d)(6); or
(B) A change in resident rights under Federal or State law or
regulations as specified in paragraph (e)(10) of this section.
(iv) The facility must record and periodically update the address
(mailing and email) and phone number of the resident representative(s).
(8) Admission to a composite distinct part. A facility that is a
composite distinct part (as defined in Sec. 483.5 must disclose in its
admission agreement its physical configuration, including the various
locations that comprise the composite distinct part, and must specify
the policies that apply to room changes between its different locations
under Sec. 483.15(b)(9).
(9) The facility must provide a notice of rights and services to
the resident prior to or upon admission and during the resident's stay.
(i) The facility must inform the resident both orally and in
writing in a language that the resident understands of his or her
rights and all rules and regulations governing resident conduct and
responsibilities during the stay in the facility.
(ii) The facility must also provide the resident with the State-
developed notice of Medicaid rights and obligations, if any.
(iii) Receipt of such information, and any amendments to it, must
be acknowledged in writing;
(10) The facility must:
(i) Inform each Medicaid-eligible resident, in writing, at the time
of admission to the nursing facility and when the resident becomes
eligible for Medicaid of--
(A) The items and services that are included in nursing facility
services under the State plan and for which the resident may not be
charged;
(B) Those other items and services that the facility offers and for
which the resident may be charged, and the amount of charges for those
services; and
(ii) Inform each Medicaid-eligible resident when changes are made
to the items and services specified in paragraphs (e)(10)(i)(A) and (B)
of this section.
(11) The facility must inform each resident before, or at the time
of admission, and periodically during the resident's stay, of services
available in the facility and of charges for those services, including
any charges for services not covered under Medicare/Medicaid or by the
facility's per diem rate.
(i) Where changes in coverage are made to items and services
covered by Medicare and/or by the Medicaid State plan, the facility
must provide notice to residents of the change as soon as is reasonably
possible;
(ii) Where changes are made to charges for other items and services
that the facility offers, the facility must inform the resident in
writing at least 60 days prior to implementation of the change.
(iii) If a resident dies or is hospitalized or is transferred and
does not return to the facility, the facility must refund to the
resident, resident representative, or estate, as applicable, any
deposit or charges already paid, less the facility's per diem rate, for
the days the resident actually resided or reserved or retained a bed in
the facility, regardless of any minimum stay or discharge notice
requirements.
(iv) The facility must refund to the resident or resident
representative any and all refunds due the resident within thirty days
from the resident's date of discharge from the facility.
(v) Where the facility requires the execution of an admission
contract by or on behalf of an individual seeking admission to the
facility, the terms of the contract must not conflict with the
requirements of these regulations.
(12) The facility must furnish to each resident a written
description of legal rights which includes--
(i) A description of the manner of protecting personal funds, under
paragraph (d)(5) of this section;
(ii) A description of the requirements and procedures for
establishing eligibility for Medicaid, including the right to request
an assessment of resources under section 1924(c) of the Social Security
Act.
(iii) A list of names, addresses (mailing and email), and telephone
numbers of all pertinent State regulatory and informational agencies,
resident advocacy groups such as the State survey and certification
agency, the State licensure office, the State Long-Term Care Ombudsman
program, the protection and advocacy agency, adult protective services
where state law provides for jurisdiction in long-term care facilities,
the local contact agency for information about returning to the
community and the Medicaid fraud control unit; and
(iv) A statement that the resident may file a complaint with the
State survey and certification agency concerning any suspected
violation of state or federal nursing facility regulations, including
but not limited to resident abuse, neglect, misappropriation of
resident property in the facility, non-compliance with the advance
directives requirements and requests for information regarding
returning to the community.
(13) The facility must protect and facilitate that resident's right
to communicate with individuals and entities within and external to the
facility, consistent with Sec. 483.10(h), including reasonable access
to:
(i) A telephone, including TTY and TDD services;
(ii) The internet, to the extent available to the facility; and
(iii) Stationery, postage, writing implements and the ability to
send mail.
(f) Privacy and confidentiality. (1) The facility must respect the
resident's right to personal privacy, including privacy in his or her
verbal (meaning spoken), written and electronic communications.
(i) This includes ensuring that a resident can send and promptly
receive mail that is unopened; as well as receive, unopened, letters,
packages and other materials delivered to the facility for the resident
through a means other than a postal service.
(ii) Personal privacy includes accommodations, medical treatment,
written and telephone communications, personal care, visits, and
meetings of family and resident groups, but this does not require the
facility to provide a private room for each resident;
(2) The facility must comply with the residents' rights in Sec.
483.10(g)(3) regarding his or her medical records.
(3) The facility must allow representatives of the Office of the
State Long-Term Care Ombudsman to examine a resident's medical, social,
and administrative records in accordance with State law.
(g) Safe environment. The facility must provide:
(1) A safe, clean, comfortable, and homelike environment, allowing
the resident to use his or her personal
[[Page 42253]]
belongings to the extent possible. This includes ensuring:
(i) That the resident can receive care and services safely.
(ii) That the physical layout of the facility maximizes
independence and does not pose a safety risk.
(2) Housekeeping and maintenance services necessary to maintain a
sanitary, orderly, and comfortable interior;
(3) Clean bed and bath linens that are in good condition;
(4) Private closet space in each resident room, as specified in
Sec. 483.90(d)(2)(iv);
(5) Adequate and comfortable lighting levels in all areas;
(6) Comfortable and safe temperature levels. Facilities initially
certified after October 1, 1990 must maintain a temperature range of
71-81 [deg]F; and
(7) For the maintenance of comfortable sound levels.
(h) Grievances. (1) The facility must make information on how to
file a grievance or complaint available to the resident, including the
information required under paragraph (f)(2) of this section.
(2) The facility must make prompt efforts to resolve grievances the
resident may have, including those with respect to the behavior of
other residents.
(3) The facility must establish a grievance policy to ensure the
prompt resolution of all grievances regarding the residents' rights
contained in Sec. 483.10. Upon request, the provider must give a copy
of the grievance policy to the resident. The grievance policy must
include:
(i) Notifying resident individually or through postings in
prominent locations throughout the facility of the right to file
grievances verbally (meaning spoken) or in writing; the right to file
grievances anonymously; the contact information of the grievance
official with whom a grievance can be filed, that is, his or her name,
business address (mailing and email) and business phone number; a
reasonable expected time frame for completing the review of the
grievance; the right to obtain a written decision regarding his or her
grievance; and the contact information of independent entities with
whom grievances may be filed, that is, the pertinent State agency,
Quality Improvement Organization, State Survey Agency and State Long-
Term Care Ombudsman program or protection and advocacy system;
(ii) Identifying a Grievance Official who is responsible for
overseeing the grievance process, receiving and tracking grievances
through their conclusion; leading any necessary investigations by the
facility; maintaining the confidentiality of all information associated
with grievances, for example, the identity of the resident for those
grievances submitted anonymously; issuing written grievance decisions
to the resident; and coordinating with State and Federal agencies as
necessary in light of specific allegations;
(iii) As necessary, taking immediate action to prevent further
potential violations of any resident right while the alleged violation
is being investigated;
(iv) Immediately reporting all alleged violations involving
neglect, abuse, including injuries of unknown source, and/or
misappropriation of resident property, by anyone furnishing services on
behalf of the provider, to the administrator of the provider; and as
required by State law;
(v) Ensuring that all written grievance decisions include the date
the grievance was received, a summary statement of the resident's
grievance, the steps taken to investigate the grievance, a summary of
the pertinent findings or conclusions regarding the resident's
concern(s), a statement as to whether the grievance was confirmed or
not confirmed, any corrective action taken or to be taken by the
facility as a result of the grievance, and the date the written
decision was issued;
(vi) Taking appropriate corrective action in accordance with State
law if the alleged violation of the residents' rights is confirmed by
the facility or if an outside entity having jurisdiction, such as the
State survey and certification agency, Quality Improvement
Organization, or local law enforcement agency confirms a violation of
any of these residents' rights within its area of responsibility; and
(vii) Maintaining evidence demonstrating the results of all
grievances for a period of no less than three years from the issuance
of the grievance decision.
(i) Contact with external entities. A facility must not prohibit or
in any way discourage a resident from communicating with Federal,
State, or local officials, including, but not limited to, Federal and
State surveyors, other Federal or State health department employees,
including representatives of the Office of the State Long-Term Care
Ombudsman and of the protection and advocacy system, regarding any
matter, whether or not subject to arbitration or any other type of
judicial or regulatory action.
0
15. Section 483.12 is revised to read as follows:
Sec. 483.12 Freedom from abuse, neglect, and exploitation.
The resident has the right to be free from abuse, neglect,
misappropriation of resident property, and exploitation as defined in
this subpart. This includes but is not limited to freedom from corporal
punishment, involuntary seclusion and any physical or chemical
restraint not required to treat the resident's medical symptoms.
(a) The facility must--
(1) Not use verbal, mental, sexual, or physical abuse, corporal
punishment, or involuntary seclusion;
(2) Not employ or otherwise engage individuals who--
(i) Have been found guilty of abuse, neglect, misappropriation of
property, or mistreatment by a court of law;
(ii) Have had a finding entered into the State nurse aide registry
concerning abuse, neglect, mistreatment of residents or
misappropriation of their property; or
(iii) Have had a disciplinary action taken against a professional
license by a state licensure body as a result of a finding of abuse,
neglect, mistreatment of residents or misappropriation of resident
property.
(3) Report to the State nurse aide registry or licensing
authorities any knowledge it has of actions by a court of law against
an employee, which would indicate unfitness for service as a nurse aide
or other facility staff.
(b) The facility must develop and implement written policies and
procedures that:
(1) Prohibit and prevent abuse, neglect, and exploitation of
residents and misappropriation of resident property,
(2) Establish policies and procedures to investigate any such
allegations, and
(3) Include training as required at paragraph Sec. 483.95.
(4) Establish coordination with the QAPI program required under
Sec. 483.75.
(5) Ensure reporting of crimes occurring in federally-funded long-
term care facilities in accordance with section 1150B of the Social
Security Act. The policies and procedures must include but are not
limited to the following elements.
(i) Annually notifying covered individuals, as defined at section
1150B(a)(3) of the Act, of that individual's obligation to comply with
the following reporting requirements.
(A) Each covered individual shall report to the State Agency and
one or more law enforcement entities for the political subdivision in
which the facility is located any reasonable suspicion of a crime
against any individual who is a resident of, or is receiving care from,
the facility.
[[Page 42254]]
(B) Each covered individual shall report not later than 2 hours
after forming the suspicion, if the events that cause the suspicion
result in serious bodily injury, or not later than 24 hours if the
events that cause the suspicion do not result in serious bodily injury.
(ii) Posting a conspicuous notice of employee rights, as defined at
section 1150B(d)(3) of the Act.
(iii) Prohibiting and preventing retaliation, as defined at section
1150B(d)(1) and (2) of the Act.
(c) In response to allegations of abuse, neglect, exploitation, or
mistreatment, the facility must:
(1) Ensure that all alleged violations involving abuse, neglect,
exploitation or mistreatment, including injuries of unknown source and
misappropriation of resident property, are reported immediately to the
administrator of the facility and to other officials (including to the
State survey and certification agency and adult protective services
where state law provides for jurisdiction in long-term care facilities)
in accordance with State law through established procedures.
(2) Have evidence that all alleged violations are thoroughly
investigated.
(3) Prevent further potential abuse, neglect, exploitation, or
mistreatment while the investigation is in progress.
(4) Report the results of all investigations to the administrator
or his resident representative and to other officials in accordance
with State law (including to the State survey and certification agency)
within 5 working days of the incident, and if the alleged violation is
verified appropriate corrective action must be taken.
Sec. 483.13 [Removed]
0
16. Remove Sec. 483.13.
0
17. Section 483.15 is revised to read as follows:
Sec. 483.15 Transitions of care.
Transitions of care include admissions to and discharges or
transfers to or from a SNF or NF. This section also addresses bed-hold
policies and therapeutic leave.
(a) Admissions policy. (1) The facility must establish and
implement an admissions policy.
(2) The facility must--
(i) Not request or require residents or potential residents to
waive their rights as set forth in this subpart and in applicable
State, Federal or local licensing or certification laws, including but
not limited to their rights to Medicare or Medicaid; and
(ii) Not request or require oral or written assurance that
residents or potential residents are not eligible for, or will not
apply for, Medicare or Medicaid benefits.
