[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Rules and Regulations]
[Pages 68688-68872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-23503]



[[Page 68687]]

Vol. 81

Tuesday,

No. 192

October 4, 2016

Part III





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, 482, et al.;





Medicare and Medicaid Programs; Reform of Requirements for Long-Term 
Care Facilities; Final Rule

Federal Register / Vol. 81 , No. 192 / Tuesday, October 4, 2016 / 
Rules and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 431, 447, 482, 483, 485, 488, and 489

[CMS-3260-F]
RIN 0938-AR61


Medicare and Medicaid Programs; Reform of Requirements for Long-
Term Care Facilities

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule will revise the requirements that Long-Term 
Care facilities must meet to participate in the Medicare and Medicaid 
programs. These 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 revisions 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: Effective date: These regulations are effective on November 28, 
2016.
    Implementation date: The regulations included in Phase 1 must be 
implemented by November 28, 2016.
    The regulations included in Phase 2 must be implemented by November 
28, 2017.
    The regulations included in Phase 3 must be implemented by November 
28, 2019.
    A detailed discussion regarding the different phases of the 
implementation timeline can be found in Section B. II ``Implementation 
Date.''

FOR FURTHER INFORMATION CONTACT: 
    LTC Regulations Team, (410) 786-6633: Sheila Blackstock, Ronisha 
Blackstone, Diane Corning, Lisa Parker.

SUPPLEMENTARY INFORMATION: 

Acronyms

    Because of the many terms to which we refer by acronym in this 
final 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
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
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
IP Infection Preventionist
IPCP Infection Prevention and Control Program
LSC Life Safety Code
LTC Long-Term Care
NATCEP Nurse Aide Training Competency Evaluation Program
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
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
SNF Skilled Nursing Facility
WHO World Health Organization

Table of Contents

This final rule is organized as follows:
I. Background
    A. Executive Summary
    1. Purpose
    2. Summary of the Major Provisions
    3. Summary of Costs and Benefits
    B. Statutory and Regulatory Authority of the Requirements for 
Long-Term Care Facilities
    C. Why revise the LTC requirements?
II. Provisions of the Proposed Regulation and Responses to Public 
Comments
    A. General Comments
    B. Implementation Date
    C. Basis and Scope (Sec.  483.1)
    D. Definitions (Sec.  483.5)
    E. Resident Rights (Sec.  483.10)
    F. Facility Responsibilities (Sec.  483.11)
    G. Freedom From Abuse, Neglect, and Exploitation (Sec.  483.12)
    H. Transitions of Care (Sec.  483.15)
    I. Resident Assessments (Sec.  483.20)
    J. Comprehensive Resident-Centered Care Planning (Sec.  483.21)
    K. Quality of Care and Quality of Life (Sec.  483.25)
    L. Physician Services (Sec.  483.30)
    M. Nursing Services (Sec.  483.35)
    N. Behavioral Health Services (Sec.  483.40)
    O. Pharmacy Services (Sec.  483.45)
    P. Laboratory, Radiology, and Other Diagnostic Services (Sec.  
483.50)
    Q. Dental Services (Sec.  483.55)
    R. Food and Nutrition Services (Sec.  483.60)
    S. Specialized Rehabilitative Services (Sec.  483.65)
    T. Outpatient Rehabilitative Services (Sec.  483.67)
    U. Administration (Sec.  483.70)
    V. Quality Assurance and Performance Improvement (Sec.  483.75)
    W. Infection Control (Sec.  483.80)
    X. Compliance and Ethics Program (Sec.  483.85)
    Y. Physical Environment (Sec.  483.90)
    Z. Training Requirements (Sec.  483.95)
III. Provisions of the Final Regulations
IV. Long-Term Care Facilities Crosswalk
V. Collection of Information Requirements
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 LTC facilities 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 reviewed regulations in an effort to 
improve the quality of life, care, and services in LTC

[[Page 68689]]

facilities, optimize resident safety, reflect current professional 
standards, and improve the logical flow of the regulations. 
Specifically, we are adding new requirements where necessary, 
eliminating duplicative or unnecessary provisions, and reorganizing 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 
revisions will eliminate or significantly reduce those instances where 
the requirements are duplicative, unnecessary, and/or burdensome.
2. Summary of Provisions
Basis and Scope (Sec.  483.1)
     We have added the statutory authority citations for 
sections 1128I(b) and (c) and section 1150B of the Social Security Act 
(the Act) to include the compliance and ethics program, quality 
assurance and performance improvement (QAPI), and reporting of 
suspicion of a crime requirements to this section.
Definitions (Sec.  483.5)
     We have added the definitions for ``abuse'', ``adverse 
event'', ``exploitation'', ``misappropriation of resident property'', 
``mistreatment'', ``neglect'', ``person-centered care'', ``resident 
representative'', and ``sexual abuse'' to this section.
Resident Rights (Sec.  483.10)
     We are retaining all existing residents' rights and 
updating the language and organization of the resident rights 
provisions to improve logical order and readability, clarify aspects of 
the regulation where necessary, and updating provisions to include 
advances such as electronic communications.
Freedom From Abuse, Neglect, and Exploitation (Sec.  483.12)
     We are requiring facilities to investigate and report all 
allegations of abusive conduct. We also are specifying 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.
Admission, Transfer, and Discharge Rights (Sec.  483.15)
     We are requiring that a transfer or discharge be 
documented in the medical record and that specific information be 
exchanged with the receiving provider or facility when a resident is 
transferred.
Resident Assessments (Sec.  483.20)
     We are clarifying what constitutes appropriate 
coordination of a resident's assessment with the Preadmission Screening 
and Resident Review (PASARR) program under Medicaid. We are also adding 
references to statutory requirements that were inadvertently omitted 
from the regulation when we first implemented sections 1819 and 1919 of 
the Act.
Comprehensive Person-Centered Care Planning (Sec.  483.21) *New 
Section*
     We are requiring facilities to develop and implement 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.
     We are adding a nurse aide and a member of the food and 
nutrition services staff to the required members of the 
interdisciplinary team that develops the comprehensive care plan.
     We are requiring that facilities develop and implement a 
discharge planning process that focuses on the resident's discharge 
goals and prepares residents to be active partners in post-discharge 
care, in effective transitions, and in the reduction of factors leading 
to preventable re-admissions. We are also implementing the discharge 
planning requirements mandated by The Improving Medicare Post-Acute 
Care Transformation Act of 2014 (IMPACT Act) by revising, or adding 
where appropriate, discharge planning requirements for LTC facilities.
Quality of Care (Sec.  483.24)
     We are requiring that each resident receive and the 
facility 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.
Quality of Life (Sec.  483.25)
     Based on the comprehensive assessment of a resident, we 
are requiring facilities to ensure that residents receive treatment and 
care in accordance with professional standards of practice, the 
comprehensive person-centered care plan, and the residents' choices.
Physician Services (Sec.  483.30)
     We are allowing attending physicians to delegate dietary 
orders to qualified dietitians or other clinically qualified nutrition 
professionals and therapy orders to therapists.
Nursing Services (Sec.  483.35)
     We are adding a competency requirement for determining the 
sufficiency of 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 individual care plans.
Behavioral Health Services (Sec.  483.40)
     We are adding 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.
     We are adding ``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)
     We are requiring that a pharmacist review a resident's 
medical chart during each monthly drug regimen review.
     We are revising existing requirements regarding 
``antipsychotic'' drugs to refer to ``psychotropic'' drugs and define 
``psychotropic drug'' as any drug that affects brain activities 
associated with mental processes and behavior. We are requiring several 
provisions intended to reduce or eliminate the need for psychotropic 
drugs, if not clinically contraindicated, to safeguard the resident's 
health.
Laboratory, Radiology, and Other Diagnostic Services (Sec.  483.50) 
*New Section*
     We are clarifying 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.
Dental Services (Sec.  483.55)
     We are prohibiting SNFs and NFs from charging a Medicare 
resident for the loss or damage of dentures determined in accordance 
with facility policy to be the facility's responsibility, and we are 
adding a requirement that the facility have a policy identifying those 
instances when the loss or damage of dentures is the facility's 
responsibility. We are requiring NFs to assist residents who are 
eligible to apply for reimbursement of dental services under the 
Medicaid state plan, where applicable.

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     We are clarifying that with regard to a referral for lost 
or damaged dentures ``promptly'' means that the referral must be made 
within 3 business days unless there is documentation of extenuating 
circumstances.
Food and Nutrition Services (Sec.  483.60)
     We are requiring facilities to 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. We are also requiring facilities to 
employ sufficient staff, including the designation of a director of 
food and nutrition service, with the appropriate competencies and 
skills sets to carry out the functions of dietary services while taking 
into consideration resident assessments and individual plans of care, 
including diagnoses and acuity, as well as the facility's resident 
census.
Specialized Rehabilitative Services (Sec.  483.65)
     We have added respiratory services to those services 
identified as specialized rehabilitative services.
Administration (Sec.  483.70)
     We have largely relocated various portions of this section 
into other sections of subpart B as deemed appropriate.
     We require facilities to conduct, document, and annually 
review a facility-wide assessment to determine what resources are 
necessary to care for its residents competently during both day-to-day 
operations and emergencies. Facilities are required to 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.
     Binding Arbitration Agreements: We are requiring that 
facilities must not enter into an agreement for binding arbitration 
with a resident or their representative until after a dispute arises 
between the parties. Thus, we are prohibiting the use of pre-dispute 
binding arbitration agreements.
Quality Assurance and Performance Improvement (QAPI) (Sec.  483.75)
     We are requiring 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)
     We are requiring facilities to develop an Infection 
Prevention and Control Program (IPCP) that includes an Antibiotic 
Stewardship Program and designate at least one Infection Preventionist 
(IP).
Compliance and Ethics Program (Sec.  483.85) *New Section*
     We are requiring the operating organization for each 
facility to have in effect 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)
     We are requiring facilities that are constructed, re-
constructed, or newly certified after the effective date of this 
regulation to accommodate no more than two residents in a bedroom. We 
are also requiring facilities that are constructed, or newly certified 
after the effective date of this regulation to have a bathroom equipped 
with at least a commode and sink in each room.
Training Requirements (Sec.  483.95) *New Section*
     We are adding 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.
3. Summary of Costs and Benefits
    We estimate the total projected cost of this final rule will be 
about $831 million in the first year and $736 million per year for 
subsequent years. While this is a large amount in total, the average 
costs per facility are estimated to be about $62,900 in the first year 
and $55,000 per year for subsequent years. Although the overall 
magnitude of cost related to this regulation is economically 
significant, we note that these costs are significantly less than the 
amount of Medicare and Medicaid spending for LTC services. According to 
the 2015 Annual Report of the Medicare Trustees, payments for SNF 
services from Medicare Part A were $29.92 billion for fiscal year 2015 
and payments for NF services were $50.6 billion for fiscal year 2013 
(see https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Statistics-Reference-Booklet/2015.html).
    We are unable to quantify the benefits of the final rule; however, 
this final rule creates new efficiencies and flexibilities for 
facilities that are likely to reduce avoidable hospital readmissions, 
increase the rate of improvement in quality throughout facilities, and 
create positive business benefits for facilities.

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 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 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) of the Act 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

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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 sections 1819(f)(2)(A)(i)(I) and 
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 (NAs).

C. Why revise the long-term care requirements

    On July 16, 2015, we published a proposed rule entitled, ``Medicare 
and Medicaid Programs; Reform of Requirements for Long-Term Care 
Facilities'' (80 FR 42168). In the proposed rule we included a robust 
discussion about the history the LTC requirements and how the current 
care and service delivery practices of LTC facilities have changed over 
time. We encourage readers to refer to the proposed rule for this 
discussion. As discussed in the proposed rule, the requirements for LTC 
facilities have not been comprehensively reviewed and updated since 
1991. In addition, the number of individuals accessing SNF care has 
increased and the health concerns of individuals residing in LTC 
facilities have become more clinically complex. These factors 
demonstrated a need to comprehensively review the regulation and 
informed our approach for revising the regulations. The following 
discussion highlights our approach for revising the LTC regulations as 
well as some of the most significant revisions set forth in this final 
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 have 
taken 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. As discussed 
in further detail, we are requiring facilities to assess their facility 
capabilities and their resident population. This competency-based 
approach is compatible with existing state requirements and business 
practices, and promotes both efficiency and effectiveness in care 
delivery.
Current HHS Quality Initiatives
    This final rule is intended to meet the spirit of current HHS 
quality initiatives that cut across various providers. 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. As discussed below, we are implementing several 
revisions consistent with these efforts.
 Reducing Avoidable Hospitalizations
    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 launched the 
``Initiative to Reduce Avoidable Hospitalizations among Nursing 
Facility Residents'' (http://innovation.cms.gov/initiatives/rahnfr/) in 
2012. This Initiative focuses 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, this final rule strengthens the minimum health and 
safety standards for LTC facilities in hopes of contributing to a 
reduction in unnecessary hospital admissions of LTC facility residents. 
We discuss those changes in more detail in the discussion that follows.
 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. To advance these initiatives, this final rule implements 
revisions that we believe will provide more opportunities to achieve 
broad based improvement and contribute to reduced healthcare costs, 
while allowing for targeted interventions specific to each LTC 
facility.
 Behavioral Health
    On March 29, 2012, CMS launched an initiative aimed at improving 
behavioral healthcare and safeguarding LTC facility residents from the 
use of unnecessary antipsychotic medications, the National Partnership 
to Improve Dementia Care in Nursing Homes. 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 LTC 
facility residents, particularly those with dementia-related behaviors 
(https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/National-Partnership-to-Improve-Dementia-Care-in-Nursing-Homes.html).
    Similarly, with regard to minimum health and safety standards, this 
final rule implements regulatory changes that may lead to a reduction 
in the unnecessary use of antipsychotic medication and improvements in 
the quality of behavioral healthcare.
 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. 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

[[Page 68692]]

privacy and security requirements that enable interoperability. This 
strategy is described in greater detail in ``Connecting Health and Care 
for the Nation: A Shared Nationwide Interoperability Roadmap'', 
available at https://www.healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf. 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).
 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. 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, will help advance the quality of care that a resident 
receives and, in turn, can substantially improve a resident's quality 
of life.

II. Provisions of the Proposed Regulation and Response to Public 
Comments

    In response to our July 16, 2015 proposed rule (80 FR 42168), we 
received over 9,800 public comments. Commenters included long-term care 
consumers, advocacy groups for long-term care consumers, organizations 
representing providers of long-term care and senior service, long-term 
care ombudsman, state survey agencies, various health care 
associations, legal organizations, and many individual health care 
professionals. Below, we have organized our response to comments as 
follows: A. General Comments; B. Implementation, and C. Public Comments 
by Regulatory Section.

A. General Comments

    Comment: Most commenters expressed overall support for the proposed 
revisions to the requirements. Commenters agreed that reforms to the 
existing requirements are necessary to ensure high quality care and 
quality of life in LTC facilities across the nation.
    Specifically, many commenters support the change in focus towards 
person-centered care. One commenter stated that ``[t]he rule would 
require that facilities learn more about who the resident is as a 
person, provide greater support for resident preferences and give 
residents increased control and choice. This focus on person-centered 
care and culture change would improve both the resident's quality of 
life and quality of care.'' Commenters also expressed support for 
improved protections of resident's rights, protections against abuse 
and neglect, and a greater emphasis on resident and representative 
participation in care planning. Commenters also stated that change is 
necessary to reflect current standards of practice, and support our use 
of geriatrics-focused medical literature in developing the proposed 
requirements.
    Response: We thank commenters for their support. Our intent in 
issuing the proposed requirements was to improve the quality of care 
and quality of life for residents of long term care facilities.
    Comment: Some commenters commended CMS for the proposed revisions 
to the requirements, while stating that CMS should have proposed 
additional changes and reforms. For example, a few commenters stated 
that we should have explicitly required facilities to accommodate 
supported decision making, which is when an individual assists a 
resident in making his or her own decisions, rather than making 
decisions on their behalf. Commenters also expressed disappointment 
that the proposed requirements did not directly address dementia care.
    Response: We thank the commenters for their responses, and believe 
that the flexible, person-centered nature of these requirements will 
support facilities in addressing each resident's goals and needs. For 
example, residents and their designated representatives can certainly 
engage in supported decision making with their care team--nothing in 
these requirements prohibits it. Further, we do address dementia care 
in the Behavioral Health sections of this final rule.
    Comment: Many commenters expressed general worries that the 
proposed changes were too broad in scope, and that incremental changes 
would be easier to implement and better for LTC residents. We directly 
requested comments on the implementation of the revised requirements 
and commenters overwhelmingly indicated their preference for a phased 
implementation. Commenters also requested more time in which to submit 
comments, due to the depth and volume of the proposed revisions.
    Response: We acknowledge that these requirements may be difficult 
to effectively implement within the standard delayed implementation 
period (typically 60 days for more comprehensive rulemakings). We are 
therefore implementing these requirements over a ``phase-in'' period. 
Please see section II.B. of this rule, ``Implementation,'' for a 
detailed discussion of the implementation timeframe. Also, in order to 
allow sufficient time for public review of the proposed rule, we did 
extend the public comment period by 30 days, instead of closing 
submissions after the typical 60-day public comment period. We thank 
the thousands of commenters who provided comments during the extended 
period.
    Comment: Some commenters expressed disappointment that we continue 
to approach LTC facilities as health care institutions rather than 
``homes.'' One commenter suggested we use the word ``nursing home'' 
instead of ``facility.''
    Conversely, many commenters believe we should acknowledge that LTC 
facilities are no longer necessarily de facto homes, but skilled health 
care facilities providing more intensive care for shorter periods of 
time, and that the requirements should address the specific needs of 
shorter-stay residents, such as those who are rehabilitating after 
medical events before returning to their private residence. For 
example, these shorter stay residents (who usually stay for fewer than 
30 days) are not likely interested in resident or family councils, or 
concerned about selecting a roommate. Commenters also expressed that 
short-stay individuals may not benefit from the same type of care 
planning as would be appropriate for longer term residents.
    Response: We recognize that for many residents, a LTC facility is 
their home. That said, LTC facilities are specialized health care 
settings for individuals not capable of living independently and are 
not directly comparable to private residences. We do support LTC 
facilities in developing a home-like environment,

[[Page 68693]]

and note that residents are indeed recognized as residents, even if 
their stay is short.
    We believe that the person-centered approach to care required in 
this rulemaking allows for flexibility in care planning and resident 
accommodations. A resident at the LTC facility for a short period of 
time may have a shorter or more focused plan of care than a long-term 
resident. Similarly, a short-term resident may elect not to participate 
in resident councils.
    Comment: One commenter, who stated that their facility provides 
short-term rehab services following hospitalizations in addition to 
long-term care, expressed the belief that our proposed requirements 
would inhibit their ability to accept patients during evenings and 
weekends. They stated that this may cause ``backups'' in hospital 
discharges, and lead to patients being inappropriately discharged to 
their private home.
    Response: We do not agree that our revised requirements limit 
admissions to long-term care facilities outside of weekday business 
hours. We encourage LTC facilities to work with local hospitals to 
ensure safe care transitions, and to exercise the flexibility allowed 
by the requirements to establish admissions and care planning policies 
appropriate for their community.
    Comment: Commenters appreciated that CMS acknowledged and proposed 
to incorporate the full scopes of practice for non-physician 
practitioners related to actions that were formerly restricted to 
physicians. They supported these changes for being both cost effective 
and responsive to current standards of care.
    Response: We agree and thank commenters for their support. Please 
note that statute restricts some positions and tasks to physicians, 
such as the requirement at section 1819(b)(6)(A) of the Act, which 
requires that the care of every resident be provided under the 
supervision of a physician. Where appropriate and permissible by 
statute, we have allowed for flexibility in who may perform certain 
tasks or services within their respective scopes of practice.
    Comment: Some commenters stated that they saw no need for CMS to 
revise requirements for LTC facilities. They expressed concerns that 
the proposed requirements would be both excessively burdensome and 
confusing. A few commenters expressly identified the regulatory 
language of the proposed requirements as confusing. Commenters also 
stated their belief that the current requirements are adequate, and 
that changes would be detrimental to care.
    Response: We thank the commenters for their input, but disagree 
that changes to the LTC requirements are unnecessary. Current 
requirements do not, in some respects, reflect advances in technology 
and the science of care delivery. In addition, while it is true that 
many facilities provide excellent care under the current requirements, 
data and incidents continue to show that there are LTC facilities that 
have room for improvement. These updated and revised requirements 
establish a framework for those facilities to raise their quality of 
care. We have reviewed and considered all comments, and in response to 
concerns over burden, we have revised some proposed requirements and 
burden estimates in this final rule. Where commenters brought up 
specific concerns, we address those in the relevant parts of this rule. 
Also, we have made clarifying revisions to several parts of the rule, 
in order to improve understanding.
    Comment: Commenters disagreed on whether the proposed requirements 
align with current standards of practice. Some believe that current 
standards of practice may be inadequate or stated that they already met 
many of the newly proposed requirements. Others expressed concerns that 
a number of the proposed requirements are unrealistic or contrary to 
sound standards of practice.
    Response: We recognize that standards of care are constantly 
evolving and have therefore tried to create meaningful, yet 
appropriately flexible, requirements. We thank the commenters for their 
input, and point out that this regulation establishes revised baseline 
requirements. These requirements are meant to ensure safe, 
professional, patient-centered care in all Medicare-and Medicaid-
participating LTC facilities, while leaving room for facilities to 
improve and excel. We commend those facilities who strive to improve 
upon them and look forward to stakeholder feedback as the requirements 
are implemented.
    Comment: A few commenters stated that they do not support the 
proposed reorganization of the Requirements of Participation and 
disagreed with the assertion that the reorganization improves the 
logical flow of the regulations. Commenters stated that working within 
the existing structure of the requirements would make it easier to 
implement new requirements and reduce burden on stakeholders.
    Response: We thank the commenters for their input. In response to 
comments, we have made some changes to the order and arrangement of the 
requirements from the proposed rule, specifically with respect to 
proposed Sec. Sec.  483.10, 483.11, and 483.25. In response to the 
concerns related to implementation, we again note that we are 
implementing the requirements over a phase-in period to allow for 
appropriate clarification and education for facilities, surveyors, and 
other stakeholders.
    Comment: A few commenters were not supportive of the designation of 
these requirements of participation as ``requirements,'' rather than 
``conditions of participation'' that apply to other Medicare-
participating providers. Specifically, the commenters are concerned 
that this terminology effectively makes any violation or unmet 
requirement a reason for surveyors to close a facility.
    Response: The term ``requirements'' reflects the statutory language 
at sections 1819 and 1919 of the Act. Although this rule establishes 
requirements for LTC facilities, and not conditions, we note that CMS 
and state agencies have always taken into consideration the scope and 
severity of violations. Except in very rare cases of serious, immediate 
health and safety risks to residents, facilities are always given an 
opportunity to address and correct deficiencies. The goal of the 
requirements and their enforcement is to ensure the health and safety 
of residents, which includes giving facilities the opportunity to 
improve and come into compliance with the requirements.
    Comment: Some commenters expressed concerns that hands-on care 
would take a backseat to paperwork and documentation under the proposed 
requirements. Other commenters suggested that we could have gone 
further and established a detailed data collection program, which could 
be used to better identify achievement and best practices in LTC 
settings.
    Response: It is not our intention to reduce staff time spent 
performing direct patient care; however, facilities must be able to 
demonstrate that care and services meet the requirements for 
participation. Unfortunately, instances of significant lapses in care 
continue to occur in facilities. Our requirements, including QAPI, 
Compliance and Ethics, and Infection Control, as well as requirements 
for policies and procedures, are intended to protect the health and 
safety of residents, prevent harm and support quality of life for 
residents. Establishing a detailed data collection program is outside 
the scope of this rule.
    Comment: Some commenters stated that revisions to the requirements 
are meaningless without appropriate enforcement. Commenters asked that,

[[Page 68694]]

prior to implementation of new requirements, CMS ensure all federal and 
state surveyors are thoroughly trained about the substance of these new 
requirements as well as current professional standards of care for all 
professionals working in nursing centers. One commenter further 
suggested that surveyors be required to demonstrate competence in all 
relevant areas, as shown through testing and monitoring. Alternately, 
one commenter offered their support for ``movement from a punitive 
survey process to more towards a process which survey agencies and care 
givers work hand in hand for positive outcomes. Surveyors have a wealth 
of knowledge and exposure to numerous facilities. Passing on best 
practices to improve care giving and focusing on training the care 
givers would be a[n] improvement.''
    Other commenters offered concerns about variability and perceived 
inconsistencies between surveys and surveyors. A few commenters urged 
CMS to provide defined consequences for noncompliance with the 
regulations, particularly those related to residents' rights, 
grievances, and abuse and neglect, including finding of Immediate 
Jeopardy (as appropriate) and, ultimately, sanctions, including large 
civil monetary penalties, temporary management, directed corrective 
actions, and exclusion from participation in Federal health care 
programs, as appropriate.
    Response: We agree that surveyors must be educated and trained on 
the new requirements and note that such training happens on a regular 
basis, especially when new requirements are issued. We will consider 
these comments for future rulemaking. We note that surveyors are not 
permitted by law to act simultaneously as consultants. Specifying 
precise consequences for facilities out of compliance with specific 
requirements is outside the scope of this rulemaking.
    Comment: Commenters expressed strong support for stakeholder 
involvement in the development of sub-regulatory materials. One 
commenter expressed concerns about the approach CMS has been recently 
taking utilizing relatively brief conference calls with numerous 
callers (too numerous to allow effective discussion) allegedly to 
engage stakeholders in development of critical implementation issues. 
The commenters felt that this did not constitute sufficient stakeholder 
engagement. One commenter observed that upon issuance of a final rule, 
CMS will need to develop sub-regulatory requirements, including 
interpretive guidelines, to provide much greater detail and guidance on 
the regulatory revisions. The commenter recommended that provider 
organizations and association representatives be involved in the 
development of these specific requirements and guidelines to ensure 
they are consistent with sound practice, pragmatic in approach, 
sufficiently flexible, cost-effective and representative of the current 
realities of providing LTC facility care to an increasingly complex and 
diverse resident population.
    Response: We thank commenters for their input and will consider 
their views for possible later action.
    Comment: Several commenters associated with rural LTC facilities 
expressed concerns that meeting the proposed requirements would be 
difficult in rural areas. They identified staffing as a particular 
hardship in rural areas, especially the proposed requirement for 
physician evaluation prior to non-emergency hospital transfer. Rural 
facilities also stated that it was already difficult to hire and retain 
qualified staff in all skilled positions, simply due to rural 
population levels. Other commenters pointed to the general labor 
shortage in health care across much of the country.
    Response: We appreciate the commenters' input and note that we have 
revised the proposed requirements to allow for greater flexibility and 
in consideration of staffing concerns. Specifically, we are not 
finalizing the proposed requirement for pre-transfer evaluation by a 
practitioner. That said, these regulations establish what we have 
identified as basic staffing needs to ensure appropriate expertise and 
quality of care. We sympathize with those facilities that are unable to 
access a large labor pool, but we cannot condone substandard care. We 
discuss physician services and staffing requirements in greater detail 
in the relevant sections of this rule.
    Comment: Commenters expressed concern about the overall burden of 
the proposed requirements, and many believe that we may have 
underestimated the burden on stakeholders. One commenter expressed 
concern about the cumulative compliance costs associated with the many 
changes proposed in the regulations. They believe that the additional 
staffing, credentialing, training, systems and contractual 
relationships that will be required for compliance will add to the 
financial stresses that LTC facilities are experiencing from ongoing 
Medicare and Medicaid cuts. Another commenter protested our issuance of 
new, burdensome requirements while at the same time ``cutting fee-for-
service reimbursements'' and implementing value-based purchasing.
    Response: We have revised some provisions, such as the requirement 
for credentialing, in response to concerns about burden. In addition, 
we have our burden estimates in response to comments. Please see 
sections V, ``Collection of Information Requirements,'' and VI, 
``Regulatory Impact Analysis (RIA),'' of this rule for more details 
about regulatory burden estimates.
    We acknowledge that the SNF value-based purchasing (VBP) program, 
which will take effect in FY 2019, is intended to tie SNF payments more 
closely to rewarding positive patient care outcomes. Under section 
1888(h)(6) of the Act, the VBP incentive payments to the higher-
performing SNFs are to be funded through a 2 percent reduction in the 
overall SNF PPS payment rates (again, effective in FY 2019); 
accordingly, under the terms of the VBP legislation, a SNF's successful 
performance in meeting the applicable quality measures can help 
mitigate the actual impact of the overall payment reduction. These 
payment changes were specifically mandated by Congress when it enacted 
the SNF VBP legislation in section 215 of the Protecting Access to 
Medicare Act of 2014 (PAMA, Pub. L. 113-93). The requirements in this 
rulemaking share the VBP program's objective of improving the quality 
of care in the LTC setting. We note in addition that SNF PPS payment 
rates have increased steadily over recent years, due to market basket 
updates.
    Comment: Many commenters stated concerns about inadequate Medicaid 
reimbursement, while others pointed out that private payer rates are 
continually rising to compensate for low Medicare reimbursement. 
Commenters worry that the current reimbursement rates are barely 
sufficient, in some cases already insufficient, to meet the current 
requirements, and that the issue will compound as facilities attempt to 
comply with the new requirements. Several commenters stated that 
falling Medicare and Medicaid reimbursement rates, relative to costs, 
will cause their facilities to close. Many of these commenters 
identified themselves as the sole LTC facilities within a geographic 
area, which would severely limit the options of their residents if 
faced with closure. One commenter suggested that, due to low Medicaid 
reimbursement rates, this rulemaking would disproportionately affect 
poor individuals who rely on Medicaid and the facilities that serve 
them. Another

[[Page 68695]]

commenter stated concerns about reduced amounts of Public Aid funding.
    Response: Reimbursement rules are outside the scope of this 
rulemaking, and Medicaid reimbursement rates are determined by the 
states, with limited involvement by CMS. We do not participate in 
disbursement of public aid funding. We encourage commenters to address 
Medicaid reimbursement and public aid concerns to relevant state 
agencies and departments. Many commenters noted that phased 
implementation would be helpful in absorbing new costs. Please see 
Section B. ``Implementation'' for our discussion of phased-in 
implementation deadlines.
    Comment: A number of commenters responded to our request for 
comments in ways that suggest misunderstandings of either current 
requirements or the proposed requirements. Notable misconceptions 
include the:
     Belief that allowing residents to choose their attending 
physician would be a new requirement.
     Impression that having a RN on the interdisciplinary care 
team would be a new requirement.
     Concerns that these requirements are entirely new, such 
that all existing health and safety activities at LTC facilities would 
need to be recreated or developed from scratch.
     Concerns that new staff would need to be hired to perform 
tasks already being handled by existing staff.
     Belief that a chaplain would be a mandatory member of the 
interdisciplinary care team.
     Belief that a complete care plan would have to be 
developed within a new resident's first 48 hours at the LTC facility.
     Belief that existing facilities would have to limit 
occupancy to two residents per room, even if that would reduce bed 
count.
     Impression that the new requirements are simply a 
duplicate of the old requirements.
     Uncertainty as to whether the LTC requirements are 
applicable to other healthcare settings, such as hospital ``swing-
beds'' or assisted living facilities.
    Some commenters also expressed concern that CMS may be unreasonably 
focused on regulating LTC facilities, to the point of not updating 
regulations and requirements for other provider types. Commenters also 
claimed that LTC facilities are ``the most regulated industry in 
America,'' and that ``the nuclear industry is less regulated'' than the 
LTC facility industry.
    Response: We recognize that the proposed rule and this final rule 
are large, detailed documents, and that many individuals relied on 
summaries to learn about the proposed requirements. We understand that 
working professionals and family caregivers can be very busy, but we 
are concerned by some of these misinterpretations. Most of the 
misconceptions fell into three categories: Unfamiliarity with the old 
requirements, misunderstanding of the proposed requirements, or 
confusion about which facilities must meet the LTC requirements.
    The comments displaying unfamiliarity with the existing 
requirements are troubling to us. The right of a LTC resident to choose 
his or her own attending physician is a long-standing patient right, 
which was established at section 1819(c)(1)(A)(i) of the Act by section 
4201 of the Omnibus Budget Reconciliation Act of 1987 and at section 
1919(c)(1)(A)(i) by section 4211 of the Omnibus Budget Reconciliation 
Act of 1987. We included the right to choose a physician in this 
rulemaking in order to support the statutory requirement, and remind 
stakeholders that it is not a new requirement and therefore should add 
no new regulatory burden. Similarly, the requirement that a RN serve as 
a member of an interdisciplinary team is not new to this rulemaking, 
but ``carried over'' from the old requirements to the revised 
requirements as an important foundational aspect of care planning. 
Also, we do not expect facilities to completely recreate health and 
safety activities. Existing effective programs may already meet the 
substance of the revised requirements completely, in which case no 
additional implementation work is necessary. We address these comments, 
and others, in greater detail in the relevant sections of this 
preamble.
    For those misunderstood provisions of the proposed rule, we have 
attempted to clarify the relevant sections of the rule, and note that 
we did not propose that chaplains must be members of all 
interdisciplinary teams, only that their inclusion is permitted as 
deemed appropriate by facilities or residents. Similarly, we did not 
propose that a full plan of care be developed within a resident's first 
48 hours, only that a baseline plan be established. The ``two persons 
per room'' requirement applies only to those facilities that receive 
approval to be constructed or reconstructed, or are newly certified 
after this rulemaking. Existing facilities with larger rooms are 
effectively grandfathered into compliance.
    For those health care providers who are not sure whether these 
requirements apply to them, we encourage them to work with their 
facility's administration and governing body to determine 
applicability. This rulemaking applies to Medicare- and Medicaid-
certified long term care facilities as defined at sections 1819 and 
1919 of the Act and all facilities receiving payment under such 
programs. Swing-bed hospital units, for example, would need to meet 
specific conditions of participation for such units, as set out at 42 
CFR 482.58, and which include a subset of the requirements contained 42 
CFR 483. We note that CMS does not issue regulations or guidance for 
assisted living facilities, nor are they eligible for Medicare 
reimbursement. While some assisted living facilities do provide health 
services (such as medication supervision, nurse support, and emergency 
medical assistance for residents), they are not classified as health 
care providers or suppliers under the Act. Some states do regulate 
them, often as social service providers rather than health care 
providers. The requirements in this rulemaking may be helpful to other 
health care and social service settings, but only LTC facilities are 
required to meet them.
    Comment: One commenter expressed concern about our use of the term 
``state plan'' throughout the rule. The commenter felt that this is not 
meant to exclude those states where all Medicaid services in long term 
care are covered by a Section 1115 waiver and recommended we add the 
phrase ``or waiver'' where appropriate.
    Response: We thank the commenter for their suggestion, but do not 
believe it is necessary to add ``or waiver.'' The commenter is correct 
that the use of the term ``state plan'' does not exclude those states 
where Medicaid-covered services in long term care facilities are 
provided pursuant to a CMS-approved demonstration project (often 
referred to as ``waivers''). Our use of the term ``state plan'' 
encompasses the plan and any such demonstrations.

