[Federal Register Volume 80, Number 136 (Thursday, July 16, 2015)]
[Proposed Rules]
[Pages 42168-42269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17207]



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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  

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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.

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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 http://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: http://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

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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

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.''

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     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.

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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]. http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/DataCompendium/index.html).
    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) (http://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 (http://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'' (http://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 http://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''.

[[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 (http://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 (http://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 http://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 http://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 http://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: 
http://wiki.siframework.org/LCC+LTPAC+Care+Transition+SWG and http://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 http://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 http://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

[[Page 42180]]

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 http://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 http://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 http://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'' (http://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. http://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 (http://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; http://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 http://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 http://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 
http://www.medicare.gov/Pubs/pdf/11376.pdf) and AHRQ (see http://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 (http://www.ahrq.gov/professionals/education/curriculum-tools/teamstepps/longtermcare/) INTERACT (http://interact2.net/), and the On-Time 
Quality Improvement Program (http://www.ahrq.gov/professionals/systems/long-term-care/resources/ontime/qualityimprov/index.html). 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 http://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 (http://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 http://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 http://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 http://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 http://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. (http://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. (http://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. http://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'' 
(http://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 (http://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 (http://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 (http://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 (http://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. http://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 [email protected], 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 (http://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 (http://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 http://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 http://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 (http://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]. 
http://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 (http://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 http://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 http://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 (http://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: 
http://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., http://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 http://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.'' (http://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 (http://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 (http://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 http://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. 
http://www.ahrq.gov/qual/ptsafetyltc/index.html). AHRQ's 
TeamSTEPPS[supreg] Long Term Care Version is a training program to 
enhance communication for front line staff in nursing homes. (http://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/index.html). 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 http://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 http://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 (http://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 http://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:

 http://www.nhqualitycampaign.org
 http://www.ascp.com
 http://www.amda.com
 http://www.ahcancal.org
 http://www.leadingage.org
 http://www.americangeriatrics.org
 http://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 http://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 (http://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 (http://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 http://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 http://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 (http://www.nursingworld.org/SafeStaffingFactsheet.aspx). 
According to a 2009 survey by the American Health Care Association 
(http://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 http://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 
http://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