(iii) Not request or require residents or potential residents to
waive potential facility liability for losses of personal property
(3) The facility must not request or require a third party
guarantee of payment to the facility as a condition of admission or
expedited admission, or continued stay in the facility. However, the
facility may request and require a resident representative who has
legal access to a resident's income or resources available to pay for
facility care to sign a contract, without incurring personal financial
liability, to provide facility payment from the resident's income or
resources.
(4) In the case of a person eligible for Medicaid, a nursing
facility must not charge, solicit, accept, or receive, in addition to
any amount otherwise required to be paid under the State plan, any
gift, money, donation, or other consideration as a precondition of
admission, expedited admission or continued stay in the facility.
However,--
(i) A nursing facility may charge a resident who is eligible for
Medicaid for items and services the resident has requested and
received, and that are not specified in the State plan as included in
the term ``nursing facility services'' so long as the facility gives
proper notice of the availability and cost of these services to
residents and does not condition the resident's admission or continued
stay on the request for and receipt of such additional services; and
(ii) A nursing facility may solicit, accept, or receive a
charitable, religious, or philanthropic contribution from an
organization or from a person unrelated to a Medicaid eligible resident
or potential resident, but only to the extent that the contribution is
not a condition of admission, expedited admission, or continued stay in
the facility for a Medicaid eligible resident.
(5) States or political subdivisions may apply stricter admissions
standards under State or local laws than are specified in this section,
to prohibit discrimination against individuals entitled to Medicaid.
(6) A nursing facility must disclose and provide to a resident or
potential resident, at or prior to time of admission, notice of special
characteristics or service limitations of the facility.
(7) A nursing facility that is a composite distinct part as defined
in Sec. 483.5(c) must disclose in its admission agreement its physical
configuration, including the various locations that comprise the
composite distinct part, and must specify the policies that apply to
room changes between its different locations under paragraph (b)(10) of
this section.
(b) Transfer and discharge--(1) Facility requirements--(i) Equal
access to quality care. (A) A facility must establish, maintain and
implement identical policies and practices regarding transfer,
discharge, and the provision of services for all individuals regardless
of source of payment;
(B) The facility may charge any amount for services furnished to
non-Medicaid residents unless otherwise limited by state law and
consistent with the notice requirement in Sec. 483.11(e)(11)(i) and
(e)(12) describing the charges; and
(C) The State is not required to offer additional services on
behalf of a resident other than services provided in the State plan.
(ii) The facility must permit each resident to remain in the
facility, and not transfer or discharge the resident from the facility
unless--
(A) The transfer or discharge is necessary for the resident's
welfare and the resident's needs cannot be met in the facility;
(B) The transfer or discharge is appropriate because the resident's
health has improved sufficiently so the resident no longer needs the
services provided by the facility;
(C) The safety of individuals in the facility is endangered due to
the clinical or behavioral status of the resident;
(D) The health of individuals in the facility would otherwise be
endangered;
(E) The resident has failed, after reasonable and appropriate
notice, to pay for (or to have paid under Medicare or Medicaid) a stay
at the facility. Non-payment does not apply unless the resident does
not submit the necessary paperwork for third party payment or until the
third party, including Medicare or Medicaid, denies the claim and the
resident refuses to pay for his or her stay. For a resident who becomes
eligible for Medicaid after admission to a facility, the facility may
charge a resident only allowable charges under Medicaid; or
(F) The facility ceases to operate.
(iii) The facility may not transfer or discharge the resident while
the appeal is pending, pursuant to Sec. 431.230 of this chapter, when
a resident exercises his or her right to appeal a transfer or discharge
notice from the facility pursuant to Sec. 431.220(a)(3) of this
chapter.
(2) Documentation. When the facility transfers or discharges a
resident under any of the circumstances specified in paragraphs
(b)(1)(i)(A) through (F) of
[[Page 42255]]
this section, the facility must ensure that the transfer or discharge
is documented in the resident's clinical record and appropriate
information is communicated to the receiving health care institution or
provider.
(i) Documentation in the resident's clinical record must include:
(A) The basis for the transfer per paragraph (b)(1)(ii).
(B) In the case of paragraph (b)(1)(ii)(A) of this section, the
specific resident need(s) that cannot be met, facility attempts to meet
the resident needs, and the service available at the receiving facility
to meet the need(s).
(ii) The documentation must be made by--
(A) The resident's physician when transfer or discharge is
necessary under paragraph (b)(1)(i)(A) or (B) of this section; and
(B) A physician when transfer or discharge is necessary under
paragraph (b)(1)(i)(C) or (D) of this section.
(iii) Information provided to the receiving provider must include a
minimum of the following:
(A) Demographic information including but not limited to name, sex,
date of birth, race, ethnicity, and preferred language.
(B) Resident representative information including contact
information.
(C) Advance Directive information.
(D) History of present illness/reason for transfer including
primary care team contact information.
(E) Past medical/surgical history, including procedures.
(F) Active diagnoses/Current problem list and status.
(G) Laboratory tests and the results of pertinent laboratory and
other diagnostic testing.
(H) Functional status.
(I) Psychosocial assessment, including cognitive status.
(J) Social Supports
(K) Behavioral Health Issues
(L) Medications.
(M) Allergies, including medication allergies.
(N) Immunizations.
(O) Smoking status.
(P) Vital signs.
(Q) Unique device identifier(s) for a patient's implantable
device(s), if any.
(R) Comprehensive Care plan goals, including health concerns,
assessment and plan, resident preferences, interventions, including
efforts to meet resident needs, and resident status.
(iv) This requirement may be satisfied by the discharge summary
providing it meets the requirements of Sec. 483.21(c) and includes at
a minimum the information specified in paragraph (b)(2)(iii) of this
section.
(3) Notice before transfer. Before a facility transfers or
discharges a resident, the facility must--
(i) Notify the resident and the resident's representative(s) of the
transfer or discharge and the reasons for the move in writing and in a
language and manner they understand. Subject to the resident's
agreement, the facility must send a copy of the notice to a
representative of the Office of the State Long-Term Care Ombudsman.
(ii) Record the reasons for the transfer or discharge in the
resident's clinical record in accordance with paragraph (b)(2) of this
section; and
(iii) Include in the notice the items described in paragraph (b)(5)
of this section.
(4) Timing of the notice. (i) Except as specified in paragraphs
(b)(4)(ii) and (b)(8) of this section, the notice of transfer or
discharge required under this section must be made by the facility at
least 30 days before the resident is transferred or discharged.
(ii) Notice must be made as soon as practicable before transfer or
discharge when--
(A) The safety of individuals in the facility would be endangered
under paragraph (b)(1)(ii)(C) of this section;
(B) The health of individuals in the facility would be endangered,
under paragraph (b)(1)(ii)(D) of this section;
(C) The resident's health improves sufficiently to allow a more
immediate transfer or discharge, under paragraph (b)(1)(ii)(B) of this
section;
(D) An immediate transfer or discharge is required by the
resident's urgent medical needs, under paragraph (b)(1)(ii)(A) of this
section; or
(E) A resident has not resided in the facility for 30 days.
(5) Contents of the notice. The written notice specified in
paragraph (b)(3) of this section must include the following:
(i) The reason for transfer or discharge;
(ii) The effective date of transfer or discharge;
(iii) The location to which the resident is expected to be
transferred or discharged;
(iv) A statement that the resident has the right to appeal the
action to the State, the name, address (mailing and email), and
telephone number of the State entity which receives such requests; and
information on how to obtain an appeal form and assistance in
completing the form and submitting the appeal hearing request;
(v) The name, address (mailing and email) and telephone number of
the Office of the State Long-Term Care Ombudsman;
(vi) For nursing facility residents with intellectual and
developmental disabilities, the mailing and email address and telephone
number of the agency responsible for the protection and advocacy of
individuals with developmental disabilities established under Part C of
the Developmental Disabilities Assistance and Bill of Rights Act of
2000 (42 U.S.C. 10802); and
(vii) For nursing facility residents with mental illness, the
mailing and email address and telephone number of the agency
responsible for the protection and advocacy of individuals with mental
illness established under the Protection and Advocacy for Mentally Ill
Individuals Act.
(6) Changes to the notice. If the information in the notice changes
prior to effecting the transfer or discharge, the facility must update
the recipients of the notice as soon as practicable once the updated
information becomes available.
(7) Orientation for transfer or discharge. A facility must provide
and document sufficient preparation and orientation to residents to
ensure safe and orderly transfer or discharge from the facility. This
orientation must be provided in a form and manner that the resident can
understand.
(8) Notice in advance of facility closure. In the case of facility
closure, the individual who is the administrator of the facility must
provide written notification prior to the impending closure to the
State Survey Agency, the Office of the State Long-Term Care Ombudsman,
residents of the facility, and the resident representatives of the
residents or other responsible parties, as well as the plan for the
transfer and adequate relocation of the residents, as required at Sec.
483.70(l).
(9) Room changes in a composite distinct part. Room changes in a
facility that is a composite distinct part (as defined in Sec. 483.5)
are subject to the requirements of Sec. 483.10(d)(7) and must be
limited to moves within the particular building in which the resident
resides, unless the resident voluntarily agrees to move to another of
the composite distinct part's locations.
(c) Notice of bed-hold policy and readmission--(1) Notice before
transfer. Before a nursing facility transfers a resident to a hospital
or the resident goes on therapeutic leave, the nursing facility must
provide written information to the resident or resident representative
that specifies--
(i) The duration of the state bed-hold policy, if any, during which
the resident is permitted to return and resume residence in the nursing
facility;
(ii) The reserve bed payment policy in the state plan, under Sec.
447.40 of this chapter, if any;
[[Page 42256]]
(iii) The nursing facility's policies regarding bed-hold periods,
which must be consistent with paragraph (c)(3) of this section,
permitting a resident to return; and
(iv) The information specified in paragraph (c)(3) of this section.
(2) Bed-hold notice upon transfer. At the time of transfer of a
resident for hospitalization or therapeutic leave, a nursing facility
must provide to the resident and the resident representative written
notice which specifies the duration of the bed-hold policy described in
paragraph (c)(1) of this section.
(3) Permitting resident to return to facility. A nursing facility
must establish and follow a written policy on permitting residents to
return to the facility after they are hospitalized or placed on
therapeutic leave. The policy must provide for the following.
(i) A resident, whose hospitalization or therapeutic leave exceeds
the bed-hold period under the State plan, is readmitted to the facility
to their previous room if available or immediately upon the first
availability of a bed in a semi-private room if the resident--
(A) Requires the services provided by the facility; and
(B) Is eligible for Medicaid nursing facility services.
(ii) A resident who is hospitalized or placed on therapeutic leave
with an expectation of returning to the facility must be notified in
writing by the facility when the facility determines that the resident
cannot be readmitted to the facility, the reason the resident cannot be
readmitted to the facility, and the information specified in paragraphs
(b)(5)(iv) through (vii) of this section.
(4) Readmission to a composite distinct part. When the nursing
facility to which a resident is readmitted is a composite distinct part
(as defined in Sec. 483.5), the resident must be permitted to return
to an available bed in the particular location of the composite
distinct part in which he or she resided previously. If a bed is not
available in that location at the time of readmission, the resident
must be given the option to return to that location upon the first
availability of a bed there.
Sec. 483.20 [Amended]
0
18. In Sec. 483.20--
0
a. Revise paragraph (b)(1) introductory text.
0
b. Revise paragraphs (b)(1)(xvi) and (xviii).
0
c. Revise paragraph (e).
0
d. Remove paragraphs (k) and (l).
0
e. Redesignate paragraph (m) as paragraph (k).
0
f. Revise newly designated paragraph (k).
The revisions read as follows:
Sec. 483.20 Resident assessment.
* * * * *
(b) * * *
(1) Resident assessment instrument. A facility must make a
comprehensive assessment of a resident's needs, strengths, goals, life
history and preferences, using the resident assessment instrument (RAI)
specified by CMS. The assessment must include at least the following:
* * * * *
(xvi) Discharge planning.
* * * * *
(xviii) Documentation of participation in assessment. The
assessment process must include direct observation and communication
with the resident, as well as communication with licensed and
nonlicensed direct care/direct access staff members on all shifts.
* * * * *
(e) Coordination. A facility must coordinate assessments with the
preadmission screening and resident review (PASARR) program under
Medicaid in subpart C of this part to the maximum extent practicable to
avoid duplicative testing and effort. Coordination includes--
(1) Incorporating the recommendations from the PASARR level II
determination and the PASARR evaluation report into a resident's
assessment, care planning, and transitions of care.