B. Implementation Date

    Comment: We received a substantial number of comments requesting 
that we consider delaying the implementation of the proposed 
requirements. Several commenters noted that the proposed rule was 
complex and that the comprehensive update of the regulations will be 
overwhelming for facilities to comply with. However, a few commenters 
noted that many of the proposed requirements will simply require 
adjustments in the current process. One commenter specifically noted 
that facilities should be well on their way with establishing a QAPI 
program and complying with the

[[Page 68696]]

proposed QAPI requirements. Many commenters also indicated concern 
regarding the financial burden associated with this regulation and 
suggested that a delayed implementation would allow facilities the time 
needed to establish compliance with the new requirements.
    Commenters provided varying suggestions for a implementation 
timeframe. Some commenters provided suggestions specific to certain 
requirements. For example, one commenter recommended a 12- to 18-month 
implementation timeframe for pharmacy services-related requirements. 
Other commenters recommended that the entire regulation be implemented 
by phasing in requirements over a certain time period. In addition, 
commenters provided varying suggestions for an implementation date of 
the entire regulation that ranged from 1 to 10 years in the future.
    Response: We appreciate the feedback from commenters. Given the 
comprehensive nature of the regulatory revisions, we agree that a 
longer period of time is necessary to implement the changes outlined in 
this final rule. We acknowledge that LTC facilities may find the 
comprehensive revision to the LTC requirements overwhelming and want to 
avoid any unintended consequences or unanticipated risks to both 
facilities and residents. We believe that allowing for a longer 
implementation period will allow LTC facilities the time necessary to 
come into compliance with the new requirements. In addition, we 
anticipate that additional time will 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.
    While commenters provided varying suggestions for the appropriate 
implementation timeframe (ranging between 1 and 10 years), overall all 
commenters agreed that implementation will require more than a year and 
the majority of commenters suggested between 3 and 5 years. After 
considering these proposals, we are finalizing a phased-in 
implementation of the requirements over a 3 year time period. We 
believe that a phased-in approach over 3 years will sufficiently allow 
for LTC facilities to achieve compliance with the revised regulations 
without jeopardizing resident care. We note that these final 
regulations will be effective 60 days following the display of this 
final rule in the Federal Register, as discussed under the ``Effective 
Date'' section. Over the 3 year time period following the effective 
date of the final rule the requirements will be implemented in three 
phases. We have categorized the three phases based on the complexity of 
the revisions and the work necessary to revise the interpretive 
guidance and survey process based on the revisions. The first phase of 
implementation will occur upon the effective date of the final rule and 
include those requirements that were unchanged or received minor 
modification. We will provide updated training to surveyors on the new 
regulatory language.
    The second phase of implementation will have a deadline of 1 year 
following the effective date of the final rule and in addition to those 
requirements implemented in phase one, this phase will also include 
those brand new requirements and those provisions that required more 
complex revisions. The additional time for implementation will allow 
for complete changes in our survey processes as well as updates to the 
survey guidance. We will provide updated guidance to facilities, update 
the traditional and QIS survey process, update the survey tags in 
accordance with the reorganization of the regulations, and provide 
training to surveyors on the new tags. The third and final phase of 
implementation will have a deadline of 3 years from the effective date 
of the final rule and include all the remaining requirements that were 
not implemented in phases 1 and 2. We expect that this final phase will 
allow for the complete set of revised requirements to be incorporated 
into the practices of LTC facilities and sufficiently enforced through 
the updated survey process.
    Below we provide a detailed chart specifying the specific 
requirements that will be implemented in phases 1, 2, and 3 of the 
implementation time period for this final rule. We note that some 
regulatory sections may have certain requirements that are implemented 
in varying phases. In those instances we highlight the specific 
requirements in a regulatory section that will be implemented in a 
different phase.

Implementation Timeframes

    **Note: These final regulations will be effective 60 days following 
the date of public inspection of this final rule in the Federal 
Register. **
    Phase 1: Upon the effective date of the final rule.
    Phase 2: 1 year following the effective date of the final rule.
    Phase 3: 3 years following the effective date of the final rule.

------------------------------------------------------------------------
           Regulatory section                Implementation deadline
------------------------------------------------------------------------
Sec.   483.1 Basis and scope...........  This entire section will be
                                          implemented in Phase 1.
Sec.   483.5 Definitions...............  This entire section will be
                                          implemented in Phase 1.
Sec.   483.10 Resident rights..........  The section will be implemented
                                          in Phase 1 with the following
                                          exception:
                                          (g)(4)(ii)-(v)
                                          Providing contact information
                                          for State and local advocacy
                                          organizations, Medicare and
                                          Medicaid eligibility
                                          information, Aging and
                                          Disability Resources Center
                                          and Medicaid Fraud Control
                                          Unit--Implemented in Phase 2.
Sec.   483.12 Freedom from abuse,        This section will be
 neglect, and exploitation.               implemented in Phase 1 with
                                          the following exceptions:
                                          (b)(4) Coordination
                                          with QAPI Plan--Implemented in
                                          Phase 3.
                                          (b)(5) Reporting
                                          crimes/1150B--Implemented in
                                          Phase 2.
Sec.   483.15 Admission, transfer, and   This section will be
 discharge rights.                        implemented in Phase 1 with
                                          the following exceptions:
                                          (c)(2) Transfer/
                                          Discharge Documentation--
                                          Implemented in Phase 2.
Sec.   483.20 Resident assessment......  This entire section will be
                                          implemented in Phase 1.
Sec.   483.21 Comprehensive person-      This section will be
 centered care planning.                  implemented in Phase 1 with
                                          the following exceptions:
                                          (a) Baseline care
                                          plan--Implemented in Phase 2.
                                          (b)(3)(iii) Trauma
                                          informed care--Implemented in
                                          Phase 3.
Sec.   483.24 Quality of life..........  This entire section will be
                                          implemented in Phase 1.

[[Page 68697]]

 
Sec.   483.25 Quality of care..........  This section will be
                                          implemented in Phase 1 with
                                          the following exception:
                                          (m) Trauma-informed
                                          care--Implemented in Phase 3.
Sec.   483.30 Physician services.......  This entire section will be
                                          implemented in Phase 1.
Sec.   483.35 Nursing services.........  This section will be
                                          implemented in Phase 1 with
                                          the following exception:
                                          Specific usage of the
                                          Facility Assessment at Sec.
                                          483.70(e) in the determination
                                          of sufficient number and
                                          competencies for staff--
                                          Implemented in Phase 2.
Sec.   483.40 Behavioral health          This section will be
 services.                                implemented in Phase 2 with
                                          the following exceptions:
                                          (a)(1) As related to
                                          residents with a history of
                                          trauma and/or post-traumatic
                                          stress disorder--Implemented
                                          in Phase 3.
                                          (b)(1), (b)(2), and
                                          (d) Comprehensive assessment
                                          and medically related social
                                          services--Implemented in Phase
                                          1.
Sec.   483.45 Pharmacy services........  This section will be
                                          implemented in Phase 1 with
                                          the following exceptions:
                                          (c)(2) Medical chart
                                          review--Implemented in Phase
                                          2.
                                          (e) Psychotropic
                                          drugs--Implemented in Phase 2.
Sec.   483.50 Laboratory, radiology,     This entire section will be
 and other diagnostic services.           implemented in Phase 1.
Sec.   483.55 Dental services..........  This section will be
                                          implemented in Phase 1 with
                                          the following exceptions:
                                          (a)(3) and (a)(5) Loss
                                          or damage of dentures and
                                          policy for referral--
                                          Implemented in Phase 2.
                                          (b)(3) and (b)(4)
                                          Referral for dental services
                                          regarding loss or damaged
                                          dentures--Implemented in Phase
                                          2.
Sec.   483.60 Food and nutrition         This section will be
 services.                                implemented in Phase 1 with
                                          the following exceptions:
                                          (a) As linked to
                                          Facility Assessment at Sec.
                                          483.70(e)--Implemented in
                                          Phase 2.
                                          (a)(1)(iv) Dietitians
                                          hired or contracted with prior
                                          to effective date--Built in
                                          implementation date of 5 years
                                          following effective date of
                                          the final rule.
                                          (a)(2)(i) Director of
                                          food & nutrition services
                                          designated to serve prior to
                                          effective--Built in
                                          implementation date of 5 years
                                          following the effective date
                                          of the final rule.
                                          (a)(2)(i) Dietitians
                                          designated to after the
                                          effective date--Built in
                                          implementation date of 1 year
                                          following the effective date
                                          of the final rule.
Sec.   483.65 Specialized                This entire section will be
 rehabilitative services.                 implemented in Phase 1.
Sec.   483.70 Administration...........  This section will be
                                          implemented in Phase 1 with
                                          the following exceptions:
                                          (d)(3) Governing body
                                          responsibility of QAPI
                                          program--Implemented in Phase
                                          3.
                                          (e) Facility
                                          assessment--Implemented in
                                          Phase 2.
Sec.   483.75 Quality assurance and      This section will be
 performance improvement.                 implemented in Phase 3 with
                                          the following exceptions:
                                          (a)(2) Initial QAPI
                                          Plan must be provided to State
                                          Agency Surveyor at annual
                                          survey--Implemented in Phase
                                          2.
                                          (g)(1) QAA committee--
                                          All requirements of this
                                          section will be implemented in
                                          Phase 1 with the exception of
                                          subparagraph (iv), the
                                          addition of the ICPO, which
                                          will be implemented in Phase
                                          3.
                                          (h) Disclosure of
                                          information--Implemented in
                                          Phase 1.
                                          (i) Sanctions--
                                          Implemented in Phase 1.
Sec.   483.80 Infection control........  This section will be
                                          implemented in Phase 1 with
                                          the following exceptions:
                                          (a) As linked to
                                          Facility Assessment at Sec.
                                          483.70(e)--Implemented in
                                          Phase 2.
                                          (a)(3) Antibiotic
                                          stewardship--Implemented in
                                          Phase 2.
                                          (b) Infection
                                          preventionist (IP)--
                                          Implemented in Phase 3.
                                          (c) IP participation
                                          on QAA committee--Implemented
                                          in Phase 3.
Sec.   483.85 Compliance and ethics      This entire section will be
 program.                                 implemented in Phase 3.
Sec.   483.90 Physical environment.....  This section will be
                                          implemented in Phase 1 with
                                          the following exceptions:
                                          (f)(1) Call system
                                          from each resident's bedside--
                                          Implemented in Phase 3.
                                          (h)(5) Policies
                                          regarding smoking--Implemented
                                          in Phase 2.

[[Page 68698]]

 
Sec.   483.95 Training requirements....  This entire section will be
                                          implemented in Phase 3 with
                                          the following exceptions:
                                          (c) Abuse, neglect,
                                          and exploitation training--
                                          Implemented in Phase 1.
                                          (g)(1) Regarding in-
                                          service training, (g)(2)
                                          dementia management & abuse
                                          prevention training, (g)(4)
                                          care of the cognitively
                                          impaired--Implemented in Phase
                                          1.
                                          (h) Training of
                                          feeding assistants--
                                          Implemented in Phase 1.
------------------------------------------------------------------------

C. Basis and Scope (Sec.  483.1)

    We proposed 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 proposed to spell out the term 
``skilled nursing facility''.
    We did not receive any comments in response to our proposals in 
this section. Therefore, we are finalizing our proposal without 
modification.

D. Definitions (Sec.  483.5)

    Current regulations at Sec.  483.5 provide definitions for terms 
commonly used in the LTC requirements. We proposed 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 will add value 
to the LTC requirements while promoting resident choice and safety.
    We retained the existing definitions for ``facility'' and 
``distinct part''. In addition, we 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 
proposed minor revisions to the definition of ``common area'' to 
recognize that some facilities have living rooms or other areas where 
residents gather. We proposed 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 proposed to relocate the definitions for ``licensed health 
professional'' and ``nurse aide'' to this section from the 
``Administration'' section at Sec.  483.75(e)(1). In addition, we 
proposed 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 proposed to amend the regulatory definition accordingly. 
We proposed to add the term ``adverse event'' to ensure clarity in our 
requirements relating to proposed requirements for QAPI. For purposes 
of this regulation, we also proposed to 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. We also noted 
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. In addition, we 
proposed to add a definition of ``person-centered care'' to be defined 
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. For purposes of these regulations, we proposed that 
``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. We proposed that ``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 proposed 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 proposed to 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.''
    We also proposed to add the term ``misappropriation of resident 
property'' and define the term 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 proposed to move the existing definition of ``transfer 
and discharge'' from Sec.  483.12(a)(1) to Sec.  483.5.
    Comment: Several commenters supported the addition of terms to the 
definitions section and indicated that making the link between terms 
that are defined in regulation and guidance will support an increased 
response to elder abuse. Multiple commenters provided suggestions for 
additional terms to be included in the definitions sections. One 
commenter indicated that there is a need to define ``behavioral 
health'' given the addition of the regulatory section focused on 
behavioral health. Other commenters also suggested that

[[Page 68699]]

the definition of ``mistreatment'' be added to the regulations for 
clarity. Lastly, one commenter suggested that definitions of ``portable 
order for scope of treatment'' and ``staffing practices'' be added to 
the regulations.
    Response: We agree with commenters and believe that improving the 
definitions section will promote resident safety and choice. For 
further clarity we have added discussion to the behavioral health 
section explaining what behavioral health is. Since behavioral health 
is largely discussed in the ``Behavioral Health'' section we believe it 
is more appropriate to add the discussion at Sec.  483.40 rather than 
in the ``Definitions'' section at Sec.  483.5.
    We agree with commenters who suggested that the term 
``mistreatment'' be defined in the regulation. Regulations at proposed 
Sec.  483.12(a)(2)(iii) specify that facilities cannot employ or 
otherwise engage individuals who have had a disciplinary action taken 
against their professional license as a result of mistreatment. 
Therefore, based on public comments and the use of the term 
``mistreatment'' in Sec.  483.12, we are revising the definitions 
section to add the term; ``mistreatment'' which means ``to 
inappropriately treat or exploit a resident.'' Lastly, we do not agree 
that the terms ``staffing practices'' and ``portable order for scope of 
treatment'' should be defined because these terms are not used in the 
regulations.
    Comment: One commenter supported moving the definition of 
``transfer and discharge'' to the ``Definitions'' section, but 
recommended that the definition also be discussed in the ``Transitions 
of Care'' section (finalized as ``Admission, Transfer, and Discharge 
Rights'') so that readers are aware of it. The commenter also 
recommended that the definition of ``transfer and discharge'' be 
revised to include language from interpretive guidance in order to help 
address the failure of LTC facilities to recognize adequately a 
resident's transfer and discharge rights.
    Response: We agree with commenters and have added a cross-reference 
to the definition of ``transfer and discharge'' at Sec.  483.15(b)(1), 
which discusses the requirements regarding a resident's transfer and 
discharge rights. We note that the definition of ``transfer and 
discharge'' aligns with the definition that is in the state operations 
manual. We are unclear what information the commenter requests to have 
added into the definition.
    Comment: Overall, commenters agreed that abuse should be defined in 
the regulations. Commenters provided varying suggestions aimed to 
improve the proposed definition. Some commenters communicated support 
for including the word ``willful'' in the definition of abuse. However, 
commenters articulated that as proposed, the definition of ``willful'' 
(as used in abuse) could potentially create major and unreasonable 
legal complications for facilities and practitioners who are forced to 
make difficult decisions in unclear circumstances. For example, 
commenters indicated that unintentional errors, such as deliberately 
providing medications to a resident that are later discovered to be 
harmful or differences of clinical opinions, such as withdrawing life-
sustaining treatment, will be inappropriately categorized as abuse.
    In addition, commenters suggested deleting the clause regarding the 
deprivation of goods and services from the definition of ``abuse''. 
Commenters indicated that the use of this clause is problematic and is 
more appropriately covered by the definition of ``neglect.'' One 
commenter further suggested that the sentence, ``This presumes that 
instances of abuse of all residents, irrespective of any mental or 
physical condition, cause physical harm, pain or mental anguish'', also 
be removed from the definition of abuse. The commenter communicated 
that definitions should not include presumptions and the phrase 
``instances of abuse of all residents'' is unclear. Another commenter 
recommended that the definition clarify further that abuse facilitated 
or enabled through the use of technology refers to platforms such as 
social media.
    Response: We appreciate the feedback from commenters regarding the 
definition of ``abuse''. We disagree with commenters and do not believe 
that the definition of ``abuse'' repeats the definition of ``neglect''. 
With regard to a deprivation of goods or services, we believe that 
``abuse'' requires a willful act, while ``neglect'' does not. We agree 
with commenters that definitions should not contain presumptions and 
therefore have revised the language ``this presumes'' to make an 
explicit statement that instances of abuse of all residents, 
irrespective of any mental or physical condition, cause physical harm, 
pain or mental anguish.'' We do not believe that the use of the term 
``willful'' should be removed from the definition of ``abuse.'' We 
encourage readers to refer to Merrimack County Nursing Home, DAB CR2352 
(December 5, 2011) (ALJ Decision) and Honey Grove Nursing Center, DAB 
CR3039 (May 8, 2014) (ALJ Decision), which discusses actions that were 
deliberate, not inadvertent or accidental or with the intent to inflict 
injury or harm. We agree that abuse enabled through the use of 
technology would include the use of social media, as well as the use of 
cameras or the Internet. Following the publication of the final rule, 
we will release updated interpretive guidance that will aid facilities 
in implementing these regulations and provide further clarification for 
this regulation. The interpretive guidance is the most appropriate 
place to further clarify and provide examples regarding abuse that is 
facilitated through the use of technology.
    Comment: One commenter indicated that an ``adverse event'' is 
adverse whether or not it is anticipated and suggested that the concept 
of anticipation be removed from the proposed definition, as it may be 
misleading. Another commenter recommended that the definition of 
``adverse event'' be expanded to include events noted in the February 
2014 OIG report entitled, ``Adverse Events in Skilled Nursing 
Facilities: National Incidence Among Medicare Beneficiaries'' (OEI-06-
11-00370), such as preventable harm due to substandard treatment, 
inadequate resident monitoring, and failure or delay of necessary care. 
The commenter indicates that the focus of the definition should be 
placed on a facility's systematic analysis and action rather than only 
on one-time events.
    Response: We appreciate the commenters' feedback. When considering 
the proposed definition of ``adverse events'' we reviewed the February 
2014 Office of the Inspector General (OIG) report referenced by 
commenters. We believe that increasing the level of specificity in the 
definition could potentially preclude recognition of additional adverse 
events. As proposed, the definition encompasses events that harm the 
patient, that are a result of substandard treatment, inadequate 
resident monitoring, and failure or delay of necessary care. In 
addition, we proposed the definition of ``adverse event'' that is 
currently defined in regulations for transplant centers. As written, 
the definition does not exclude anticipated events, but rather states 
``adverse events'' are ``usually unanticipated.''
    Comment: Several commenters supported the clarification added to 
the definition of ``composite distinct part'' which prohibits the use 
of a composite distinct part designation as a means to segregate 
residents by payment status or on any other basis other than care 
needs.
    Response: We appreciate the support from commenters and believe 
that the

[[Page 68700]]

clarification will help to avoid creating inequitable care situations.
    Comment: Many commenters supported our proposal to add a definition 
of ``exploitation'' to the regulations. A few commenters provided 
suggestions to improve the proposed definition. One commenter indicated 
that the use of the term ``selfish'' in the definition of 
``exploitation'' is misplaced and unnecessary. Another commenter 
disagreed with the use of the term ``manipulation'' in the definition 
because manipulation is difficult to identify and pinpoint. The 
commenter indicated that the definition of ``exploitation'' should not 
create unanticipated consequences and recommended substituting the use 
of the term ``manipulation'' with ``deception''.
    Response: We appreciate the commenters' feedback and believe that 
further revisions are needed to improve clarity. We agree that the term 
``selfish'' may possibly be hard to identify and evaluate. However, we 
prefer to use the term ``manipulation'' rather than ``deception,'' as 
recommended by commenters. We believe that the term ``manipulation'' is 
generally understood and appropriately indicates when power is being 
used in an unacceptable manner. Overall, in response to comments we 
have revised the definition of ``exploitation'' to ``taking advantage 
of a resident for personal gain by using manipulation, intimidation, 
threats, or coercion.''
    Comment: A few commenters suggested that the definition of 
``licensed health professional'' be expanded to include pharmacists, 
respiratory therapists, dietitians, and psychologists.
    Response: The statute at section 1819(b)(5)(G) of the Act defines 
``licensed health professional'' as ``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; registered respiratory therapist or certified respiratory 
therapy technician.'' Therefore, in an effort to conform our definition 
to the statute, we have added respiratory therapists to the regulatory 
definition of ``licensed health professional.'' We have not added 
``pharmacists, dietitians, and psychologists,'' since they are not 
included in the statutory definition.
    Comment: Several commenters supported including the definition of 
``misappropriation of property'' in the ``Definitions'' section. One 
commenter recommended replacing the term ``deliberate'' with 
``willful'' for consistency throughout the definitions, since 
``willful'' is used in the definition of ``abuse''. Another commenter 
requested that the definition of ``misappropriation of property'' be 
revised to add language to ensure that the facility remains responsible 
for replacing or reimbursing for items that are lost or stolen.
    Response: We appreciate the commenters' feedback, but disagree with 
the suggestions. The term ``willful'' is defined specifically, since it 
is an element of the definition of ``abuse.'' We believe that the term 
``deliberate'' is correctly used in the definition of 
``misappropriation of property''. In addition, it is not appropriate to 
add language regarding facility responsibilities to the definition of 
``misappropriation of property''. The definition was added to clarify 
what constitutes as the misappropriation of a resident's property. 
Regulations at Sec.  483.12(c) discuss the requirements that must be 
met in response to allegations of the misappropriation of resident 
property. While our regulations do not require replacement or 
reimbursement, facilities have the flexibility to establish their own 
policies related to internal remedies for replacement or reimbursement 
of resident property.
    Comment: Multiple commenters supported the addition of the 
definition of ``neglect''. One commenter indicated that mental disorder 
is not a condition that can be attributed to neglect. The commenter 
recommended modifying the definition of ``neglect'' to explicitly state 
that neglect could lead to increased psychiatric or behavioral 
symptoms. Another commenter recommended the definition of ``neglect'' 
be revised to remove the statement that an individual suspected of 
neglect must have acted willfully.
    Response: We agree that the wording in the definition of 
``neglect'' can be improved and have revised the definition to clarify 
that the facility and its employees are neglectful when a reasonable 
person would conclude that a deprivation of the omitted goods and 
services would cause, among other things, emotional distress (rather 
than mental disorder). As proposed, the definition of ``neglect'' does 
not include the term ``willful''. We have revised the definition of 
``neglect'' to read, ``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 emotional 
distress.''
    Comment: One commenter indicated that ``nursing aide'' is an 
obsolete term and the correct terminology is ``nursing assistant''.
    Response: We appreciate the commenter's feedback, however we are 
maintaining the use of the term ``nursing aide'' since that is the term 
used in the statute.
    Comment: Several commenters supported promoting individual choices 
and individualized care and agreed that adding a definition of 
``person-centered care'' is necessary. Commenters suggested additional 
terms to replace ``person-centered care''. A few commenters provided 
suggestions to improve the definition. One commenter indicated that the 
proposed definition only addresses resident choice and is too narrow. 
The commenter notes that the concept of ``focusing on the resident as 
the locus of control'' is vague and unsurveyable. Furthermore the 
commenter suggests that the definition should specify the actions that 
facilitate individualized care and not just focus on the resident as 
the locus of control.
    Another commenter recommended that the definition of ``person-
centered care'' be modified to include that the relationship between 
residents and providers is a collaborative partnership.
    Response: The term ``person-centered care'' is recognized in the 
long-term care community. However, we understand that some facilities 
and health care professionals may use alternative terms and wording to 
describe a similar care model. We have used the term ``person-centered 
care'', but facilities have the flexibility to use any term they choose 
internally as long as the principles described in the regulation are 
met. Facilities should implement the principle of ``person-centered 
care'' by developing internal guidelines that promote resident choice 
and control over their individual care. The definition of ``person-
centered care'' has been added to the regulation to assist in meeting 
these requirements and to provide some guidance regarding our intent 
and expectations. We note that the interpretive guidance for this 
regulation will also provide more detailed information and best 
practices for implementing person-centered care.
    Comment: Many commenters believe that as proposed the definition of 
``resident representative'' may create potential problems and supersede 
state law, regulations, or case law regarding a resident's surrogate 
decision makers. The commenters indicated that allowing for both a 
representative of the resident's choice as well as a representative 
with legal standing might create issues in instances where these

[[Page 68701]]

two individuals disagree. They note that the regulation is not clear as 
to who supersedes and these types of decisions should not be made by 
the facility.
    Other commenters recommended that the definition of ``resident 
representative'' be revised to appropriately capture the many 
relationships that individuals may have with the resident. Commenters 
indicated that the definition should clearly identify the rights that 
such individuals have acting on behalf of or advocating with the 
resident. Commenters also noted that it is important to clarify that 
residents are not obligated to choose or designate anyone as a 
representative. Commenters recommended the use of terms, such as 
``resident enabler'' and ``resident supporter'' to more appropriately 
incorporate the concept of supported decision-making. One commenter 
recommended that our definition be revised to align with the definition 
in the State Long-Term Care Ombudsman Program regulations found at 45 
CFR 1327.1 (recently relocated to 45 CFR 1324.1; see the final rule, 
``Administration for Community Living Regulatory Consolidation'' (81 FR 
35644, June 3, 2016).
    One commenter affirmed the need to highlight the equal treatment of 
same-sex spouses, while another commenter suggested that the discussion 
regarding the selection of a same-sex spouse as a representative be 
removed from the definition. The commenter notes that same-sex spouses 
are now covered under state law and it is unnecessary to specify one 
particular group in this definition while omitting others.
    Response: We appreciate the feedback from commenters and agree that 
the definition of ``resident representative'' can be improved. Our 
intent behind proposing the definition of ``resident representative'' 
was to recognize that a resident has the right to designate an 
individual or individuals who can support them in their decision-
making. We did not intend to expand the scope of authority of any 
representative or to supersede state law, regulations, or case law 
regarding a resident's surrogate decision makers. As one commenter 
noted, a definition of ``resident representative'' can be found in 
existing HHS regulations. The regulations at 45 CFR 1324.1 define a 
``resident representative'' as ``(1) An individual chosen by the 
resident to act on behalf of the resident in order to support the 
resident in decision-making; access medical, social or other personal 
information of the resident; manage financial matters; or receive 
notifications; (2) A person authorized by state or federal law 
(including but not limited to agents under power of attorney, 
representative payees, and other fiduciaries) to act on behalf of the 
resident in order to support the resident in decision-making; access 
medical, social or other personal information of the resident; manage 
financial matters; or receive notifications ; (3) Legal Representative, 
as used in 712 of the Older Americans Act; or (4) The court-appointed 
guardian or conservator of a resident. (5) Nothing in this rule is 
intended to expand the scope of authority of any resident 
representative beyond that authority specifically authorized by the 
resident, State or Federal law, or a court of competent jurisdiction.''
    We believe that this definition matches our intent behind defining 
``resident representative'' in the LTC regulations and to align with 
existing HHS regulation, we are revising the definition of ``resident 
representative'' to match the definition found at 45 CFR 1324.1. 
Generally speaking, the authority of an individual vested with 
decision-making power under state law would exceed that of an 
individual without formal legal recognition.
    Comment: One commenter recommended that the definition of ``sexual 
abuse'' be modified in an effort to avoid categorizing accidental 
touching, which may occur while moving or cleaning a resident, as 
abuse. Another commenter recommended that the definition of ``sexual 
abuse'' be modified to include the use of technology to sexually abuse 
a resident.
    Response: We understand that accidental touching is possible; 
however the term ``sexual abuse'' has been added to the regulations in 
an effort to prevent harmful acts. It was not added to prevent or 
complicate care, but to ensure that residents are protected especially 
in vulnerable situations. For acts such as bathing a resident or 
assisting a resident with using the restroom, it is the facility's 
responsibility to have procedures and guidelines in place for what is 
acceptable and appropriate for providing assistance. We believe that 
the use of technology to harm a resident is covered by the definition 
of ``abuse'' which speaks specifically to abusive situations 
facilitated through technology.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications. 
We have--
     Revised the definition of ``abuse'' to read, ``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. 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 that the individual must have acted 
deliberately, not that the individual must have intended to inflict 
injury or harm.''
     Revised the definition of ``exploitation'' to read, 
``taking advantage of a resident for personal gain through the use of 
manipulation, intimidation, threats, or coercion.''
     Revised the definition of ``licensed health professional'' 
by adding ``registered respiratory therapist or certified respiratory 
therapy technician.''
     Added a definition of ``mistreatment'' and defined it as 
``inappropriate treatment or exploitation of a resident.''
     Revised the definition of ``neglect'' to read, ``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 emotional distress.''
     Revised the definition of ``resident representative'' to 
read (in accordance with 45 CFR 1324.1), ``(1) An individual chosen by 
the resident to act on behalf of the resident in order to support the 
resident in decision-making; access medical, social or other personal 
information of the resident; manage financial matters; or receive 
notifications; (2) A person authorized by State or Federal law 
(including but not limited to agents under power of attorney, 
representative payees, and other fiduciaries) to act on behalf of the 
resident in order to support the resident in decision-making; access 
medical, social or other personal information of the resident; manage 
financial matters; or receive notifications; (3) Legal representative, 
as used in section 712 of the Older Americans Act; or (4) The court-
appointed guardian or conservator of a resident. (5) Nothing in this 
rule is intended to expand the scope of authority of any resident 
representative beyond that authority specifically authorized by the 
resident, State or Federal law, or a court of competent jurisdiction.''

[[Page 68702]]

E. 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 proposed 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 warranted it, and to update 
provisions to include technological advances such as electronic 
communications. In order to achieve these objectives, we proposed 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 proposed to add a new 
Sec.  483.11, to focus on the responsibilities of the facility, 
including relevant provisions currently included in Sec.  483.10 and 
Sec.  483.15. As with Sec.  483.10, we proposed multiple re-
designations and revisions to improve logical order and readability, 
clarify aspects of the regulation that warranted it, and reflect 
technological advances such as electronic communications. Under our 
proposal, some existing provisions would have components in both Sec.  
483.10 and Sec.  483.11. We discuss below our proposed revisions to 
those provisions retained in or moved to Sec.  483.10 and note that 
regulatory citations have been updated throughout to reflect the 
proposed new structure.
    We proposed to revise Sec.  483.10 to focus specifically on 
resident rights. In proposed Sec.  483.10(a)(2), we clarified 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 clarified the 
resident's right to designate a representative to exercise only those 
rights delegated by the resident, and the resident's retention of 
rights not delegated, including the right to revoke a delegation.
    In Sec.  483.10(a)(4) we proposed to clarify that a resident who 
was adjudged incompetent under the laws of a state would retain 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. 
Lastly, in our December 12, 2014 proposed rule ``Medicare and Medicaid 
Programs; Revisions to Certain Patient's Rights Conditions of 
Participation and Conditions for Coverage'' (79 FR 73873), we proposed 
at Sec.  483.10(a)(4) to require that the same-sex spouse of a resident 
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. We proposed to re-designate 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).
    In proposed Sec.  483.10(b), we included resident rights related to 
planning and implementing care. We proposed to re-designate and revise 
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 proposed 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. We further specified 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 proposed 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 proposed to specify 
the resident's right to participate in the development of his or her 
comprehensive care plan. We also proposed 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 proposed 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.
    We proposed 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 added new paragraphs 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.
    In Sec.  483.10(d), we proposed 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 proposed 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 noted that 
married couples, whether opposite or same sex, are addressed by Sec.  
483.10(d)(5). Our proposed provision provided 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.
    In proposed Sec.  483.10(e), we proposed to revise a number of 
provisions relating to resident self-determination. We proposed 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 resident can receive his or her visitors of choice at the time 
of his or her choosing. We proposed 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.
    In Sec.  483.10(f), we proposed to re-designate and revise a number 
of provisions relating to resident access to information. We proposed 
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 also 
proposed 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.