(2) Referring all level II residents and all residents with newly
evident or possible serious mental illness, intellectual disability, or
a related condition for level II resident review upon a significant
change in status assessment.
* * * * *
(k) Preadmission screening for individuals with mental illness and
individuals with intellectual disability. (1) A nursing facility must
not admit, on or after January 1, 1989, any new resident with--
(i) Mental illness as defined in paragraph (k)(3)(i) of this
section, unless the State mental health authority has determined, based
on an independent physical and mental evaluation performed by a person
or entity other than the State mental health authority, prior to
admission,
(A) That, because of the physical and mental condition of the
individual, the individual requires the level of services provided by a
nursing facility; and
(B) If the individual requires such level of services, whether the
individual requires specialized services; or
(ii) Intellectual disability, as defined in paragraph (k)(3)(ii) of
this section, unless the State intellectual disability or developmental
disability authority has determined prior to admission--
(A) That, because of the physical and mental condition of the
individual, the individual requires the level of services provided by a
nursing facility; and
(B) If the individual requires such level of services, whether the
individual requires specialized services for intellectual disability.
(2) Exceptions. For purposes of this section--
(i) The preadmission screening program under paragraph (k)(1) of
this section need not provide for determinations in the case of the
readmission to a nursing facility of an individual who, after being
admitted to the nursing facility, was transferred for care in a
hospital.
(ii) The State may choose not to apply the preadmission screening
program under paragraph (k)(1) of this section to the admission to a
nursing facility of an individual--
(A) Who is admitted to the facility directly from a hospital after
receiving acute inpatient care at the hospital,
(B) Who requires nursing facility services for the condition for
which the individual received care in the hospital, and
(C) Whose attending physician has certified, before admission to
the facility that the individual is likely to require less than 30 days
of nursing facility services.
(3) Definition. For purposes of this section--
(i) An individual is considered to have mental illness if the
individual has a serious mental illness as defined in Sec.
483.102(b)(1).
(ii) An individual is considered to have an intellectual disability
if the individual has an intellectual disability as defined in Sec.
483.102(b)(3) or is a person with a related condition as described in
Sec. 435.1010 of this chapter.
(4) A nursing facility must notify the state mental health
authority or state intellectual disability authority, as applicable,
promptly after a significant change in the mental or physical condition
of a resident who has mental illness or intellectual disability for
resident review.
0
19. Section 483.21 is added to read as follows:
Sec. 483.21 Comprehensive person-centered care planning.
(a) Baseline care plans. (1) The facility must develop a baseline
care plan for each resident that includes the instructions needed to
provide effective
[[Page 42257]]
and person-centered care of the resident that meet professional
standards of quality care. The baseline care plan must--
(i) Be developed within 48 hours of a resident's admission.
(ii) Include the minimum healthcare information necessary to
properly care for a resident including, but not limited to--
(A) Initial goals based on admission orders.
(B) Physician orders.
(C) Dietary orders.
(D) Therapy services.
(E) Social services.
(F) PASARR recommendation, if applicable.
(2) The facility may develop a comprehensive care plan in place of
the baseline care plan if the comprehensive care plan--
(i) Is developed within 48 hours of the resident's admission.
(ii) Meets the requirements set forth in paragraph (b) of this
section (excepting paragraph (b)(2)(i) of this section).
(b) Comprehensive care plans. (1) The facility must develop a
comprehensive person-centered care plan for each resident, consistent
with Sec. 483.10(b)(1) and Sec. 483.11(b)(1), that includes
measurable objectives and timetables to meet a resident's medical,
nursing, and mental and psychosocial needs that are identified in the
comprehensive assessment. The comprehensive care plan must describe the
following--
(i) The services that are to be furnished to attain or maintain the
resident's highest practicable physical, mental, and psychosocial well-
being as required under Sec. 483.25 or Sec. 483.40; and
(ii) Any services that would otherwise be required under Sec.
483.25 or Sec. 483.40 but are not provided due to the resident's
exercise of rights under Sec. 483.10, including the right to refuse
treatment under Sec. 483.10(b)(4).
(iii) Any specialized services or specialized rehabilitative
services the nursing facility will provide as a result of PASARR
recommendations. If a facility disagrees with the findings of the
PASARR, it must indicate its rationale in the resident's medical
record.
(iv) In consultation with the resident and the resident's
representative(s)--
(A) The resident's goals for admission and desired outcomes.
(B) The resident's preference and potential for future discharge.
Facilities must document whether the resident's desire to return to the
community was assessed and any referrals to local contact agencies and/
or other appropriate entities, for this purpose.
(C) Discharge plans in the comprehensive care plan, as appropriate,
in accordance with the requirements set forth in paragraph (c) of this
section.
(2) A comprehensive care plan must be--
(i) Developed within 7 days after completion of the comprehensive
assessment.
(ii) Prepared by an interdisciplinary team, that includes but is
not limited to--
(A) The attending physician.
(B) A registered nurse with responsibility for the resident.
(C) A nurse aide with responsibility for the resident.
(D) A member of food and nutrition services staff.
(E) A social worker.
(F) To the extent practicable, the participation of the resident
and the resident's representative(s). An explanation must be included
in a resident's medical record if the participation of the resident and
their resident representative is determined not practicable for the
development of the resident's care plan.
(G) Other appropriate staff or professionals in disciplines as
determined by the resident's needs or as requested by the resident.
(iii) Reviewed and revised by the interdisciplinary team after each
assessment, including both the comprehensive and quarterly review
assessments.
(3) The services provided or arranged by the facility, as outlined
by the comprehensive care plan, must--
(i) Meet professional standards of quality.
(ii) Be provided by qualified persons in accordance with each
resident's written plan of care.
(iii) Be culturally-competent and trauma-informed.
(c) Discharge planning--(1) Discharge planning process. The
facility must develop and implement an effective discharge planning
process that focuses on the resident's discharge goals and preparing
residents to be active partners in post-discharge care, effective
transition of the resident from SNF to post-SNF care, and the reduction
of factors leading to preventable readmissions. The facility's
discharge planning process must--
(i) Ensure that the discharge needs of each resident are identified
and result in the development of a discharge plan for each resident.
(ii) Include regular re-evaluation of residents to identify changes
that require modification of the discharge plan. The discharge plan
must be updated, as needed, to reflect these changes.
(iii) Involve the interdisciplinary team, as defined by Sec.
483.20(b)(2)(ii), in the ongoing process of developing the discharge
plan.
(iv) Consider caregiver/support person availability and the
resident's or caregiver's/support person(s) capacity and capability to
perform required care, as part of the identification of discharge
needs.
(v) Involve the resident and resident representative in the
development of the discharge plan and inform the resident and resident
representative of the final plan.
(vi) Address the resident's goals of care and treatment
preferences.
(vii) Document that a resident has been asked about their interest
in receiving information regarding returning to the community.
(A) If the resident indicates an interest in returning to the
community, the facility must document any referrals to local contact
agencies or other appropriate entities made for this purpose.
(B) Facilities must update a resident's comprehensive care plan and
discharge plan, as appropriate, in response to information received
from referrals to local contact agencies or other appropriate entities.
(C) If discharge to the community is determined to not be feasible,
the facility must document who made the determination and why.
(viii) For residents who are transferred to another SNF or who are
discharged to a HHA, IRF, or LTCH, assist residents and their resident
representatives in selecting a post-acute care provider by using data
that includes, but is not limited to SNF, HHA, IRF, or LTCH
standardized patient assessment data, data on quality measures, and
data on resource use to the extent the data is available. The facility
must ensure that the post-acute care standardized patient assessment
data, data on quality measures, and data on resource use is relevant
and applicable to the resident's goals of care and treatment
preferences.
(ix) Document, complete on a timely basis based on the resident's
needs, and include in the clinical record, the evaluation of the
resident's discharge needs and discharge plan. The results of the
evaluation must be discussed with the resident or resident's
representative. All relevant resident information must be incorporated
into the discharge plan to facilitate its implementation and to avoid
unnecessary delays in the resident's discharge or transfer.
(2) Discharge summary. When the facility anticipates discharge a
resident must have a discharge summary that
[[Page 42258]]
includes, but is not limited to, the following:
(i) A recapitulation of the resident's stay that includes, but is
not limited to, diagnoses, course of illness/treatment or therapy, and
pertinent lab, radiology, and consultation results.
(ii) A final summary of the resident's status to include items in
paragraph (b)(1) of Sec. 483.20, at the time of the discharge that is
available for release to authorized persons and agencies, with the
consent of the resident or resident's representative.
(iii) Reconciliation of all pre-discharge medications with the
resident's post-discharge medications (both prescribed and over-the-
counter).
(iv) A post-discharge plan of care that is developed with the
participation of the resident and, with the resident's consent, his or
her family, which will assist the resident to adjust to his or her new
living environment. The post-discharge plan of care must indicate where
the individual plans to reside, any arrangements that have been made
for the resident's follow up care and any post-discharge medical and
non-medical services.
0
20. Section 483.25 is revised to read as follows:
Sec. 483.25 Quality of care and quality of life.
Each resident must receive and the facility must provide the
necessary care and services to attain or maintain the highest
practicable physical, mental, and psychosocial well-being, consistent
with the resident's comprehensive assessment and plan of care.
(a) Based on the comprehensive assessment of a resident and
consistent with the resident's needs and choices, the facility must
provide the necessary care and services to ensure that a resident's
abilities in activities of daily living do not diminish unless
circumstances of the individual's clinical condition demonstrate that
such diminution was unavoidable. This includes the facility ensuring
that:
(1) A resident is given the appropriate treatment and services to
maintain or improve his or her ability to carry out the activities of
daily living, including those specified in paragraph (b) of this
section,
(2) A resident who is unable to carry out activities of daily
living receives the necessary services to maintain good nutrition,
grooming, and personal and oral hygiene, and
(3) Personnel provide basic life support, including CPR, to a
resident requiring such emergency care prior to the arrival of
emergency medical personnel and subject to the resident's advance
directives.
(b) Activities of daily living. (1) Hygiene--bathing, dressing,
grooming, and oral care,
(2) Mobility--transfer and ambulation,
(3) Elimination-toileting,
(4) Dining-eating, including meals and snacks,
(5) Communication, including
(i) Speech,
(ii) Language,
(iii) Other functional communication systems.
(c) Activities. (1) The facility must provide, based on the
comprehensive assessment and care plan and the preferences of each
resident, an ongoing program to support residents in their choice of
activities, both facility-sponsored group and individual activities and
independent activities, designed to meet the interests of and support
the physical, mental, and psychosocial well-being of each resident,
encouraging both independence and interaction in the community.
(2) The activities program must be directed by a qualified
professional who is a qualified therapeutic recreation specialist or an
activities professional who--
(i) Is licensed or registered, if applicable, by the State in which
practicing; and
(ii) Is:
(A) Eligible for certification as a therapeutic recreation
specialist or as an activities professional by a recognized accrediting
body on or after October 1, 1990; or
(B) Has 2 years of experience in a social or recreational program
within the last 5 years, 1 of which was full-time in a therapeutic
activities program; or
(C) Is a qualified occupational therapist or occupational therapy
assistant; or
(D) Has completed a training course approved by the State.
(d) Special care issues. Based on the comprehensive assessment of a
resident, the facility must ensure that residents receive treatment and
care, in accordance with professional standards of practice and the
residents choices, related to the following special concerns--
(1) Restraints. The facility must ensure that the resident is free
from physical or chemical restraints imposed for purposes of discipline
or convenience and that are not required to treat the resident's
medical symptoms. When the use of restraints is indicated, the facility
must use the least restrictive alternative for the least amount of time
and document ongoing re-evaluation of the need for restraints.
(2) Bed rails. The facility must ensure correct installation, use
and maintenance of bed rails, including but not limited to the
following elements.
(i) Attempt to use alternatives prior to installing a side or bed
rail.
(ii) Assess resident for risk of entrapment from bed rails prior to
installation.
(iii) Review the risks and benefits of bed rails with the resident
or resident representative and obtain informed consent prior to
installation
(iv) Ensure that the resident's size and weight are appropriate for
the bed's dimensions.
(v) Follow the manufacturers' recommendations and specifications
for installing and maintaining bed rails.
(3) Vision and hearing. To ensure that residents receive proper
treatment and assistive devices to maintain vision and hearing
abilities, the facility must, if necessary, assist the resident--
(i) In making appointments, and
(ii) By arranging for transportation to and from the office of a
practitioner specializing in the treatment of vision or hearing
impairment or the office of a professional specializing in the
provision of vision or hearing assistive devices.
(4) Skin integrity--(i) Pressure ulcers. Based on the comprehensive
assessment of a resident, the facility must ensure that--
(A) A resident receives care, consistent with professional
standards of practice, to prevent pressure ulcers and does not develop
pressure ulcers unless the individual's clinical condition demonstrates
that they were unavoidable; and
(B) A resident with pressure ulcers receives necessary treatment
and services, consistent with professional standards of practice, to
promote healing, prevent infection and prevent new ulcers from
developing.
(ii) Foot care. To ensure that residents receive proper treatment
and care to maintain mobility and good foot health, the facility must:
(A) Provide foot care and treatment, in accordance with
professional standards of practice, including to prevent complications
from the resident's medical condition(s) and
(B) If necessary, assist the resident in making appointments with a
qualified person, and arranging for transportation to and from such
appointments.
(5) Mobility. (i) The facility must ensure that a resident who
enters the facility without limited range of motion does not experience
reduction in range of motion unless the resident's clinical condition
demonstrates that a reduction in range of motion is unavoidable; and
[[Page 42259]]
(ii) A resident with limited range of motion receives appropriate
treatment and services to increase range of motion and/or to prevent
further decrease in range of motion.
(iii) A resident with limited mobility receives appropriate
services, equipment, and assistance to maintain or improve mobility
with the maximum practicable independence unless a reduction in
mobility is demonstrably unavoidable.
(6) Incontinence. (i) The facility must ensure that resident who is
continent of bladder and bowel on admission receives services and
assistance to maintain continence unless his or her clinical condition
is or becomes such that continence is not possible to maintain.
(ii) For a resident with urinary incontinence, based on the
resident's comprehensive assessment, the facility must ensure that--
(A) A resident who enters the facility without an indwelling
catheter is not catheterized unless the resident's clinical condition
demonstrates that catheterization was necessary;
(B) A resident who enters the facility with an indwelling catheter
or subsequently receives one is assessed for removal of the catheter as
soon as possible unless the resident's clinical condition demonstrates
that catheterization is necessary and
(C) A resident who is incontinent of bladder receives appropriate
treatment and services to prevent urinary tract infections and to
restore as much normal bladder function as possible.
(iii) For a resident with fecal incontinence, based on the
resident's comprehensive assessment, the facility must ensure that a
resident who is incontinent of bowel receives appropriate treatment and
services to restore as much normal bowel function as possible.
(7) Colostomy, ureterostomy, or ileostomy care.
(8) Assisted nutrition and hydration. (Includes naso-gastric and
gastrostomy tubes, both percutaneous endoscopic gastrostomy and
percutaneous endoscopic jejunostomy, and enteral fluids). Based on a
resident's comprehensive assessment, the facility must ensure that a
resident--
(i) Maintains acceptable parameters of nutritional status, such as
usual body weight or desirable body weight range and protein levels,
unless the resident's clinical condition demonstrates that this is not
possible or resident preferences indicate otherwise;
(ii) Is offered sufficient fluid intake to maintain proper
hydration and health; and
(iii) Is offered a therapeutic diet when there is a nutritional
problem and the health care provider orders a therapeutic diet.
(iv) A resident who has been able to eat enough alone or with
assistance is not fed by enteral methods unless the resident's clinical
condition demonstrates that enteral feeding was clinically indicated
and consented to by the resident; and
(v) A resident who is fed by enteral means receives the appropriate
treatment and services to restore, if possible, oral eating skills and
to prevent complications of enteral feeding including but not limited
to aspiration pneumonia, diarrhea, vomiting, dehydration, metabolic
abnormalities, and nasal-pharyngeal ulcers.
(9) Parenteral fluids.
(10) Accidents. The facility must ensure that--
(i) The resident environment remains as free of accident hazards as
is possible; and
(ii) Each resident receives adequate supervision and assistance
devices to prevent accidents.
(11) Respiratory care, including tracheostomy care and tracheal
suctioning. See Sec. 483.65 re: Specialized rehabilitative services.
(12) Prostheses.
(13) Pain management.
(14) Dialysis.
(15) Trauma-informed care. The facility must ensure that residents
who are trauma survivors receive culturally-competent, trauma-informed
care in accordance with professional standards of practice and
accounting for residents' experiences and preferences in order to
eliminate or mitigate triggers that may cause re-traumatization of the
resident.
0
21. In the table below, each section and paragraph indicated in the
first column is redesignated as the section and paragraph indicated in
the second column:
------------------------------------------------------------------------
New CFR
Existing CFR section section
------------------------------------------------------------------------
Sec. 483.30.............................................. Sec.
483.35
Sec. 483.35.............................................. 483.60
Sec. 483.40.............................................. 483.30
Sec. 483.45.............................................. 483.65
Sec. 483.60.............................................. 483.45
Sec. 483.65.............................................. 483.80
Sec. 483.70.............................................. 483.90
Sec. 483.75.............................................. 483.70
------------------------------------------------------------------------
0
22. In newly redesignated Sec. 483.30--
0
a. Revise the introductory text.
0
b. Revise paragraph (b)(3).
0
c. Redesignate paragraphs (e) and (f) as paragraphs (f) and (g),
respectively.
0
d. Amend newly designated paragraph (f)(1) introductory text by
removing the reference ``paragraph (e)(2)'' and adding in its place the
reference ``paragraph (f)(4)''.
0
e. Add a new paragraph (e).
0
f. Amend newly redesignated paragraph (f) by further redesignating
paragraph (f)(2) as paragraph (f)(4).
0
g. Add new paragraphs (f)(2) and (f)(3).
The revisions and additions read as follows:
Sec. 483.30 Physician services.
A physician must personally approve in writing a recommendation
that an individual be admitted to a facility. Each resident must remain
under the care of a physician. A physician, physician assistant, nurse
practitioner, or clinical nurse specialist must provide orders for the
resident's immediate care and needs.
* * * * *
(b) * * *
(3) Sign and date all orders with the exception of influenza and
pneumococcal vaccines, which may be administered per physician-approved
facility policy after an assessment for contraindications.
* * * * *
(e) Availability of a physician, physician assistant, nurse
practitioner, or clinical nurse specialist to evaluate resident for
non-emergent transfer to a hospital. The facility must provide or
arrange for an in-person evaluation of a resident by a physician, a
physician assistant, nurse practitioner, or clinical nurse specialist
prior to transferring the resident to a hospital.
(1) The evaluation must occur expeditiously once the potential need
for a transfer is identified.
(2) This requirement does not apply in emergency situations where
the health or safety of the individual would be endangered.
(f) * * *
(2) A physician may delegate the task of writing dietary orders,
consistent with Sec. 483.60, to a qualified dietitian or other
clinically qualified nutrition professional who--
(i) Is acting within the scope of practice as defined by State law;
and
(ii) Is under the supervision of the physician.
(3) A physician may delegate the task of writing therapy orders,
consistent with Sec. 483.65, to a qualified therapist who--
(i) Is acting within the scope of practice as defined by State law;
and
(ii) Is under the supervision of the physician.
* * * * *
0
23. In newly redesignated Sec. 483.35--
[[Page 42260]]
0
a. Revise the introductory text.
0
b. Amend paragraph (a)(1)(i) by removing the reference ``paragraph
(c)'' and adding in its place the reference ``paragraph (e)''.
0
c. Revise paragraph (a)(1)(ii).
0
d. Add paragraphs (a)(3) and (4).
0
e. Amend paragraphs (b)(1) and (b)(2) by removing the reference
``paragraph (c) or (d)'' and adding in its place the reference
``paragraph (e) or (f)''.
0
f. Redesignate paragraphs (c), (d) and (e) as paragraphs (e), (f), and
(g), respectively.
0
g. Add new paragraphs (c) and (d).
0
h. Revise redesignated paragraphs (e)(6) and (7).
0
i. Revise redesignated paragraphs (f)(1)(iv) and (v).
The revisions and additions read as follows:
Sec. 483.35 Nursing services.
The facility must have sufficient nursing staff with the
appropriate competencies and skills sets to provide nursing and related
services to assure resident safety and attain or maintain the highest
practicable physical, mental, and psychosocial well-being of each
resident, as determined by resident assessments and individual plans of
care and considering the number, acuity and diagnoses of the facility's
resident population in accordance with the facility assessment required
at Sec. 483.70(e).
(a) * * *
(1) * * *
(ii) Other nursing personnel, including but not limited to nurse
aides.
* * * * *
(3) The facility must ensure that licensed nurses have the specific
competencies and skill sets necessary to care for residents' needs, as
identified through resident assessments, and described in the plan of
care.
(4) Providing care includes but is not limited to assessing,
evaluating, planning and implementing resident care plans and
responding to resident's needs.
* * * * *
(c) Proficiency of nurse aides. The facility must ensure that nurse
aides are able to demonstrate competency in skills and techniques
necessary to care for residents' needs, as identified through resident
assessments, and described in the plan of care.
(d) Requirements for facility hiring and use of nursing aides--(1)
General rule. A facility must not use any individual working in the
facility as a nurse aide for more than 4 months, on a full-time basis,
unless:
(i) That individual is competent to provide nursing and nursing
related services; and
(ii)(A) That individual has completed a training and competency
evaluation program, or a competency evaluation program approved by the
State as meeting the requirements of Sec. Sec. 483.151 through
483.154; or
(B) That individual has been deemed or determined competent as
provided in Sec. 483.150(a) and (b).
(2) Non-permanent employees. A facility must not use on a
temporary, per diem, leased, or any basis other than a permanent
employee any individual who does not meet the requirements in
paragraphs (d)(1) (i) and (ii) of this section.
(3) Minimum competency. A facility must not use any individual who
has worked less than 4 months as a nurse aide in that facility unless
the individual--
(i) Is a full-time employee in a State-approved training and
competency evaluation program;
(ii) Has demonstrated competence through satisfactory participation
in a State-approved nurse aide training and competency evaluation
program or competency evaluation program; or
(iii) Has been deemed or determined competent as provided in Sec.
483.150(a) and (b).
(4) Registry verification. Before allowing an individual to serve
as a nurse aide, a facility must receive registry verification that the
individual has met competency evaluation requirements unless--
(i) The individual is a full-time employee in a training and
competency evaluation program approved by the State; or
(ii) The individual can prove that he or she has recently
successfully completed a training and competency evaluation program or
competency evaluation program approved by the State and has not yet
been included in the registry. Facilities must follow up to ensure that
such an individual actually becomes registered.
(5) Multi-State registry verification. Before allowing an
individual to serve as a nurse aide, a facility must seek information
from every State registry established under sections 1819(e)(2)(A) or
1919(e)(2)(A) of the Act that the facility believes will include
information on the individual.
(6) Required retraining. If, since an individual's most recent
completion of a training and competency evaluation program, there has
been a continuous period of 24 consecutive months during none of which
the individual provided nursing or nursing-related services for
monetary compensation, the individual must complete a new training and
competency evaluation program or a new competency evaluation program.
(7) Regular in-service education. The facility must complete a
performance review of every nurse aide at least once every 12 months,
and must provide regular in-service education based on the outcome of
these reviews. In-service training must comply with the requirements of
Sec. 483.95(g).
(e) * * *
(6) The State agency granting a waiver of such requirements
provides notice of the waiver to the Office of the State Long-Term Care
Ombudsman (established under section 712 of the Older Americans Act of
1965) and the protection and advocacy system in the State for
individuals with developmental disabilities or mental illnesses; and
(7) The nursing facility that is granted such a waiver by a State
notifies residents of the facility and their resident representatives
of the waiver.
(f) * * *
(1) * * *
(iv) The Secretary provides notice of the waiver to the Office of
the State Long-Term Care Ombudsman (established under section 712 of
the Older Americans Act of 1965) and the protection and advocacy system
in the State for individuals with developmental disabilities or mental
illnesses; and
(v) The facility that is granted such a waiver notifies residents
of the facility and their resident representatives of the waiver.
* * * * *
0
24. Section 483.40 is added to read as follows:
Sec. 483.40 Behavioral health services.
Each resident must receive and the facility must provide the
necessary behavioral health care and services to attain or maintain the
highest practicable physical, mental, and psychosocial well-being, in
accordance with the comprehensive assessment and plan of care.