[[Page 68703]]

    Federal requirements and expectations related to the privacy and 
confidentiality of patient records, in particular regulations governing 
protected health information, changed substantially with the enactment 
of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA) and subsequent issuance of the HIPAA Privacy and Security Rules 
(see 45 CFR part 160 and subparts A, C, and E of part 164), the Health 
Information Technology for Economic and Clinical Health (HITECH) Act 
and the issuance of the HIPAA Breach Notification Rule and HIPAA Final 
Rule (45 CFR part 160 and subpart D of part 164; 78 FR 5566, January 
25,2013). For simplicity, we hereinafter collectively refer to these 
laws and their implementing regulations as ``HIPAA.'' We note that 
administration and enforcement of the privacy, security, and breach-
related portions of the HIPAA regulatory scheme are delegated to the 
HHS Office for Civil Rights (OCR) and more detailed information related 
to these regulations can be accessed through the OCR Web site at http://www.hhs.gov/ocr/privacy.
    We proposed 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 recognized 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 the proposed regulation do not conflict in 
any way with the 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, 
covered entities and business associates must comply with the 
requirements in HIPAA to ensure individuals are afforded these 
additional rights. Therefore, we proposed revisions to 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 proposed 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 proposed to specify in paragraph (f)(3)(ii) 
that the facility could impose a reasonable, cost-based fee for 
providing copies of the medical records, provided that the fee included 
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 requested 
that the electronic copy be provided on portable media; and postage, 
when the individual requested that the copy be mailed. This is 
consistent with 45 CFR 164.524(c)(4). We noted in the proposed rule 
that this proposal does not address the creation or provision of 
summary reports, which could be provided in accordance with applicable 
law. More detailed information about the HIPAA right to access at 45 
CFR 164.524 can be found at http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/.
    In Sec.  483.10(g)(1) we proposed to revise a number of provisions 
related to resident privacy and confidentiality to update the language 
to accommodate electronic communications. We proposed 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 
retained the provisions of existing Sec.  483.10(e)(2) and (3).
    In Sec.  483.10(h), we proposed to re-designate and revise a number 
of provisions relating to resident communications. Specifically, we 
proposed a new Sec.  483.10(h) Communications, with Sec.  483.10(h)(1) 
revised to include Teletypewriter (TTY) and Telecommunications Device 
for the Deaf (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.
    In Sec.  483.10(i), we proposed to revise the language to state 
that the resident has a right to a safe, clean, comfortable, home-like 
environment, and a right to receive treatment safely. In Sec.  
483.10(j), we proposed to revise language relating to resident 
grievances to add that a resident could not be deterred from voicing a 
grievance for fear of reprisal or discrimination.
    Comment: A number of commenters expressed concern about the way in 
which CMS proposed to restructure the section on Resident Rights, and 
particularly the fact that there was not complete parity between 
residents' rights and facility responsibilities. One commenter stated 
that, since residents, their families and advocates look at the 
residents' rights language to know what residents' rights are (and they 
may be given copies of the federal rights), it is important that the 
statement of residents' rights be thorough, comprehensive, and 
accurate. The commenter recommended that CMS add rights currently found 
under Facility Responsibilities but not under Resident Rights to the 
Resident Rights section. Another commenter stated that the list of 
residents' rights should be complete and comprehensive and should not 
require review of other requirements of participation (RoPs) in order 
to identify all residents' rights.
    One commenter stated that they were concerned with the likely 
disruption of administrative and judicial decisions over the past 25 
years interpreting the current regulations. Administrative Law Judges 
and state and federal court judges could view changes in regulatory 
language as signaling changes in administrative interpretation of the 
Nursing Home Reform Law. They will view prior long-standing 
interpretations of similar current regulations as no longer legally 
binding as they interpret new regulatory language, following the legal 
principle that an agency intends a new interpretation when it changes 
the language of a regulation. They believed that an agency does not 
change regulatory language unless it wants to make a change in the 
prior interpretation of that language.
    The commenter further objected to the reorganization of existing 
RoPs because the commenter felt it would inevitably involve 
unnecessarily long (but avoidable) delay. The commenter stated that CMS 
would need to draft the final standards in response to public comments, 
give facilities time to understand and implement the new Requirements, 
create a new survey protocol, and train state and federal surveyors in 
the new protocol, at the very least. As these multiple changes are 
made, effective enforcement of RoPs, already weak, will be further 
postponed.
    The commenter noted that, to maintain the same regulatory standards 
within the definition of substandard quality of care requires CMS to 
combine subsections of multiple RoPs. The commenter recommended that, 
instead of reorganizing the regulations, as CMS proposes, CMS should 
retain the current regulatory structure as much as possible and to make 
all revisions within that existing, familiar structure. Keeping the 
current structure will save time and

[[Page 68704]]

effort on the part of CMS, surveyors, advocates, and providers alike, 
time and effort that would be better spent on addressing RoPs that 
actually reflect substantive change and improvement.
    Response: We considered commenters' concerns regarding proposed 
Sec.  483.10 and Sec.  483.11. Rather than increase duplication by 
adding language to both sections, we have combined these two sections 
for a comprehensive section that includes in a single location both 
statements of resident rights and, co-located, the attendant facility 
responsibilities to support those rights. We believe this addresses 
commenters' concerns and meets the commenter's suggestion that the 
statement of resident rights be thorough, comprehensive and accurate. 
This reorganization, to the extent that the regulatory language is 
unchanged, does not reflect any intent by CMS to change prior 
interpretations of regulatory language. Rather, our intent, as stated 
in the preamble to the proposed rule, is to improve the logical order, 
readability, and clarity of the regulations. We continue to believe 
that it is helpful to ensure that regulatory section titles reflect the 
content of the section. Thus, we have included provisions that state 
``the resident has a right to . . .'', in general, in a regulatory 
section titled ``Residents Rights,'' we have included provisions about 
prohibiting and preventing abuse, neglect and exploitation in a section 
titled ``Freedom from Abuse, Neglect, and Exploitation,'' and we have 
withdrawn our proposal to rename ``Admission, Discharge, and Transfer 
Rights'' to retain the title that most clearly relays the content of 
the section to the non-expert reader. We further clearly expressed in 
the preamble to the proposed rule that we do not intend in this update 
to diminish resident rights or protections. Rather, we want to ensure 
that those rights and protections encompass advancements, such as in 
the area of telecommunications, that were not envisioned when the 
original regulations were written.
    With regard to concerns that this revision will delay enforcement 
of the requirements and that keeping the current structure would save 
time and effort in updating facilities, surveyors, advocates, 
providers, and, we would add, current and future residents, we disagree 
that this effort is unnecessary or poorly focused. The commenter 
contends that enforcement of the current requirements is already weak. 
The efforts that we will undertake as a result of this rule to update 
and improve interpretive guidance, to train surveyors, and to outreach 
to the affected community of providers, residents, and caregivers will 
lead to stakeholders' improved understanding of our higher 
expectations, could result in improved efficiencies, and improve the 
effectiveness of our survey process. This final rule will be effective 
60 days after its publication, maintaining existing protections for 
residents, with delayed implementation deadlines for certain sections, 
where there are new expectations and requirements that require 
additional time for providers to implement. Please see our discussion 
of implementation in section II.B. of this preamble for additional 
detail.
    We received a significant number of specific comments on both 
proposed sections Sec.  483.10 and Sec.  483.11. As we will finalize 
these sections as a single section, we respond to all specific comments 
on both proposed sections, following our description of our proposals 
regarding facility responsibilities, below.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We finalize a consolidated section Sec.  483.10, which 
contains provisions proposed in Sec.  483.10 and Sec.  483.11. Specific 
revisions are addressed in the following section.

F. Facility Responsibilities (Sec.  483.11)

    We proposed a new Sec.  483.11 ``Facility Responsibilities,'' in 
which we combined many of the regulations addressing facility 
responsibilities which are currently dispersed throughout the existing 
provisions regarding resident rights and quality of life.
    Consistent with Sec.  483.10 and based on existing requirements, 
the introductory language for proposed Sec.  483.11 would have 
established that the facility would have to 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 would be required to protect and 
promote the resident's rights, as specified in Sec.  483.10. Further, 
the facility would be required to recognize each resident's 
individuality and provide services in a person-centered manner. We 
proposed 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 proposed a requirement that the facility would have to 
promote and protect the rights of the resident. These are not new 
requirements, and are already set out in our regulations as residents' 
rights. In order to ensure clarity, we restated clearly in this 
provision that it would be the responsibility of the facility to 
recognize and effectuate those rights. Proposed Sec.  483.11(a)(1) 
provided that the facility ensure that the resident could exercise his 
or her rights without interference, coercion, discrimination, or 
reprisal from the facility. We proposed 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 specified that the facility would have to treat the decisions 
of a resident representative as the decisions of the resident to the 
extent required by a court, or as delegated by the resident, with the 
condition that the facility could not extend greater authority to the 
resident representative than would be permitted under applicable law. 
In addition, we proposed to add a new Sec.  483.11(a)(5) to 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, the facility would have to comply 
with any state reporting requirements that might apply.
    In proposed Sec.  483.11(b), ``Facility responsibilities'' would 
include ensuring that the resident was informed of, and participated 
in, his or her treatment to the extent practicable, consistent with 
Sec.  483.10(b). The resident could participate in care planning, 
making informed decisions, and self-administering drugs when 
appropriate. We also proposed new requirements in Sec.  483.11(b)(1) to 
require that the facility ensured that the care planning process 
facilitated the inclusion of the resident or resident representative, 
included an assessment of the resident's strengths and needs, and 
incorporated the resident's personal and cultural preferences in 
developing goals of care. We proposed 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 would know the name, 
specialty and

[[Page 68705]]

means of contacting the professionals officially responsible for his or 
her care, whether that provider was a physician, nurse practitioner, 
physician assistant, or clinical nurse specialist. We further proposed 
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 would have a 
responsibility to ensure that the resident's attending physician had 
appropriate professional credentials and met 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 proposed to add a 
new Sec.  483.11(c)(3) to specify that if the resident subsequently 
found a new physician who met the necessary requirements, the facility 
would be required to honor that selection.
    We proposed a new Sec.  483.11(d) to address the facility's 
responsibilities related to resident self-determination. We proposed to 
re-designate Sec.  483.10(j), regarding access to the resident, as 
Sec.  483.11(d)(1), and revised 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. In addition, we proposed to add a 
new Sec.  483.11(d)(2) to require that the facility have written 
policies and procedures regarding visitation rights of residents. We 
proposed to re-designate Sec.  483.15(c)(5) as Sec.  483.11(d)(3)(ii) 
and revised 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. In the proposed rule, we 
clarified 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 
proposed a new Sec.  483.11(d)(4), to incorporate requirements 
currently specified in Sec.  483.10(h) and specify that the facility is 
responsible for ensuring that a resident is not required to perform 
services for the facility.
    We proposed a new Sec.  483.11(d)(5), to incorporate requirements 
from Sec.  483.10(c) that focus on the facility's responsibility 
related to the protection of resident funds. Specifically, we proposed 
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 
proposed 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 proposed 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 or NF.
    We proposed 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. We proposed 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. We proposed 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 proposed to establish a new Sec.  483.11(e) to incorporate 
multiple provisions related to information and communication. With the 
exception of medical records, we proposed 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.
    We proposed 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). We proposed in paragraph (e)(2)(i) to 
require that facilities provide residents with access to their 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 proposal included 
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 proposed at Sec.  483.11(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 proposed 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 proposed 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) of the Act. 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 proposed Sec.  483.11(e)(1), it must be in a form and manner 
accessible to and understandable by the resident.
    We proposed 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 Agency, the state 
licensure

[[Page 68706]]

office, the State Long-Term Care Ombudsman Program, the Protection and 
Advocacy Network, and the Medicaid Fraud Control Unit. We also proposed 
to require that the facility post a statement that a resident may file 
a complaint with the State Survey Agency. The facility is already 
required at existing Sec.  483.10(b)(7) to provide this information in 
the written description of legal rights provided to the resident. The 
provision would be re-designated at proposed Sec.  483.11(e)(12).
    We proposed 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.
    We proposed 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 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 proposed 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 proposed 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 proposed to revise Sec.  483.10(b)(5)(i) and (ii) and re-
designate them as Sec.  483.11(e)(10). The revised provision specifies 
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 paragraph (e)(11)(i) of this section.
    We proposed to revise and re-designate Sec.  483.10(b)(6) as new 
Sec.  483.11(e)(11). In addition, we proposed 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.
    To improve clarity, we proposed 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 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 proposed 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 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 proposed a new Sec.  483.11(e)(13) that establishes 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) replaces Sec.  483.10(k) and Sec.  
483.11(e)(13)((iii) revises and replaces 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 proposed a new Sec.  483.11(f) to include provisions related to 
privacy and confidentiality. Proposed Sec.  483.11(f)(1) requires that 
the facility respect the resident's right to personal privacy. Proposed 
(f)(1)(ii) incorporates the definition of personal privacy currently 
set out at Sec.  483.10(e)(1). We proposed 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 proposed to re-designate 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 proposed a new Sec.  483.11(h) Grievances, to incorporate the 
facility responsibilities expressed in existing Sec.  483.10(f) and 
also require that facilities ensure that residents know how to file 
grievances. The proposed provision also requires that the facility 
establish a grievance policy to ensure the prompt resolution of 
grievances, and identify a Grievance Officer. Additionally, the 
facility is 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

[[Page 68707]]

    5. Maintain evidence demonstrating the resolution of complaints 
and grievances for at least 3 years.

    Finally, we proposed a new Sec.  483.11(i) which requires 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.
General
    Comment: Many commenters supported specific aspects or the overall 
intent of our proposed revisions to resident rights and facility 
responsibilities, and provided wording suggestions or relocations, 
identified specific improvements, or raised concerns about specific 
provisions. Some commenters recommended we retain the existing language 
for a number of sections.
    Response: We appreciate commenters support. We have considered each 
wording suggestion, suggested improvement and area of concern. We did 
not accept some wording changes or relocations that did not affect the 
meaning of or add substantial clarity to the regulatory requirement, or 
that were more appropriate to sub-regulatory guidance. Although we 
considered them, we do not specifically address all of those 
suggestions below. We also considered retaining existing language where 
suggested but do not specifically address each suggestion below. We 
discuss our response to comments on restructuring in section C. 
Resident Rights (Sec.  483.10) of this preamble and address other 
specific concerns and suggestions for change in the subsequent 
sections.
    Comment: Some commenters suggested we use the term ``oral'' instead 
of ``verbal'' in a number of places.
    Response: While both terms are accurate, we agree we should be 
consistent. Therefore, we have replaced the term ``verbal'' with 
``oral'' throughout the regulation.
    Comment: One commenter stated, with regard to resident rights as 
enumerated at Sec.  483.10, that the proposed rule encourages a culture 
change towards a more resident-focused approach towards long term care. 
They note that improving quality of life and quality of care, allowing 
choices in daily living, and assisting individuals to make informed 
health care decisions are all major goals of culture change and person-
centered care. They further state that involving individuals in choices 
about food and dining such as food selections, dining locations, and 
meal times can help them maintain a sense of dignity, control, and 
autonomy and they applaud CMS for proposing to revise its regulations 
in accordance with this resident-focused philosophy.
    Response: We thank the commenter for their support. Person-centered 
care was one over-arching principle of our proposal. In addition, we 
believe that principles of quality of life and quality of care are also 
over-arching principles that apply to all the requirements for long-
term care facilities. Many of the items the commenter mentions speak 
directly to each of these principles.
    Comment: Some commenters stated that these requirements involve 
costly measures for nursing facilities. One commenter stated this would 
require them to employ translators, procure translation technology, or 
overhaul facility communications.
    Response: Facilities should already have access to these services. 
Facilities are currently required to have the ability to communicate 
effectively, verbally and in writing, with residents. For example, 
facilities must inform residents in a language they can understand of 
their total health status and to provide notice of rights and services 
both orally and in writing in a language the resident understands.
Resident's Rights
    Comment: Some commenters expressed concern that proposed revisions 
would diminish resident rights.
    Response: We have maintained existing resident rights and 
protections, and have made revisions to ensure that those rights and 
protections encompass advancements, such as in the area of 
telecommunications, that were not envisioned when the original 
regulations were written.
    Comment: One commenter recommended strengthening the wording of 
Sec.  483.10(b)(5)(ii) to include asking residents their goals first. 
The commenter stated that the best and most respectful practice 
relative to establishing goals with residents starts with inquiry of 
the resident as to their preferred goals.
    Response: This provision establishes the resident's right to 
participate in the care planning process. Section 483.21 addresses 
comprehensive person-centered care planning and is responsive to the 
commenter's concern. Please see our discussion of Sec.  483.21(b), 
comprehensive care plans.
    Comment: One commenter strongly support the new language that 
reads: ``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.'' Several commenters 
suggested that ``facility'' be changed to ``home or nursing home.''
    Response: We thank the commenters for their support and their 
suggestion. We have retained the term ``facility'' throughout the 
regulation in keeping with the statutory language that serves as the 
basis for these regulations.
Exercise of Rights
    Comment: A few commenters recommended that CMS explicitly include 
the right to vote and to require facilities to have policies and 
procedures to support voting. One commenter suggests that such policies 
and procedures include:
     A process for informing new residents about voting 
registration or change of address procedures;
     assistance in registering as needed and desired by the 
resident;
     procedures for informing residents of elections, including 
date, time, and location of voting places and community resources 
available to provide assistance;
     assistance with transportation to polling places;
     processes for reaching out to election officials to 
develop a plan for officials to come to the facility to register 
residents and conduct voting to the maximum extent election officials 
have the ability to do this;
     the designation of staff charged with assisting with 
voting; and
     training of designated staff in how to help a resident who 
requires assistance to vote where election officials are unable to 
provide that service to the extent needed.
    The commenters contend that currently, residency in a LTC facility 
poses an enormous obstacle to exercising voting rights.
    Response: The regulations, as proposed, state that 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, that the facility 
must ensure that the resident can exercise his or her rights without 
interference, coercion, discrimination, or reprisal from the facility, 
and that 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. Furthermore, 
facility staff

[[Page 68708]]

must be trained with regard to these rights and the facility 
responsibilities with regard to these rights, and residents must be 
informed of their rights. These requirements certainly include the 
right to vote. The suggested policies and procedures represent best 
practices, but we are concerned that some of the suggestions, such as 
requiring that facilities train designated staff to help a resident who 
requires assistance to vote where election officials are unable to 
provide that service, are overly prescriptive and burdensome. We would 
defer additional specificity with regard to this section to 
interpretive guidance.
    Comment: A number of commenters expressed concern about the role of 
the resident's representative. One commenter urged CMS to encourage an 
appropriately expansive view of the representative's role while 
ensuring respect for the resident's right to self-determination. One 
commenter strongly supports proposed requirements that clarify that 
representatives can only exercise the rights delegated to them. Another 
commenter recommended that nursing facilities be required to have 
clearly defined procedures regarding resident representatives. The 
commenter recognized that a resident may not be prepared to designate a 
representative at the time of admission due to other pressing issues 
and suggests that nursing facilities should periodically remind 
residents that they have the option to select one or more 
representatives. Some commenters were concerned that nursing facility 
staff may not become aware of the resident's selection of a 
representative and recommended that CMS require nursing facilities to 
establish a mechanism for formally recording the designation of a 
representative and informing staff of the resident's selection and 
scope of delegation of responsibilities. Commenters also recommended 
that nursing facilities have a process for the residents to designate 
what they want to happen in the event that a resident is adjudged to be 
incompetent under the state law.
    Some commenters stated that they disagreed that a resident has 
``the right to revoke delegation'' of a court-appointed guardian when 
they have been deemed incompetent by a court. Similarly, if the 
practitioner in their professional opinion has determined the 
resident's medical condition impairs their decision-making capacity 
such that a resident's representative appointed by advanced directive 
or durable power of attorney needs to make decisions, a resident cannot 
revoke that representative. Some commenters expressed that the resident 
representative should be making decisions in the best interest of the 
resident or consistent with the resident's specified wishes and that 
the facility should try to resolve discrepancies and, if unresolvable, 
seek to legally remove the assigned representative.
    Some commenters objected to allowing residents to have more than 
one representative. One commenter expressed concern that having a 
resident representative in addition to one appointed by the court or by 
the resident's own authorization through advance directives or a 
durable power of attorney will slow notifications and increase the 
likelihood of disagreements which may delay health-care decisions and 
necessary care. The commenter recommended that the definition of 
resident representative be modified to apply only when the resident 
does not have either a court-appointed guardian or an already 
designated health care proxy such as a durable power of attorney for 
health care or person specified in a living will to avoid having 
multiple resident representatives that will delay decision-making while 
differences are reconciled and requiring multiple notifications of 
numerous parties.
    With regard to residents who have been adjudged incompetent, some 
commenters agreed that residents should retain as many rights as 
possible and their preferences be elicited and honored whenever 
possible. Once commenter felt that our proposed language will likely 
add confusion and is not internally consistent. The commenter stated 
that the court order for scope of decisions is not always clearly 
defined and the distinction between medical care decisions in the 
context of frail elderly in LTC facilities and personal decisions 
regarding quality of life often is not clear, resulting in confusion 
about who is the appropriate decision maker. The commenter is concerned 
that multiple decision makers will make this situation worse.
    One commenter recommended that the definition of ``resident 
representative'' be modified to apply only when the resident has 
neither a court-appointed guardian nor a designated healthcare proxy 
through advance directives nor an identified durable power of attorney.
    Response: We believe we have taken a comprehensive view of the role 
of resident representatives and the right of residents to choose 
whomever they want to assist them in making healthcare and other 
decisions both while the resident retains decision-making capacity and 
in the event a resident should not have or would lose after admission 
this capacity. See our discussion above, regarding the definition of 
``resident representative.'' The term is not intended to create a new 
role, but instead is a general term intended to encompass several terms 
used to describe an individual who a resident or court provides with 
authority, in accordance with federal or state law, to participate in 
health care discussions or to make decisions on behalf of a resident. 
Nothing in this paragraph requires that a resident appoint or have a 
resident representative. We agree that a resident who is adjudicated 
incompetent cannot revoke a court's delegation of authority to a 
representative, which is why Sec.  483.10(b)(3)(ii) defers to state 
law. In addition, residents adjudged incompetent by a court of 
competent jurisdiction are separately addressed in Sec.  483.10(b)(7). 
With regard to limiting the rights of residents to have more than one 
representative, we decline to do so and defer to state law, to the 
extent that state law does or does not address this concern. While we 
acknowledge that multiple representatives could create complexity in 
decision making, we do not believe it is necessary or appropriate for 
us to limit the resident's ability to do so when state law would allow 
this. With regard to medical determinations of incapacity, we again 
defer to state law. Physicians can and do make determinations regarding 
an individual's decision-making capacity. We are aware that, at least 
in some states, if a patient disputes a determination of incapacity, a 
surrogate's decision-making cannot be substituted for the patient's 
until a court decides the matter. For certain situations, more than one 
physician's determination that a patient lacks decision-making capacity 
is required. With regard to the comprehensive nature of court 
decisions, we agree that generally such a decision would be in regard 
to an individual's ability to make all decisions. However, should a 
court's determination be more limited, we believe it is important that 
a resident be allowed to exercise his or her rights and to not have the 
facility extend the court's decision in deferring to a court-appointed 
representative. With regard to our reference to a court's order, 
generally, a court's determination would be formalized through a court 
order. However, for clarity in the event that a court's determination 
does not result in an order, we have modified our language to refer to 
the court's determination. We note that, in

[[Page 68709]]

Sec.  483.10(b)(4), we require 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 delegated by the resident, in 
accordance with applicable law. This requirement presumes that a 
facility knows when a resident has a representative and the nature of 
the representative's appointment. We will not, at this time, be 
prescriptive regarding what a facility must do to fulfill this 
obligation, however, we would expect a facility to have process in 
place in order to ensure that they meet this requirement.
    Comment: One commenter requested that CMS explicitly incorporate 
the concept of negotiated risk into proposed Sec.  483.10(a)(2), which 
states that the resident has the right to be free of interference, 
coercion, discrimination, and reprisal from the facility, and to be 
supported by the facility in exercising his or her rights.
    Response: The rights of the resident to be informed about and agree 
to, refuse, and/or discontinue treatments are established under 
planning and implementing care, Sec.  483.10(c), and further addressed 
section Sec.  483.21, ``Care Planning.'' We defer any additional 
discussion to sub-regulatory guidance.
    Comment: Another commenter recommended that we amend language at 
proposed Sec.  483.10(a)(4) (iii) to read: ``The resident's wishes and 
preferences must be considered in the exercise of rights by the court-
appointed representative'' rather than ``the resident's wishes and 
preferences must be considered in the exercise of rights by the 
representative.''
    Response: A resident representative, whether court-appointed or 
not, should take the resident's wishes and preferences into 
consideration in the exercise of delegated authority. However, CMS has 
no authority to compel any action on the part of representatives, 
regardless of status.
    Comment: One commenter suggested that the intent of proposed Sec.  
483.10(a)(4)(i) was unclear.
    Response: Our intent is to ensure that, in the case of a limited 
guardianship, a facility does not defer all decision making to a 
guardian, when a court's determination does not require it. While 
guardianships are often general in nature, giving all decision making 
authority to a guardian, in some case a guardianship may be limited. A 
limited guardian has the authority to make decisions only in specific 
areas, such as financial or residential. Typically, a court's findings 
of fact and orders or the guardian's letters of appointment will 
identify these areas. Facilities are expected to be aware of when a 
guardianship is limited and not automatically defer all decisions to a 
guardian. We are finalizing this provision at Sec.  483.10(b)(7)(i) and 
have revised it to state that, in the case of a resident representative 
whose decision-making authority is limited by State law or court 
appointment, the resident retains the right to make those decision 
outside the representative's authority.
    Comment: One commenter stated that in proposed Sec.  483.10(a)(5), 
the first sentence in this section covers everyone who is covered under 
state law. Therefore, it is superfluous to single out a specific group 
later on in the paragraph.
    Response: The provision in question states that ``In the case of a 
resident who has not been adjudged incompetent by the state court, the 
resident has the right to designate a representative, in accordance 
with state law and any legal surrogate so designated 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.'' We originally included this language to 
account for State law that did not recognize the validity of same sex 
marriages. Although all states must now, pursuant to the Supreme 
Court's decision in Obergefell v. Hodges (576 U.S. __, 135 S.Ct. 2584 
(2015)) both issue same-sex marriage licenses and recognize the 
validity of such licenses issued in other states, in order to emphasize 
the importance of this provision, we are finalizing it as proposed.
    Comment: One commenter asked if proposed Sec.  483.11(a)(3) and (4) 
overrides a state statute that permits a NF provider to refuse to 
comply with health care agents' directives where they question the 
agent's ``good faith'' and to have the issue resolved by a court or 
agency as needed. The comments asked if the NF provider had to comply 
with a resident representative's decision until and unless the NF 
obtains court authority pursuant to Sec.  483.11(a)(5).
    Response: Proposed Sec.  483.11(a)(3) and(4) are finalized as Sec.  
483.10(b)(4) and (5). Both provisions state that the requirement is 
``in accordance with applicable law,'' which would include applicable 
state law. Proposed Sec.  483.11(a)(5), finalized at Sec.  
483.10(b)(6), requires the facility to report, when a resident 
representative is making decisions or taking actions that the facility 
believes are not in the best interests of the resident as required by 
state law. Our regulations defer to state laws rather than preempt 
them.
    Comment: One commenter was concerned that proposed Sec.  
483.11(a)(5) is confusing and could lead to underreporting of suspicion 
of crimes.
    Response: We agree our language could be confusing and have 
modified it to state: ``[i]f 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 shall report such 
concerns in the manner required under State law'', finalizing it at 
Sec.  483.10(b)(6).
    Comment: One commenter suggested that the order of proposed Sec.  
483.11(d)(3)(iii)(A) (limiting the requirement to act on residents' of 
families' requests and grievances) and (B) (requiring that facilities 
demonstrate that they have responded to such requests and grievances) 
should be reversed to emphasize that while a facility must have a 
response for every grievance or recommendation from a resident or 
family group, not every request has to be adopted as recommended.
    Response: We agree that the suggested modification better conveys 
the information and have the provision accordingly, finalizing it at 
Sec.  483.10(f)(5)(iv)(A)&(B).
    Comment: One commenter requested that we clarify that proposed 
Sec.  483.11(d)(5)(v) precludes a facility from taking resident funds 
for past due balances before the facility conveys any personal funds to 
a resident or resident representative.
    Response: Proposed Sec.  483.11(d)(6), which we finalize at Sec.  
483.10(f)(11), addresses those items and services for which a facility 
may or may not impose a charge against the resident's personal funds.
    Comment: CMS begins the newly-named ``Facility Responsibilities'' 
section by expanding on existing requirements that facilities must 
treat residents with respect and dignity, and provide care and services 
that maintain or enhance the resident's quality of life and protect the 
resident's rights. The commenter supported the new ``Exercise of 
Rights'' Sec.  483.11(a), including proposed Sec.  483.11(a)(2)'s 
requirement that facilities 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.'' The commenter encouraged CMS to 
provide greater clarity on proposed Sec.  483.11(a)(3) and (4) over the

[[Page 68710]]

expectations of facilities deferring to resident representatives for 
decisions that exceed the scope of a court order, resident delegation, 
or other applicable law. Similarly, proposed Sec.  483.11(a)(5)'s 
language of expectations for facilities complying with state 
requirements in the case of a resident representative making decisions 
not in the best interest of the resident seems rather vague and may 
provide potential for abuse.
    Response: We thank the commenter for their support. Please see our 
previous response with regard to resident representatives. As we 
discussed in the preamble, we understand that there is a potential for 
abuse in the relationship between a resident and his or her resident 
representative, such as a guardian, and we want to ensure that 
facilities recognize their role in identifying and reporting such 
concerns in accordance with applicable state law. We would defer more 
detailed discussion to interpretive guidance.
    Comment: Some commenters were concerned about the requirement that 
``[t]he facility must provide equal access to quality care regardless 
of diagnosis, severity of condition, or payment source.'' One commenter 
felt that this suggests that every facility must provide care for every 
individual regardless of the facility's care expertise or the ability 
to care for every condition any individual might have. For example, a 
person may require the use of a ventilator yet not every facility has 
the ability to provide care for such patients. Similarly, a facility 
that provides care for frail elders is unlikely to have the expertise 
to care for a child who requires facility care. The commenter suggested 
we delete ``diagnosis.'' One commenter pointed out that facilities, 
like clinics, may specialize in providing services to residents with 
specific conditions. Another commenter, while supporting the 
expectation to provide quality care (that is, safe, effective, person-
centered, equitable, efficient, and timely) to everyone, recommends 
deleting ``equal access to,'' stating that terms such as ``equal 
access'' can easily be misconstrued as requiring the same amount of 
care or comparable treatments regardless of need or condition.
    Response: We note that the phrase ``equal access to quality care'' 
is statutory language, specifically identified as a requirement 
relating to residents' rights in both sections 1819(c)(4) and 
1919(c)(4) of the Act, and refers to the issue of possible 
discrimination in treatment based on the source of payment. We 
therefore are retaining the language as proposed in Sec.  483.11(a)(2), 
finalizing it at Sec.  483.10(a)(2).
    This provision is not intended to require that every facility have 
every possible capability and unlimited capacity. However, a facility 
cannot choose, deliberately or inadvertently, to provide higher quality 
care to some residents over other residents in the facility based on 
diagnosis, severity of condition, or payment source. For example, if 
two residents require the same care, one resident cannot receive a 
lesser quality because the payer is Medicaid rather than Medicare. The 
amount and type of care is based on the resident's needs and goals, as 
evidenced by the care plan.
    These provisions are also not intended to facilitate selective 
admissions or transfers. We considered, but did not include, admissions 
when we reviewed the existing requirement that requires a facility to 
establish and maintain identical policies and practices regarding 
transfer and discharge. Facilities are expected, as required by our 
provision for a facility assessment, to know their own capabilities and 
capacities when making admissions decisions. This expectation would 
apply to the second example provided by the commenter. Once an 
individual is a resident of the facility, the facility is obligated to 
provide equal access to quality of care, as stated in this provision. 
Thus, a facility that admits a pediatric resident is expected to 
provide quality care to that resident, based on that resident's needs. 
If a resident's condition changes such that a facility does not have 
the ability and is unable make accommodations to provide the care that 
a resident requires, that is an acceptable reason for discharge or 
transfer under Sec.  483.15, as it is permissible to discharge or 
transfer a resident when it is necessary for the resident's welfare and 
the resident's needs cannot be met in the facility. This provision 
would apply in the instance where a resident's condition declines such 
that a ventilator is required in a facility that does not have the 
expertise or equipment to provide care to a ventilator dependent 
resident. However, the facility will have to 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 will meet the resident's needs.
    Comment: Some commenters were concerned that we do not include 
admission in the statement regarding equal access to quality of care 
and are concerned that this can result in discrimination in violation 
of Title VI of the Civil Rights Act of 1964. Another suggested that we 
expressly prohibit all forms of discrimination against residents.
    Response: Nothing in these regulations allows facilities to violate 
other statutes or regulations. Furthermore, facilities are expressly 
required by Sec.  483.70(b) to operate in compliance with all 
applicable Federal, State, and local laws, regulations, and codes. This 
includes, for example, the Americans with Disabilities Act and section 
504 of the Rehabilitation Act. In addition, Sec.  483.70(c) explicitly 
requires compliance with other HHS regulations. This would include but 
not be limited to those regulations 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); non-
discrimination on the basis of race, color, national origin, sex, age, 
or disability (45 CFR part 92); 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). These provisions cover all phases of patient care, 
including, but not limited to, admissions.
Planning and Implementing Care
    Comment: One commenter supported proposed changes to ensure that 
the resident is informed of, and participates in, his or her treatment, 
and that the resident participates in care planning. However, the 
commenter urged CMS to include stronger language with regard to 
including the resident or the resident's representative. The commenter 
strongly suggested that CMS include specific language that would 
require nursing facilities to provide reasonable advance notice to 
resident representatives of the care planning meeting, establish 
alternative means of participating (for example, via telephone or video 
conferencing), offer a reasonable choice of dates and times, and 
document the same. This would help facilitate the participation of 
resident representatives in care planning.
    Response: We thank the commenter for their support of our proposal 
at Sec.  483.11(b), which we are finalizing at Sec.  483.10(c), and for 
their comments regarding care planning. We refer readers to our 
discussion of Sec.  483.21 for further discussion of care planning.
    Comment: Some commenters suggested that we add that residents have 
a right to a copy of the care plan.
    Response: We appreciate the comments that were submitted on this