(a) The facility must have sufficient direct care/direct access
staff with the appropriate competencies and skills sets to provide
nursing and related services to assure resident safety and attain or
maintain the highest practicable physical, mental and psychosocial
well-being of each resident, as determined by resident assessments and
individual plans of care and considering the number, acuity and
diagnoses of the facility's resident population in accordance with
Sec. 483.70(e). These competencies and skills sets include,
[[Page 42261]]
but are not limited to, knowledge of and appropriate training and
supervision for:
(1) Caring for residents with mental illnesses and psychosocial
disorders, as well as residents with a history of trauma and/or post-
traumatic stress disorder, that have been identified in the facility
assessment conducted pursuant to Sec. 483.70(e), and
(2) Implementing non-pharmacological interventions.
(b) Based on the comprehensive assessment of a resident, the
facility must ensure that--
(1) A resident who displays or is diagnosed with mental or
psychosocial adjustment difficulty, or who has a history of trauma and/
or post-traumatic stress disorder, receives appropriate treatment and
services to correct the assessed problem or to attain the highest
practicable mental and psychosocial well-being, and
(2) A resident whose assessment did not reveal or who does not have
a diagnosis of a mental or psychosocial adjustment difficulty or a
documented history of trauma and/or post-traumatic stress disorder does
not display a pattern of decreased social interaction and/or increased
withdrawn, angry, or depressive behaviors, unless the resident's
clinical condition demonstrates that development of such a pattern was
unavoidable.
(c) If rehabilitative services such as but not limited to physical
therapy, speech-language pathology, occupational therapy, and
rehabilitative services for mental illness and intellectual disability,
are required in the resident's comprehensive plan of care, the facility
must--
(1) Provide the required services, including specialized
rehabilitation services as required in Sec. 483.45; or
(2) Obtain the required services from an outside resource (in
accordance with Sec. 483.75(g) of this part) from a Medicare and/or
Medicaid provider of specialized rehabilitative services.
(d) The facility must provide medically-related social services to
attain or maintain the highest practicable mental and psychosocial
well-being of each resident.
0
25. In newly redesignated Sec. 483.45--
0
a. Amend the introductory text by removing the reference ``Sec.
483.75(h) of this part'' and add in its place the reference ``Sec.
483.70(g)''.
0
b. Redesignate paragraph (c)(2) as paragraph (c)(4).
0
c. Add new paragraphs (c)(2) and (3).
0
d. Revise newly designated paragraph (c)(4).
0
e. Redesignate paragraphs (d) and (e) as paragraphs (g) and (h),
respectively.
0
f. Add new paragraphs (d), (e), and (f).
The additions and revisions read as follows:
Sec. 483.45 Pharmacy services.
* * * * *
(c) * * *
(2) This review must include a review of the resident's medical
chart at least every 6 months and:
(i) When the resident is new, that is the individual has not
previously been a resident in that facility; or
(ii) When the resident returns or is transferred from a hospital or
other facility; and
(iii) During each monthly drug regimen review when the resident has
been prescribed or is taking a psychotropic drug, an antibiotic, or any
drug the QAA Committee has requested be included in the pharmacist's
monthly drug review.
(3) A psychotropic drug is any drug that affects brain activities
associated with mental processes and behavior. These drugs include, but
are not limited to, drugs in the following categories:
(i) Anti-psychotic;
(ii) Anti-depressant;
(iii) Anti-anxiety;
(iv) Hypnotic;
(v) Opioid analgesic; and
(vi) Any other drug that results in effects similar to the drugs
listed in paragraphs (c)(3)(i) through (v) of this section.
(4) The pharmacist must report any irregularities to the attending
physician and the facility's medical director and director of nursing,
and these reports must be acted upon.
(i) Irregularities include, but are not limited to, any drug that
meets the criteria set forth in paragraph (d) of this section for an
unnecessary drug.
(ii) Any irregularities noted by the pharmacist during this review
must be documented on a separate, written report that is sent to the
attending physician and the facility's medical director and director of
nursing and lists, at a minimum, the resident's name, the relevant
drug, and the irregularity the pharmacist identified.
(iii) The attending physician must document in the resident's
medical record that the identified irregularity has been reviewed and
what, if any, action has been taken to address it. If there is to be no
change in the medication, the attending physician should document his
or her rationale in the resident's medical record.
(d) Unnecessary drugs--General. Each resident's drug regimen must
be free from unnecessary drugs. An unnecessary drug is any drug when
used:
(1) In excessive dose (including duplicate drug therapy); or
(2) For excessive duration; or
(3) Without adequate monitoring; or
(4) Without adequate indications for its use; or
(5) In the presence of adverse consequences which indicate the dose
should be reduced or discontinued; or
(6) Any combinations of the reasons stated in paragraphs (d)(1)
through (5) of this section.
(e) Psychotropic drugs. Based on a comprehensive assessment of a
resident, the facility must ensure that--
(1) Residents who have not used psychotropic drugs are not given
these drugs unless the medication is necessary to treat a specific
condition as diagnosed and documented in the clinical record;
(2) Residents who use psychotropic drugs receive gradual dose
reductions, and behavioral interventions, unless clinically
contraindicated, in an effort to discontinue these drugs;
(3) Residents do not receive psychotropic drugs pursuant to a PRN
order unless that medication is necessary to treat a diagnosed specific
condition that is documented in the clinical record; and
(4) PRN orders for psychotropic drugs are limited to 48 hours and
cannot be continued beyond that time unless the resident's physician or
primary care provider documents the rationale for this continuation in
the resident's clinical record.
(f) Medication errors. The facility must ensure that its--
(1) Medication error rates are not five percent or greater; and
(2) Residents are free of any significant medication errors.
* * * * *
0
26. A new Sec. 483.50 is added and is amended as follows:
0
a. Section heading is added.
0
b. New paragraphs (a) and (b) are redesignated from paragraphs (j) and
(k) of newly redesignated Sec. 483.70.
0
c. Newly designated paragraphs (a)(2)(i), (a)(2)(ii), (b)(2)(i) and
(b)(2)(ii) are revised.
The additions and revisions read as follows:
Sec. 483.50 Laboratory, radiology, and other diagnostic services.
(a) * * *
(2) * * *
(i) Provide or obtain laboratory services only when ordered by a
physician; physician assistant; nurse practitioner or clinical nurse
specialist in accordance with State law, including scope of practice
laws.
(ii) Promptly notify the ordering physician, physician assistant,
nurse
[[Page 42262]]
practitioner, or clinical nurse specialist of laboratory results that
fall outside of clinical reference ranges in accordance with facility
policies and procedures for notification of a practitioner or per the
ordering physician's orders.
* * * * *
(b) * * *
(2) * * *
(i) Provide or obtain radiology and other diagnostic services only
when ordered by a physician; physician assistant; nurse practitioner or
clinical nurse specialist in accordance with State law, including scope
of practice laws.
(ii) Promptly notify the ordering physician, physician assistant,
nurse practitioner, or clinical nurse specialist of results that fall
outside of clinical reference ranges in accordance with facility
policies and procedures for notification of a practitioner or per the
ordering physician's orders.
* * * * *
0
27. Section 483.55 is amended by--
0
a. Amending paragraph (a)(1) by removing the reference ``Sec.
483.75(h) of this part'' and adding in its place the reference ``Sec.
483.70(g)''.
0
b. Redesignating paragraph (a)(3) and (4) as paragraphs (a)(4) and (5),
respectively.
0
c. Adding a new paragraph (a)(3).
0
d. Revising newly redesignated paragraph (a)(4) introductory text and
(a)(4)(ii).
0
e. Revising newly redesignated paragraph (a)(5).
0
f. Amending paragraph (b)(1) introductory text by removing the
reference ``Sec. 483.75(h) of this part'' and adding in its place the
reference ``Sec. 483.70(g)''.
0
g. Revising paragraph (b)(2) introductory text, (b)(2)(ii), and (b)(3).
0
h. Adding paragraphs (b)(4) and (5).
The revisions and additions read as follows:
Sec. 483.55 Dental services.
* * * * *
(a) * * *
(3) May not charge a resident for the loss or damage of dentures
determined in accordance with facility policy to be the facility's
responsibility;
(4) Must if necessary or if requested, assist the resident--
* * * * *
(ii) By arranging for transportation to and from the dental
services location; and
(5) Promptly, within three days, refer residents with lost or
damaged dentures for dental services. If a referral does not occur
within three days, the facility must provide documentation of the
extenuating circumstances that led to the delay.
(b) * * *
(2) Must, if necessary or if requested, assist the resident--
* * * * *
(ii) By arranging for transportation to and from the dental
services locations;
(3) Must promptly, within three days, refer residents with lost or
damaged dentures for dental services. If a referral does not occur
within three days, the facility must provide documentation of the
extenuating circumstances that led to the delay;
(4) May not charge a resident for the loss or damage of dentures
determined in accordance with facility policy to be the facility's
responsibility; and
(5) Must assist residents who are eligible and wish to participate
to apply for reimbursement of dental services as an incurred medical
expense under the State plan.
0
28. Newly redesignated Sec. 483.60 is revised to read as follows:
Sec. 483.60 Food and nutrition services.
The facility must provide each resident with a nourishing,
palatable, well-balanced diet that meets his or her daily nutritional
and special dietary needs, taking into consideration the preferences of
each resident.
(a) Staffing. The facility must employ sufficient staff with the
appropriate competencies and skills sets to carry out the functions of
the food and nutrition service, taking into consideration resident
assessments, individual plans of care and the number, acuity and
diagnoses of the facility's resident population in accordance with the
facility assessment required at Sec. 483.70(e). This includes:
(1) A qualified dietitian or other clinically qualified nutrition
professional either full-time, part-time, or on a consultant basis. A
qualified dietitian or other clinically qualified nutrition
professional is one who is qualified based on:
(i) Meeting State requirements to practice dietetics, including
licensure or certification, or
(ii) If the state does not have requirements, registration by the
Commission on Dietetic Registration of the Academy of Nutrition and
Dietetics, or
(iii) For dietitians hired or contracted with prior to [effective
date of final rule], meets these requirements no later than 5 years
after [effective date of final rule] or as required by state law.
(2) If a qualified dietitian or other clinically qualified
nutrition professional is not employed full-time, the facility must
designate a person to serve as the director of food and nutrition
services who:
(i) For designations prior to [effective date of final rule], meets
the following requirements no later than 5 years after [effective date
of final rule], is:
(A) A certified dietary manager; or
(B) A certified food service manager, or
(C) Has similar national certification for food service management
and safety from a national certifying body; or
(D) Has an associate's or higher degree in food service management
or hospitality from an accredited institution of higher learning; or
(ii) In States that have established standards for food service
managers or dietary managers, meets State requirements for food service
managers or dietary managers, and
(iii) Receives frequently scheduled consultations from a qualified
dietitian or other clinically qualified nutrition professional.
(3) Support staff. The facility must provide sufficient support
personnel to safely and effectively carry out the functions of the food
and nutrition service.
(b) A member of the Food and Nutrition Services staff must
participate on the interdisciplinary team as required in Sec.
483.21(b)(2)(ii).
(c) Menus and nutritional adequacy. Menus must--
(1) Meet the nutritional needs of residents in accordance with
established national guidelines or industry standards.;
(2) Be prepared in advance;
(3) Be followed;
(4) Reflect the religious, cultural and ethnic needs of the
residents, as well as input received from residents and resident
groups;
(5) Be updated periodically;
(6) Be reviewed by the facility's dietitian or other clinically
qualified nutrition professional for nutritional adequacy; and
(7) Nothing in this paragraph should be construed to limit the
resident's right to make personal dietary choices.
(d) Food and drink. Each resident receives and the facility
provides--
(1) Food prepared by methods that conserve nutritive value, flavor,
and appearance;
(2) Food and drink that is palatable, attractive, and at a safe and
appetizing temperature;
(3) Food prepared in a form designed to meet individual needs;
(4) Food that accommodates resident allergies, intolerances, and
preferences;
(5) Appealing substitutes of similar nutritive value to residents
who choose not to eat food that is initially served or who request an
alternative meal; and
[[Page 42263]]
(6) Drinks, including water and other liquids consistent with
resident needs and preferences and sufficient to maintain resident
hydration.
(e) Therapeutic diets. (1) Therapeutic diets must be prescribed by
the attending physician.
(2) The attending physician may delegate to a registered or
licensed dietitian the task of prescribing a resident's diet, including
a therapeutic diet, to the extent allowed by State law.
(f) Frequency of meals. (1) Each resident must receive and the
facility must provide at least three meals daily, at regular times
comparable to normal mealtimes in the community or in accordance with
resident needs, preferences, requests, and plan of care.
(2) Suitable, nourishing alternative meals and snacks must be
available for residents who want to eat at non-traditional times or
outside of scheduled meal service times and in accordance with the
resident plan of care.
(g) Assistive devices. The facility must provide special eating
equipment and utensils for residents who need them and appropriate
assistance to ensure that the resident can use the assistive devices
when consuming meals and snacks.
(h) Paid feeding assistants--(1) State-approved training course. A
facility may use a paid feeding assistant, as defined in Sec. 488.301
of this chapter, if--
(i) The feeding assistant has successfully completed a State-
approved training course that meets the requirements of Sec. 483.160
before feeding residents; and
(ii) The use of feeding assistants is consistent with State law.
(2) Supervision. (i) A feeding assistant must work under the
supervision of a registered nurse (RN) or licensed practical nurse
(LPN).
(ii) In an emergency, a feeding assistant must call a supervisory
nurse for help.
(3) Resident selection criteria. (i) A facility must ensure that a
feeding assistant provides dining assistance only for residents who
have no complicated feeding problems.
(ii) Complicated feeding problems include, but are not limited to,
difficulty swallowing, recurrent lung aspirations, and tube or
parenteral/IV feedings.
(iii) The facility must base resident selection on the
interdisciplinary team's assessment and the resident's latest
assessment and plan of care. Appropriateness for this program should be
reflected in the comprehensive care plan.
(i) Food safety requirements. The facility must--
(1) Procure food from sources approved or considered satisfactory
by Federal, State, or local authorities;
(i) This may include food items obtained directly from local
producers, subject to applicable State and local laws or regulations.
(ii) This provision does not prohibit or prevent facilities from
using produce grown in facility gardens, subject to compliance with
applicable safe growing and food-handling practices.
(iii) This provision does not preclude residents from consuming
foods not procured by the facility.
(2) Store, prepare, distribute, and serve food in accordance with
professional standards for food service safety.
(3) Have a policy regarding use and storage of foods brought to
residents by family and other visitors to ensure safe and sanitary
storage, handling, and consumption, and
(4) Dispose of garbage and refuse properly.
0
29. In newly redesignated 483.65, revise paragraphs (a) introductory
text and (a)(2) to read as follows:
Sec. 483.65 Specialized rehabilitative services.
(a) Provision of services. If specialized rehabilitative services
such as but not limited to physical therapy, speech-language pathology,
occupational therapy, respiratory therapy, and rehabilitative services
for mental illness and intellectual disability or services of a lesser
intensity as set forth at Sec. 483.120(c), are required in the
resident's comprehensive plan of care, the facility must--
* * * * *
(2) Obtain the required services from an outside resource (in
accordance with Sec. 483.70(g)) from a Medicare and/or Medicaid
provider of specialized rehabilitative services.
* * * * *
0
30. Section 483.67 is added to read as follows:
Sec. 483.67 Outpatient rehabilitation services.
If the facility provides outpatient rehabilitation, physical
therapy, occupational therapy, audiology, or speech pathology services,
the services must meet the needs of the patients in accordance with
acceptable standards of practice and the facility must meet the
following requirements.
(a) Organization and staffing. (1) The organization of the service
must be appropriate to the scope of the services offered.
(2) The facility must ensure the services are organized and staffed
to ensure the health and safety of residents.
(b) Personnel. (1) The facility must assign one or more individuals
to be responsible for outpatient rehabilitative services. The
individual responsible for the outpatient rehabilitative services must
have the necessary knowledge, experience, and capabilities to properly
supervise and administer the services.
(2) The facility must have appropriate professional and
nonprofessional personnel available at each location where outpatient
services are offered, based on the scope and complexity of outpatient
services.
(3) Physical therapy, occupational therapy, speech-language
pathology or audiology services, if provided, must be provided by
qualified physical therapists, physical therapist assistants,
occupational therapists, occupational therapy assistants, speech-
language pathologists, or audiologists as defined in part 484 of this
chapter.
(c) Delivery of services. (1) Services must only be provided under
the orders of a qualified and licensed practitioner who is responsible
for the care of the patient, acting within his or her scope of practice
under state law.
(2) All rehabilitation services orders and progress notes must be
documented in the patient's clinical record in accordance with the
requirements at Sec. 483.70(i).
(3) The provision of care and the personnel qualifications must be
in accordance with national acceptable standards of practice.
0
31. In newly redesignated Sec. 483.70--
0
a. Revise paragraph (c).
0
b. Revise paragraph (d)(2).
0
c. Add paragraph (d)(3).
0
d. Revise paragraph (e).
0
e. Remove paragraphs (f), (j), (k), (m), (o), and (q).
0
f. Redesignate paragraphs (g), (h), (i), (l), (n), (p), (r), (s), and
(t) as paragraphs (f), (g), (h), (i), (j), (k), (l), (m), and (o),
respectively.
0
g. Revise newly redesignated paragraphs (i)(1) introductory text, and
(i)(2), (3), (4), and (5).
0
h. Revise newly redesignated paragraphs (j)(1)(i) and (ii).
0
i. Revise newly redesignated paragraph (m).
0
j. Add new paragraph (n).
0
k. Add new paragraph (p).
0
l. In the table below, for each newly redesignated paragraph indicated
in the first and second columns, remove the reference indicated in the
third column and add the reference indicated in the fourth column.
------------------------------------------------------------------------
Paragraphs Remove Add
------------------------------------------------------------------------
(g)(1)........................... (h)(2)............ (g)(2).
[[Page 42264]]
(k)(3)........................... (p)(2)............ (k)(2).
(m).............................. (r)............... (l).
(o)(2) introductory text......... (t)(1)(i)......... (o)(1)(i).
------------------------------------------------------------------------
The revisions and additions read as follows:
Sec. 483.70 Administration.
* * * * *
(c) Relationship to other HHS regulations. In addition to
compliance with the regulations set forth in this subpart, facilities
are obliged to meet the applicable provisions of other HHS regulations,
including but not limited to those pertaining to nondiscrimination on
the basis of race, color, or national origin (45 CFR part 80);
nondiscrimination on the basis of disability (45 CFR part 84);
nondiscrimination on the basis of age (45 CFR part 91); protection of
human subjects of research (45 CFR part 46); and fraud and abuse (42
CFR part 455) and protection of individually identifiable health
information (45 CFR parts 160 and 164). Violations of such other
provisions may result in a finding of non-compliance with this
paragraph.
(d) * * *
(2) The governing body appoints the administrator who is--
(i) Licensed by the State;
(ii) Responsible for management of the facility; and
(iii) Reports to and is accountable to the governing body.
(3) The governing body is responsible and accountable for the QAPI
program, in accordance with Sec. 483.75(f).
(e) Facility assessment. The LTC facility must conduct and document
a facility-wide assessment to determine what resources are necessary to
care for its residents competently during both day-to-day operations
and emergencies. The facility must review and update that assessment,
as necessary, and at least annually. The facility must also review and
update this assessment whenever there is, or the facility plans for,
any change that would require a substantial modification to any part of
this assessment. The facility assessment must address or include:
(1) The facility's resident population, including, but not limited
to,
(i) Both the number of residents and the facility's resident
capacity;
(ii) The care required by the resident population considering the
types of diseases, conditions, physical and cognitive disabilities,
overall acuity, and other pertinent facts that are present within that
population;
(iii) The staff competencies that are necessary to provide the
level and types of care needed for the resident population;
(iv) The physical environment, equipment, services, and other
physical plant considerations that are necessary to care for this
population; and
(v) Any ethnic, cultural, or religious factors that may potentially
affect the care provided by the facility, including, but not limited
to, activities and food and nutrition services.
(2) The facility's resources, including but not limited to,
(i) All buildings and/or other physical structures and vehicles;
(ii) Equipment (medical and non-medical);
(iii) Services provided, such as physical therapy, pharmacy, and
specific rehabilitation therapies;
(iv) All personnel, including managers, staff (both employees and
those who provide services under contract), and volunteers, as well as
their education and/or training and any competencies related to
resident care;
(v) Contracts, memorandums of understanding, or other agreements
with third parties to provide services or equipment to the facility
during both normal operations and emergencies; and
(vi) Health information technology resources, such as systems for
electronically managing patient records and electronically sharing
information with other organizations.
(3) A facility-based and community-based risk assessment, utilizing
an all-hazards approach.
* * * * *
(i) Medical records. (1) In accordance with accepted professional
standards and practices, the facility must maintain medical records on
each resident that are--
* * * * *
(2) The facility must keep confidential all information contained
in the resident's records, regardless of the form or storage method of
the records, except when release is--
(i) To the individual, or their resident representative where
permitted by applicable law;
(ii) Required by Law;
(iii) For treatment, payment, or health care operations, as
permitted by and in compliance with 45 CFR 164.506;
(iv) For public health activities, reporting of abuse, neglect, or
domestic violence, health oversight activities, judicial and
administrative proceedings, law enforcement purposes, organ donation
purposes, research purposes, or to coroners, medical examiners, funeral
directors, and to avert a serious threat to health or safety as
permitted by and in compliance with 45 CFR 164.512.
(3) The facility must safeguard medical record information against
loss, destruction, or unauthorized use;
(4) Medical records must be retained for--
(i) The period of time required by State law; or
(ii) Five years from the date of discharge when there is no
requirement in State law; or
(iii) For a minor, three years after a resident reaches legal age
under State law.
(5) The medical record must contain--
(i) Sufficient information to identify the resident;
(ii) A record of the resident's assessments;
(iii) The comprehensive plan of care and services provided;
(iv) The results of any preadmission screening and resident review
evaluations and determinations conducted by the State;
(v) Physician's, nurse's, and other licensed professional's
progress notes; and
(vi) Laboratory, radiology and other diagnostic services reports as
required under Sec. 483.50.
(j) * * *
(1) * * *
(i) Residents will be transferred from the facility to the
hospital, and ensured of timely admission to the hospital when transfer
is medically appropriate as determined by the attending physician or,
in an emergency situation, by another practitioner in accordance with
facility policy and consistent with state law; and
(ii) Medical and other information needed for care and treatment of
residents and, when the transferring facility deems it appropriate, for
determining whether such residents can receive appropriate services or
receive services in a less restrictive setting than either the facility
or the hospital, or reintegrated into the community, will be exchanged
between the providers, including but not limited to the information
required under Sec. 483.15(b)(2)(iii).
* * * * *
(m) Facility closure. The facility must have in place policies and
procedures to ensure that the administrator's duties and
responsibilities involve providing the appropriate notices in the event
of a facility closure, as required at paragraph (l) of this section.
(n) Binding arbitration agreements. If the facility enters into an
agreement for binding arbitration with its residents:
(1) The facility must ensure that:
(i) The agreement is explained to the resident in a form and manner
that he
[[Page 42265]]
or she understands, including in a language the resident understands,
and
(ii) The resident acknowledges that he or she understands the
agreement.
(2) The agreement must:
(i) Be entered into by the resident voluntarily;
(ii) Provide for the selection of a neutral arbiter;
(iii) Provide for selection of a venue convenient to both parties.
(3) Admission to the facility must not be contingent upon the
resident or the resident representative signing a binding arbitration
agreement.
(4) The agreement must not contain any language that prohibits or
discourages the resident or anyone else from communicating with
Federal, State, or local officials, including but not limited to,
Federal and State surveyors, other federal or state health department
employees, and representatives of the Office of the State Long-Term
Care Ombudsman, in accordance with Sec. 483.11(i).
(5) The agreement may be signed by another individual if:
(i) Allowed by state law;
(ii) All of the requirements in this section are met; and
(iii) That individual has no interest in the facility.
* * * * *
(p) Social worker. Any facility with more than 120 beds must employ
a qualified social worker on a full-time basis. A qualified social
worker is:
(1) An individual with a minimum of a bachelor's degree in social
work or a bachelor's degree in a human services field including, but
not limited to, sociology, gerontology, special education,
rehabilitation counseling, and psychology; and
(2) One year of supervised social work experience in a health care
setting working directly with individuals.
0
32. A new Sec. 483.75 is added to read as follows:
Sec. 483.75 Quality assurance and performance improvement.
(a) Quality assurance and performance improvement (QAPI) program.
Each LTC facility, including a facility that is part of a multiunit
chain, must develop, implement, and maintain an effective,
comprehensive, data-driven QAPI program that focuses on indicators of
the outcomes of care and quality of life. The facility must:
(1) Maintain documentation and demonstrate evidence of its ongoing
QAPI program that meets the requirements of this section;
(2) Present its QAPI plan to the State Agency Surveyor at the first
annual recertification survey that occurs after [the effective date of
this regulation];
(3) Present its QAPI plan to a State Agency or Federal surveyor at
each annual recertification survey and upon request during any other
survey and to CMS upon request; and
(4) Present documentation and evidence of its ongoing QAPI
program's implementation and the facility's compliance with
requirements to a State Agency, Federal surveyor or CMS upon request.