[[Page 68711]]

issue. While we agree that a resident should be able to review their 
own comprehensive care plan, we also understand that the comprehensive 
care plan is a clinically oriented document that is frequently reviewed 
and updated based on the needs of the resident. Therefore, in an effort 
to further promote a resident's right to be informed, while balancing 
the burden imposed on facilities, we have revised Sec.  483.21(a)(3) to 
require facilities to provide residents and their resident 
representatives with a summary of their baseline care plan. This 
summary must include, but is not limited to, the initial goals of the 
resident, a summary of the resident's medications and dietary 
instructions, any services and treatments to be administered by the 
facility and personnel acting on behalf of the facility, and any 
updated information based on the details of the comprehensive care 
plan, as necessary. Note that this summary is subject to the provisions 
at Sec.  483.10(g)(3) and must be provided 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.
    Furthermore, we note that Sec.  483.10(c)(2)(v) gives the resident 
the right to see the care plan, along with the right to sign it after 
significant changes. 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 believe that the combination of these 
resident rights, with the responsibility of the facility to provide a 
summary of the baseline care plan and include the resident as a member 
of the interdisciplinary care team, will actively engage residents in 
their care planning process.
    Lastly, we would encourage a facility to provide a copy of the full 
comprehensive care plan upon request; with the understanding that care 
plans are dynamic documents that may change frequently. We believe that 
the comprehensive care plan should serve as an important tool for 
delivering patient-centered care and encourage facilities to explore 
ways to allow residents, families, and other representatives to access 
the care plan on a routine basis as appropriate, for instance, using 
technology solutions that enable real-time access for authorized users 
and dynamic updating by members of the care team. In addition, as 
finalized, residents have a right to review and obtain a copy of their 
medical record, or any portion thereof under Sec.  483.10(g)(2)(ii). 
The care plan is included in the medical records. Sections 
1819(b)(6)(C) and 1919(b)(6)(C) of the Act state that clinical records 
on all residents include the plans of care and the residents' 
assessments. We discuss our use of the term ``medical record'' in our 
discussion of Sec.  483.70(i). As noted in that discussion, we regard 
the terms ``medical record'' and ``clinical record'' as synonymous.
    Comment: Some commenters expressed concern about proposed 
requirements to inform the resident in advance of changes to the care 
plan and the right to see and sign the care plan after the changes are 
made. Commenters stated that the care plan is an evolving document and 
suggested that care could be delayed to wait on getting a signature, 
placing residents at risk for fall, skin breakdown, weight loss, and 
other undesirable outcomes.
    Response: The right of the resident to be informed, in advance, 
about care and treatment and of changes in care and treatment that may 
affect the resident's well-being is not new. It is important that the 
resident receives information necessary to make a health care decision, 
including information about his or her medical condition and changes in 
medical condition, about the benefits and reasonable risks of the 
treatment, and about reasonable available alternatives. Care necessary 
to prevent an adverse event or outcome should not be delayed just to 
obtain a signature on a care plan. However, we expect that residents 
will be involved, to the extent possible and as desired by the 
resident, in care planning. This includes seeing the care plan 
initially and after changes are made. Allowing the resident to sign the 
care plan after changes are made documents the resident's involvement. 
Furthermore, it supports both staff and resident perceptions that the 
resident is a vital member of the care planning team. We understand 
that care plans are evolving documents and would not expect that 
facilities would ask residents to sign care plans on a daily basis, 
and, therefore, have modified Sec.  483.10(c)(2)(v), as finalized, to 
state that the resident has the right to sign the care plan after 
significant changes.
    Comment: Some commenters suggested that CMS specifically include 
language related to informed consent. Others felt that language in 
proposed Sec.  483.10(b)(2)(iii) needed further definition. One 
commenter appreciated CMS' proposed language recognizing the residents' 
right to be informed in advance of the risks and benefits of proposed 
care and treatment, especially with respect to the use of antipsychotic 
drugs often without first obtaining informed consent. The commenter 
believed that nursing facilities should be required to document that 
the attending physician discussed the benefits, risks, and alternatives 
of a drug with the resident and/or the resident's representative and 
that the doctor obtain informed consent prior to administering the 
drug(s). Some commenters suggested that this language was too 
restrictive and could delay care. One commenter suggested we revise the 
regulatory language to say ``the right to be informed, to the extent 
practicable, in advance of changes to the plan of care.'' Another 
commenter stated that advising the resident of the risks and benefits 
of proposed care, treatment and treatment alternatives or options are 
the responsibilities of the practitioner, not the facility, and 
recommends we revise the language accordingly. The commenter also 
stated that the resident should be informed of his or her right to 
refuse the medication and of alternative behavioral interventions, and 
this should be documented, as well. With respect to a resident's right 
to refuse a particular treatment or medication, the commenter was 
concerned that language stating that ``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'', as currently worded, could be used by nursing facility 
physicians and staff to deny a resident's/representative's request for 
alternative behavioral interventions on the basis that a physician or 
nursing facility nurse believes that a drug regimen is a better or more 
appropriate treatment. The commenter suggested that, in order to 
protect the resident's right to self-autonomy, CMS should clarify the 
definition of ``medically unnecessary or inappropriate'' in this 
context to make it clear that such decisions should be evidence-based. 
Another commenter suggested that CMS clarify the meaning of 
``clinically appropriate.''
    Response: Antipsychotic medications are addressed in Sec.  483.45. 
Please see our discussion of comments related to that section. Although 
the requirements do not use the term ``informed consent,'' and informed 
consent laws may vary from state to state, the elements of informed 
consent are generally contained in the statements of resident rights. 
Proposed Sec.  483.10(b)(3) establishes the resident's right to be 
informed in advance of the risks and

[[Page 68712]]

benefits of proposed care, of treatment and treatment alternative or 
treatment options, and to choose the alternative or option that the 
resident prefers. We note that the right to be informed in advance 
about care and treatment is not a new right and the facilities are 
already required to meet this requirement. Proposed Sec.  483.10(b)(4) 
establishes the resident's right to request, refuse, or discontinue 
treatment. We agree that it is the responsibility of the practitioner 
to discuss the risks and benefits of proposed care, treatment and 
treatment alternatives or options with a resident or their 
representative and have modified the provision accordingly, now at 
Sec.  483.10(c)(5). In addition, the practitioner is responsible for 
documenting this discussion in the medical record. The facility has a 
role in supporting the resident's rights, for example, by ensuring a 
resident or resident representative knows how to contact a provider. As 
one commenter noted, facilities can help residents facilitate existing 
informed consent rights, but may not abridge or abrogate them. With 
regard to clarifying the definition of medically unnecessary or 
inappropriate, we believe that there is a clear distinction between an 
alternative that a provider may not prefer and a treatment or service 
that is medically unnecessary or inappropriate. We defer additional 
discussion/examples of ``medically unnecessary'' as well as 
``clinically appropriate'' to interpretive guidance.
    Comment: Some commenters stated that they were pleased to see that 
the proposed regulations support the resident's right to participate in 
care planning. One commenter suggests we require that CMS require the 
planning process to identify staffing practices that maximize staff's 
delivery of person-centered care and the prevention of adverse events.
    Response: We considered these suggestions, but are not 
incorporating them at this time. Staffing provisions address the need 
to ensure that nursing and other staff have 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). Adverse events, including monitoring and prevention, are 
addressed by QAPI.
    Comment: One commenter was concerned that the use of some terms is 
unclear. The commenter stated that the use of the term ``roles'' in 
proposed Sec.  483.10(b)(5)(i) was confusing and should be replaced 
with a word that is clearer as to the intent. Other commenters asked if 
this meant that the resident could choose which nurse/therapist/aide 
would participate in the care plan meeting or if the meeting could not 
proceed if that individual was unable to participate. One commenter was 
concerned that the meaning of the phrase ``and the disciplines that 
will furnish care'' in proposed Sec.  483.10(b)(2) was unclear and 
suggested ``The right to be informed, in advance, of the care to be 
furnished and the professions/practitioners/departments that will 
furnish care.'' The commenter offered other specific language 
alternatives.
    Response: We reviewed these sections. We believe the term ``roles'' 
is appropriate. A resident may not be able to identify a specific 
person they want included in the planning process, or a specific 
individual may be unable to participate, but that should not prevent 
the resident from including a role, such as an individual to provide 
spiritual, nutritional, or behavioral health input. With regard to the 
term ``disciplines,'' to improve clarity, we have revised it to read 
``type of care giver or professional'' that will furnish care.
    Comment: Some commenters were concerned about adequate resident 
involvement in the care planning process. One commenter stated that 
``often the resident or their representative is not aware of the right 
to participate in the development and implementation of his or her 
person-centered plan of care.'' The commenter was concerned that, 
although proposed Sec.  483.10(b)(5)(i) allows the resident to request 
the right to participate in the planning process, if the resident isn't 
aware of the right, they are unable to implement it. The commenter 
recommended that CMS add language requiring the facility to ask the 
resident or resident representative at least quarterly if they choose 
to participate in the planning process, and to inform the resident of 
the date and time of the meeting. Another commenter suggested setting a 
minimum number of care planning meetings per year, such as monthly or 
quarterly, that the facility must invite the resident or representative 
to attend.
    Response: We believe that our proposed requirements adequately 
address resident involvement in the care planning process. Regulations 
at Sec.  483.21(b)(2)(ii)(E) require that to the extent possible the 
resident and/or their representative(s) must participate on the IDT 
that develops the resident's care plan. In addition, regulations at 
Sec.  483.21(b)(2)(ii)(E) require that the facility provide an 
explanation in the resident's medical record if the participation of 
the resident and their representative is determined not practicable for 
the development of the resident's care plan. We encourage readers to 
refer to section H, ``Comprehensive Person-Centered Care Planning'' 
(Sec.  483.21) for a detailed discussion regarding the care planning 
requirements.
    Comment: Some commenters applauded CMS's inclusion of advance 
directives in several provisions of the proposed rule and recommended 
that CMS incorporate other advance care planning tools in all 
provisions relating to advance directives. Commenters specifically 
recommended CMS incorporate recognition of Physician Orders for Life 
Sustaining Treatment (POLST) in several sections of the regulation, 
including defining ``Portable Order for Scope of Treatment.'' 
Commenters further suggested adding such orders as required 
documentation in the resident's medical record, if applicable and with 
the resident's consent, including such orders in both the baseline and 
comprehensive care plan, when applicable, and a review and update of 
such orders as part of the discharge planning process. One commenter 
recommended that CMS encourage repeated conversations related to 
advance care planning throughout a resident's stay.
    Response: We thank the commenters for their support for the 
inclusion of advance directives. We note that advance directives are 
currently included in the requirements for participation and our 
proposed revisions were primarily to improve clarity and readability. 
We also thank the commenters for their suggestions but decline to add 
additional regulatory requirements regarding portable orders for scope 
of treatment at this time. We recognize that these tools serve a 
function beyond advance directives. Several of our requirements are 
also intended to facilitate shared, informed decision making and 
communication between health care professionals and residents with 
serious, progressive illness or frailty. These requirements apply both 
to the resident's care within a facility and to communication with 
other providers when a resident is transferred or discharge. We would 
expect that the issues that are addressed by portable orders for scope 
of treatment would be raised in the context of advanced directives as 
well in ongoing

[[Page 68713]]

discussions related to care planning and keeping in mind residents' 
goals of care and treatment preferences. To the extent applicable, such 
concerns should also be reflected in resident's discharge plan and 
discharge summary. All physician orders are documented in a residents' 
care plans. We note that a few states have developed POLST programs, a 
few states do not have such a program, and many states are in the 
process of developing such programs. Consistent with state law, it 
would be appropriate for facilities to inform residents about portable 
orders for scope of treatment, as those tools are referenced and 
recognized within the state. We note that current requirements already 
require a facility to provide written information to residents that 
includes a description of the facilities policies to implement advance 
directives and applicable state law.
    Comment: One commenter was concerned with regard to Advance 
Directives that providing information is inadequate unless the facility 
explains what the information means, and suggested that CMS add 
language to require that an explanation to the resident or resident 
representative about what the various advance directives mean, 
including different code statuses, and that it can be changed if 
desired in the future.
    Response: Facilities are required to provide written advance 
directive information in accordance with 42 CFR part 489, subpart I. In 
addition, residents have a right to be informed of their total health 
status; the right to be informed in advance, by the physician or other 
practitioner or professional, 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; and the right to 
request, refuse, and/or discontinue treatment. We also proposed and are 
finalizing provisions related to resident and resident representative 
participation in the care planning process, which includes discussion 
of resident goals of care and preferences. We would expect that the 
discussions resulting from these rights would include discussions 
tailored to the resident's specific situation, including, as 
appropriate, discussions around the types of care that would be covered 
by advance directives.
    Comment: Some commenters supported CMS's proposal to strengthen 
resident rights related to care planning, but believed the proposed 
rule does not go far enough in creating truly person-centered planning 
and saw no reason why the person-centered planning process in nursing 
facilities should not be more consistent with the process mandated for 
Medicaid-funded home and community-based services. Some commenters 
recommended changes that would give more control to residents and 
permit residents to play a greater role in directing their own care. 
One commenter recommended specific revisions to the proposed regulatory 
language, including incorporating the term `informed consent' and 
emphasizing the resident's right to direct the care-planning process.
    Response: Our proposed regulatory language establishes that each 
resident has the right to be fully informed, in language that he or she 
can understand, of his or her total health status, and to make many 
types of decisions regarding his or her care. We believe that the 
rights set out in this section comprise the essential elements of 
informed consent, and are phrased in language that residents and their 
representatives can easily understand.
    As we noted in the preamble to the proposed rule, our proposals 
support the guidance issued by HHS 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. 
We agree that the principles in that guidance regarding dignity and 
self-direction apply equally to individuals who reside in a nursing 
facility. Although nursing facilities are expressly not considered home 
and community based settings (42 CFR 441.301(b)(1)(ii)), we have 
incorporated many requirements that are supportive of the principles 
reflected in the process mandated for Medicaid-funded home and 
community-based services. We refer readers to our discussion of Sec.  
483.21 regarding comprehensive person-centered care planning.
Choice of Attending Physician
    Comment: Many commenters were concerned about facilities' 
requirement or ability to establish credentialing requirements for 
physicians. Commenters supported the right of residents to choose their 
own attending physicians and to require facilities to protect and 
promote that right. One commenter specifically supported changes 
designed to ensure that residents are the driving force in their care, 
so they can make choices that preserve their dignity, reflect their 
preferences, and support their independence. Nevertheless, the 
commenter was concerned by the lack of clarity around what is meant by 
the ``professional credentialing requirements of the facility,'' which 
is not otherwise defined in existing regulations. The commenter was 
concerned that leaving this level of flexibility to facilities could 
allow facilities inclined to not accept residents' choices with a 
potentially fairly easy way to undermine this right, and urges CMS to 
make clear that credentialing requirements cannot be used for the 
purpose of denying a resident's right to choose their own physician 
without good cause and/or right of appeal. The commenter requested 
clarification about how this right would be maintained when residents 
are in facilities that have closed medical staff models or facilities 
that employ their own physicians. The commenter also noted that 
credentialing itself does nothing to ensure adequate performance or 
competent care so they urge CMS to ensure that quality programs 
incorporate physician performance indicators and measures.
    Another commenter urged CMS to confirm that this requirement 
applies to the attending physician only and not to a covering physician 
since that list can be extremely long and may change frequently. To the 
extent that CMS would apply this requirement to covering physicians, 
this would likely result in the unintended consequences of significant 
on-call coverage problems as well as potentially discouraging 
physicians from caring for SNF residents at a time when the agency is 
striving for greater and more frequent physician involvement in SNF 
care.
    The commenter also pointed out that verification of professional 
credentialing requirements can take time which may result in a 
resident's physician being unable to serve as the attending physician 
upon admission. Thus, the resident would be under the care of another 
``credentialed'' attending physician until their physician completes 
the facility's credentialing process. This switching of physicians is 
not a best practice and may result in resident's experiencing adverse 
events, as such attending physician may not be familiar with the 
resident. The commenter recommended amending Sec.  483.10(c) to read: 
``Choice of attending physician. The resident has the right to choose 
his or her attending physician. (1) The facility must develop its own 
credentialing process that does not require primary source 
verification, which is typically conducted by state licensure entities 
or the process for conveying hospital admitting privileges or managed 
care certification. (2) The physician must be licensed to practice, and 
(3) The physician must meet the professional credentialing requirements 
of the facility within a timely manner

[[Page 68714]]

following the resident's admission to the facility.''
    Yet another commenter recommended additional wording in order to 
support the role of the medical director in ensuring practitioner 
accountability for improved performance. The commenter stated that 
credentialing refers only to background, education, training, 
licensing, etc. Just requiring credentialing is not enough to ensure 
adequate physician performance (for example, timely visits and 
competent care). Addressing the challenges of medical care requires 
holding people accountable for their performance and practice, not just 
their credentials. The commenter suggested that we modify the 
requirement to read: ``(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, practice, and performance requirements 
of the facility.''
    Other commenters recommended that CMS delete the credentialing 
requirement entirely. The commenters stated that CMS proposes, without 
explanation, to limit residents' free choice of physician to physicians 
who meet their facilities' credentialing requirements and that the 
commenters do not see a need for such a requirement. Further, one 
commenter is concerned that the proposal does not provide any standards 
for credentialing. The commenter stated that the public policy concerns 
about physicians have always been the lack of appropriate medical care 
in LTC facilities and how few physicians actually provide care to 
residents and that the new credentialing requirement would not improve 
the medical care of residents and could further reduce the number of 
qualified physicians providing care to residents. One commenter stated 
that, if the intent of the requirement is to improve the care provided 
by attending physicians, CMS should pull stakeholders together to 
determine how that could best be done and assess whether credentialing 
would accomplish that goal. If the intent is to remove a physician of 
the resident's choosing who is failing to fulfill a given requirement 
(for example, frequency of physician visits, unnecessary drugs), the 
current interpretive guidelines that outline such a process could be 
retained (``the facility will have the right, after informing the 
resident, to seek alternate physician participation to assure provision 
of appropriate and adequate care and treatment''). The commenter 
further states that the proposed requirement is contrary to federal law 
at section 1819(c)(1)(A)(i) of the Act, which gives residents an 
unfettered right to choose their physician. The commenter stated that 
they oppose the proposed requirement as it is written and recommends it 
be deleted.
    Response: Based on commenter concerns, we have withdrawn the 
proposed requirement related to physician credentialing. We are 
finalizing the requirements that the physician must be licensed to 
practice and must meet applicable regulatory requirements as well as 
the requirement that, in the event that it becomes necessary for a 
facility to seek alternate physician participation, the facility must 
discuss this with the resident and honor the resident's selection of a 
new attending physician.
    Comment: Some commenters suggested that the resident's right to 
select his or her attending physician was a new right and stated that 
this could be burdensome and problematic.
    Response: The right of a resident to choose his or her attending 
physician is not new. It is in current regulations and is a statutory 
requirement at both sections 1819(c)(1)(A)(i) and 1919(c)(1)(A)(i) of 
the Act. All facilities should already be in compliance with this 
requirement. We proposed requirements to ensure that physicians chosen 
by resident complied with requirements for licensing and credentialing. 
As a result of public comments, we are withdrawing our proposal 
regarding credentialing. Please see our previous response on this 
issue.
    Comment: One commenter stated that the requirement to honor a 
resident's preference regarding a physician must be related to the 
physician's responsibility to practice appropriately and provide 
quality care and that the failure to hold physicians to this standard 
has major adverse consequences for long-term and post-acute care 
residents/patients. The commenter suggests adding the word ``relevant'' 
to emphasize that the choice needs to consider the physician's 
performance and practice as well as other factors.
    Response: We have revised these requirements to state that the 
physician must be licensed to practice and must meet applicable 
regulatory requirements as well as a requirement that, in the event 
that it becomes necessary for a facility to seek alternate physician 
participation, the facility must discuss this with the resident and 
honor the resident's selection of a new attending physician. We do not 
agree that the requested revision is necessary and defer additional 
specificity to sub-regulatory guidance.
    Comment: A commenter is concerned that proposed revisions relating 
to choice of physician in proposed Sec.  483.10(c)(2) and (3) and 
proposed Sec.  483.11(c)(2) conflict.
    Response: We have withdrawn proposed Sec.  483.10(c)(2) and have 
co-located the provisions related to choice of physician in Sec.  
483.10(d).
Respect and Dignity
    Comment: A few commenters are concerned that the proposed rules 
require facilities to allow residents to use their personal belongings, 
but do not impose any obligations on facilities to assure the security 
of residents' property from loss or theft. These commenters recommend 
that CMS add additional requirements relating to the protection of 
residents' belongings. Others stated that CMS should specify that the 
use of person possession must meet fire code.
    Response: Our proposed rule requires that a facility provide to a 
resident a safe, clean, comfortable, and homelike environment, allowing 
the resident to use his or her personal belongings to the extent 
possible. A safe, home-like environment includes the security of the 
residents' personal belongings. Therefore, in response to commenters' 
suggestions, we have added language at proposed paragraph (j), safe 
environment, finalized at Sec.  483.10(i) stating that the facility 
shall exercise reasonable care for the protection of the resident's 
property from loss or theft. We defer additional detail to interpretive 
guidance. We agree that the use of personal possessions must comply 
with fire safety. We note that we require that such use must not 
infringe upon the safety of other residents. Furthermore, facilities 
are required to comply with requirements related to Life Safety Code, 
which are located at Sec.  483.90(a).
    Comment: Commenters both supported and opposed our proposed changes 
to visitation requirements. One commenter strongly supports the 
language requiring that the ``facility'' provide immediate access to a 
resident by immediate family member and other relatives of the 
resident, and by others who are visiting with the consent of the 
resident, subject to the resident's right to deny or withdraw consent 
at any time. The commenter noted that this was included in the 2009 
interpretive guidelines but having it in the regulations makes it an 
even stronger requirement. One commenter strongly supports changes to 
expand the rights of residents related to self-determination, to enable 
immediate access to the resident by the resident representative,

[[Page 68715]]

and the requirement that facilities must have written policies and 
procedures regarding visitation rights of residents. The commenter 
further supports providing residents with more flexibility around when 
they receive visitors and who may visit. Some commenters support 
proposed visitation provisions that enable residents to receive 
visitors of the resident's choosing, at the time of the resident's 
choosing, stating that this is an essential element of self-
determination and, since the facility is the resident's home, residents 
should have the same 24-hour access to visitors as those who live in 
the community. Some commenters felt that residents don't want visitors 
late at night and prefer that the doors are locked. These commenters 
felt that our proposal unreasonably imposed visitors upon residents.
    Many commenters expressed safety concerns with regard to open 
visitation. Some commenters stated that having unexpected visitors 
entering the facility at any time of day or night is unreasonable, 
disruptive, and potentially dangerous, but suggested that pre-arranged 
visits during ``off-hours'' could be accommodated and felt that, in 
order for a facility to provide a safe and secure environment for all 
patients and residents, there must be reasonable parameters applied to 
this visiting provision. One commenter suggested establishing specific 
time frames. Another commenter stated that their facility used a 
security code to ensure that staff knows when a visitor is in the 
facility. Some commenters stated that it is important that residents, 
visitors and staff understand that visitation privileges does not 
include a visitor living in the facility. Another concern is visitors 
who are extremely boisterous, confrontational, under the influence of 
drugs or alcohol. One commenter stated that a center must have the 
ability to protect staff and residents from this disruptive behavior. 
Other commenters noted that the rights of other facility residents must 
considered in an ``open visitation'' policy. One commenter highlighted 
important distinctions between hospitals and LTC facilities that should 
be considered, including concerns that LTC facilities do not employ 
distinct security personnel, or, if they do employ security personnel, 
they are typically not present around the clock. The commenter stated 
that it is more common for a LTC facility to have a receptionist at the 
main entrance who welcomes and guides visitors and that reception staff 
are present until early evening hours. The commenter stated that around 
the clock visitation would require increased staffing, at a minimum, 
which did not seem to be included in CMS' estimate of costs per 
facility for implementation of these rules. Commenters noted that, 
currently, facilities accommodate visitors at any time when a request 
is made or the clinical situation of the resident is such that the 
presence of visitors is essential. This provides everyone involved with 
the time to prepare and to accommodate everyone's needs. Mandatory 
``open visitation'' in what is both a home and a health care facility 
means there will be more unanticipated visitors, and this could lead to 
facility resources being diverted to quickly arrange for an appropriate 
visiting environment for all involved, as opposed to attending to other 
needs. The commenter urges CMS to clarify this section of the proposed 
rule to ensure that facilities maintain the ability to limit 
visitations if those limitations are based on clinical or safety 
considerations that are outlined in the facility's policies and 
procedures and shared with each resident.
    One commenter expressed concern about facilities establishing their 
own policies and procedures for visitation. For example, the commenter 
suggested that rather than allowing a facility to make its own 
decisions about restricting visits in the event of an infectious 
disease, the commenter suggested instead that the facility should 
follow CDC guidelines, which are evidence-based. The commenter also 
expressed a concern about permitting 24-hour visitation, stating that 
24-hour visitation is already allowed but questions about 24-hour 
visitation still arise and many facilities still post signs indicating 
only specific hours for visitation. The commenter recommends that the 
regulations clarify this point.
    Some commenters felt that the regulatory language impermissibly 
limited visits to residents from CMS, the State Survey Agency, family 
members and was concerned that CMS proposed to redefine access and 
visitation rights, currently at Sec.  483.10(j), as a subcategory under 
``self-determination,'' both for residents' rights (Sec.  483.10) and 
facility responsibilities (Sec.  483.11), with some language only 
included in proposed Sec.  483.11. Some commenters object to the 
proposed language that would make visits from other visitors subject to 
reasonable ``clinical and safety restrictions'' and allow the facility 
to create written policies and procedures restricting resident access 
to visitors for clinical or safety reasons. One commenter stated that 
these requirements would gut resident visitation rights by giving 
facilities complete latitude to create whatever policies they want. 
Other commenters were concerned that proposed language erodes resident 
visitation rights by placing restrictions on visits that go beyond what 
is permitted under the Nursing Home Reform Law. Some commenters 
recommended that CMS delete proposed Sec.  483.11(d)(2) in its entirety 
as inconsistent with the requirements of the Nursing Home Reform Law.
    One commenter notes that relatives are not ``subject to reasonable 
clinical and safety restrictions'' in the way ``others who are visiting 
with a resident'' are and recommended that CMS delete all references to 
``clinically necessary or reasonable restriction or limitation or 
safety restriction or limitation'' and that the facility policies and 
procedures clearly state that residents have the right to 24-hour 
visitation by anyone they choose. Another commenter stated that 
sometimes the facility needs to protect the resident against certain 
visitors.
    Response: As noted above, several commenters suggested that our 
proposed provisions related to visitation were in conflict with 
statutory requirements. We have reviewed and revised this section to 
eliminate any confusion. Sections 1819 and 1919 of the Act establish 
specific requirements regarding access and visitation for residents of 
long term care facilities. Specifically, the statute requires that a 
facility permit immediate access to any resident by any representative 
of the Secretary, by any representative of the state, by an ombudsman 
described in paragraph (2)(B)(iii)(II), or by the resident's individual 
physician; (B) permit immediate access to a resident, subject to the 
resident's right to deny or withdraw consent at any time, by immediate 
family or other relatives of the resident; (C) permit immediate access 
to a resident, subject to reasonable restrictions and the resident's 
right to deny or withdraw consent at any time, by others who are 
visiting with the consent of the resident; (D) permit 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 (E) permit 
representatives of the State ombudsman (described in paragraph 
(2)(B)(iii)(II)), with the permission of the resident (or the 
resident's legal representative) and consistent with state law, to 
examine a resident's clinical records. Our regulations are intended to 
be fully compliant with these statutory requirements. We have revised 
the

[[Page 68716]]

language related to the resident's right to receive visitors to clarify 
that restrictions on visitation apply only to those categories of 
visitors where such restriction is permitted by statute. As noted 
earlier, in order to be responsive to public comments, we have revised 
Sec.  483.10 and Sec.  483.11 into a single regulatory section, so that 
all of the provisions relating to visitation are now located at Sec.  
483.10(f).
    We note that, in the proposed rule, in addition to the statutorily 
mandated individuals (any representative of the Secretary, by any 
representative of the state, by an ombudsman described in paragraph 
(2)(B)(iii)(II), or by the resident's individual physician) we expanded 
the individuals who must be provided immediate access to the resident 
to include the resident's representative as well as 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 (Pub. L. 106-402, codified at 42 U.S.C. 15001 et 
seq.), and any representative of the agency responsible for the 
protection and advocacy system for individuals with a mental disorder 
established under the Protection and Advocacy for Mentally Ill 
Individuals Act of 2000 (Pub. L. 99-319, codified at 42 U.S.C. 10801 et 
seq.) as we believe that immediate access to a resident by these 
entities is important to the health and safety of a resident.
    With respect to statutory language regarding reasonable 
restrictions and reasonable access, we proposed to add the caveat that 
those restrictions or limitations on access must be based on clinical 
or safety concerns. Furthermore, such restrictions and the rationale 
for such restrictions must be included in a facility policy on 
visitation that is consistent with the regulatory requirements. We 
believe limiting the bases for restrictions to reasons of health (that 
is, clinical concerns) and safety as well as requiring that the 
facility have their procedures and restrictions, including rationale, 
included in written procedures are useful in identifying and preventing 
inappropriate restrictions on visitation. We note that these 
limitations apply only to ``others who are visiting with the consent of 
the resident,'' based on the statute's language regarding ``reasonable 
restrictions'' and to ``any entity or individual that provides health, 
social, legal, or other services to the resident,'' based on the 
statute's language requiring ``reasonable access.'' As noted above, we 
believe that ``reasonable restrictions'' as well as ``reasonable 
access'' should only be limited based on clinical or safety concerns, 
such as those commenters identified. Commenters identified a number of 
safety restrictions that may be imposed by facilities. These 
restrictions protect the security of all the facility's residents, and 
include requirements such as keeping the facility locked at night; 
visitors making prior arrangements for late night access, denying 
access or providing limited and supervised access to a visitor if that 
individual has been found to be abusing, exploiting, or coercing a 
resident; denying access to a visitor who has been found to have been 
committing criminal acts such as theft; or denying access to visitors 
who are inebriated and disruptive. In addition, we agree that clinical 
restrictions in order to prevent the spread of communicable disease are 
appropriate.
    With regard to ``imposing'' visitors upon residents, we have, 
consistent with the statute, included language that defers to a 
resident's choice when allowing visitors. Generally, residents do not 
have to have visitors unless they choose to have visitors.
    Comment: One commenter objects to the word ``visitation'' as it can 
be defined as ``an official or formal visit, a disaster or difficulty 
regarded as a divine punishment. . .'' and recommends changing it to 
``visit'' or ``visiting,'' which is not the same thing as 
``visitation.''
    Response: We appreciate the commenter's suggestion; however decline 
to make this change. We acknowledge that there are multiple definitions 
of the term ``visitation,'' including, perhaps most simply, as ``the 
act of visiting,'' which is applicable to the context in which we use 
it. Further, the term ``visitation'' is in the statute, specifically at 
sections 1819(c)(3) and 1919(c)(3) of the Act, to establish the 
specific right upon which this regulatory right is premised and in 
other regulations addressing similar subject matter, such as the 
hospital and critical access hospital conditions of participation.
    Comment: Some commenters expressed concerns about provisions 
relating to resident and family groups. One commenter suggested that we 
expand those who have a right to participate to include ``friends of 
the resident who have his or her permission''. Another commenter 
recommended that it be clarified that it is also the right of family 
members or resident representatives themselves as well as other persons 
interested in the welfare of the resident or residents to participate 
in family groups. The commenter supports the intent of the proposed 
language that requires nursing facilities to provide a resident or 
family group, if one exists with private space, but believes that the 
facility should be prohibited from impeding and should be required to 
facilitate the formation or continued existence of such groups. The 
commenter believes that nursing facilities should be required to, with 
the approval of the groups, take reasonable steps to notify, through 
conspicuous postings, and other means, residents and family members of 
the groups and of upcoming meetings in a timely manner. The commenter 
supports our clarification that the designated staff person who 
participates in a resident or family group must be approved by the 
resident or family group and by the facility, but suggests CMS be clear 
that the designated staff person does not necessarily have to be the 
same person for both the resident group and the family group. The 
commenter also suggested CMS clarify that resident and family groups 
can convene without a facility staff member present and may convene 
off-site. Commenters support the proposal that the grievances and 
recommendations of the groups must be addressed, and if not 
implemented, the rationale for this must be provided to the group but 
recommend that we require a written response to the group within a 
specific timeframe.
    Response: CMS fully supports family and caregiver engagement. 
However, we believe that the right of family members to participate in 
a family group is a result of and subordinate to the resident's right 
in this instance. We can envision circumstances where a resident would 
not want and it would not be appropriate to allow a family member, such 
as an estranged spouse or an abusive relative, to participate in a 
family group as a result of a residents' presence in a facility. 
Therefore, we have retained this language as written. We proposed to 
expand this right to include resident representatives in order to 
ensure that individuals of the resident's choosing, whether a familial 
relation or not, can also participate in these groups. We believe this 
supports the resident's ability to choose who they consider `family.' 
We also provide that visitors may attend at the groups' request. We 
decline to give ``friends'' or ``other persons interested in the 
welfare of the resident or residents'' a right to participate 
independently of an invitation from the group, as this additional 
participation should be determined by the group rather than imposed 
upon it. Other provisions require that facilities make residents aware 
of contact information for State

[[Page 68717]]

and local advocacy organizations, such as the State Long-Term Care 
Ombudsman program, and the Aging and Disability Resource Center or 
other program in the No Wrong Door System, should residents wish to 
invite such entities to a resident- or family group. In addition, 
nothing precludes an individual interested in the welfare of the 
resident or residents from requesting such an invitation. With regard 
to group meetings outside of the facility, nothing in these 
requirements precludes a resident or family group from meeting outside 
the facility and the resident has a right to interact with members of 
the community and participate in community activities both inside and 
outside the facility. We agree that facilities should take reasonable 
steps to ensure that residents and family members are aware of upcoming 
group meetings and have revised accordingly, finalizing this provision 
at Sec.  483.10(f)(5)(i).
    We defer to sub-regulatory guidance further discussion of the 
designated staff person(s) assigned to provide resident or family 
groups with assistance and response. We note that we already state that 
staff or visitors may attend group meetings at the group's invitation.
    We require that facilities must respond to a grievance voiced by a 
resident or family group with a response and a corresponding rationale. 
We expect that such response would generally be a written response, but 
might also take another form. For example, if a resident group requests 
a specific action and the facility can show that the action has been 
taken, there may be no need for a written response. We have clarified 
that the facility response must be timely, but decline at this time to 
specify a time frame, given the potential variation in such grievances 
and recommendations.
    We require the facility to provide a notice of rights and services 
to the resident prior to or upon admission and during the resident's 
stay, both orally and in writing in a language that the resident 
understands. This includes all of his or her rights and all rules and 
regulations governing resident conduct and responsibilities during the 
stay in the facility. We further require notification if those rights 
change. These rights include the right of the resident to organize and 
participate in resident groups.
    Comment: One commenter recommended that CMS explicitly prohibit the 
facility from taking any action that would discourage the formation 
and/or activities of resident and family groups, and that CMS require 
the facility to (1) provide the resident or family group access to a 
bulletin board or other public notice space for their exclusive use to 
communicate with other residents, friends, and family, and (2) provide, 
at the group's request, a roster of the group members, including name 
and contact information, excluding information of those member who have 
declined such inclusion in writing.
    Response: We appreciate the commenter's suggestion, but are 
concerned that these requirements are overly prescriptive. Furthermore, 
we believe that the underlying concerns can be addressed either by 
individuals through the grievance process or by the resident and family 
groups' facility representative and complaints/recommendations made by 
the group to the facility.
    Comment: One commenter stated that both residents and families need 
to be able to freely raise and discuss issues in their respective 
groups and the presence of one or more residents at a family group 
would likely prevent at least some family members from speaking out 
candidly or at all. The commenter stated that this undermines the 
purpose of such a group and suggests revisions to these provisions to 
address participation across groups.
    Response: The requirements as written provide for both resident 
groups and family groups. We have clarified that staff, visitors, or 
other guests may attend the resident group or family group at the 
respective group's invitation. We understand the commenter's concern 
and believe that family groups can determine how to best manage this 
issue. We would not prohibit residents from participating in family 
groups. We defer additional discussion to sub-regulatory guidance.
    Comment: Some commenters were concerned about the protection of 
resident personal funds and recommend additional requirements. One 
commenter supported CMS efforts to pull provisions related to the 
protection of residents' funds together into one place for clarity, to 
update those requirements and to add limitations on the kinds of things 
for which facilities may charge residents. Suggestions to strengthen 
these requirements included requiring that facilities periodically 
review accounts of resident funds for suspicious withdrawals, requiring 
administrators to take training in protecting resident accounts, and 
providing the residents or resident representative monthly accounting 
statements so that any changes are noticed as quickly as possible. 
Another commenter expressed concern that the proposed rules under 
residents' rights as they relate to protection of resident funds are 
extremely limited, and the other specific current rights at Sec.  
483.10(c) are shifted solely to the proposed Sec.  483.11(d)(5). The 
commenter stated that residents' rights provisions need to include 
sufficient detail to ensure that residents and their families and 
representatives know what the rights are. The commenter suggested that 
we restore all of the language at current Sec.  483.10(c) to proposed 
Sec.  483.10(e)(9) and restore an independent title ``Protection of 
resident funds'', stating that resident funds should not be a 
subcategory of the term ``self-determination.''
    Response: We thank the commenters. As addressed earlier in this 
section, we have consolidated proposed Sec.  483.10 and Sec.  483.11, 
which addresses commenter concerns about residents rights containing 
sufficient detail to ensure that resident know both their rights and 
the facility's responsibility to support those rights. We maintain that 
it is appropriate to retain all of this information in the section 
relating to the resident's right to manage his or her financial 
affairs, and therefore have not restored an independent title of 
``protection of resident funds.'' Under current requirements, the 
facility must hold, safeguard, manage, and account for the personal 
funds of the resident deposited with the facility, including 
establishing and maintaining 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 and providing the individual financial record 
through a quarterly statement as well as on request. Current 
interpretive guidance establishes that ``hold, safeguard, manage and 
account for'' means that the facility must act as fiduciary of the 
resident's funds, report at least quarterly on the status of these 
funds in a clear and understandable manner, and includes money that an 
individual gives to the facility for the sake of providing a resident 
with a non-covered service. We have revised paragraph Sec.  
483.10(f)(10)(i), as finalized, to state that the facility must act as 
a fiduciary of a resident's funds. According to Cornell University Law 
School, a fiduciary duty is a legal duty to act solely in another 
party's interests. Parties owing this duty are called fiduciaries. The 
individuals to whom they owe a duty are called principals. Fiduciaries 
may not profit from their relationship with their principals unless 
they have the principals' express