(b) Program design and scope. A facility must design its QAPI
program to be ongoing, comprehensive, and to address the full range of
care and services provided by the facility. It must:
(1) Address all systems of care and management practices;
(2) Include clinical care, quality of life, and resident choice;
(3) Utilize the best available evidence to define and measure
indicators of quality and facility goals that reflect processes of care
and facility operations that have been shown to be predictive of
desired outcomes for residents of a SNF or NF.
(4) Reflect the complexities, unique care, and services that the
facility provides.
(c) Program feedback, data systems and monitoring. A facility must
establish and implement written policies and procedures for feedback,
data collections systems, and monitoring, including adverse event
monitoring. The policies and procedures must include, at a minimum, the
following:
(1) Facility maintenance of effective systems to obtain and use of
feedback and input from direct care/direct access workers, other staff,
residents, and resident representatives, including how such information
will be used to identify problems that are high risk, high volume, or
problem-prone, and opportunities for improvement.
(2) Facility maintenance of effective systems to identify, collect,
and use data from all departments, including but not limited to the
facility assessment required at Sec. 483.75(e) and including how such
information will be used to develop and monitor performance indicators.
(3) Facility development, monitoring, and evaluation of performance
indicators, including the methodology and frequency for such
development, monitoring, and evaluation.
(4) Facility adverse event monitoring, including the methods by
which the facility will systematically identify, report, track,
investigate, analyze and use data and information relating to adverse
events in the facility, including how the facility will use the data to
develop activities to prevent adverse events.
(d) Program systematic analysis and systemic action. (1) The
facility must take actions aimed at performance improvement and, after
implementing those actions, measure its success, and track performance
to ensure that improvements are realized and sustained.
(2) The facility will develop and implement policies addressing:
(i) How they will use a systematic approach (such as root cause
analysis, reverse tracer methodology, or health care failure and
effects analysis) to determine underlying causes of problems impacting
larger systems;
(ii) Development of corrective actions that will be designed to
effect change at the systems level to prevent quality of care, quality
of life, or safety problems; and
(iii) How the facility will monitor the effectiveness of its
performance improvement activities to ensure that improvements are
sustained.
(e) Program activities. (1) The facility must set priorities for
its performance improvement activities that focus on high-risk, high-
volume, or problem-prone areas; consider the incidence, prevalence, and
severity of problems in those areas; and affect health outcomes,
resident safety, resident autonomy, resident choice, and quality of
care.
(2) Performance improvement activities must track medical errors
and adverse resident events, analyze their causes, and implement
preventive actions and mechanisms that include feedback and learning
throughout the facility.
(3) The facility must conduct distinct performance improvement
projects. The number and frequency of improvement projects conducted by
the facility must reflect the scope and complexity of the facility's
services and available resources, as reflected in the facility
assessment required at Sec. 483.70(e). Improvement projects must
include at least annually a project that focuses on high risk or
problem-prone areas identified through the data collection and analysis
described in paragraphs (c) and (d) of this section.
(f) Governance and leadership. The governing body and/or executive
leadership (or organized group or individual who assumes full legal
authority and responsibility for operation of the facility) is
responsible and accountable for ensuring that:
(1) An ongoing QAPI program is defined, implemented, and maintained
and addresses identified priorities.
[[Page 42266]]
(2) The QAPI program is sustained during transitions in leadership
and staffing;
(3) The QAPI program is adequately resourced, including ensuring
staff time, equipment, and technical training as needed;
(4) The QAPI program identifies and prioritizes problems and
opportunities based on performance indicator data, and resident and
staff input that reflects organizational processes, functions, and
services provided to residents.
(5) Corrective actions address gaps in systems, and are evaluated
for effectiveness; and
(6) Clear expectations are set around safety, quality, rights,
choice, and respect.
(g) Quality assessment and assurance. (1) A facility must maintain
a quality assessment and assurance committee consisting at a minimum
of:
(i) The director of nursing services;
(ii) The Medical Director or his/her designee;
(iii) At least 3 other members of the facility's staff, at least
one of who must be the administrator, owner, a board member or other
individual in a leadership role; and
(iv) The infection control and prevention officer.
(2) The quality assessment and assurance committee reports to the
facility's governing body, or designated person(s) functioning as a
governing body regarding its activities, including implementation of
the QAPI program required under paragraphs (a) through (e) of this
section. The committee must:
(i) Meet at least quarterly and as needed to coordinate and
evaluate activities under the QAPI program, such as identifying issues
with respect to which quality assessment and assurance activities,
including performance improvement projects required under the QAPI
program, are necessary; and
(ii) Develop and implement appropriate plans of action to correct
identified quality deficiencies; and
(iii) Regularly review and analyze data, including data collected
under the QAPI program and data resulting from drug regimen reviews,
and act on available data to make improvements.
(h) Disclosure of information. (1) A State or the Secretary may not
require disclosure of the records of such committee except in so far as
such disclosure is related to the compliance of such committee with the
requirements of this section.
(2) Demonstration of compliance with the requirements of this
section may require State or Federal surveyor access to:
(i) Systems and reports demonstrating systematic identification,
reporting, investigation, analysis, and prevention of adverse events;
(ii) Documentation demonstrating the development, implementation,
and evaluation of corrective actions or performance improvement
activities; and
(iii) Other documentation considered necessary by a State or
Federal surveyor in assessing compliance.
(i) Sanctions. Good faith attempts by the committee to identify and
correct quality deficiencies will not be used as a basis for sanctions.
0
33. Newly redesignated Sec. 483.80 is revised to read as follows:
Sec. 483.80 Infection control.
The facility must establish and maintain an infection prevention
and control program designed to provide a safe, sanitary, and
comfortable environment and to help prevent the development and
transmission of communicable diseases and infections.
(a) Infection prevention and control program. The facility must
establish an infection prevention and control program (IPCP) that must
include, at a minimum, the following elements:
(1) A system for preventing, identifying, reporting, investigating,
and controlling infections and communicable diseases for all residents,
staff, volunteers, visitors, and other individuals providing services
under a contractual arrangement based upon the facility assessment
conducted according to Sec. 483.75(e) and following accepted national
standards;
(2) Written standards, policies, and procedures for the program,
which must include, but are not limited to:
(i) A system of surveillance designed to identify possible
communicable diseases or infections before they can spread to other
persons in the facility;
(ii) When and to whom possible incidents of communicable disease or
infections should be reported;
(iii) Standard and transmission-based precautions to be followed to
prevent spread of infections;
(iv) When isolation should be used for a resident;
(v) The circumstances under which the facility must prohibit
employees with a communicable disease or infected skin lesions from
direct contact with residents or their food, if direct contact will
transmit the disease; and
(vi) The hand hygiene procedures to be followed by staff involved
in direct resident contact,
(3) An antibiotic stewardship program that includes antibiotic use
protocols and a system to monitor antibiotic use.
(4) A system for recording incidents identified under the
facility's IPCP and the corrective actions taken by the facility.
(b) Infection prevention and control officer. The facility must
designate one individual as the infection prevention and control
officer (IPCO) for whom the IPCP at that facility is a major
responsibility. The IPCO must:
(1) Be a clinician who works at least part-time at the facility,
and
(2) Have specialized training in infection prevention and control
beyond their initial professional degree.
(c) IPCO participation on quality assessment and assurance
committee. The person designated as the IPCO must be a member of the
facility's quality assessment and assurance committee and report to the
committee on the IPCP on a regular basis.
(d) Influenza and pneumococcal immunizations--(1) Influenza. The
facility must develop policies and procedures to ensure that--
(i) Before offering the influenza immunization, each resident or
the resident's representative receives education regarding the benefits
and potential side effects of the immunization;
(ii) Each resident is offered an influenza immunization October 1
through March 31 annually, unless the immunization is medically
contraindicated or the resident has already been immunized during this
time period;
(iii) The resident or the resident's representative has the
opportunity to refuse immunization; and
(iv) The resident's medical record includes documentation that
indicates, at a minimum, the following:
(A) That the resident or resident's representative was provided
education regarding the benefits and potential side effects of
influenza immunization; and
(B) That the resident either received the influenza immunization or
did not receive the influenza immunization due to medical
contraindications or refusal.
(2) Pneumococcal disease. The facility must develop policies and
procedures to ensure that--
(i) Before offering the pneumococcal immunization, each resident or
the resident's representative receives education regarding the benefits
and potential side effects of the immunization;
(ii) Each resident is offered a pneumococcal immunization, unless
the immunization is medically contraindicated or the resident has
already been immunized;
(iii) The resident or the resident's representative has the
opportunity to refuse immunization; and
[[Page 42267]]
(iv) The resident's medical record includes documentation that
indicates, at a minimum, the following:
(A) That the resident or resident's representative was provided
education regarding the benefits and potential side effects of
pneumococcal immunization; and
(B) That the resident either received the pneumococcal immunization
or did not receive the pneumococcal immunization due to medical
contraindication or refusal.
(e) Linens. Personnel must handle, store, process, and transport
linens so as to prevent the spread of infection.
(f) Annual review. The facility will conduct an annual review of
its IPCP and update their program, as necessary.
0
34. Section 483.85 is added to read as follows:
Sec. 483.85 Compliance and ethics program.
(a) Definitions. For purposes of this section, the following
definitions apply:
Compliance and ethics program means, with respect to a facility, a
program of the operating organization that--
(i) Has been reasonably designed, implemented, and enforced so that
it is likely to be effective in preventing and detecting criminal,
civil, and administrative violations under the Act and in promoting
quality of care; and
(ii) Includes, at a minimum, the required components specified in
paragraph (c) of this section.
High-level personnel means individual(s) who have substantial
control over the operating organization or who have a substantial role
in the making of policy within the operating organization.
Operating organization means the individual(s) or entity that
operates a facility.
(b) General rule. Beginning on [1 year after the effective date of
the final rule], the operating organization for each facility must have
in operation a compliance and ethics program (as defined in paragraph
(a) of this section) that meets the requirements of this section.
(c) Required components for all facilities. The operating
organization for each facility must develop, implement, and maintain an
effective compliance and ethics program that contains, at a minimum,
the following components:
(1) Established written compliance and ethics standards, policies,
and procedures to follow that are reasonably capable of reducing the
prospect of criminal, civil, and administrative violations under the
Act and promote quality of care, which include, but are not limited to,
the designation of an appropriate compliance and ethics program contact
to which individuals may report suspected violations, as well as an
alternate method of reporting suspected violations anonymously without
fear of retribution; and disciplinary standards that set out the
consequences for committing violations for the operating organization's
entire staff; individuals providing services under a contractual
arrangement; and volunteers, consistent with the volunteers' expected
roles.
(2) Assignment of specific individuals within the high-level
personnel of the operating organization with the overall responsibility
to oversee compliance with the operating organization's compliance and
ethics program's standards, policies, and procedures, such as, but not
limited to, the chief executive officer (CEO), members of the board of
directors, or directors of major divisions in the operating
organization.
(3) Sufficient resources and authority to the specific individuals
designated in paragraph (c)(2) of this section to reasonably assure
compliance with such standards, policies, and procedures.
(4) Due care not to delegate substantial discretionary authority to
individuals who the operating organization knew, or should have known
through the exercise of due diligence, had a propensity to engage in
criminal, civil, and administrative violations under the Social
Security Act.
(5) The facility takes steps to effectively communicate the
standards, policies, and procedures in the operating organization's
compliance and ethics program to the operating organization's entire
staff; individuals providing services under a contractual arrangement;
and volunteers, consistent with the volunteers' expected roles.
Requirements include, but are not limited to, mandatory participation
in training as set forth at Sec. 483.95(f) or orientation programs, or
disseminating information that explains in a practical manner what is
required under the program.
(6) The facility takes reasonable steps to achieve compliance with
the program's standards, policies, and procedures. Such steps include,
but are not limited to, utilizing monitoring and auditing systems
reasonably designed to detect criminal, civil, and administrative
violations under the Social Security Act by any of the operating
organization's staff, individuals providing services under a
contractual arrangement, or volunteers, having in place and publicizing
a reporting system whereby any of these individuals could report
violations by others anonymously within the operating organization
without fear of retribution, and having a process for ensuring the
integrity of any reported data.
(7) Consistent enforcement of the operating organization's
standards, policies, and procedures through appropriate disciplinary
mechanisms, including, as appropriate, discipline of individuals
responsible for the failure to detect and report a violation to the
compliance and ethics program contact identified in the operating
organization's compliance and ethics program.
(8) After a violation is detected, the operating organization must
ensure that all reasonable steps identified in its program are taken to
respond appropriately to the violation and to prevent further similar
violations, including any necessary modification to the operating
organization's program to prevent and detect criminal, civil, and
administrative violations under the Act.
(d) Additional required components for operating organizations with
five or more facilities. In addition to all of the other requirements
in paragraphs (a), (b), (c), and (e) of this section, operating
organizations that operate five or more facilities must also include,
at a minimum, the following components in their compliance and ethics
program:
(1) A mandatory annual training program on the operating
organization's compliance and ethics program that meets the
requirements set forth in Sec. 483.95(f).
(2) A designated compliance officer for whom the operating
organization's compliance and ethics program is a major responsibility.
This individual must report directly to the operating organization's
governing body and not be subordinate to the general counsel, chief
financial officer or chief operating officer.
(3) Designated compliance liaisons located at each of the operating
organization's facilities.
(e) Annual review. The operating organization for each facility
must review its compliance and ethics program annually and revise its
program as needed to reflect changes in all applicable laws or
regulations and within the operating organization and its facilities to
improve its performance in deterring, reducing, and detecting
violations under Act and in promoting quality of care.
0
35. In newly redesignated Sec. 483.90--
0
a. Revise paragraph (c).
0
b. Revise paragraphs (d)(1)(i) and (d)(2)(i).
0
c. Revise paragraph (e).
0
d. Revise paragraphs (f) introductory text and (f)(1).
[[Page 42268]]
0
e. Revise paragraph (g)(2).
0
f. Add paragraph (h)(5).
The revisions and additions read as follows:
Sec. 483.90 Physical environment.
* * * * *
(c) Space and equipment. The facility must--
(1) Provide sufficient space and equipment in dining, health
services, recreation, living, and program areas to enable staff to
provide residents with needed services as required by these standards
and as identified in each resident's assessment and plan of care; and
(2) Maintain all mechanical, electrical, and patient care equipment
in safe operating condition.
(3) Conduct regular inspection of all bed frames, mattresses, and
bed rails, if any, as part of a regular maintenance program to identify
areas of possible entrapment. When bed rails and mattresses are used
and purchased separately from the bed frame, the facility must ensure
that the bed rails, mattress, and bed frame are compatible.
(d) * * *
(1) * * *
(i) Accommodate no more than four residents. For facilities that
receive approval of construction or reconstruction plans by State and
local authorities or are newly certified after [effective date of final
rule], bedrooms must accommodate no more than two residents.
* * * * *
(2) * * *
(i) A separate bed of proper size and height for the safety and
convenience of the resident;
* * * * *
(e) Toilet facilities. Each resident room must be equipped with or
located near toilet and bathing facilities. For facilities that receive
approval of construction or reconstruction plans from State and local
authorities or are newly certified after [effective date of the final
rule], each resident room must have its own bathroom equipped with at
least a toilet, sink and shower.
(f) Resident call system. The facility must be adequately equipped
to allow residents to call for staff assistance through a communication
system which relays the call directly to a staff member or to a
centralized staff work area from--
(1) Each resident's bedside; and
* * * * *
(g) * * *
(2) Be well ventilated;
* * * * *
(h) * * *
(5) Establish policies, in accordance with applicable Federal,
State, and local laws and regulations, regarding smoking, including
tobacco cessation, smoking areas and safety, including but not limited
to non-smoking residents.
0
36. Section 483.95 is added to subpart B to read as follows:
Sec. 483.95 Training requirements.
A facility must develop, implement, and maintain an effective
training program for all new and existing staff; individuals providing
services under a contractual arrangement; and volunteers, consistent
with their expected roles. A facility must determine the amount and
types of training necessary based on a facility assessment as specified
at Sec. 483.70(e). Training topics must include but are not limited
to--
(a) Communication. A facility must include effective communications
as mandatory training for direct care/direct access personnel.
(b) Resident's rights and facility responsibilities. A facility
must ensure that staff members are educated on the rights of the
resident and the responsibilities of a facility to properly care for
its residents as set forth at Sec. 483.10 and Sec. 483.11,
respectively.
(c) Abuse, neglect, and exploitation. In addition to the freedom
from abuse, neglect, and exploitation requirements in Sec. 483.12,
facilities must also provide training to their staff that at a minimum
educates staff on--
(1) Activities that constitute abuse, neglect, exploitation, and
misappropriation of resident property as set forth at Sec. 483.12.
(2) Procedures for reporting incidents of abuse, neglect,
exploitation, or the misappropriation of resident property.
(d) Quality assurance and performance improvement. A facility must
include as part of its QAPI program mandatory training that outlines
and informs staff of the elements and goals of the facility's QAPI
program as set forth at Sec. 483.75.
(e) Infection control. A facility must include as part of its
infection prevention and control program mandatory training that
includes the written standards, policies, and procedures for the
program as described at Sec. 483.80(a)(2).
(f) Compliance and ethics. The operating organization for each
facility must include as part of its compliance and ethics program, as
set forth at Sec. 483.85--
(1) An effective way to communicate that program's standards,
policies, and procedures through a training program or in another
practical manner which explains the requirements under the program.
(2) Annual training if the operating organization operates five or
more facilities.
(g) Required in-service training for nurse aides. In-service
training must--
(1) Be sufficient to ensure the continuing competence of nurse
aides, but must be no less than 12 hours per year.
(2) Include dementia management training and resident abuse
prevention training.
(3) Address areas of weakness as determined in nurse aides'
performance reviews and facility assessment at Sec. 483.70(e) and may
address the special needs of residents as determined by the facility
staff.
(4) For nurse aides providing services to individuals with
cognitive impairments, also address the care of the cognitively
impaired.
(h) Required training of feeding assistants. A facility must not
use any individual working in the facility as a paid feeding assistant
unless that individual has successfully completed a State-approved
training program for feeding assistants, as specified in Sec. 483.160.
(i) Behavioral health. A facility must provide behavioral health
training consistent with the requirements at Sec. 483.40 and as
determined by the facility assessment at Sec. 483.70(e).
Sec. 483.118 [Amended]
0
37. In Sec. 483.118, amend paragraphs (b)(1) and (c)(2)(i) by removing
the reference ``Sec. 483.12(a)'' and adding in its place the reference
``Sec. 483.15(b)''.
Sec. 483.130 [Amended]
0
38. In Sec. 483.130, amend paragraphs (m)(5) and (m)(6) by removing
the reference ``Sec. 483.12(a)'' and adding in its place the reference
Sec. 483.15(b)''.
Sec. 483.138 [Amended]
0
39. In Sec. 483.138, amend paragraphs (a) introductory text and (b)(1)
by removing the reference ``Sec. 483.12(a)'' and adding in its place
the reference ``Sec. 483.15(b)''.
Sec. 483.151 [Amended]
0
40. In Sec. 483.151, amend paragraph (a)(3) by removing the reference
``Sec. 483.75(e)'' and adding in its place the reference ``Sec.
483.35(c) and (d) and Sec. 483.95(g)''.
Sec. 483.204 [Amended]
0
41. In Sec. 483.204, amend paragraph (b) by removing the reference
``Sec. 483.12 of this part'' and adding in its place the reference
``Sec. 483.15(h)''.
[[Page 42269]]
Sec. 483.206 [Amended]
0
42. In Sec. 483.206, amend paragraph (a) by removing the reference
``(See Sec. Sec. 483.5 and 483.12(a)(1))'' and adding in its place the
reference ``(See Sec. 483.5)''.
PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
0
43. The authority citation for part 485 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395(hh)).
Sec. 485.635 [Amended]
0
44. In Sec. 485.635, amend paragraph (a)(3)(vii) by removing the
reference ``Sec. 483.25(i)'' and adding in its place the reference
``Sec. 483.25(d)(8)''.
0
45. In Sec. 485.645, paragraphs (d)(1) through (9) are revised and
paragraph (d)(10) is added to read as follows:
Sec. 485.645 Special requirements for CAH providers of long-term care
services (``swing-beds'').
* * * * *
(d) * * *
(1) Resident rights (Sec. 483.10(a)(4)(iv), (b), (c), (d)(1),
(d)(3), (e)(8), (g), and (h)(3)).
(2) Facility responsibilities (Sec. 483.11(d)(1)(i), (d)(1)(iii),
(d)(4), (e)(11), (e)(12), (e)(14)(iii), and (f)(1)(i)).
(3) Transitions of care (Sec. 483.5(n), Sec. 483.15(b)(1),
(b)(2), (b)(3)(i) through (iii), (b)(4), (b)(5)(i) through (vii), and
(b)(7)).
(4) Freedom from abuse, neglect and exploitation (Sec. 483.12).
(5) Patient activities (Sec. 483.25(c)), except that the services
may be directed either by a qualified professional meeting the
requirements of Sec. 485.25(c)(2), or by an individual on the facility
staff who is designated as the activities director and who serves in
consultation with a therapeutic recreation specialist, occupational
therapist, or other professional with experience or education in
recreational therapy.
(6) Social services (Sec. 483.40(d) and Sec. 483.75(p)).
(7) Comprehensive assessment, comprehensive care plan, and
discharge planning (Sec. 483.20(b), and Sec. 483.21(b) and (c)),
except that the CAH is not required to use the resident assessment
instrument (RAI) specified by the State that is required under Sec.
483.20(b), or to comply with the requirements for frequency, scope, and
number of assessments prescribed in Sec. 413.343(b) of this chapter).
(8) Specialized rehabilitative services (Sec. 483.65).
(9) Dental services (Sec. 483.55).
(10) Nutrition (Sec. 483.25(d)(8) of this chapter).
PART 488--SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
0
46. The authority citation for part 488 continues to read as follows:
Authority: Secs. 1102, 1128I and 1871 of the Social Security
Act, unless otherwise noted (42 U.S.C. 1302, 1320a-7j, and 1395hh);
Pub. L. 110-149, 121 Stat. 1819. Sec. 1102 of the Social Security
Act (42 U.S.C. 1302).
Sec. 488.56 [Amended]
0
47. In Sec. 488.56, paragraph (a) introductory text is amended by
removing the reference ``Sec. 483.30'' and adding in its place the
reference ``Sec. 483.35''.
0
48. Section 488.301 is amended by revising the definitions of ``nurse
aide'', ``paid feeding assistant'', and ``substandard quality of care''
to read as follows:
Sec. 488.301 Definitions.
* * * * *
Nurse aide means an individual, as defined in Sec. 483.5(n) of
this chapter.
* * * * *
Paid feeding assistant means an individual who meets the
requirements specified in Sec. 483.60(h)(1) of this chapter and who is
paid to feed residents by a facility, or who is used under an
arrangement with another agency or organization.
* * * * *
Substandard quality of care means one or more deficiencies related
to participation requirements under Sec. 483.10 ``Resident rights'',
paragraphs (d) and (e); Sec. 483.11 ``Facility Responsibilities'',
paragraphs (d) and (g); Sec. 483.12 ``Freedom from abuse, neglect, and
exploitation''; Sec. 483.25 ``Quality of care, and quality of life'';
Sec. 483.40 ``Behavioral health services'', paragraphs (b) and (d);
Sec. 483.45 ``Pharmacy services'', paragraphs (d), (e), and (f); and
Sec. 483.80 ``Infection control'', paragraph (d) of this chapter,
which constitute either immediate jeopardy to resident health or
safety; a pattern of or widespread actual harm that is not immediate
jeopardy; or a widespread potential for more than minimal harm, but
less than immediate jeopardy, with no actual harm.
* * * * *
Sec. 488.426 [Amended]
0
49. In Sec. 488.426, paragraph (b) is amended by removing the
reference ``Sec. 483.75(r)'' and adding in its place the reference
``Sec. 483.70(l)'' and paragraph (c) is amended by removing the
reference ``Sec. 483.75(r)(1)(ii)'' and adding in its place the
reference ``Sec. 483.70(l)''.
Sec. 488.446 [Amended]
0
50. In Sec. 488.446, the introductory text is amended by removing the
reference ``Sec. 483.75(r)'' and adding in its place the reference
``Sec. 483.70(l)''.
Dated: May 12, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
Approved: July 8, 2015.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-17207 Filed 7-13-15; 8:45 am]
BILLING CODE 4120-01-P