[[Page 68718]]

informed consent. They also have a duty to avoid any conflicts of 
interest between themselves and their principals or between their 
principals and the fiduciaries' other clients. A fiduciary duty is the 
strictest duty of care recognized by the U.S. legal system. (see 
https://www.law.cornell.edu/wex/fiduciary_duty)
    Although current sub-regulatory guidance already identifies the 
facilities responsibility for resident accounts as a fiduciary 
responsibility, we would strengthen this expectation by spelling it out 
in regulation. We believe that this addresses the commenters concern 
but allows for some flexibility in implementation. We defer additional 
specificity to sub-regulatory guidance.
    Comment: One commenter recommended stricter oversight of resident 
funds, including the use of auditors with an accounting background.
    Response: We have strengthened the requirements related to resident 
funds, as discussed in the previous response. Establishing requirements 
that facilities hire independent auditors to audit resident accounts is 
outside the scope of the current rulemaking, but we will keep this 
suggestion in mind for future occasions.
    Comment: Several commenters supported revisions to a resident's 
choice of roommate. One commenter strongly supported new language that 
states: ``The right to share a room with her or his roommate of choice 
when practicable, when both residents live in the same home and both 
residents consent to the arrangement,'' which could include same sex or 
opposite sex couples or individuals choosing to share a room.
    Response: We thank the commenter for their support. We agree that 
choice of roommate is significant to a resident's quality of life and 
an important aspect of treating a resident with respect and dignity.
    Comment: Some commenters objected to our proposed provision 
regarding choice of roommate. One commenter expressed concern that the 
right of one resident to have a roommate of choice could violate the 
rights of an existing roommate. Other commenters suggested that this 
meant that a resident who didn't want a roommate would have to be 
provided a private room.
    Response: Section 483.10(e)(5) states that the resident has 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. It does not require the provision 
of a private room. Furthermore, we have included the phrase ``when 
practicable'', as we realize that such arrangements may not always be 
possible, or may require some delay in order to accommodate. For 
example, such a move may require waiting until a room is available for 
both residents who want to be roommates to move into. We would not 
expect a facility to accommodate such a request when doing so would 
violate the rights of another resident.
    Comment: Some commenters recommended that we strengthen language 
related to involuntary changes in room or roommate. One requested that 
we better define notice. Another suggested that we qualify a resident's 
right to refuse a transfer to not apply when the resident's medical 
needs can't be met. Another commenter stated that the impact of moving 
residents against their will is well documented, and can lead to both 
psychosocial and physical harm and suggests that, given the potential 
risk of any move that is not the resident's choice, such moves should 
only be permitted for certain reasons and written notice should be 
provided within a set timeframe. The commenter noted that several 
states, including Connecticut, Colorado, Texas and Indiana, require 
written notice when the facility is proposing to move a resident. The 
commenter further stated that facilities should be required to prepare 
a resident for a transfer in the same way as required for a transferred 
or discharged. The commenter suggested that involuntary changes in room 
only be allowed if the transfer is necessary for medical reasons as 
determined by the attending physician; or the transfer is necessary for 
the welfare of the resident or other residents, and the resident must 
be given notice, including the name, address, and telephone number of 
the local and state long term care ombudsman and, if applicable, the 
mailing address and telephone number of the agency responsible for the 
protection and advocacy at least 5 business days before relocation. In 
addition, the commenter suggested that the facility be required to 
develop a relocation plan to orient and prepare the resident for the 
move, including taking the resident to see his or her new room and unit 
and meeting staff who will be assigned to him or her.
    Response: We agree that, absent extenuating circumstances, many of 
the commenters' suggestions make sense. Involuntary transfers should 
not be undertaken solely for the convenience of the staff. However, 
there are circumstances, generally involving safety, where advance 
notice and preparation may not be appropriate. Examples could include 
when one roommate is diagnosed with a communicable illness or when a 
move is necessary for the safety of either resident in a room, even if 
one of the roommates disagrees. We have revised Sec.  483.10(e)(6), to 
require written notice, including the reason for the change, and 
paragraph (e)(7), to give the resident the right to refuse a transfer 
that is made solely for the convenience of the staff. We will consider 
requirements for a specific timeframe and preparation for a room change 
for inclusion in future rule-making.
    Comment: One commenter requested that we clarify our use of the 
term ``eviction'' as opposed to ``discharge''.
    Response: The term ``eviction'' is used to reflect an involuntary 
discharge from a place of residence. To ``evict'' is to make a person 
leave a place (http://www.merriam-webster.com/dictionary/evict). Not 
all residents consider the LTC facility his or her place of residence, 
but for those who do, an involuntary discharge is equivalent to an 
eviction.
Self-Determination
    Comment: Some commenters were pleased to see that the proposed 
regulations include the resident's right to choose schedules. One 
commenter suggested we require that these choices are communicated to 
staff who are assigned using staffing practices that maximize staff's 
ability to fulfill the resident's choices and that we further state 
that residents must be able to choose from a range of activities that 
correspond to their interests. Other commenters expressed concern that 
they would be unable to accommodate every request every time and would 
be penalized as a result. Some commenters pointed out that these rights 
must be balanced with other residents' rights.
    Response: While we considered these suggestions, we will defer to 
interpretive guidance for more detailed discussion of how a facility 
can meet the requirement that residents have the right to choose 
activities and schedules.
    Comment: One commenter stated that, with regard to proposed Sec.  
483.10(e)(2), not all patients/residents are realistically able to 
participate in activities outside the facility. The commenter suggests 
that we amend this paragraph to by adding ``as appropriate based on the 
resident's functional capability.'' Other commenters suggest that 
residents should have free access both inside and outside of the 
facility.
    Response: Some residents may not, realistically, be able to 
participate in activities outside the facility. However, many may be 
able to do so, particularly

[[Page 68719]]

with family or other assistance or planning. The facility has a 
responsibility to promote and facilitate resident self-determination, 
rather than act as a hindrance or barrier. At the same time, we 
recognize that there may be safety and security concerns with 
unfettered access to outside spaces and in and out of the facility. 
These competing interests must be balanced, taking into consideration 
the needs and preferences of residents in the facility.
    Comment: One commenter stated that, with regard to proposed Sec.  
483.10(e)(5), not all facilities have family groups and in those 
centers that provide care for post-acute, short-stay patients, it is 
seldom that these individuals and their families have interest in 
participating in a family group. The commenter suggests we add the 
qualifier ``if any.''
    Response: There is no requirement for a facility to have a resident 
or family group if the residents or their representatives do not want 
one. However, if interest does exist, the facility should support the 
formation of such a group, as required by this section. Adding ``if 
available'' may imply that if such a group does not already exist, the 
right to participate does not exist. This is not accurate.
    Comment: One commenter is concerned that, as written, proposed 
Sec.  483.10(e) could be interpreted to require that a facility 
contract with any and all hospice providers, therapists/therapy 
companies, etc. and conflicts with the proposed Sec.  483.10(c) Choice 
of attending physician. The commenter recommends amending the provision 
by adding ``consistent with Sec.  483.10(c) and other relevant 
contracting requirements''
    Response: We considered the commenters concern and added ``and 
other applicable provisions of this Part'' to the provision.
    Comment: Some commenters were concerned that the residents' right 
to choose health care and providers of health care services consistent 
with their interests, assessments, and plan of care would require 
facilities contract with, utilize, or arrange for a health care 
subcontractor that had not previously been contracted with or approved 
by the facility. They were concerned that such entities might be on the 
OIG's list of excluded individuals or entities, might have failed 
background checks, or might be operating outside of their legally 
permissible scope of service. They also suggested that such entities 
might not be not properly licensed or insured, might not meet the 
quality standards of the facility, or could potentially create an 
unsafe situation for the resident. The commenters further contend that 
the facility must be able to control the expenses related to who 
provides services due to bundled payments.
    Response: Facilities cannot subcontract to health care entities 
that are on the OIG's list of excluded individuals or entities, and 
should not contract for any services with entities otherwise unsuitable 
for providing services. However, residents should not be required to 
accept services from providers to which they object, or entities that 
impose unreasonable charges on the resident's personal funds. We would 
expect facilities to work with residents to reach agreements.
    Comment: One organization stated that they support CMS's proposal 
``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.'' The commenter noted that client 
satisfaction is critical and expressed support for the resident-
centered concept of care. The commenter further stated that many of 
their members believe it is their duty to provide residents with 
everything they need during their stay and that members report that 
client satisfaction improves oral intake, nutritional status, quality 
of life and well-being and is likely to result in fewer 
hospitalizations. They suggested that comparable and reasonable 
substitutions, as determined by the registered dietitian, should be 
permitted. The commenter sought confirmation that the special food and 
meals purchased for a resident must be in alignment with a required 
specific diet order as a therapeutic diet in order for the items not to 
be charged to the resident. In addition, they request guidance as to 
whether facilities could require residents or their families to provide 
their own special supplements or functional foods if the facilities did 
not have them in their formularies.
    Response: Facilities are required to provide the services and 
activities to attain or maintain the highest practicable physical, 
mental, and psychosocial well-being of each resident in accordance with 
a written plan of care. If a special diet is included in a resident's 
plan of care, the facility is obligated to provide it. For situations 
in which special foods are requested without being part of the plan of 
care, we defer the matter to sub-regulatory guidance.
    Comment: Some commenters objected to the requirement that 
facilities convey the resident's funds and a final accounting of those 
funds to the resident or the resident's estate, within 30 days of 
death, eviction, or discharge. Commenters stated that this time frame 
is too short, that third-party payers do not pay the facility in a 
timely manner and that an accurate accounting is likely to take longer. 
Other commenters felt that the resident's funds should be returned more 
quickly.
    Response: The existing requirement for the final accounting and 
return of funds is already 30 days in the event of death, and no 
changes were proposed to this standard in the proposed rule. We are 
therefore retaining this standard as proposed.
Information and Communication
    Comment: One commenter stated that, since all facilities must 
convey their MDS data electronically, all facilities have Internet 
access and proposed language related to facility access and expense is 
not needed and could be used to deny residents electronic access. The 
commenter finds limits placed on resident access to electronic 
communication problematic. Other commenters objected to the burden of 
requiring an expanded electronic footprint.
    Response: We disagree that our requirement that facilities convey 
MDS data electronically means, consequently, that all facilities will 
have Internet access that can be made available to residents. Some 
facilities may utilize a vendor to submit MDS data and may not have 
onsite Internet access. Other facilities may have Internet access, but 
that access might not include capacity sufficient to accommodate 
expanded user access. We did not propose to require facilities to 
expand their Internet access. We are finalizing proposed Sec.  
483.11(e)(13) at Sec.  483.10(g)(7).
    Comment: Some commenters stated that, with regard to proposed Sec.  
483.10(h)(2), it is important that whatever Internet research is being 
done by residents is legal. For example, access to sites that promote 
child pornography or other illegal activities must be limited. 
Furthermore, providing absolute privacy for each resident wanting to 
use email and video communication may require advance planning. For 
example, if a facility has one room with several computer terminals 
available for residents' use, privacy may require a resident to 
schedule private use in advance, during which time no other resident 
may use a terminal in that room. The commenter suggested we revise the 
provision to read ``The resident has the right to have reasonable 
access to and privacy in their use of electronic communications such as 
email and video communications and

[[Page 68720]]

for Internet research. All such activities are limited to legal Web 
sites/activities as determined by state and federal laws. If absolute 
privacy is required, the facility may require advance scheduling of a 
computer to assure such privacy.'' Some commenters asked if the 
facility was required to ensure that communications were secure.
    Response: We agree that use of the Internet, or any form of 
communication, including the U.S. Postal service, must be in compliance 
with other legal limitations and restrictions relating to those devices 
or systems. We have added language to that effect at finalized Sec.  
483.10(g)(9)(iii). We acknowledge that for devices provided for the 
community, advance planning may be required. Further, one resident's 
use of video communications must not infringe upon the rights of other 
residents. These were considerations when we used the term ``reasonable 
access.''
    Comment: Several commenters were concerned that our proposal limits 
the type of information that residents can access, including their 
records. One commenter stated that CMS provides no rationale for 
restricting residents' access solely to medical records other than to 
conform the requirements to 45 CFR 164.524(c)(4) and stated that such 
justification is not sufficient. Some commenters recommended that CMS 
retain the current language. One commenter supported the expansion of 
accessibility to information by the resident (proposed Sec.  
483.11(e)), including the language stating ``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.'' The commenter supported the 
requirement that facilities provide residents with access to medical 
records in the form and format requested by the individual if they are 
readily producible, and if not, then in written form or in another form 
as agreed to by the individual and the facility. This requirement 
builds on the existing requirements that such information be made 
available within 24 hours, and upon oral and written request. 
Reflecting the reality that many nursing facility residents cannot 
access records electronically, the commenter appreciated that the 
proposed rule leaves the decision to the resident as to whether to 
access records electronically or in another ``readily producible'' 
format. One commenter suggested that retrieving electronic information 
in a format that is user friendly is actually more difficult than non-
electronic information. Another commenter was concerned that our 
proposal mandated that facilities be able to provide an electronic copy 
of the medical record. One commenter suggested that access to a 
person's own medical record should not be contingent on weekday 
staffing and recommends striking the parenthetical statement, 
``excluding weekends and holidays,'' as well as the requirement for 
inspection prior to purchase of the medical record. One commenter 
believed that CMS should clarify that a resident is entitled to his or 
her complete set of medical records, and proposed that the definition 
of ``medical records'' include all records concerning the resident 
during the period of time the resident was in the nursing facility's 
care. Without clarification, the commenter was concerned that nursing 
facilities may self-define what records it considers to be ``medical 
records'' for the purposes of responding to resident requests to the 
exclusion of records related to outside consultations, financial 
records, and other records that may be kept outside of the facility 
medical records. Allowing nursing facilities this degree of flexibility 
may undermine the resident's right to access his or her own records and 
allow a nursing facility to conceal any deficient care provided to the 
resident.
    Some commenters were concerned that 2 working days advance notice 
may not be adequate time depending upon the size of the records. One 
commenter stated that this should be 30 days, consistent with HIPAA. 
Other commenters suggested that there should be a definition of 
``working day.'' These commenters suggested we amend proposed Sec.  
483.10(f) (3)(ii) to read: ``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 
to 5 working days (working days defined as between 8 a.m. and 6 p.m., 
Monday through Friday) advance notice to the facility. Some commenters 
recommended that residents have access to their records 24 hours a day, 
7 days a week so that they can review records with family members at 
any time, including weekends and holidays.
    Response: We thank those commenters who supported our proposals. We 
agree that flexibility, contingent upon the resident's ability to 
access and understand the information, is important. It is not our 
intent to reduce a resident's access to information. Although sections 
1819(c)(1)(iv) and 1919(c)(1)(iv) of the Act only require access to 
current clinical records, we agree that it is important that LTC 
facility residents also have access to certain other records about 
themselves that may be held by a long-term care facility, such as their 
financial or social records. We have reviewed our proposals and 
expanded the language which we are finalizing at Sec.  483.10(g)(2) and 
at Sec.  483.10(h) to include both personal and medical records. We 
acknowledged in the proposed rule that we were proposing changes 
related to facilities providing access to and copies of medical records 
in order to ensure consistency with HIPAA. 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 HIPAA. Thus, aligning with 
other statutory requirements that apply to long-term care facilities 
was one aspect of updating the requirements for long-term care 
facilities.
    With regard to medical records, the resident has access to the 
medical record itself and the right to access a copy of that record, 
not a version of the medical record that has been revised to ensure the 
resident's understanding. Summaries of medical records are addressed by 
the privacy regulations at 45 CFR 164.524. We retain the access 
limitations related to weekends and holidays based on statutory 
requirements in section 1819(c)(1)(A)(iv) of the Act. We disagree that 
48 hours is not sufficient time to provide a copy of the resident's 
record. This is a long-standing standard and we did not propose to 
change the time frame. Further, for those facilities using electronic 
records, the electronic record may simplify the effort needed to print 
or create an electronic copy of the record, depending on the specific 
software system used by the facility. We do not mandate that facilities 
be able to provide an electronic copy of the medical record, unless the 
records are maintained in an electronic format and are readily 
producible in that format. We also agree that, while residents or their 
representatives may wish to do so, they should not be required to 
inspect a record prior to purchasing it. Therefore, we have removed 
this requirement at finalized Sec.  483.10(g)(2)(ii).
    With regard to our use of the term ``medical record'', please see 
our discussion of Sec.  483.70(i). As noted in that discussion, we 
regard the terms ``medical record'' and ``clinical record'' as 
synonymous. Section 1819(b)(6)(C) of the Act states that clinical 
records on all residents include the plans of care and

[[Page 68721]]

the residents' assessments. We further note that for ``covered 
entities'' as defined at 45 CFR 160.103, individuals have a right to 
access protected health information in a ``designated record set.'' A 
``designated record set'' is defined at 45 CFR 164.501 as a group of 
records maintained by or for a covered entity that comprises the 
medical records and billing records about individuals maintained by or 
for a covered health care provider; enrollment, payment, claims 
adjudication, and case or medical management record systems maintained 
by or for a health plan; or other records that are used, in whole or in 
part, by or for the covered entity to make decisions about individuals. 
The term ``record'' means any item, collection, or grouping of 
information that includes protected health information and is 
maintained, collected, used, or disseminated by or for a covered 
entity. Thus, individuals have a right to a broad array of health 
information about themselves maintained by or for covered entities, 
including: Medical records; billing and payment records; insurance 
information; clinical laboratory test results; medical images, such as 
X-rays; wellness and disease management program files; and clinical 
case notes; among other information used to make decisions about 
individuals. In responding to a request for access, a covered entity is 
not, however, required to create new information, such as explanatory 
materials or analyses that does not already exist in the designated 
record set. A ``designated record set'' under HIPAA is not synonymous 
with ``personal and medical records'' under these requirements. 
However, as noted earlier, 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 final rule, covered entities 
and business associates must comply with the requirements in HIPAA to 
ensure individuals are afforded these additional rights. As noted in a 
separate response under this section, we expect that most, if not all, 
long-term care facilities are covered entities who must comply with 
HIPAA.
    Comment: Some commenters thought that we were requiring facilities 
to provide electronic copies of medical records and expressed concern 
that this would require the purchase of new equipment and new staff to 
manage the task.
    Response: Proposed Sec.  483.10(f)(3)(i) specified that the 
resident would have a right to receive medical records in the form and 
format requested if the requested records are readily producible in 
such form and format. We are not requiring facilities to provide 
records in an electronic format if the record is not maintained or 
readily producible in an electronic format. We are finalizing this 
provision at Sec.  483.10(g)(2)(i).
    Comment: Several commenters object to our proposed standards for 
the fees that facilities may charge for these records. Some oppose the 
proposal to move from a community standard to a cost-based standard 
under which the fee may include the cost of labor for copying the 
requested health information, the supplies for creating the paper copy 
or electronic media, and postage, which could be abused and could 
inappropriately and unfairly impede a resident's access to his or her 
own health records. The commenter recommends, at a minimum, a limit on 
fees that can be charged, and to ensure that said fee includes any 
labor charges (research fees, clerical fees, handling fees or related 
costs). One commenter recommends the establishment of a ``hardship 
exemption'' for low-income residents, allowing them to receive copies 
of their records at no charge, perhaps upon providing an affidavit of 
inability to pay or otherwise demonstrating an inability to pay fees. 
Another commenter stated that there are a large number of residents who 
use Medicaid who are required to contribute most of their income to 
their care and are left with a small personal needs allowance, a 
minimum of $25 per month, who cannot afford these larger amounts to get 
copies of their records. The commenter suggests we restore the existing 
regulatory language and include parallel language as a resident's 
right. Commenters are concerned that the costs CMS proposes to allow, 
specifically labor costs, in this section create an opportunity for a 
nursing facility to create a financial burden and barrier to a 
resident's right to receive a copy of their own medical record. Some 
commenters recommend that facilities provide a copy of the medical 
record on an annual basis at no charge to the resident, and otherwise, 
costs should be limited to supplies and postage.
    Response: We thank the commenters for their concern. Prior to 
development of the proposed rule, we received input regarding the 
definition of ``community standard'' and concern about exorbitant 
charges for medical records. Commenters to the proposed rule have 
suggested the community standard be set at the amount charged by a 
local library, Post Office, or commercial copy center, or a set fee. We 
considered these options. However, the cost that providers who are 
subject to HIPAA (``covered entities'') may charge for medical records 
is established by the HIPAA Privacy Rule at 45 CFR 164.524(c)(4). Our 
proposal is consistent with that standard, which states that a facility 
may charge a reasonable, cost-based fee that can include only cost of 
copying, including supplies and labor, and postage, if the patient 
requests that the copy be mailed. The fee may not include costs 
associated with reviewing the request, searching for and retrieving the 
requested records, and segregating or otherwise preparing the record 
that is responsive to the request for copying. Given that long-term 
care facilities are generally likely to be subject to HIPAA and we 
require in Sec.  483.70 that facilities comply with other HHS 
regulations, we believe that our policy here should be consistent with 
the HIPAA Privacy rule at 45 CFR 164.524(c)(4). Therefore, we will 
finalize our proposal at Sec.  483.10(g)(2)(ii) without change. We 
again refer readers to recently released HHS guidance on individuals' 
right under HIPAA to access their health information http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/index.html).
    Comment: One commenter stated that they are pleased that CMS is 
proposing to require facilities to make reports related to surveys, 
certifications, complaint investigations, and plans of correction 
available for individuals to review, and to post a notice of this 
information's availability. Other information the commenter recommends 
be made available to residents includes:
     Results from independent resident/family caregiver 
experience surveys (resident and family)--such as the Consumer 
Assessment of Healthcare Providers and Systems (CAHPS) Nursing Home 
Surveys;
     Whether or not the facility provides special care services 
and if so, the kinds of services provided;
     Policies of the facility. For example, whether it has 
family groups, allows pets, etc.; and
     Information available in other languages, as appropriate.
    CMS may wish to consider, where appropriate, whether the existing 
standards that apply to medical records--that they be made available 
within 24 hours and upon oral and written request should be extended to 
the other types of information that are required to be made available 
under proposed Sec.  483.11(e).
    Response: We thank the commenter for their support. We considered 
but are not, at this time, expanding the information which must be 
provided to every resident. We note that facilities are required at 
finalized Sec.  483.10(g)(16)

[[Page 68722]]

to provide a notice of rights and services to the resident prior to or 
upon admission and are generally required at finalized Sec.  
483.10(g)(3) to ensure that information is provided in a form and 
manner that a resident can understand. As a result of comments 
concerned that our proposal limited the information about themselves 
that residents have access to, we have expanded our provisions relating 
to medical records to include personal records, to the extent 
applicable.
    Comment: One commenter requested that we clarify in the regulations 
that ``readily accessible'' means not having to ask a staff person for 
access in order to review survey reports or plans of correction. 
Another commenter stated that it was unreasonable to require the 
availability of 3 years of reports.
    Response: Section 1919(c)(8) of the Act requires that a nursing 
facility must post in a place readily accessible to residents, and 
family members and legal representatives of residents, the results of 
the most recent survey of the facility. This requirement is not 
premised upon a request. In contrast, section 1819(c)(1)(A)(ix) of the 
Act imposes this same requirement premised upon a ``reasonable 
request.'' We note that we generally deem all requests to be reasonable 
unless the requestor demands unreasonable deadlines or more information 
than is contained in the document. We have revised Sec.  483.10(g)(11) 
to reflect the stricter standard imposed by the statutory language in 
section 1919(c)(8) of the Act, which does not require a request. With 
regard to 3 years of survey, certification, complaint investigation 
reports, both sections 1819(d) and 1919(d) of the Act states that these 
must be available ``upon request.'' We have revised this language, with 
the addition of availability of any plan of correction in effect with 
respect to the facility, as we proposed, to better reflect the 
statutory requirements, including the requirements that the notice of 
availability of such reports are prominent and accessible to the public 
and shall not make available identifying information about complainants 
or residents.
    Comment: One commenter stated that providing every survey, 
certification, and complaint report available ``in a form 
understandable by residents'' is excessive and incomprehensively 
burdensome.
    Response: We understand that these reports are in specific formats 
and may be lengthy, and that an unaltered copy of the report is the 
expected document. Therefore, in finalized Sec.  483.10(g)(11) we have 
eliminated the phrase as recommended, as well as added these reports to 
the documents excepted from the requirement at finalized Sec.  
483.10(g)(3) that 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.
    Comment: One commenter supported many of the provisions in proposed 
Sec.  483.11(e)(7) requiring that facilities immediately notify the 
resident, consult with the resident's physician and notify the 
resident's representative when there is a change in the resident's 
condition, when treatment needs to be altered in a significant way, or 
when the resident is to be transferred or discharged. One commenter 
stated that physicians should be involved in managing significant 
injures, and that it is reasonable to allow facilities to notify 
physicians when the injury is significant enough to require a medical 
assessment and/or intervention. The commenter suggested that each 
facility have and use a protocol for physician notification and that 
the staff make a preliminary assessment and then monitor for delayed 
complications. Another commenter suggested that we add ``or change'' to 
the provision ``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).'' One commenter 
was concerned that this requirement must be consistent with resident 
representative state law, or the authority granted by the court in 
instances of a resident who has been adjudged incompetent, or the 
authority granted to the individual with the durable power of attorney 
and another was concerned about the number of notifications that could 
be required. Another commenter was concerned that the term 
``immediately'' was not defined and an expectation on the part of CMS 
that multiple individuals be notified simultaneously is unreasonable.
    Response: We thank the commenters for their support. As suggested, 
we have added ``or change'' to the parenthetical in finalized Sec.  
483.10(g)(14)(i)(C). We believe that a protocol, as suggested by the 
commenter, could be consistent with our proposal. As written, the 
requirement is that a facility immediately inform the physician when 
there is an accident that involves injury that has the potential to 
require the physician's intervention. A protocol, as suggested, would 
be a useful tool to help a facility objectively and consistently 
determine when an injury has the potential to require physician 
intervention. We noted in the preamble to the proposed rule that 
effective communication among caregivers is helpful in improving 
outcomes and quality of care. In addition, with have added ``consistent 
with his or her authority'' in reference to notifying a resident 
representative. With regard to the term ``immediately,'' we note that 
this requirement is not new. We would expect facilities to make such 
notifications without delay, and, in the case of a resident's death, in 
accordance with state law.
    Comment: A commenter supports proposed changes to information that 
must be provided to residents, but states that there are differences 
between proposed Sec.  483.10 and proposed Sec.  483.11 and recommends 
that we add `exploitation' consistent with the incorporation of this 
concept in other areas addressing abuse and neglect.
    Response: In response to other comments we have combined Sec.  
483.10 and Sec.  483.11. The information in question is now located in 
Sec.  483.10(g)(4). We have also incorporated `exploitation' into that 
provision, as suggested. Information includes both information that 
must be included in the written description of legal rights and other 
information of importance to the resident. For example, the written 
description of legal rights must include a statement that the resident 
may file a complaint with the State Survey Agency concerning any 
suspected violation of state or federal nursing facility regulations, 
including but not limited to resident abuse, neglect, exploitation, 
misappropriation of resident property in the facility, non-compliance 
with the advance directives requirements and requests for information 
regarding returning to the community. In addition, the resident has a 
right to receive, information and contact information for filing 
grievances or complaints and the facility must post similar 
information, in a form and manner accessible and understandable to 
residents, and resident representatives.
    Comment: One commenter notes that the term ``support person'' is 
not defined and appears nowhere else in the proposed regulations.
    Response: A patient's ``support person'' does not necessarily have 
to be the resident's representative who is legally responsible for 
making medical decisions on the resident's behalf. A support person 
could be a family member, friend, or other individual who is there to 
support the resident during the course of the stay. We refer readers to 
our discussion of the meaning of

[[Page 68723]]

``support person'' in the preamble to the final rule, ``Medicare and 
Medicaid Programs: Changes to the Hospital and Critical Access Hospital 
Conditions of Participation To Ensure Visitation Rights for All 
Patients'' (75 FR 70833, November 19, 2010).
    Comment: Commenters recommended that the prohibition regarding 
admission contracts conflicting with regulatory requirements apply to 
all admission contracts, whether required by the facility or not.
    Response: We agree and have modified final Sec.  483.10(g)(18)(v) 
to refer to all admission contracts. We emphasize that no language in a 
contract may permissibly require LTC facility residents or prospective 
residents to waive any of the rights set out in this provision, and 
that review of admissions contacts may be part of our facility surveys.
    Comment: One commenter recommended that we require the facility to 
post a list of the names, titles, dates of service and addresses 
(mailing and email), and telephone number of the members of the 
facility's governing body, the administrator, and the director of 
nursing, stating that this would implement section 6106 of the 
Affordable Care Act.
    Response: We thank the commenter for their suggestion. Section 6106 
of the ACA added section 1128I(g) to the Act, Affordable Care Act. 
Section 1128I(g) pertains to the submission of staffing data by LTC 
facilities, and specifies that the Secretary, after consulting with 
certain stakeholders, require a facility to electronically submit to 
the Secretary direct care staffing information based on payroll and 
other verifiable and auditable data in a uniform format according to 
specifications established by the Secretary in consultation with such 
programs, groups, and parties. CMS finalized requirements implementing 
section 6106 of the ACA on August 4, 2015 in the final rule ``Medicare 
Program; 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'' (80 FR 46390). That rule added a new Sec.  483.75(u) 
``Mandatory submission of staffing information based on payroll data in 
a uniform format''. Section 6106 of the ACA does not include reporting 
requirements for management/ownership information.
Privacy and Confidentiality
    Comment: Some commenters support our proposed changes to this 
section.
    Response: We thank the commenters for their support. This section 
now includes language accommodating electronic communications, among 
other changes. We believe this changes are important in updating the 
requirements of participation for long-term care facilities.
    Comment: One commenter recommended that CMS limit representatives 
of the Office of the State Long-Term Care Ombudsman access to resident 
records based on requirements established at 45 CFR 1327.11.
    Response: We thank the comment for their suggestion. We note that 
the Administration for Community Living (ACL) published a final rule 
amending its regulations to reflect the creation of ACL in 2012 and 
consolidate all of its regulations under a single subchapter (see 81 FR 
35645, 35646, June 3, 2016). As a result, the regulations that the 
commenter referred to are now found at 45 CFR 1324.11. We have reviewed 
the language at 45 CFR 1324.11(e)(2), which sets forth requirements for 
the State Long-Term Care Ombudsman or the State agency to establish 
policies and procedures for timely access to facilities, residents, and 
appropriate records. Proposed Sec.  483.10(f)(2) does not conflict with 
the requirements at 45 CFR 1324.11(e)(2) and reflects the statutory 
language found in sections 1819(c)(3)(C) and 1919(c)(3)(C) of the Act. 
Therefore, proposed Sec.  483.10(f)(2) is finalized at Sec.  
483.10(h)(3)(ii) without change.
Safe Environment
    Comment: Some commenters supported our proposed changes to this 
section.
    Response: We thank the commenters for their support.
    Comment: With respect to the resident's right to a safe, clean, 
comfortable, homelike, environment, one commenter recommended amending 
the requirement to state that the resident has a right to an equitable 
balance of a safe, clean, comfortable, homelike environment, and a 
right to receive treatment safely, as no one right should outweigh nor 
compromise another right. Some commenters felt that we should use 
language more reflective of the fact that the long-term care facility 
is home for many residents. Some commenters recommended avoiding 
institutional language and changing ``. . . homelike'' environment to 
``. . . home''
    Response: We thank the commenters for their suggestions. As noted 
in the preamble to the proposed rule, long-term care facilities are 
likely to serve multiple populations. Throughout this rule, CMS has 
tried to maintain an appropriate balance reflecting these multiple 
populations. While for many residents, the LTC facility is a home and 
we have striven to make sure this fact is reflected in the regulations, 
for others, the LTC facility is a temporary stay as they regain the 
physical capacity to return to their home. Both of these populations 
deserve high quality care in a safe, clean, comfortable, and homelike 
environment. We agree that no single right outweighs another right and 
sometimes this requires balance; however, we believe that residents can 
and should live in a safe, clean, comfortable, and homelike environment 
that is also provides safe treatment.
    Comment: Some commenters expressed concern that residents could 
receive contraband or harmful items through the mail and wanted to know 
what rights the facility has with regard to monitoring for such items.
    Response: The right of residents to receive unopened mail is not 
new. We would expect facilities to already be in compliance with this 
requirement and have processes in place to address situations where 
resident rights and resident safety are of concern.
    Comment: One commenter requested that we clarify under ``safe 
environment'' that the physical layout of the facility should maximize 
resident independence.
    Response: We thank the commenter for their suggestion and have 
revised the requirement, finalized at Sec.  483.10(i)(1)(i) to include 
``resident independence.''
    Comment: One commenter agreed that facility temperatures should not 
be extreme, but suggested that CMS add a qualifier to the regulations 
that would require Medicare and Medicaid-participating facilities to 
adjust temperatures in different areas of the facility based on 
resident needs and comfort and/or scientific evidence.
    Response: We thank the commenter for their suggestion. We would 
expect facilities to make adjustments, as suggested, within the 
permissible range of 71 to 81 degrees Fahrenheit. We note that this is 
a long-standing requirement on which we received very few comments. We 
would want to seek specific public input on a specific proposal to 
change this requirement before making such a change.
Grievances
    Comment: Some commenters supported our proposals related to 
grievances. One commenter commended CMS for significantly enhancing 
residents' rights to voice grievances, stating that this emphasizes the 
importance and seriousness of resident concerns. Another commenter 
stated

[[Page 68724]]

that the ability to make a grievance and to have it taken seriously by 
the facility is an important right and protection for residents. One 
commenter was pleased to see that facilities must create a grievance 
policy and appoint a grievance official. Another commenter stated that 
they are pleased to see that this right has been expanded to give 
residents the right to voice grievances without fear of discrimination 
or reprisal. One commenter was pleased to see that CMS is proposing 
that grievances be investigated and written decisions issued to 
residents and urges CMS to include this information about grievances in 
the Resident's Rights section as well. Another commenter was pleased 
that CMS proposed that the official issue written grievance decisions, 
and supports the proposed content of the decisions. One commenter 
stated that it is very helpful to have a person specifically tasked 
with handling grievances from beginning to end who is required to take 
immediate action to prevent further potential violations, although this 
should include any violations of state and federal requirements, not 
just resident rights.
    Some commenters recommended revisions to our proposal. Some 
suggested we establish timeframes for resolution. One commenter 
recommended that CMS delete all language from proposed Sec.  483.11(h) 
regarding the grievance policy and incorporate the policy requirements 
into Sec.  483.75, QAPI. Some commenters objected to the requirement 
for a grievance official, stating this this is unnecessary and 
burdensome. One commenter suggested that designating one individual 
could hinder timely resolution.
    Some commenters were concerned about the scope of actionable 
grievances. Some commenters feel we have limited the scope of 
grievances. One commenter stated that the proposed rules omits current 
language ``including those with respect to the behavior of other 
residents'' from resident rights, noting it is included in proposed 
Sec.  483.11(h)(2) and recommends that CMS restore the full language of 
Sec.  483.10(f)(2).'' Other commenters suggested that we broaden the 
scope of actionable grievances. One commenter is concerned that the 
proposed language does not state that the resident can file grievances 
with the State Survey Agency and another recommends we add adult 
protective services to the list of independent entities with which 
grievances may be filed. Some commenters recommended that the 
subsection be revised to require that facilities make information on 
how to file a grievance available to the resident upon admission and 
upon request and also give a copy of the grievance policy to every 
resident. Some commenters suggested that there are other formats more 
useful to a resident than a copy of the policy, such as a question and 
answer document. One commenter suggested that the grievance official 
should be responsible for protecting the complainant from retaliation, 
since many residents will not speak up because they fear reprisal. One 
commenter recommended that residents be given the room number in the 
facility if the official is housed within the facility and a toll free 
number if not, and be provided with information about where they can 
turn within the facility organization if they are not satisfied with 
the decision. The commenter also suggested that CMS require that the 
grievance decision be provided to each resident in a form and manner 
the resident can access and understand and that the grievance official 
take corrective action in conjunction with the administrator and other 
appropriate staff. One commenter suggested that the grievance policy 
include the establishment of a grievance committee that would consist, 
at a minimum, of the administrator of the facility or his or her 
designee, a resident selected by the resident population of the 
facility, the facility social worker, and the grievance official. The 
commenter further suggested that the work of the grievance official 
would be reviewed by the full committee so he or she is not operating 
in a vacuum and there would be resident involvement in the process.
    Some commenters were concerned about maintaining evidence related 
to grievances for 3 years and felt that creating and maintaining such 
files would be burdensome. Others were concerned about the potential 
for these requirements to negatively influence surveyors and asked if 
every complaint would be deemed a grievance. Another commenter 
suggested that we specifically require that facilities maintain all 
investigative documentation related to the grievance for three years. 
This commenter also suggested that, with regard to reporting, we 
reference federal law. Several commenters offered other specific 
recommendations for regulatory language.
    Response: We thank commenters for their support and their 
suggestions. We agree that resident concerns should be taken seriously 
and that the ability to voice a grievance is an important right and 
protection for residents. The timeframes required to resolve a 
grievance may depend largely on the issue associated with the grievance 
and other situation-specific factors. We are not, at this time, 
requiring prescriptive timeframes, and defer to guidance to suggest 
what constitutes timely. The purpose of requiring the facility to have 
a grievance official is to ensure that there is an individual who has 
both the responsibility and authority for ensuring, through direct 
action or coordination with others, that grievances are appropriately 
managed and resolved. This person would be a resource for residents, 
staff, and oversight entities. We expect that most facilities already 
have a person or persons who serve this function, if not with the 
specific title, and that the work of a grievance official would be 
coordinated with the LTC facility administrator and the director of 
nursing. It is not our expectation that every facility hire a new, 
full-time individual to perform this function, but, instead, that every 
facility have a designated individual to serve this function, 
consistent with the needs of that facility. We do not agree that this 
would hinder timely resolution of grievances.
    Evidence demonstrating the results of all grievances for a period 
of no less than 3 years provides a record of this work and can serve as 
a valuable information resource for facilities. However, we do not 
agree it is necessary to explicitly require that all investigation 
documentation be retained for 3 years. Further, such evidence may be 
maintained electronically, rather than utilizing physical storage 
space. We defer additional specificity to sub-regulatory guidance.
    Grievances may provide valuable input to a facilities QAPI program. 
In fact, grievances are one likely source of data and feedback from 
residents and resident representatives; however, we do not believe that 
addressing grievances should be relegated solely to the QAPI program. 
Depending on the size of the facility and the number or grievances 
received, duties associated with grievances may only consume a small 
portion of the individual's time. In very large facilities, or in 
facilities with many grievances, more time may be required. Either way, 
we maintain that it is important that all facilities have a designated 
point of contact for grievances. While we agree that a grievance 
official cannot and should not resolve grievances in a vacuum, we are 
concerned that a grievance committee is not feasible for every 
facility, and therefore are not requiring such a committee at this 
time.
    With regard to the scope of grievances, we have revised our

[[Page 68725]]

proposed requirement, finalizing it at Sec.  483.10(j), to state that 
grievances include those with respect to care and treatment which has 
been furnished as well as that which has not been furnished, the 
behavior of staff and of other residents; and other concerns regarding 
their LTC facility stay. We will finalize proposed requirements 
regarding notifying resident individually or through postings in 
prominent locations throughout the facility of the right to file 
grievances orally (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. We also 
finalize the requirement to provide a copy of the grievance policy to 
the resident upon request. We agree that other formats may be useful to 
the resident and could be used to provide information on how to file a 
grievance available to the resident, but if the resident requests a 
copy of the facility policy, it must be provided. The facility is 
required, at final Sec.  483.10(g)(16) to provide a notice of rights 
and services to the resident prior to or upon admission and during the 
resident's stay; this includes the right to file a grievance. We have 
added ``federal'' to Sec.  483.10(j)((4)(iv) so that it reads 
``immediately reporting all alleged violations involving neglect, 
abuse, including injuries of unknown source, and/or misappropriate of 
resident property, by anyone furnishing services on behalf of the 
provider; and as required by federal or state law.'' Requirements for 
reporting suspicion of a crime are separately addressed in Sec.  
483.12(b). We defer additional detailed information relating to 
grievances to sub-regulatory guidance.
Contact With External Entity
    Comment: One commenter felt that the requirement stating that 
facilities must not prohibit or discourage a resident from 
communicating with state and federal representatives was unnecessary.
    Response: We disagree. It is imperative that residents and their 
representatives feel free to discuss concerns, particularly safety and 
quality of care concerns, with representatives of the state and federal 
government, surveyors, ombudsmen, and representatives of the protection 
and advocacy system.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We have consolidated proposed Sec.  483.10 and proposed 
Sec.  483.11 into a single section, Sec.  483.10, ``Resident rights'' 
and removed or updated all cross-references as appropriate.
     We have replaced the term ``verbal'' with ``oral'' 
throughout this section.
     Introductory language from proposed Sec.  483.10 and 
proposed Sec.  482.11, as well as proposed Sec.  483.11(a)(2) are now 
finalized in Sec.  483.10(a) ``Resident rights.''
     Proposed Sec.  483.10(a)(1) through (5), and proposed 
Sec.  483.11(a)(1), and (a)(3) through (5) have been consolidated into 
final Sec.  483.10(b), ``Exercise of rights.''
     We have revised proposed Sec.  483.10(a)(3), finalizing it 
at Sec.  483.10(b)(3) and incorporating previously existing language 
clarifying that the provision applies to residents who have not been 
adjudged incompetent by a state court.
     We have revised language from proposed Sec.  483.11(a)(4), 
as consolidated in finalized Sec.  483.10(b)(7)(i), to clarify that, in 
the case of a limited guardianship, a facility does not defer all 
decision making to a guardian, when a court's determination does not 
require it.
     We have consolidated proposed Sec.  483.10(b) and proposed 
Sec.  483.11(b) into Sec.  483.10(c), ``Planning and implementing 
care.''
     We have changed the term ``disciplines'' in proposed Sec.  
483.10(b)(2) to ``the type of care giver or professional,'' finalizing 
it at Sec.  483.10(c)(4).
     We have revised proposed Sec.  483.10(b)(5)(v) to state 
``the right to sign after significant changes to the plan of care,'' 
finalizing it at Sec.  483.10(c)(2)(v).
     We have clarified in Sec.  483.10(c)(5) that the physician 
or other practitioner or professional informs the resident of the risks 
and benefits of proposed care, of treatment and treatment alternatives 
or treatment options.
     We have consolidated Sec.  483.10(b)(6) and Sec.  
483.11(b)(2), finalizing these requirements at Sec.  483.10(c)(7) which 
now states ``The right to self-administer medications if the 
interdisciplinary team, as defined by Sec.  483.21(b)(2)(ii), has 
determined that this practice is clinically appropriate.''
     We have withdrawn proposed Sec.  483.10(c)(2) to require 
that physician's meet facility credentialing requirements and 
consolidated proposed Sec.  483.10(c)(1) and (3), and proposed Sec.  
483.11(c)(1) through (3), finalizing these provisions at Sec.  
483.10(d).
     We have re-designated proposed Sec.  483.10(d) at Sec.  
483.10(e), revised finalized paragraph (e)(6) to specify that the 
resident has a right to receive written notice, including the reason 
for the change when the resident's room or roommate in the facility is 
change and added a new, final (e)(7)(iii) to clarify that a room change 
cannot be solely for the convenience of staff.
     We have consolidated proposed Sec.  483.10(e) and proposed 
Sec.  483.11(d), finalizing these provisions at Sec.  483.10(f), Self-
determination.
     We have added ``and other applicable provisions of this 
Part'' to proposed Sec.  483.10(e)(1) and finalize this provision at 
Sec.  483.10(f)(1).
     We have consolidated proposed Sec.  483.10(e)(3) and 
proposed Sec.  483.11(d)(1), finalizing these provisions at Sec.  
483.10(f)(4), and clarifying that: (1) The resident's right to deny 
visitation is ``when applicable;'' (2) a facility must have written 
policies and procedures for visitation that includes restrictions, when 
such limitation may apply consistent with the requirements of this 
subpart, that the facility may need to place on such rights and the 
reasons for the clinical or safety restriction or limitation; and (3) 
the facility must inform each resident not only of any limitation, but 
also to whom the restrictions apply.
     We have added a new Sec.  483.10(f)(5)(i) to specify that 
a facility must take reasonable steps, with the approval of the group, 
to make residents and family members aware of upcoming meetings in a 
timely manner.
     We have added ``or other guests'' to the list of 
individuals who may only attend a resident or family group meeting at 
the group's invitation at finalized Sec.  483.10(f)(5)(ii).
     We have consolidated proposed Sec.  483.10(e)(8) and 
proposed Sec.  483.11(d)(4) into finalized Sec.  483.10(f)(9).
     We have consolidated proposed Sec.  483.10(e)(9) and 
proposed Sec.  483.11(d)(5) into finalized Sec.  483.10(f)(10).
     We have changed ``may'' to ``must'' in finalized Sec.  
483.10(f)(11)(i).
     We have changed ``health care provider'' to ``physician, 
physician assistant, nurse practitioner, or clinical nurse specialist'' 
in finalized Sec.  483.10(f)(11)(ii)(L)(1).

[[Page 68726]]

     We have consolidated proposed Sec.  483.10(f) and (h) and 
proposed Sec.  483.11(e) into finalized Sec.  483.10(g).
     We revised proposed Sec.  483.10(f)(3) to include both 
personal and medical records and finalized it at Sec.  483.10(g)(2).
     We revised proposed Sec.  483.10(g)(3)(ii) to remove the 
requirement that a resident must inspect a medical record prior to 
requesting to purchase a copy and finalized it at Sec.  
483.10(g)(2)(ii).
     We updated the cross-reference to Sec.  483.11(e)(2) in 
proposed Sec.  483.11(e)(1), to cross-reference Sec.  483.10(g)(2) and 
(g)(11) to reflect that we do not require facilities to translate or 
summarize personal and medical records and survey reports. Proposed 
Sec.  483.11(e)(1) is finalized at Sec.  483.10(g)(3).
     We added ``State Survey Agency'' to proposed Sec.  
483.10(f)(2), finalized Sec.  483.10(g)(4)(ii), and added ``any 
suspected violation of state or federal nursing facility regulations'' 
to proposed Sec.  483.10(f)(2)(vi), finalized at (g)(4)(vi).
     We added ``requests for information regarding returning to 
the community'' to proposed Sec.  483.11(e)(4), finalized at Sec.  
483.10(g)(5)(ii).
     We require at finalized Sec.  483.10(g)(9)(iii) that 
electronic communications under this section must comply with state and 
federal law.
     We have revised proposed Sec.  483.11(e)(3), finalized at 
Sec.  483.10(g)(11), to reflect the stricter standard imposed by the 
section 1919(c)(8) of the Act, statutory language and to better reflect 
both sections 1819(d) and 1919(d) of the Act, retaining the addition of 
availability of any plan of correction in effect with respect to 
facility, as proposed, and including the requirements that the notice 
of availability of such reports are prominent and accessible to the 
public and shall not make available identifying information about 
complainants or residents.
     We have revised proposed Sec.  483.11(e)(11)(v), finalized 
at Sec.  483.10(g)(18)(v), to specify that any admission contract, 
whether the facility requires it or not, must not conflict with the 
requirements of these regulations.
     We have consolidated proposed Sec.  483.10(g) and proposed 
Sec.  483.11(f), finalized at Sec.  483.10(h), consolidating 
duplicative language in proposed Sec.  483.10(g)(2) and proposed Sec.  
483.11(f)(1)(ii) at finalized Sec.  483.10(h)(1), consolidating 
proposed Sec.  483.11(f)(1) and (f)(1)(i), finalized at Sec.  
483.10(h)(2), and deleting proposed Sec.  483.11(f)(2) as an 
unnecessary cross-reference.
     We have consolidated proposed Sec.  483.10(i) and proposed 
Sec.  483.11(g), ``Safe environment'', finalized at Sec.  483.10(i).
     We have added a new Sec.  483.10(i)(1)(ii) to require that 
the facility exercise reasonable care for the protection of the 
resident's property from loss or theft.
     We have consolidated proposed Sec.  483.10(j) and proposed 
Sec.  483.11(h), ``Grievances'' at finalized Sec.  483.10(j).
     We have revised proposed Sec.  483.10(j)(1) by adding 
``the behavior of staff and of other residents; and other concerns 
regarding their LTC facility stay'' to the statement regarding what 
grievances may include.
     We finalize, as proposed, Sec.  483.11(i) at Sec.  
483.10(k).

G. Freedom From Abuse, Neglect, and Exploitation (Sec.  483.12)

    Currently, Sec.  483.13 is titled ``Resident Behavior and Facility 
Practices.'' We proposed 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.
    Currently, paragraph Sec.  483.13(a) addresses the use of 
restraints. We proposed 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 maintained 
the prohibition of the inappropriate use of restraints. We proposed to 
further address restraints in proposed section Sec.  483.25(d)(1) on 
Quality of Care and Quality of Life.
    We proposed that existing paragraph Sec.  483.13(b) also be 
included in the new introductory paragraph to revised Sec.  483.12. We 
proposed 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.
    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 proposed 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.
    We proposed 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 proposed 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 proposed to add a new Sec.  
483.12(b)(3) to require that the policies and procedures include 
training as required by proposed Sec.  483.95. Finally, we proposed 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 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 section 
1150B(a)(3) of the Act, includes notification of that individual's 
obligation, as specified at section 1150B(b)(1) of the Act, 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 section 1150B(b)(2) of the Act, the reporting required 
by 1150B(b)(1) must occur immediately, but 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.
    We proposed 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 proposed to add the term ``exploitation'' in 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

[[Page 68727]]

language would be unchanged from Sec.  483.12(c)(2). We proposed 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.
    Comment: One commenter expressed concern that we had moved Sec.  
483.13 into Sec.  483.10, ``Resident rights,'' stating that downplayed 
the seriousness of alleged or confirmed acts of abuse neglect, 
misappropriation or mistreatment of residents by staff, visitors, 
family and other residents. The commenter suggested that it should 
remain its own section.
    Response: The provisions of Sec.  483.13 are maintained, with 
revision, in proposed Sec.  483.12, under a new title ``Freedom from 
abuse, neglect and exploitation.'' We believed this new title 
highlights, rather than downplays, the need to ensure that residents of 
long-term care facilities are free from to abuse, neglect, or 
exploitation.
    Comment: One commenter is concerned that CMS did not address the 
use of resident alarms (bed alarms, tabs alarms, etc.) in the section 
addressing restraints. The commenter supports CMS including language to 
eliminate the use of resident alarms in light of the absence of any 
documented evidence that alarms are effective in reducing resident 
falls. In fact, alarms are often used to in place of facility staff to 
ensure that residents are provided with adequate care and supervision.
    Response: We did not address the use of alarms in the proposed rule 
and would seek additional input prior to considering banning or 
specifically regulating the use of alarms. We would expect the use of a 
position alarm to be addressed in a resident's comprehensive care plan. 
If an alarm is used as a restraint, it is subject to our provisions 
relating to restraints. We understand that some alarms may have a 
limited use for diagnostic purposes and a useful role in the assessment 
process, as facility staff are learning about an individual. In 
addition, we recognize that there is a clear distinction between 
position change alarms and door alarms. We will continue to evaluate 
this issue, address it in sub-regulatory guidance, and consider it for 
future rule-making.
    Comment: A number of commenters supported the addition of this 
section to emphasize the protection of residents from abuse, neglect 
and exploitation. Commenters specifically appreciated the reference to 
chemical and physical restraints, and the inclusion of language that 
complies with the Affordable Care Act regarding the reporting of 
crimes. Some commenters also stated that they supported the inclusion 
of violations in this section in the definition of ``substandard 
quality of care.''
    Response: We thank the commenters for their support. Ensuring that 
residents of long-term care facilities are protected is an important 
purpose of these requirements.
    Comment: One commenter suggested that we add ``exploitation'' to 
paragraphs (a)(2)(i) and (a)(2)(ii).
    Response: Thank you. We have added ``exploitation'' to proposed 
paragraphs (a)(2)(i), (ii), and (iii), as finalized at Sec.  
483.12(a)(3)(i), (ii), and (iii), since we believe that the comment was 
intended to apply to all the situations described in what we have now 
re-designated as Sec.  483.12(a)(3).
    Comment: One commenter urges CMS to carefully describe the 
consequences for violations of the proposed provisions relating to 
prohibiting certain hiring and urged that they be implemented 
consistent with the HHS Office of Inspector General's statutory 
provision related to hiring or retaining people who have been excluded 
from participating in federally funded health care programs, including 
but not limited to civil monetary penalties. By increasing the severity 
of adverse consequences for hiring staff that could potentially harm 
residents, CMS will properly encourage facilities' compliance with 
these requirements.
    Response: Enforcement is outside the scope of these regulations. We 
will take this matter under consideration and share this suggestion 
with the HHS OIG.
    Comment: Some commenters supported our proposed revisions at Sec.  
483.12(a)(2) to prohibit facilities not only from employing certain 
individuals, but also from engaging these individuals through other 
mechanisms and for expanding the prohibition on employment to 
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 or mistreatment of residents or misappropriation of 
resident property. Some commenters expressed concern about the impact 
of (a)(2) on volunteers and one commenter asked we clarify its 
application to volunteers or to employees of contracted services such 
as when a facility hires a contractor to perform renovations. One 
commenter strongly recommended that subsections (a)(2)(ii) and 
(a)(2)(iii) be broadened to apply to abuse, neglect, exploitation, or 
misappropriation of property of any persons serving as nurse aides or 
other direct care workers and that this requirement be expanded to 
include all staff employed by the LTC facility.
    Response: We thank the commenters for their suggestions and 
support. Our primary concern is to protect the health and safety of 
residents. We are not, at this time, requiring criminal background 
checks on volunteers, but would expect facilities to exercise 
reasonable care consistent with the volunteers' expected roles and not 
knowingly engage volunteers who have been found guilty of abuse, 
neglect, exploitation, misappropriation of property, or mistreatment by 
a court of law. With regard to the employees of contractors such as 
those performing renovations, who would not be providing care to or 
interacting directly with residents, we would expect the facility to 
exercise reasonable care in selecting the contractor. We defer 
additional discussion to subregulatory guidance. We are not further 
expanding the prohibition at this time, but will evaluate the issue and 
consider it for future rule-making.
    Comment: Some commenters expressed concern that these employment 
prohibitions could involve the application of long-resolved findings 
against a person. A potential employee might be able to demonstrate 
extenuating circumstances or rehabilitation after time has passed. The 
commenters noted that these prohibitions could disqualify a person for 
life, even if the previous findings were unrelated to their care of LTC 
facility patients. One commenter asked if the regulations can address a 
process by which nurse aides and licensed personnel can show successful 
rehabilitation and be eligible to work in an LTC setting again. Another 
suggested that it would be appropriate to look at the circumstances and 
details of each situation, and not exclude all individuals, as 
proposed. One commenter suggested that the prohibition on employment be 
based only on felony convictions related to care or services for an 
individual. Another commenter suggested that CMS consider issuing 
guidance that would urge states to extend the due process requirements 
that govern the National Background Check Program, including those 
requiring an independent process for appealing or disputing the 
accuracy of the information obtained, and for consideration of the 
passage of time, extenuating circumstances, demonstration of 
rehabilitation, and relevancy of the particular disqualifying 
information with respect to the current employment of the individual.

[[Page 68728]]

    Response: In response to these comments, we have modified proposed 
Sec.  483.12(a)(2)(iii) relating to licensed personnel to prohibit 
employment based on disciplinary action for those actions currently in 
effect, which we will finalize as Sec.  483.12(a)(3)(iii). This 
provision, as finalized, will prohibit facilities from employing 
certain individuals who have a disciplinary action in effect against a 
professional license. We believe that this provides facilities some 
flexibility to exercise discretion with regard to previous disciplinary 
actions. Where a facility is aware of previous disciplinary actions 
against a professional license, but those actions have been resolved, 
the facility makes their own hiring decisions based on the specific 
nature and circumstances of those previous disciplinary actions and in 
keeping with their responsibility to protect the health and safety of 
residents.
    Proposed Sec.  483.12(a)(2)(i) and (ii), which we will finalize as 
Sec.  483.12(a)(3)(i) and (ii), prohibit facilities from employing or 
otherwise engaging individuals who have been found guilty of abusing, 
neglecting or mistreating residents by a court of law, or who have had 
a finding entered into the State nurse aide registry concerning abuse, 
neglect, mistreatment of residents or misappropriation of their 
property. We believe additional consideration and research is necessary 
before we propose to further modify these provisions. Any additional 
changes would be proposed in future rule-making.
    With regard to the suggestion that CMS consider issuing guidance 
that would urge states to extend the due process requirements that 
govern the National Background Check Program, including those requiring 
an independent process for appealing or disputing the accuracy of the 
information obtained, and for consideration of the passage of time, 
extenuating circumstances, demonstration of rehabilitation, and 
relevancy of the particular disqualifying information with respect to 
the current employment of the individual, we will consider this for 
future action.
    Comment: One commenter stated that, without a centralized registry 
for actions against an individual's state licensure, it is impossible 
for a facility to check with all 50 states for disciplinary action 
against a professional license. One commenter recommended we delete the 
language at Sec.  483.12(a)(2)(iii). Another stated that without a 
centralized registry, it was unreasonable to expect a facility to check 
for disciplinary action against a professional license and raised the 
question of what would constitute a disciplinary action. The commenter 
further stated that his state does not indicate when disciplinary 
action has been taken against an individual.
    Response: We agree that a facility is not expected to query 50 
states for information on each licensed individual. We would expect the 
facility to check with the state in which the facility is located and 
care is delivered and potentially bordering states or other states that 
the individual is known to have been licensed in, based on the 
individuals resume or other employment information available to the 
facility. We checked the Web site for state nursing board for the state 
mentioned and found that it does indicate the status of the license 
(active, revoked, probation, etc.). We would expect facilities to 
exercise reasonable efforts to determine if a state licensing board has 
taken disciplinary action against a professional license, based on the 
licensing board's definition of disciplinary action. We have revised 
the provision to state ``. . . a disciplinary action in effect against 
his or her professional license by a state licensure body as a result 
of a finding of abuse, neglect, mistreatment of residents or 
misappropriation of resident property.'' We defer additional discussion 
the sub-regulatory guidance.
    Comment: One commenter recommended that we clarify here or in the 
definition section what is meant by ``unfitness for service'' and 
discuss what the State Survey Agency would do with this information 
once reported as required under Sec.  483.12(a)(4).
    Response: Section 483.12(a)(4) requires that the facility report to 
the State nurse aide registry or licensing authorities any knowledge it 
has of actions by a court of law which would indicate unfitness for 
services as a nurse aide or facility staff. Sub-regulatory guidance 
provides additional information to assist facilities and surveyors in 
implementing this provision. If a facility determined that action by a 
court of law against an employee are such that they indicate that the 
individual is unsuited to work in a LTC facility, or ``unfit for 
service'', (for example, felony conviction of child abuse, sexual 
assault, or assault with a deadly weapon), we would expect the facility 
to report that individual to the nurse aide registry (if a nurse aide) 
or to the state licensing authorities (if a licensed staff member). 
Facility reporting to the state nurse aide registry or licensing 
authorities is not limited to mistreatment, neglect and abuse of 
residents and misappropriation of their property, but to any treatment 
of residents or others inside or outside the facility which the 
facility determines to be such that the individual should not work in a 
LTC facility environment. Federal requirements related to the state 
administration of the nurse aide registry, including information 
disclosure requirements and State Survey Agency responsibilities, are 
set forth at 42 CFR 483.156 and 488.335.
    Comment: One commenter notes that provisions relating to reporting 
of a crime have already been incorporated into the current survey 
process and therefore these provisions could be implemented one year 
following adoption of a final rule.
    Response: We deliberately established regulatory requirements based 
on existing expectations of facilities based on the statutory language. 
We would expect that all facilities are currently in compliance with 
the Act.
    Comment: A commenter recommends that in Sec.  483.12(b)(4), we say 
``coordinate'' instead of ``establish coordination.''
    Response: We agree and have made this change.
    Comment: Several commenters asked that we harmonize the reporting 
requirements for reporting a reasonable suspicion of a crime in Sec.  
483.12(b) and the requirements for reporting allegations of abuse, 
neglect, and exploitation to the LTC facility administrator in Sec.  
483.12(c). Commenters state that the two provisions should use the same 
timeframes.
    Response: We generally agree and have revised Sec.  483.12(c)(1) to 
require that all allegations of abuse be reported immediately, but not 
later than 2 hours after allegation is made, and allegations of neglect 
or exploitation to be reported to the administrator of the facility 
immediately, but 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. We note that all allegations of abuse, 
with or without injury, fall into the immediate reporting category, as 
we believe it is imprudent to allow delay reporting of any abuse. 
Furthermore, we note that the 2-hour and 24-hour time frames represent 
maximums and we would expect that most reports would occur more 
quickly. In all cases, we would expect prompt action to protect 
individuals and address concerns, and delays in reporting, even within 
the allowable time frames, must be reasonable and not be related to 
attempts to obscure events or evade responsibility.

[[Page 68729]]

    Comment: Several commenters are concerned about the inclusion of 
the resident representative in proposed Sec.  483.12(c)(4). A few 
commenters suggested that this was a technical error and should have 
referred to the administrator's designee.
    Response: The commenters are correct that the reference in this 
paragraph was intended to be to the LTC facility administrator's 
designee or designated representative. We have corrected the provision.
    Comment: One commenter suggests that we add ``as required by state 
law'' at the end of Sec.  483.12(b)(5).
    Response: While facilities are expected to comply with state law, 
this provision is specific to compliance with section 1150B of the Act. 
We are not revising at this time.
    Comment: One commenter stated that giving covered individuals up to 
2 hours to report to law enforcement and the state agency in cases of 
serious bodily injury is unacceptable.
    Response: We revised Sec.  483.12(b)(5)(i)(B) to state ``. . . 
shall report immediately, but not later than 2 hours . . .'' in 
accordance with 1150B of the Act.
    Comment: One commenter stated that individuals living in the 
community would immediately call the police if they had reason to 
believe items had been stolen from their home and the same expectations 
should apply in a LTC facility, where theft of resident personal 
possessions continues to be a serious problem. Reporting suspected 
theft as a crime could serve as a deterrent and send a message that 
stealing will not be tolerated. The commenter recommends that CMS 
clarify in guidelines that suspicion of theft of resident property is 
considered a reportable crime.
    Response: This regulation does not preclude a covered individual 
from reporting theft immediately. However, covered individuals must 
report suspicion of crimes not resulting in harm no later than 24 
hours. Crimes are defined by laws of the applicable political 
subdivision where the facility is located, therefore, we will defer 
further discussion of reportable crimes to sub-regulatory guidance.
    Comment: One commenter suggests that current CMS sub-regulatory 
guidelines related to subsection (b) be put into regulation to ensure 
resident safety, with additional language to specify the rights of 
staff during investigations, since far too often staff members are 
inappropriately terminated without a substantiated investigation.
    Response: We will review the sub-regulatory guidance and evaluate 
the appropriateness of incorporating it into regulations in future 
rulemaking.
    Comment: One commenter recommended adding an express prohibition of 
all forms of discrimination against residents.
    Response: We did not propose such a prohibition; however, 
facilities are expressly required by Sec.  483.70(b) to operate in 
compliance with all applicable Federal, State, and local laws, 
regulations, and codes. This includes, for example, the Americans with 
Disabilities Act and section 504 of the Rehabilitation Act. In 
addition, Sec.  483.70(c) explicitly requires compliance with other HHS 
regulations. This would include but not be limited to those regulations 
pertaining to non-discrimination 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). We note that 45 CFR part 92, non-discrimination on the basis of 
race, color, national origin, sex, age, or disability, was finalized 
after the issuance of our proposed rule. Based on this comment, we have 
added it to the list of regulations at Sec.  483.70(c). We will 
consider an express prohibition in future rule-making.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We revised paragraphs (a)(2)(i),(ii), and (iii) to include 
``exploitation.''
     We revised paragraph (a)(2)(iii) to read ``. . . Have a 
disciplinary action in effect against his or her professional license 
by a state licensure body as a result of a finding of abuse, . . .''
     We revised paragraph (b)(5)(i)(B) to read ``Each covered 
individual shall report immediately, but not later than 2 hours . . .''
     We revised paragraph (c)(1) to require that allegations of 
abuse, neglect, or exploitation to be reported to the administrator of 
the facility immediately, but not later than 2 hours after forming the 
suspicion, if the events that cause the suspicion involve abuse or 
result in serious bodily injury, or not later than 24 hours if the 
events that cause the suspicion do not involve abuse and do not result 
in serious bodily injury.
     We corrected paragraph (c)(4) to read ``Report the results 
of all investigations to the administrator or his designated 
representative and . . .''

H. Admission, Transfer, and Discharge Rights (Sec.  483.15)

    We proposed to re-designate current Sec.  483.12 ``Admission, 
transfer, and discharge rights'' as new Sec.  483.15, and revised 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.
    In new Sec.  482.15(a) we proposed to include requirements for 
admissions policies and moved these requirements to the beginning of 
the section to reflect chronological order. We proposed a new paragraph 
(a)(1) to require that the facility establish an admissions policy.
    Additionally, we proposed to 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 
proposed 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 
further proposed 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.
    We also proposed 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 proposed to re-designate Sec.  483.12(a) as proposed Sec.  
483.15(b) and address transfers and discharges. We proposed at Sec.  
483.15(b)(1)(ii)(C) to revise existing Sec.  483.12(a)(2)(iii) and 
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 Sec.  483.15(b)(1)(ii)(E), we proposed to 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. Finally, we proposed a new Sec.  483.15(b)(1)(iii) to specify 
that the facility may not transfer or discharge the

[[Page 68730]]

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).
    In the proposed revision to paragraph Sec.  483.15(b)(2), we made a 
number of revisions based on the importance of effective communication 
between providers during transitions of care. First, we proposed 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. In addition, we proposed 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 will meet the resident's needs.
    We proposed 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 did not propose a specific form, format, or 
methodology for this communication. Instead, we proposed specific data 
elements or a set of information that must be communicated during the 
transfer process. 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 did not establish a time frame 
for this communication, as this may vary based on the circumstances 
surrounding the transfer; however, in the proposed rule we indicated 
that we 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.
    In paragraph (b)(3)(i), we proposed to update the language 
currently in Sec.  483.12(a)(4)(i) to reflect our ``resident 
representative'' language and proposed 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. In paragraph 
(b)(3)(ii), we proposed 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 Sec.  483.15(b)(5)(iii), we proposed 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 proposed 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 proposed 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 proposed to re-designate Sec.  483.12(a)(7) as Sec.  
483.15(b)(7) and revised 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. Finally, in Sec.  
483.15(b)(9), we proposed to clarify that room changes in a composite 
distinct part are subject to the requirements of proposed Sec.  
483.10(d)(7).
    In paragraph Sec.  483.15(c) we proposed 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 proposed 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. Finally, we proposed to redesignate existing Sec.  
483.12(a)(3) as Sec.  483.15(c)(3) and revised 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).
    Comment: One commenter found the reorganization of this section 
confusing.
    Response: We thank the commenter for their comment. We have 
incorporated many suggestions from commenters and believe that the 
resulting provisions are much clearer.
    Comment: Some commenters supported our proposal to re-designate 
Sec.  483.12 ``Admission, transfer, and discharge rights as new Sec.  
483.15 to address all transitions of care. We also received several 
comments suggesting that the title change from ``Admission, transfer, 
and discharge rights'' to ``Transitions of care'' may make it more 
difficult for some readers, particularly residents of LTC facilities 
and their representatives, to find information on admissions, transfers 
and discharges and that the term ``transitions'' was not easily 
understandable and could have unintended implications. In addition, 
many commenters were very concerned that the term ``rights'' was 
removed from the title and felt this could negatively impact residents. 
Several commenters suggested we retain the original title. One 
commenter suggested we revise the title to ``Resident's Rights and 
Transitions of Care.'' One commenter suggests moving all content 
describing resident rights in Sec.  483.15 be moved to Sec.  483.10, 
Resident rights.
    Response: We acknowledge these concerns. Therefore, we will retain 
the original title ``Admission, transfer, and discharge rights''.
    Comment: Several commenters suggested specific wording and 
punctuation changes throughout this section. This included several 
changes to make the language used in the regulation less institutional. 
One commenter stated that some person-

[[Page 68731]]

centered language would require a distinction between long-stay and 
short-stay residents.
    Response: We reviewed and considered each suggested wording and 
punctuation change, but do not discuss each one separately below. If we 
felt that the suggested change improved clarity, we have incorporated 
it. If the suggested change does not improve clarity, we have not 
incorporated it. Comments suggesting wording changes that substantively 
alter our intended meaning are discussed below.
    Comment: Some commenters recommended that we implement similar 
requirements for exchanging information for hospitals.
    Response: Conditions of participation for hospitals are outside the 
scope of this rule. However, we refer commenters to a proposed rule, 
``Medicare and Medicaid Programs; Revisions to Requirements for 
Discharge Planning for Hospitals, Critical Access Hospitals, and Home 
Health Agencies'' published on November, 1, 2015 (80 FR 68126) which 
can be viewed at https://www.gpo.gov/fdsys/pkg/FR-2015-11-03/pdf/2015-27840.pdf. This rule addresses discharge planning requirements for 
hospitals and other post-acute care providers, including requirements 
for exchange of information upon transfer.
    Comment: Some commenters expressed support for the addition of 
``request'' in subsections (a)(2)(i) through (iii) and (3). These 
commenters felt this would help prevent attempts to evade current law 
by using the term ``request'' to seek what is intended as a 
requirement.
    Response: We thank the commenter and agree that sometimes the word 
``request'' can be used for what is effectively a requirement.
    Comment: One commenter suggested that CMS modify the language in 
Sec.  483.15(a)(2)(iii) to reflect a relatively recent statutory 
provision that allow a continuing care retirement community to require 
residents to spend on their care resources declared for the purposes of 
admission before such residents can apply for medical assistance.
    Response: We thank the commenter for this suggestion. We have 
reviewed the Medicaid requirements at section 1919(c)(5)(B)(v) of the 
Act. We will develop any necessary regulatory requirements and propose 
to incorporate them in future notice and comment rule-making. However, 
we note that LTC facility requirements are for purposes of surveying 
the facility and the provision applies to a select subset of LTC 
facilities.
    Comment: One commenter was concerned that the term ``service 
limitations'' is not defined. A number of commenters felt that this 
provision could allow facilities to improperly discriminate in 
admissions, transfers, and discharges. One commenter felt that this 
would allow facilities to reduce or eliminate their responsibility for 
complying with our requirements. One commenter suggested that it would 
be more helpful for a resident to understand the services a facility 
provides instead of requiring disclosure of special characteristics or 
services limitations. Another commenter suggested we clearly state that 
facilities must provide all services required by federal law and 
regulation and cannot refuse to provide any services that it is 
required by federal law to provide to residents who need such services. 
Some commenters recommend we delete this provision in its entirety. One 
commenter recommended that if the provision is retained, any disclosure 
of special characteristics or service limitations must occur prior to 
the time of admission.
    Response: We agree that this disclosure should occur prior to 
admission and have modified the regulations text accordingly. We 
considered deleting this provision or changing it to require that 
facilities disclose the services they do provide, however, we believe 
that the proposed requirement is the option that is likely to ensure 
prospective residents receive information they are not likely to 
receive absent a requirement and which can inform decision making. We 
do not agree that providing this information allows or encourages 
providers to discriminate in the admissions process, nor does requiring 
it allow a facility to fail to provide required services.
    Comment: One commenter suggested removing ``of the residents'' and 
``or other responsible parties'' from subsection (b)(8), as these 
phrases are redundant and create confusion.
    Response: We thank the commenter and have revised the paragraph, 
now (c)(8), as suggested.
    Comment: One commenter supported new language at Sec.  483.15(a)(7) 
requiring facilities that are a composite distinct part to disclose in 
its admission agreement its physical configurations, including the 
various locations that comprise the composite distinct part, and must 
specify the policies that apply to room changes between its different 
locations.
    Response: We thank the commenter and agree that this important 
information for residents and their representatives.
    Comment: Several comments objected to our addition of the phrase 
``expected to be'' in proposed Sec.  483.15(b)(5)(iii). The commenters 
suggested this will allow a facility to get the resident's agreement to 
a transfer and subsequently change the location to a location the 
resident objects without giving the resident 30 day notice, taking away 
important resident protections. Commenters suggested either not 
finalizing the proposal or establishing that the 30 day notice 
``resets'' if the notice is changed.
    Response: We agree and have removed the phrase ``expected to be'' 
from this provision, which we finalize at Sec.  483.15(c)(5)(iii), as 
suggested.
    Comment: Several commenters appreciated the addition of ``and 
implement'' to the statement that facilities must establish an 
admissions policy. One commenter was concerned that CMS does not 
clarify what is anticipated by this requirement.
    Response: We thank the commenters for their support and agree that 
implementation of policies at Sec.  483.15(a)(1) is essential to making 
requirements effective. Our expectations that a facility ``establish 
and implement'' an admissions policy means that a facility must have 
such a policy, that the policy must be compliant with the requirements 
for participation, and that the facility must follow its policy.
    Comment: Commenters supported the proposed provision requiring 
facilities to establish, maintain, and implement identical policies and 
practices regarding transfer, discharge, and the provision of services 
for all individuals regardless of source of payment.
    Response: We thank the commenter for support. We have re-designated 
this provision as new Sec.  483.15(b)(1).
    Comment: Some commenters supported our proposal to revise 
``safety'' in paragraph (c)(1)(i)(C) as ``safety due to the clinical or 
behavioral status of the resident.'' Some commenters suggested that CMS 
require facilities to demonstrate that the resident poses a legitimate 
safety concern, what steps it has taken before discharging or 
transferring, and how it provided access to mental health services for 
the resident. One commenter felt that this language is too broad and 
could result in inappropriate discharges of residents whose behavior is 
challenging.
    Response: We thank the commenters who support this revision. 
Currently, the language simply states that a resident can be discharged 
if safety of individuals in the facility is endangered. We do not agree 
that adding the caveat ``due the clinical or behavioral status of the 
resident'' is broader and would

[[Page 68732]]

create greater opportunity for inappropriate discharges. We are 
implementing requirements in this rule regarding the information that 
must be documented when a resident is transferred or discharged. Those 
requirements include the basis for the transfer or discharge. When the 
basis for the transfer or discharge is the clinical or behavioral 
status of the resident, we expect that status to be part of the 
documentation.
    Comment: Some commenters suggested that CMS explicitly require that 
the discharging facility facilitate a transition to another facility.
    Response: Facilities are required to provide specific information 
to the receiving provider and to provide sufficient preparation and 
orientation to the resident for the transfer 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. These 
requirements are intended to facilitate a transition to another 
facility.
    Comment: One commenter stated that they strongly support improved 
approaches to managing behavior, but opposed the proposal to create a 
topic called ``behavioral health'' that is not, and cannot be, 
adequately defined. The commenter feels behavior issues can be covered 
under other sections; for example, psychosocial assessment and 
functional status, and underlying causes can be covered under active 
diagnoses, history of present illness, and current problem list. The 
commenter stated that, ultimately, regardless of the name, the issue to 
be conveyed is whether behavior is personally and socially appropriate, 
or at least not excessively disruptive or destructive to the individual 
and to others.
    Response: We disagree. Please see our discussion of Sec.  483.40 in 
section L. Behavioral Health of this preamble.
    Comment: Some commenters were concerned about charges related to 
bed-hold policies. One commenter suggested CMS prohibit facilities from 
asking a family member to hold a bed or at least restrict the fee a 
nursing facility can charge to no more than the Medicaid per diem 
direct rate or no more than the amount the state would pay to hold the 
bed. In addition, the commenter suggested that CMS require facilities 
to provide information on the current occupancy rate.
    Response: We appreciate the commenters' suggestions. We will 
evaluate the implications of such a policy and consider it for future 
notice and comment rule-making.
    Comment: Some commenters objected to the requirement that 
facilities not request or require residents or potential residents to 
waive potential liability for losses of personal property. Commenters 
felt that, while a facility should offer a secure place to store 
valuables, it is unreasonable for a facility to be responsible for all 
losses of resident's personal property and that other requirements 
addressed the issue. One commenter recommended that facilities include 
in their admissions policy information on how a resident can safely 
store personal items to prevent potential loss of personal property. 
Others suggested that facilities only be liable for items included on 
an official inventory of the resident's personal items. Several other 
commenters supported the proposed provision that prohibits waivers of a 
facility's liability for loss of personal property, but felt that the 
prohibition should apply to all waivers of liability.
    Response: A resident's broad waiver of liability could allow a 
facility to avoid liability even when the facility is responsible for a 
loss of personal property. This provision does not make the facility 
automatically liable for every loss of personal property, nor preclude 
the facility from having policies that establish when the facility is 
liable. Rather, we would protect the resident from facilities 
inappropriately avoiding liability by failing to take reasonable care 
in protecting residents' personal property.
    Comment: Some commenters were concerned that facilities evade the 
prohibition on requiring a third-party to guarantee payment, which we 
are finalizing at 483.15(a)(3), by using contracts that require a 
resident representative to commit to paying facility charges out of 
resident resources and suing the representative for breach of contract 
if the resident's bill is unpaid.
    Response: We need to further investigate this concern and consider 
it for future notice and comment rule-making.
    Comment: Several commenters were concerned about provisions 
relating to non-payment. Some commenters were concerned about having to 
wait for a third-party denial. One commenter felt that residents should 
have to demonstrate that they have applied for Medicaid or other third-
party payment under Sec.  483.15(c)(1)(i)(E) within a specified period 
of time from the date a facility notifies the resident that Medicare 
payment will expire in order to be protected by the prohibition on 
discharging a resident who has applied for third party payment. Another 
commenter suggested we reword our provision regarding non-payment to 
state that non-payment only applies if the resident has submitted the 
necessary paperwork for third party payment or after the third party 
payor, including Medicare or Medicaid, denies the claim and the 
resident refuses to pay for his or her stay. Another commenter 
suggested that we clarify that non-payment does not apply if the 
resident is in the process of submitting the paperwork for third-party 
and that conversion from the private pay rate to payment at the 
Medicaid rate does not constitute non-payment.
    Response: We thank the commenters for their suggestions. In 
addition to the proposed language regarding reasonable and appropriate 
notice, we have revised the provision to state that non-payment applies 
if the resident does not submit the necessary paperwork for third party 
payment or after the third party payor denies the claim and the 
resident refuses to pay for his or her stay. We defer additional 
discussion to sub-regulatory guidance.
    Comment: One commenter stated that equal access to quality of care, 
proposed Sec.  483.12(b)(1) does not make sense in its new location and 
that equal access to quality of care needs to be its own subsection or 
added to an entirely new and independent location such as residents 
rights.
    Response: We agree with the commenter that this section should have 
been its own subsection. We have corrected this and it is now Sec.  
483.15(b).
    Comment: One commenter was concerned that the prohibition on 
discharging a resident while an appeal is pending could result in 
forcing a facility to keep a resident whose care the facility is not 
able to adequately and safely provide. In addition, the commenter felt 
that, if the facility cannot discharge the resident, Medicaid must be 
required to pay for the cost of the resident's care while the appeal is 
pending. Other commenters supported the prohibition on involuntary 
transfer or discharge while an appeal is pending. One commenter 
recommended instituting high dollar fines for any facility that 
improperly transfers, discharges, or refuses to readmit a resident.
    Response: We have clarified that this provision applies unless the 
failure to transfer or discharge would endanger the health or safety of 
the resident or other individuals in the facility. In the event that 
failure to discharge or transfer would endanger the health or safety of 
the resident or other individuals in the facility, the facility must 
document what danger the failure to transfer would pose. Instituting 
fines for improper transfers, discharges, or

[[Page 68733]]

refusals to allow a resident to return to the facility are beyond the 
scope of this regulation. However, we will take these comments into 
consideration for future rulemaking.
    Comment: Generally, all commenters supported efforts to improve 
transitions of care. We received comments both supporting and objecting 
to the specific pieces of information we proposed to require facilities 
to send to a receiving provider when a resident is transferred. Some 
commenters want CMS to add additional elements to the list of 
information that a facility must include in transfer documentation. For 
example, one commenter suggested that we include the name and contact 
information of the resident's family member(s). Others suggested a 
number of elements related to diet and nutritional needs and status and 
another suggest we add behavioral symptoms and triggers to the list of 
specific information. Other suggestions included indicating the 
resident's assisted technology, durable medical requirement needs, and 
communication methods. One commenter felt that transfer information 
should include portable orders for scope of treatment, if applicable. 
Another commenter suggested the proposed list includes items that may 
be irrelevant in many cases and is more extensive than what is required 
when a hospital discharges a patient. Some commenters oppose this 
requirement as proposed. One commenter stated that this requirement 
would be difficult to meet in a timely and accurate manner without 
interoperable health information exchange, yet LTC facilities did not 
receive incentives for the adoption of health information technology 
that would help to enable such exchange. Some commenters suggest that 
the federal government should provide meaningful use incentives or 
other funding to LTC facilities if we finalize this requirement.
    Response: We thank commenters for their support and their 
suggestions. We have reviewed our proposed list, concerns about the 
applicability of items in the proposed list, and suggestions for 
additional items that could be added. While we continue to believe that 
much of the information we proposed should be exchanged for residents 
to whom it applies, as well as many of the additional suggestions we 
received, at this time, we are requiring a more flexible set of 
requirements. We understand that the information required may vary 
based on the circumstances of an individual's discharge or transfer, 
including the urgency of the transfer. We defer to sub-regulatory 
guidance for additional discussion of circumstances when a discharge 
summary would be expected, as in a discharge to home and community 
based services, versus when it would not be appropriate to delay, such 
as when a resident requires an emergency transfer. The revised set of 
requirements includes the following:
     Contact information of the practitioner responsible for 
the care of the resident,
     resident representative information including contact 
information,
     advance directive information,
     special instructions or precautions for ongoing care,
     the resident's comprehensive care plan goals,
     all other necessary information, including a copy of the 
resident's discharge summary, consistent with Sec.  483.21(c)(2), as 
applicable, and any other documentation, as applicable, to ensure a 
safe and effective transition of care.
    We note that the discharge summary mentioned above must include the 
medication reconciliation, as well as a recapitulation of the 
resident's stay, a final summary of the resident's status, and the 
post-discharge plan of care. Please see our discussion of portable 
orders for scope of treatment in section D, in the comments and 
responses relating to planning and implementing care.
    While we have increased the flexibility in these requirements, we 
continue to support alignment discussed in the proposed rule between 
this approach and the common clinical data set which providers 
participating in the EHR Incentive Program(s) have focused on 
electronically exchanging through the use of certified EHR technology 
(80 FR 62693). We encourage facilities to identify opportunities to 
streamline data collection and exchange by using data they are already 
capturing electronically, for instance, as part of the MDS data 
collection.
    Comment: One commenter suggested that CMS mandate a specific form 
and format for the transmission of discharge information.
    Response: No specific form or format has been developed at this 
time. In addition, some states have their own mandated form. We are not 
mandating a specific form at this time, but we will consider this for 
future development and rule-making.
    Comment: One commenter supported the requirement that the discharge 
notice include information on the agency for the protection and 
advocacy of individuals with intellectual and developmental 
disabilities when individuals discharged have such disabilities and on 
the agency for the protection and advocacy of individuals with a mental 
disorder when discharged residents have a mental disorder, and 
suggested that we extend this to individuals with related disabilities, 
such as traumatic or acquired brain injury.
    Response: We thank the commenter for their suggestion and have 
modified these provisions to include individuals with related 
disabilities.
    Comment: One commenter suggested that the information required to 
be in the discharge notice, as specified as proposed Sec.  483.15(b)(5) 
include the name, address, and telephone number of the representative 
of the Office of the State Long-Term Care Ombudsman.
    Response: In this final rule, we are requiring that this 
information be provided to the resident in the written description of 
legal rights (Sec.  483.10(g)(4)(ii)), and posted in an accessible 
manner (Sec.  483.10(g)(5)). In addition, a copy of the notice must be 
sent to the Long-Term Care Ombudsman (Sec.  483.15(c)(3)(i)).
    Comment: A number of commenters were concerned that the obligation 
at proposed Sec.  483.15(b)(5)(iv) to assist a resident with completing 
and submitting an appeal unfairly turns the facility into the 
resident's legal representative. Furthermore, the notice of discharge 
provides contact information for the Ombudsman, who helps residents get 
in touch with legal resources to file hearing requests.
    Response: This provision does not make a facility or any of its 
employees the legal representative of the resident under state laws; 
moreover, a facility cannot engage in the practice of law. The 
provision does not require that the facility provide legal advice or 
counsel. It does mean that a facility must, as it does in other ways, 
physically assist a resident in obtaining access to services, and, 
importantly, cannot act as a barrier to a resident exercising a right. 
``Assistance with completing'' could be helping the resident to contact 
the Ombudsman or helping the resident get a copy of the pertinent form. 
``Submitting'' could mean putting a letter in outgoing mail. We defer 
further discussion to sub-regulatory guidance.
    Comment: Some commenters supported our proposal to require that 
discharge notices be sent to a representative of the Office of the 
State Long Term Care Ombudsman. Several commenters suggested that 
requiring resident agreement for sending the notice to the LTC 
Ombudsman was potentially confusing and unnecessary.

[[Page 68734]]

Others suggested that we specify that the notice go to the local 
ombudsman. Another requested clarification on the intended effect of 
sending the notice and whether or not sending the notice constituted a 
request for assistance and if not, what the resident would need to do 
to make such a request. One commenter stated that it is unclear why the 
ombudsman's office would need notification of every routine discharge 
or transfer and that such notification should be reserved for 
situations where the transfer or discharge is contested. The commenter 
doubted that ombudsman offices have the capacity to receive and act 
upon even a small portion of this information.
    Response: We have eliminated language requiring resident consent. 
We consulted with the Administration for Community Living in the 
development of this proposal and believe that sending these notices to 
the State Long-Term Care Ombudsman will provide added protection to the 
resident and assist the State Long-Term Care Ombudsman to keep informed 
of facility activities.
    Comment: Some commenters were concerned that our proposed revision 
at Sec.  483.15(b)(4)(ii), which changes ``may'' to ``must,'' could 
imply that a facility has an obligation to always provide the most 
limited notice period possible and recommend that we retain ``may.''
    Response: The facility must give notice at least 30 days in advance 
unless an exception is met. When an exception is met, the facility must 
give the notice as soon as it can. The facility does not have the 
discretion to delay as long as possible because an exception applies. 
The ``must'' in this provision requires the facility to provide notice 
as soon as practicable when it cannot provide notice at least 30 days 
in advance of the transfer or discharge. We defer to sub-regulatory 
guidance to further explicate this requirement.
    Comment: Several commenters supported our proposed requirement that 
residents who are being readmitted (following a hospitalization or 
other absence) to a facility should be assigned to the same room he or 
she was in previously, if such room is available.
    Response: We thank the commenters for their support. Particularly 
for residents whose home is the facility, returning to the same room is 
important.
    Comment: One commenter asked, since we do not regulate private-pay 
rates, why we include proposed Sec.  483.15(b)(1)(i)(B), which 
authorizes facilities to charge ``any amount for services furnished to 
non-Medicaid residents . . .'' The commenter was further concerned that 
the restriction of state law is too limited if it means solely 
statutory or regulatory law specifically addressing payment by private 
pay residents.
    Response: As with the provision of the Social Security Act which it 
tracks, Sec.  483.15(b)(2) is intended as a modifier to Sec.  
483.15(b)(1), and is consistent with section 1919(4)(c)(B)(i) of the 
Act, which states: ``Nothing prohibiting any charges for non-Medicaid 
patients.--Subparagraph (A) [regarding identical policies and practices 
regarding transfer, discharge, and the provision of services required 
under the state plan for all individuals regardless of source of 
payment] shall not be construed as prohibiting a nursing facility from 
charging any amount for services furnished, consistent with the notice 
in paragraph (1)(B) describing such charges.'' We do not intend to 
limit the application of state law and proposed to add ``unless 
otherwise limited by state law'' in recognition of the fact that some 
states may have regulator or statutory law that addresses limits on 
charges to private pay residents, consumer protection statutes that 
would prohibit exorbitant charges, or case law that addresses the 
concern. The Medicare program has a similar provision with respect to 
equal access to care, but no specific provision regarding statutory 
construction with respect to private pay residents.
    Comment: One commenter suggested that we clarify that documentation 
requirements in proposed paragraph (b)(2) only apply in non-emergency 
circumstances.
    Response: We have revised the documentation requirements at 
proposed Sec.  483.15(b)(2)(ii), which we are finalizing at Sec.  
483.15(c)(2)(ii), to provide greater flexibility for facilities when 
providing information about a transferring resident. However, even in 
an emergency, the receiving facility will need information about the 
resident.
    Comment: One commenter felt that requiring the physician to 
directly document the information required for transfers was not 
feasible, especially during an urgent transfer. The commenter suggested 
we revise this section to state that the documentation must be made by 
or based on information from the physician. The commenter stated that 
sending the physician's previously documented history and physical, 
pertinent progress notes, consultations, and laboratory tests, 
supplemented by nursing documentation of the events and rationale 
leading to the transfer, should suffice.
    Response: We thank the commenter for their suggestion. This comment 
is in reference to Sec.  483.15(c)(2)(ii), which specifies the 
information that a physician must document in the resident's record 
under certain transfer/discharge scenarios. We have clarified that the 
physician must document the basis for the transfer, the resident's 
needs that cannot be met at the facility, the facility attempts to meet 
the resident's needs, and the services available at the receiving 
facility to meet the resident's needs. This does not include all of the 
information required by Sec.  483.15(c)(2)(iii). We agree that sending 
the physician's previously documented history and physical, pertinent 
progress notes, consultations, and laboratory tests, supplemented by 
nursing documentation of the events and rationale leading to the 
transfer is appropriate when addressing the requirements of Sec.  
483.15(c)(2)(iii).
    Comment: One commenter suggested that the proposed requirement at 
proposed Sec.  483.15(b)(2) appeared to ignore the growing presence of 
telemedicine, which is often highly effective at managing condition 
changes appropriately and preventing hospitalization. Other commenters 
more generally recommended that the requirements for LTC facilities 
address telemedicine.
    Response: We are aware of the growing presence of telemedicine and 
agree it may be useful in managing condition changes and preventing 
hospitalization. However, when a transfer does occur, it is important 
that both the sending and receiving facilities communicate effectively 
with each other, including the exchange of pertinent clinical and non-
clinical information. We will consider further addressing telemedicine 
in future rule making.
    Comment: Some commenters supported our proposal to require 
facilities to document their attempts to meet the resident's needs, and 
the service available at the receiving facility to meet the need(s). 
One commenter suggested that this could result in fewer transfer and 
discharge notices.
    Response: We thank the commenters. We believe that this requirement 
will help ensure that residents are transferred appropriately.
    Comment: One commenter suggested we include a cross-reference to 
Sec.  483.15(b) in Sec.  483.21(c)(1).
    Response: We are finalizing proposed Sec.  483.15(b) at Sec.  
483.15(c). We have added a cross-reference to Sec.  483.15(c) at Sec.  
483.21(c)(1) based on the commenter's suggestion. Please refer to 
section J. Comprehensive Person-Centered Care Planning (Sec.  483.21) 
for a more detailed explanation.

[[Page 68735]]

    Comment: Some commenters supported our proposal to require 
facilities to notify a resident who has been transferred to another 
facility, expecting that he/she will return to the facility, in 
writing, of the reason the resident cannot be readmitted and the 
information required in the notice before transfer. One commenter 
believed this may reduce inappropriate discharges or transfers. Some 
commenters opposed this proposal. One commenter was concerned that this 
language encourages and supports the practice of facility dumping.
    Response: At the time a facility determines that a resident cannot 
be readmitted to the facility, the resident is effectively discharged 
from the facility. We have revised our language to acknowledge this. 
Specifically, we use the term ``return'' instead of ``readmit'' and we 
require facilities, at the time they determine a resident cannot return 
to the facility, to comply with the requirements of paragraph Sec.  
483.15(c) as they pertain to discharges.
    Comment: Some commenters were concerned that some facilities charge 
their private pay rate to hold a bed under the bed-hold requirements 
and suggested that we limit this charge to no more than the Medicaid 
rate.
    Response: We thank the commenters for their suggestion. We need to 
further investigate and evaluate this practice. Payment rates for bed-
hold charges are beyond the scope of this rulemaking, but we will 
consider addressing it in future notice and comment rule-making.
    Comment: One commenter stated that it is not feasible to provide a 
bed-hold notice upon transfer. The commenter stated that the focus 
should be on the resident's well-being and not money.
    Response: This is an existing requirement which we did not propose 
to eliminate or substantially modify. We would expect all facilities to 
already be in compliance with this requirement. We agree that the 
resident's well-being is of utmost importance. However, the information 
provided may be very important to the resident or their representative 
in order to ensure their ability to return to the facility at an 
appropriate time.
    Comment: One commenter suggested that we create a new subsection to 
address readmission after a state's fair hearing regarding entitlement 
to continuing coverage or other issues.
    Response: Medicaid's State plan requirements with respect to 
Medicaid fair hearing processes for applicants and beneficiaries are 
set forth at 42 CFR 431 subpart E. Corrective action is addressed at 
Sec.  431.246.
    Comment: One commenter recommended adding the specific language at 
proposed Sec.  483.15(b)(5) to the definition of ``substandard quality 
of care'' at Sec.  488.301.
    Response: The provision in question includes information on the 
contents of a discharge notice. We agree that it is important that this 
information is provided to the resident and that failure to do so 
should be addressed, we do not agree that this language should be 
included in the definition of ``substandard quality of care''.
    Comment: Some commenters requested that CMS clarify that residents 
would have an appeal right of a facility's refusal to readmit a 
resident after a hospitalization or other therapeutic leave. The 
commenters further recommended that the regulation specify that a 
facility could only refuse a bed-hold or a readmission right if the 
resident's needs could not be met in the facility, the resident's 
presence in the facility would endanger others' safety or health, or 
the resident's condition would not allow for the facility to follow the 
standard notice procedures for involuntary transfers and discharges. 
The commenter stated that a hospitalization should not be a means for a 
facility to evade the normal procedural requirements applicable to 
involuntary transfers and discharges.
    Response: As previously noted, our Medicaid State requirements with 
respect to state fair hearings for applicants and beneficiaries are set 
forth at 42 CFR part 431 subpart E. Provisions regarding when a hearing 
is required are set out at Sec.  431.220. Medicare beneficiaries may 
have separate appeal rights under Medicare. We have revised paragraph 
(c)(3), ``Notice before transfer'' to better address concerns that, as 
proposed, it would allow patient dumping.
    Comment: One commenter suggests that at proposed paragraph (b)(8), 
we require that the administrator also be required to notify staff 
members of the impending closure.
    Response: We thank the commenter for their suggestion. In the event 
of an impending closure, facilities are required to ensure the safe and 
orderly transfer, discharge and adequate relocation of all residents. 
As a part of the process, the facility must have closure plans and 
procedures. The plans and procedures should include, among other items, 
notification of all facility staff, vendors, contractors, and unions, 
as appropriate. However, we cannot require notice to staff unless such 
notice is related to the health and safety of residents.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We have withdrawn our proposal to rename proposed section 
Sec.  483.15, ``Transitions of Care'' and add introductory language, 
and retain the current title ``Admission, transfer, and discharge 
rights.''
     We corrected references to ``clinical record'' to 
``medical record.''
     We eliminated the introductory language which defined 
transitions of care, as the term is no longer used.
     We revised paragraph (a)(6) to require that a facility 
disclose to a resident or potential resident, prior to admission, 
notice of special characteristics or service limitations of the 
facility. We redesignated proposed (b)(1) as paragraph (b), and added a 
cross-reference to the definition of transfer and discharge in Sec.  
483.5 and a cross-reference to resident rights at Sec.  483.10(a)(2).
     We redesignated proposed (b) Transfer and discharge, as 
(c), and renumbered paragraphs (ii) through (iii) to (i) through (ii).
     In paragraph (c)(1)(i)(E), we have revised the provision 
to state that non-payment applies if the resident does not submit the 
necessary paperwork for third party payment or after the third party 
payor denies the claim and the resident refuses to pay for his or her 
stay.
     We have clarified that paragraph (c)(1)(ii) applies unless 
the failure to transfer or discharge would endanger the health or 
safety of the resident or other individuals in the facility. In the 
event that failure to discharge or transfer would endanger the health 
or safety of the resident or other individuals in the facility, the 
facility must document what danger the failure to transfer would pose.
     We revised paragraph (c)(2)(ii) to clarify that the term 
``documentation'' refers to the documentation specified in paragraph 
(2)(i).
     We revised paragraph (c)(2)(iii), documentation, to 
reflect a more flexible list of elements to be documented in the 
resident's medical record and communicated to the receiving health care 
institution or provider. The documentation must include: Contact 
information of the practitioner responsible for the care of the 
resident, resident representative information including contact 
information, advance directive information, all special instructions or 
precautions for ongoing care, as appropriate, the resident's 
comprehensive care plan goals, all other necessary information, 
including a copy

[[Page 68736]]

of the residents discharge summary, consistent with Sec.  483.21(c)(2), 
as applicable, and any other documentation, as applicable, to ensure a 
safe and effective transition of care.
     We removed the requirement for resident consent in 
paragraph (c)(3).
     We revised paragraph (c)(5)(iii) to remove the phrase 
``expected to be.''
     We revised paragraph (c)(5)(iv) to require the discharge 
notice to include a statement of the resident's appeal rights, 
including the name, address (mailing and email), and telephone number 
of the 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; and expanded paragraphs (vi) and 
(vii) to include individuals with related disabilities.
     We revised paragraph (c)(8) by removing ``of the residents 
or other responsible parties.''
     We revised ``readmissions'' to ``returns'' in paragraphs 
(d) and (e).
     We revised proposed paragraph (c)(3) as paragraph (e). 
Paragraph (e)(1) is revised to state that ``a facility must establish . 
. .'' and (e)(1)(i)(B) is revised to read ``Is eligible for Medicare 
skilled nursing facility services or Medicaid nursing facility 
services'' and revised proposed paragraph (c)(3)(ii) as (e)(2)(ii) to 
state that if the facility that determines that a resident who was 
transferred with an expectation of returning to the facility cannot 
return to the facility, the facility must comply with the requirements 
of paragraph (c) as they apply to discharges.

I. Resident Assessment (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 restructuring of subpart B, we proposed to 
remove and re-designate current Sec.  483.20(k) and Sec.  483.20(l), 
which set forth requirements for care plans and discharge planning, to 
Sec.  483.21(b) and Sec.  483.21(c), respectively. Similarly, we 
proposed to re-designate Sec.  483.20(m) as Sec.  483.20(k). The 
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. We proposed 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 proposed to revise the regulations to 
specify that CMS (not the State) prescribes the resident assessment 
instrument. At Sec.  483.20(b)(1)(xvi) we proposed 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 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. We proposed to add new Sec.  483.20(e)(1) and 
Sec.  483.20(e)(2). In new Sec.  483.20(e)(1), we proposed 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 proposed to clarify 
that PASARR coordination also includes referring all level II residents 
and all residents with newly evident or possible serious a mental 
disorder, 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).
    As mentioned earlier in this section, we are proposed to re-
designate existing Sec.  483.20(m) as Sec.  483.20(k). In addition, we 
proposed to make a few technical corrections at proposed Sec.  
483.20(k). First, we proposed 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 a mental disorder and 
individuals with intellectual disability for admittance into a nursing 
facility. We proposed at Sec.  483.20(k)(2) to add these statutory 
exceptions that were inadvertently omitted when this regulation was 
initially written. Second, we proposed 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. We proposed at Sec.  483.20(k)(4) to add this statutory 
requirement that was inadvertently omitted when CMS first implemented 
sections 1819 and 1919 of the Act). Lastly, we proposed to replace 
``mental retardation'' with the term ``intellectual disability'' 
throughout Sec.  483.20(k), as appropriate.
    Comment: Commenters supported CMS' revisions to clarify that the 
comprehensive assessment of each resident extends to assessing 
residents' strengths, goals, life history, and preferences. Commenters 
indicated that such changes are instrumental to providing person-
centered care and engaging residents as partners in their care. One 
commenter noted that information, such as life history and preferences, 
may not be possible to obtain and this factor should be noted in the 
regulation. Another commenter indicated that the MDS does not include 
information such as resident's strengths and life history, so the 
addition of this requirement is not useful.
    Response: We appreciate the feedback from commenters. We agree that 
information such as a resident's life history may not be readily 
available; however we believe that facilities have an obligation to 
make their best attempts to obtain this information because the 
information could prove to be valuable to the resident's care. While 
the MDS is not completely structured around a resident's life history, 
the MDS does have a person-centered focus and contains questions that 
ask about preferences (see Section F for activity preferences), life 
history in terms of socioeconomic status, marital status, and prior 
care. In addition, new Section GG of the MDS addresses a resident's 
goals related to function and has a person-centered focus on items such 
as pain. We understand that the MDS is an evolving assessment tool, and 
we will consider the feedback from commenters for possible efforts to 
improve the assessment in the future.
    Comment: Commenters also asked whether the proposed changes related 
to coordinating assessments with the preadmission screening and 
resident review (PASARR) program under Medicaid in subpart C of part 
483 will add any meaningful benefit to residents. Commenters noted that 
the current PASARR reporting process is flawed and many residents are 
admitted into facilities with incorrect or missing diagnoses, confusing 
medication regiments, and barely controlled symptoms. Commenters 
further questioned the efficacy of PASARR and whether PASARR continues 
to serve a purpose for nursing home residents. Another commenter noted 
that the regulation uses the acronym ``PASARR'', which is inconsistent 
with the acronym that is used on the Medicaid.gov Web site.

[[Page 68737]]

    Response: The regulations for LTC facilities found in subpart B 
include some PASARR regulations that apply strictly to nursing 
facilities. The July 2015 proposed rule provided updates to the 
regulations for clarity, but did not change the PASARR program or 
procedures in any state. The requirements specific to the PASARR 
program are found in subpart C of part 483, which pertain to all 
entities and includes the responsibilities of various state agencies. 
The PASARR Technical Assistance Center (PTAC) at www.PASRRassist.org is 
a useful resource for finding answers to questions regarding the PASARR 
program and for providing feedback regarding how the program can be 
improved. We are aware that the acronym varies between what is used in 
the Code of Federal Regulations (CFR) and what is used on the Medicaid 
Web site. For consistency we are continuing to use the acronym PASARR 
for purposes of the CFR. We may revise the term in future rulemaking.
    Comment: Several commenters requested clarification regarding the 
meaning of ``direct care/direct access staff members'' as used at Sec.  
483.20(b)(1)(xviii) and suggested that the term ``direct access staff'' 
be defined in the ``Definitions'' section. One commenter suggested that 
the phrase be replaced with ``staff members of all shifts who provide 
services directly to the resident.'' Another commenter indicated that 
the phrase should include housekeeping and maintenance staff, as they 
often have contact and interaction with residents and may be able to 
provide valuable information regarding a resident's preferences and 
needs.
    Response: On August 4, 2015 we published a final rule entitled, 
``Medicare Program; 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'' (80 FR 46389), which established a definition of ``direct 
care staff'' in 42 CFR part 483. When we use the term ``direct care/
direct access staff'' we are referring to those individuals who, 
through interpersonal contact with residents or resident care 
management, provide care and services to allow residents to attain or 
maintain the highest practicable physical, mental, and psychosocial 
well-being. We were not referring to individuals whose primary duty is 
maintaining the physical environment of the long term care facility 
(for example, housekeeping). For clarity we have removed the reference 
to ``direct access staff'' at Sec.  483.20(b)(1)(xvii) and elsewhere 
throughout the regulatory text as appropriate.
    Comment: One commenter provided comment regarding the language at 
Sec.  483.20(k)(2)(ii)(C) which indicates that the state may choose to 
not apply the preadmission screening program for individuals with a 
mental disorder if it is anticipated by a physician that the individual 
will be in a nursing facility for less than 30 days. The commenter 
noted that if it is discovered that the individual requires more than a 
30 day stay, they are not protected against transfer. The commenter 
suggested that CMS add language ensuring that residents affected by 
this section be given the same protections as other residents with 
regard to the transfer/eviction process.
    Response: We appreciate the commenters' feedback. However, we 
believe that the intention of the policy was to limit the program to 
those with an expectation of staying 30 days or more.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following revision:
     Remove the reference to ``direct access staff'' at Sec.  
483.20(b)(1)(xviii).

J. Comprehensive Person-Centered Care Planning (Sec.  483.21)

    In accordance with the proposed reorganization of part 483, subpart 
B, we proposed to add a new Sec.  483.21 ``Comprehensive Person-
Centered Care Planning''. We proposed to retain in this section certain 
existing provisions of current Sec.  483.20 as well as other additions 
and revisions discussed in detail below. 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. We proposed 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 Sec.  483.21. In addition to 
relocating existing provisions, we also proposed to add new 
requirements as discussed in detail below.
Proposed Sec.  483.21(a)
    We proposed 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. We proposed to require that the baseline care plan be 
completed within 48 hours of a resident's admission. At Sec.  
483.21(a)(1)(ii), we proposed 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. In 
the proposed rule, we indicated that 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.
    At Sec.  483.21(a)(2), we proposed 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 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 
proposed to re-designate this section as a new Sec.  483.21(b). In 
addition, we also proposed to add a new Sec.  483.21(b)(1)(iii), 
requiring that any specialized services or specialized rehabilitation 
services that a nursing facility provided pursuant to a PASARR 
recommendation be included in the resident's care plan.
    We also proposed to add a new Sec.  483.21(b)(1)(iv)(B) to require 
that discharge assessment and planning to be a part of developing the 
comprehensive care plan. We proposed 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. We proposed 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.
    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

[[Page 68738]]

resident's family/legal representative are all required to participate 
in the IDT. We proposed 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. We proposed 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. Additionally, we proposed 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. Further, at Sec.  483.21(b)(2)(ii)(F) we proposed 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.
    Lastly, we proposed to add 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.
Proposed Sec.  483.21(c)
    Current regulations at Sec.  483.20(l) set forth the requirements 
for a discharge summary. As mentioned above, we proposed to re-
designate this section as a new Sec.  483.21(c). At Sec.  483.21(c)(1) 
we proposed to improve the discharge planning for LTC facilities by 
adding a requirement that facilities must develop and implement an 
effective discharge planning process. In the proposed rule, we 
indicated that 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. We note that in 
compliance with the Supreme Court Olmstead decision (Olmstead v. L.C ex 
rel. Zimring, 527 U.S. 581, 119 S. Ct. 2176 (1999)), we encourage 
facilities and their community partners to strive to serve individuals 
in their preferred settings, when feasible. In addition, we proposed 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. We proposed that the discharge plan 
must also be updated, as needed, to reflect these changes. We also 
proposed 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 proposed 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. We also proposed to 
require that the discharge plan address the resident's goals of care 
and treatment preferences. In the proposed rule, we indicated that 
facilities 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 indicates 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 must document who made the determination and why. We note that 
on May 20, 2016 the HHS Office for Civil Rights' issued a report 
entitled ``Guidance and Resources for Long Term Care Facilities: Using 
the Minimum Data Set to Facilitate Opportunities to Live in the Most 
Integrated Setting'' (see http://www.pasrrassist.org/events/webinar/ocr-guidance-and-resources-long-term-care-facilities-using-minimum-data-set). We encourage facilities to review this guidance for 
information to assist facilities in complying with civil rights 
obligations by administering the Minimum Data Set (MDS) appropriately 
so that their residents receive services in the most integrated setting 
appropriate to their needs. 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.
    As required under section 1899B(i)(1) of the Act, to help inform 
the discharge planning process, we proposed 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 proposed 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, 
we proposed that the facility must 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.
    Finally, at Sec.  483.21(c)(1)(viii), we proposed 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 proposed 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 proposed 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 
proposed to revise the current requirements for the post-discharge plan 
of care to specify that a recapitulation of a resident's stay include, 
but not be limited to,

[[Page 68739]]

diagnoses, course of illness/treatment or therapy, and pertinent lab, 
radiology, and consultation results. We also proposed 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 include any community care options, resources, and 
available supports and services presented and arranged by the community 
care provider as needed.
    At Sec.  483.21(c)(2)(iii), we proposed to add a new requirement to 
require facilities to reconcile all pre-discharge medications both 
prescribed and non-prescription, with the resident's post discharge 
medications. We proposed that this medication reconciliation be 
included as part of the discharge summary. Lastly, we also proposed 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.
    Comment: Commenters supported the recognition of the need to plan 
for person-centered care and the incorporation of person-centered care 
into the care planning process. One commenter did not support 
specifying that a resident's care plan be person-centered. The 
commenter noted that the Institute of Medicine (IOM) has identified 
several major quality attributes including safety, effectiveness, 
efficiency, timeliness, patient-centeredness, and equitability. The 
commenter suggests that the regulations should recognize all elements 
of quality and not just selected ones.
    Response: We appreciate the commenters' feedback. The intent of 
creating a section devoted to person-centered care planning was not to 
diminish the necessity of other quality attributes. We received insight 
and recommendations from the OIG ((OEI-02-09-00201), https://oig.hhs.gov/oei/reports/oei-02-09-00201.asp), internal workgroups, and 
stakeholders regarding the lack of resident involvement in the care 
planning process. In response, we determined that it is necessary to 
highlight the importance of focusing on the resident as the locus of 
control when developing care plans. The regulation as a whole focuses 
on the additional quality attributes mentioned by commenters; safety, 
effectiveness, efficiency, timeliness, and equitability. Some of the 
proposals that focus on these attributes include the addition of the 
QAPI requirements, strengthening the rights of residents, and the 
overall promotion of resident choice.
    Comment: Commenters also supported the need to include discharge 
planning as part of the comprehensive care plan. Commenters insisted 
that discharge planning, including referrals for community transition, 
be initiated as early in the admission process as possible to prevent 
any unnecessary period of institutionalization.
    Response: We agree that discharge planning should be initiated as 
early as possible in the admission process. In addition to requiring 
discharge assessment and planning to be a part of developing the 
comprehensive care plan, we also proposed at Sec.  483.21(b)(1)(iv)(B) 
that facilities document whether the facility assessed a resident's 
desire to return the community. We noted in the proposed rule that the 
discharge assessment may include referral to a community transition 
planning agency to explore community living options, resources, and 
available supports and services.
    Comment: Multiple commenters questioned whether a qualified mental 
health professional and a member of clergy would be required to 
participate on the IDT. Commenters indicated that ``qualified mental 
health professional'' should be defined and that such a requirement 
would be costly, while noting that access to these professionals is 
limited. Some commenters indicated that they offer clergy services to 
residents and a few noted that many residents may request that their 
own religious leaders come into the facility to provide them services.
    Response: In the preamble discussion of the proposed rule (see 80 
FR 42193) we indicated that we proposed to add the term ``other 
appropriate staff'' to the requirement for the individuals who must 
participate on a resident's IDT at Sec.  483.21(b)(2)(ii). We provided 
examples for ``other appropriate staff'' that may be appropriate for 
participation on the IDT and for inclusion in the development of a 
resident's care plan. We used the examples of a mental health 
professional for a resident who is diagnosed with a mental health 
disorder or a chaplain based on a resident's needs. We did not require 
that these individuals participate in the IDT. For clarity, we proposed 
at Sec.  483.21(b)(2)(ii) that a resident's care plan must be developed 
by an IDT that includes but is not limited to the attending physician, 
a registered nurse with responsibility for the resident, a nurse aide 
with responsibility for the resident, a member of food and nutrition 
services staff, a social worker, the resident or the resident's 
representative, and other appropriate staff as indicated by the 
resident's needs.
    Comment: Many commenters supported our proposal to add a 
requirement for a baseline care plan. Commenters indicated that the 
requirement for a baseline care plan recognizes the planning needed to 
meet the immediate, short-term needs of newly admitted patients. One 
commenter recommended that the baseline care plan also include 
information about the current health condition and diagnosis of a 
resident rather than be based on admission orders from another facility 
in order to determine if they are still relevant. Another commenter 
recommended that the baseline care plan also include information about 
a resident's customary routines and preferences. A few commenters 
indicated that the proposed 48 hour timeframe for completing the 
baseline care plan may be problematic if an individual is admitted on a 
Friday afternoon or on a holiday. Another commenter indicated that the 
proposed 48 hour timeframe was too long and stated that the plan should 
be developed upon admission. One commenter indicated that staff with 
specific or specialized training would be required to complete the 
baseline care plan and this would have a negative financial impact of 
facilities.
    Response: We expect that a resident's current health status and 
diagnosis will be included in the admission orders. Section 
483.15(c)(2)(iii) of this final rule requires that certain information 
be provided to a receiving provider for a transfer including all 
special instructions or precautions for ongoing care and the contact 
information of the practitioner responsible for the care of the 
resident. If a resident is transferred from another facility, the 
requirements at Sec.  483.15(c)(2)(iii) would apply. If the information 
provided is missing or unclear, the facility or admitting professional 
is not precluded from following up to gain additional information. 
Furthermore, we believe the information necessary to complete the 
baseline care plan will be readily available or accessible through 
discussions and follow-up upon admission. Therefore, we do not agree 
with the commenter who indicated that additional staff with specialized 
or specific training is necessary to complete the baseline care plan 
causing a negative financial impact on facilities. While a resident's 
customary routine and preferences provide valuable information 
regarding a resident's care, we believe it would be overly burdensome 
to include this information in the baseline care plan. The purpose

[[Page 68740]]

of the baseline care plan is to serve as an interim care plan within 
the initial period of residency to avoid poor quality care and reduce 
the risk of hospital readmission as a result of missing information. 
The comprehensive care plan required at Sec.  483.21(b) is a more 
detailed and exhaustive plan of care for each resident that is person-
centered and includes a resident's needs and preferences.
    In addition, we understand that admissions to a facility can take 
place on a weekend or over a holiday, however we expect that quality 
care will still be provided including the need to formulate a plan of 
care for the resident. Furthermore, regulations at Sec.  483.35(b)(1) 
require the facility to use the services of a registered nurse for at 
least 8 consecutive hours a day, 7 days a week. Therefore, we expect, 
at a minimum, that a registered nurse will be available to develop a 
baseline care plan regardless of whether it is a holiday or a weekend. 
Finally, we expect that facilities will begin developing the baseline 
care plan upon admission in order to meet the 48 hour timeframe. The 48 
hour timeframe serves as a deadline for having the plan completed and 
does not preclude facilities from completing the plan sooner. We 
believe that 48 hours is an appropriate timeframe as it will allow the 
facility sufficient time to obtain necessary information to complete 
the baseline care plan while also addressing the need for continuity of 
care during transition, a high-risk period when residents are 
particularly vulnerable to adverse health events.
    Comment: One commenter recommended that the language at Sec.  
483.21(a) be revised to clearly state that facilities must not only 
develop a baseline care plan, but must also implement the plan. The 
proposed language only stated that the plan must be developed and 
implied that it must also be implemented. The commenter request that 
CMS clearly state that the plan must be also be implemented.
    Response: We agree and have revised the language at Sec.  483.21(a) 
to indicate that facilities must both develop and implement a baseline 
care plan. Similarly, the proposed language only stated that the 
comprehensive person-centered care plan must be ``developed.'' 
Therefore, for consistency, we have also revised the language at Sec.  
483.21(b) to indicate that facilities must both develop and implement a 
comprehensive person-centered care plan.
    Comment: One commenter recommended that we consider the care plan 
requirements in regard to short-stay vs long-stay residents due to the 
significant variation in their treatment regimens. The commenter 
suggests that residents receive a short-term interim care plan for a 
period of up to 100 days from admission. Once a resident is no longer 
``short-stay'' then the requirement for a comprehensive assessment and 
care plan to be completed with 14 days of the change could then be 
completed.
    Response: We disagree with the commenter. We believe that a 
comprehensive person-centered care plan should be developed for all 
residents regardless of length of stay. The need for an assessment and 
a plan of care is not dependent on the length of time an individual 
spends in a facility. Rather comprehensive assessments and care 
planning is necessary to provide all residents with the proper care and 
services that will help them to attain or maintain their highest 
practicable physical, mental, and psychosocial well-being.
    Comment: One commenter recommended revising the language at Sec.  
483.21(b)(1) by replacing the term ``timetables'' with ``timeframe'' as 
they are not the same. The commenter notes that timetables are rigid 
and predictable unlike timeframes. Another commenter requested that 
Sec.  483.21(b)(1) be revised to also address a resident's goals not 
just their needs.
    Response: We have replaced the term ``timetables'' and revised the 
language at Sec.  483.21(b)(1) to ``the facility must develop and 
implement a comprehensive person-centered care plan for each resident, 
consistent with Sec.  483.10(c)(2) and Sec.  483.10(c)(3), that 
includes measurable objectives and timeframes to meet a resident's 
medical, nursing, and mental and psychosocial needs that are identified 
in the comprehensive assessment.''
    Comment: One commenter suggested that medications or pharmacy 
services should be added to the list of information necessary for 
completing the baseline care plan. Another commenter suggested that the 
terms ``prescriptions'' or ``recommendations'' be used in place of 
``orders''. The commenter indicated that the term ``order'' is used in 
the military which reinforces a resident's feelings that they are 
``inmates'' at the LTC facility.
    Response: Regulations at Sec.  483.21(a)(1)(ii)(B) require that the 
baseline care plan include the physicians orders. We expect that the 
physician orders will include any initial medications and pharmacy 
services that are needed for the resident. We do not agree that the 
term ``orders'' as used in ``admission orders'', ``physician orders'', 
and ``dietary orders'' should be removed. The term ``orders'' is a 
widely used term throughout the medical field and understood by medical 
professionals of all specialties and skills.
    Comment: A few commenters were against requiring that a nursing 
assistant with responsibility for the resident and a member of dietary 
services to be a part of the IDT, while some commenters indicated 
support for the proposal. Overall commenters supported the intent of 
the requirement; however commenters opposing the proposal stated that 
participating on the IDT would require a significant amount of time and 
would reduce the amount of time that the nursing assistant would be 
available to provide direct care to residents. Commenters also noted 
shortages in the number of dietary staff and their limited availability 
to participate in meetings. Commenters recommended that each facility 
have the flexibility to determine how best to obtain input from direct-
care staff in a manner that is more cost effective and less disruptive 
to resident care. One commenter noted that they do not hire nursing 
assistants to provide primary care to their Medicare Part A rehab 
patients, but rather uses Licensed Practical Nurses (LPNs) and RNs to 
provide care.
    Response: We continue to believe that it is most appropriate for a 
nursing assistant with responsibility for the resident to be a part of 
the IDT. Nursing assistants spend much of their time interacting 
directly with residents providing them day-to day care. In addition, 
their knowledge of a resident's care plan and medical needs directly 
relates to how well they can care for a resident and including them on 
the IDT may also contribute to improved outcomes. For those facilities 
that do not hire nursing assistants, as indicated by the commenter, we 
note that the regulation at Sec.  483.21(b)(ii) also requires a RN with 
responsibility of the resident to participate on the IDT as well. We 
expect that these facilities will meet these additional requirements 
for IDT members and be able to demonstrate their lack of nursing 
assistants on staff. Likewise, we also believe that nutrition is a 
fundamental part of a resident's overall health and well-being and that 
a member of nutrition services will provide invaluable information to 
the IDT. We do not require that any of the members of the IDT 
participate in person. Facilities have the flexibility to determine how 
to hold IDT meetings whether in person or by conference call. The 
facility may determine that participation by the nursing assistant or

[[Page 68741]]

any member, may be best met through email participation or written 
notes. We believe that this added flexibility will help to alleviate 
concerns of shortage and availability.
    Comment: One commenter requested that we provide an explanation for 
how we expect the social worker to participate on the IDT when 
facilities with 120 or fewer beds are not mandated to have a social 
worker and those with more than 120 are only required to have one 
social worker.
    Response: We appreciate the feedback from the commenter. After 
further consideration, we are removing our proposal that requires the 
social worker to participate on the IDT. We agree that the proposal 
would not be appropriate given that all facilities are not required to 
employ a social worker. However, we strongly encourage facilities to 
leverage the many valuable assets that social workers can provide to 
LTC residents and their families. Often social workers can serve as a 
critical link between the facility and families of the residents, 
including arranging post-discharge services and addressing mental and 
behavioral health care needs. In addition, social services can be used 
by the facilities to promote resident choices and enhance the 
individualized quality of care and life specific to each resident.
    Comment: One commenter recommended that a pharmacist should also be 
required to participate on the IDT to highlight the importance of 
medication therapy as part of the care plan. Another commenter 
suggested that an activity professional should also be required to 
participate in the IDT and that many activity professionals are already 
a part of the resident assessment and the IDT.
    Response: We considered requiring the pharmacist to participate on 
the IDT and determined that it would be overly burdensome. However, the 
pharmacist is not precluded from participating in the IDT if it is 
determined to be necessary for a particular resident. In addition, we 
believe that the proposed requirements at Sec.  483.45 strengthen the 
involvement of the pharmacist in a resident's care including the need 
for a pharmacist to review the drug regimen of each resident at least 
once a month and the need to review a resident's medical chart every 6 
months (Sec.  483.45(c)(1) and (2)). Similarly, the activity 
professional is not precluded from participating on the IDT if it is 
determined to be necessary for a particular resident, even though they 
are not specifically listed at Sec.  483.21(2)(ii). Those facilities 
that currently involve the activity professional may continue to 
include these individuals.
    Comment: One commenter recommended that members of the IDT be 
required to provide explanation in the resident's medical record if 
they are unable to attend IDT meeting that discuss the resident.
    Response: Given the diversity of long term care providers, we have 
attempted to develop health and safety standards that can be applied 
across all types. We want to allow facilities the flexibility to 
determine how to ensure that the necessary professionals are involved 
in the development of each resident's care plan. We believe that adding 
a requirement for each member of the IDT to provide explanation in the 
resident's medical record of when they miss a meeting would be too 
burdensome.
    Comment: One commenter noted that a cost is associated with having 
additional individuals participate on the IDT and that CMS did not 
adequately identify the costs. To reduce the cost, the commenter 
suggested that instead the additional individuals could be interviewed 
prior to the meeting to obtain their valuable information.
    Response: In the regulatory impact analysis section of the proposed 
rule we indicated that we estimated that it will cost all long-term 
facilities $97,911,840 to have the additional individuals participate 
on the IDT (see FR 80 42237). We envision that these staff members are 
already regularly discussing resident's needs and their plans of care. 
In addition, we did not specify the type of communication the IDT must 
use for their meetings. In the proposed rule, we noted that to reduce 
cost, the IDT members may use electronic communication to participate 
in the IDT meetings. Facilities have the flexibility to determine how 
to conduct the IDT meetings and incorporate the staff who have been 
added to participate.
    Comment: One commenter indicated that the proposed rule does not 
reflect the expectation that a comprehensive person-centered care plan 
must include the participation of the resident or their representative. 
The commenter notes that the regulation includes the participation ``to 
the extent practicable.'' The commenter noted the failure of facilities 
to include resident's in the development of the care plan sited in the 
July 2012 OIG 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 commenter 
further notes that the OIG report references different types of 
resident representatives including the resident's family or legal 
representative.
    Response: Our proposed regulations at Sec.  483.21(b)(2)(ii)(F) 
would require that to the extent possible the resident and/or their 
representative(s) must participate on the IDT that develops the 
resident's care plan. For clarity, one example of when it may not be 
practical for a resident to participate in the development of their 
care plan may be in the case of a resident whose ability to make 
decisions about care and treatment is impaired, or a resident who has 
been formally declared incompetent by a court. We would expect that to 
the extent practicable these residents would be kept informed and 
consulted on personal preferences regarding their care.
    In the preamble of the proposed rule (see 80 FR 42192) we noted the 
gaps in care planning revealed by the July 2012 OIG report referenced 
by the commenter as well as another 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), conducted in February of 2013. In response to these 
reports and the gaps revealed, we also proposed at Sec.  
483.21(b)(2)(ii)(F) that the facility must provide an explanation in 
the resident's medical record if the participation of the resident and 
their representative is determined not practicable for the development 
of the resident's care plan. We note that the definition of ``resident 
representative'' includes individuals of the resident's choice (which 
may include family members) and individuals with legal standing.
    Comment: One commenter recommended that the requirement for a 
written explanation be provided when a resident or their representative 
does not participate in the development of their care plan be removed 
from the regulations and discussed in the interpretive guidance.
    Response: We disagree with the commenter. The July 2012 OIG report 
discussed previously and in the proposed rule (see 80 FR 42192) 
revealed that 91 percent of the care plans reviewed in the study did 
not contain evidence that the resident or a representative participated 
in the care planning process. Given this evidence and feedback from 
stakeholders, we continue to believe that residents should be involved 
in making decisions about their care and that it is appropriate for 
facilities to be held accountable for whether or not they actively 
include the resident and their representatives in the development of 
their care plan.
    Comment: One commenter indicated that the resident or their 
representative

[[Page 68742]]

should be invited to participate in the review or revision of their 
care plan in order for it to truly be person-centered.
    Response: Regulations at Sec.  483.21(b)(2)(ii)(E) require that the 
resident and/or their resident representative participate on the IDT 
that develops their care plan. In addition, regulations at Sec.  
483.21(b)(2)(iii) require that the care plan be reviewed and revised by 
the IDT. Therefore, the resident and/or their representative have the 
right to participate in the review or revision of their care plan under 
our proposal.
    Comment: Several commenters recommended that the regulations 
require a resident's participation in developing their care plan be 
strengthened by adding that the facility must provide advance written 
notice of the date and time of the care plan meeting, make reasonable 
accommodation of the schedules of the resident and any resident 
representatives invited to participate, and arrange for conference 
calls or video conferencing if necessary to enable resident 
participation.
    Response: Regulations at Sec.  483.10(c)(2) set forth the rights a 
resident has regarding their participation in the development and 
implementation of their plan of care which includes, among other 
rights, the right to request meetings, request revisions to their care 
plan, and the right to be informed, in advance, of changes to their 
plan of care. Regulations at Sec.  483.10(c)(3) provide that the 
facility has a responsibility to inform the resident of their right to 
participate in his or her treatment and support the resident in this 
right. Therefore, we believe that the regulations address the 
commenters' concerns and revisions are not necessary.
    Comment: A few commenter asked that ``trauma-informed care'' be 
defined as used at Sec.  483.21(b)(3)(iii) and added to the definitions 
section. One commenter noted that it is reasonable to tailor 
interventions to cultural preferences and difference, but indicated 
that this is different from requiring facilities to adhere to concepts 
such as ``culturally competent'' or ``trauma-informed''. The commenter 
indicated concern for surveyors to consistently and fairly identify 
whether a facility's efforts are sufficient. The commenter suggested 
instead requiring that facilities be mindful of and tailor services 
outlined by a resident's care plan to cultural differences and 
preferences. Another commenter noted that staff would need to be 
trained on trauma-informed care and that additional implementation time 
should be provided to allow for such training.
    Response: Culturally-competent and trauma-informed care are 
approaches that help to minimize triggers and re-traumatization. Care 
that addresses the unique needs of Holocaust survivors and survivors of 
war, disasters, and other profound trauma are an important aspect of 
person-centered care for these individuals. We noted in the proposed 
rule that 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. We do not believe 
that a definition of trauma-informed care should be added to the 
definitions section, but note that the interpretative guidelines and 
the resource noted previously will provide further information 
regarding culturally-competent and trauma-informed care. In addition, 
as with all of our requirements, surveyors will use uniform sub-
regulatory guidance and surveyor training will be provided to promote 
consistent enforcement. In addition, we note that the requirement 
related to trauma-informed care at Sec.  483.21(b)(3)(iii) has a 
delayed implementation deadline that is 3 years following the effective 
date of this final rule. For more detailed information regarding the 
implementation timeframe of this final rule, readers may refer to 
Section II.B., ``Implementation Date''.
    Comment: One commenter provided resources for facilities to refer 
to for information and material addressing culturally competent and 
trauma-informed care. The resources include The Council on Social Work 
Education, NASW's standards and indicators for cultural competence 
(available at http://www.socialworkers.org/practice/standards/index.asp), and The National Standards for Culturally and 
Linguistically appropriate Services in Health and Health Care 
(developed by the Office of Minority Health in HHS).
    Response: We appreciate the commenter's feedback and encourage 
readers to refer to these resources for information.
    Comment: One commenter recommended that the final rule make a 
better connection between care planning and a resident's quality of 
life. The commenter suggested that facilities should be encouraged to 
develop and share care planning documents that highlight resident 
goals. The commenter notes that a care plan that includes a wheelchair 
dependent resident's desire to gain strength to walk or a resident's 
food preference would be more beneficial to a activities director and 
member of food and nutrition services.
    Response: Regulations at Sec.  483.21(b)(1)(iv)(A) require that a 
resident's comprehensive care plan describe a resident's goals for 
admission and desired outcomes. In addition, we expect that any person 
who is involved in the implementation of a resident's plan of care will 
have access to their care plan. In order to fulfil a resident's plan of 
care it is necessary for facilities to share information with the 
appropriate members of a resident's care team. We expect that 
facilities are already doing this.
    Comment: One commenter suggested that facilities be required to 
provide copies of the care plan to residents when the plan is revised 
and require facilities to ensure that the plan is written in a manner 
that is understandable to the resident, not in medical jargon.
    Response: Since the comprehensive care plan is intended to be a 
working document that is constantly being reviewed and updated based on 
the needs of the resident, we believe that it would be overly 
burdensome to require facilities to make copies of the comprehensive 
care plan every time it is updated. However, we note that regulations 
at Sec.  483.10(c)(2)(iii) indicate that a resident has the right to be 
informed, in advance, of changes made to their plan of care and 
regulations at Sec.  483.10(c)(2)(v) indicate that the resident has the 
right to see their care plan including the right to sign after 
significant changes are made to their plan of care.
    In addition, we note that as discussed previously we received 
comments requesting that the right to receive a copy of the care plan 
be added to the list of resident rights discussed in Sec.  483.10. In 
response to these comments we have added a provision at Sec.  
483.21(a)(3) that requires facilities to provide residents and their 
resident representatives with a summary of their baseline care plan. 
This summary must include, but is not limited to, the initial goals of 
the resident, a summary of the resident's medications and dietary 
instructions, any services and treatments to be administered by the 
facility and personnel acting on behalf of the facility, and any 
updated information based on the details of the comprehensive care 
plan, as necessary. Note that this summary is subject to the provisions 
at Sec.  483.10(g)(3) and must be

[[Page 68743]]

provided 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.
    Furthermore, we believe that the comprehensive care plan should 
serve as an important tool for delivering patient-centered care and 
encourage facilities to explore ways to allow residents, families, and 
other representatives to access the care plan on a routine basis as 
appropriate, for instance, using technology solutions that enable real-
time access for authorized users and dynamic updating by members of the 
care team.
    Comment: One commenter recommended that a new subsection be added 
to the care planning regulations to require facilities to engage in an 
ongoing process of advance care planning that may include the 
completion of advance directives, education on the National Physician 
Orders for Life-Sustaining Treatment (POLST) Paradigm, and education 
regarding do-not-resuscitate and similar state-specific forms. This 
process should include assisting residents and their representatives to 
complete any related forms if desired.
    Response: We thank the commenter for their recommendations but 
decline to add additional requirements regarding advance directives and 
physician orders for life-sustaining treatment at this time. We note 
that advance directives are currently included in the requirements for 
participation and we proposed revisions that were primarily to improve 
clarity and readability (See our discussion of Sec.  483.10 Resident 
Rights). We recognize that the tools and education recommended by 
commenters may serve a function beyond advance directives and several 
of our requirements are also intended to facilitate shared, informed 
decision making and communication between health care professionals and 
residents with serious, progressive illness or frailty. We would expect 
that the issues that are addressed by physician orders for life-
sustaining treatment would be raised in the context of advance 
directives as well in ongoing discussions related to care planning and 
keeping in mind residents' goals of care and treatment preferences. To 
the extent applicable, such concerns should also be reflected in 
resident's discharge plan and discharge summary. All physician orders 
are documented in a residents' care plans. We note that a few states 
have developed POLST programs, a few states do not have such a program, 
and many states are in the process of developing such programs. 
Consistent with State law, it would be appropriate for facilities to 
inform residents about POLST, as those tools are referenced and 
recognized within the state. We note that current requirements already 
require a facility to provide written information to residents that 
includes a description of the facilities policies with respect to 
advance directives and applicable State law.
Discharge Planning
    Comment: Several commenters supported the addition of the Discharge 
Planning section. Commenters noted support for involving the IDT in the 
ongoing process of developing the discharge plan. Commenters also noted 
that the proposed requirements are superior to existing regulations and 
will help protect residents from the dangerous consequences of 
unexpected discharges. A few commenters indicated that discharge 
planning starts on the day of admission and is therefore a very time 
consuming and lengthy process.
    Response: We appreciate the commenters' feedback. We believe that 
the proposed requirements help to highlight the importance of safe 
transitions across care settings and support the need to safely reduce 
hospital readmissions and unnecessary hospitalizations.
    Comment: One commenter indicated that the discharge planning 
requirements should be revised to include transfer and discharge 
rights. The commenter noted that the proposed requirements may be 
misconstrued to authorize facilitates to discharge residents who still 
need LTC facility care after their Medicare coverage ends.
    Response: Facilities are required to adhere to all of the 
requirements for participation set forth in subpart B. Therefore, while 
meeting the discharge planning requirements at Sec.  483.21(c), 
facilities are also responsible for adhering to the requirements set 
forth in Sec.  483.15 regarding admission, transfer, and discharge 
rights and the requirements set forth at Sec.  483.10 regarding the 
rights of a resident and a facility's responsibility to support those 
rights. However, to avoid any confusion, we have added to the stem 
statement of Sec.  483.21(c)(1) a cross-reference to the regulations at 
Sec.  483.15 which sets forth the requirements related to transitions 
of care and requires facilities to establish, maintain, and implement 
identical policies and practices regarding transfer, discharge, and the 
provision of services for all individuals regardless of source of 
payment. Specifically, we have added language to indicate that a 
facility must develop and implement a discharge planning process that 
is consistent with the discharge rights set forth at Sec.  483.15(b) as 
applicable.
    Comment: One commenter requested that Sec.  483.21(c)(1)(i) require 
that the discharge planning process address a resident's goals not just 
their needs. The commenter indicated that the revision would be 
consistent with Section Q of the Resident Assessment Instrument Minimum 
Data Set (MDS 3.0) which focuses on residents' ability and desire to 
return to the community.
    Response: Regulations at Sec.  483.21(c)(1)(vi) require that the 
facility's discharge planning process must also address the resident's 
goals of care and treatment preferences.
    Comment: Commenters supported the need to consider the availability 
of family caregivers, and support persons, during the discharge 
planning process since these individuals are often involved in a 
resident's care following discharge from a facility. Commenters 
suggested that the regulation also require that facilities note whether 
an individual has a caregiver and their contact information, whether 
the family caregiver has voluntarily agreed to provide assistance, and 
whether the caregiver was provided with supports.
    Response: We appreciate the commenters' feedback and agree that the 
availability of a support system is crucial following discharge from a 
facility. We believe that the requirement at Sec.  483.21(c)(1)(iv) for 
a facility to 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, reflects the concerns raised by the commenter. The 
interpretative guidelines for this final rule would be the appropriate 
place to discuss specific questions/discussions that can be used to 
engage with the resident and their caregiver during the discharge 
process.
    Comment: Most commenters supported strengthening the requirements 
for the discharge summary and the proposal for facilities to reconcile 
all pre-discharge medications with residents' post discharge 
medications and to include this information as part of the discharge 
summary. The majority of commenters noted that strengthening the 
discharge summary will help to avoid unnecessary medication, prevent 
adverse drug interactions, and assist individuals and their caregivers 
post-discharge. One commenter questioned whether the requirement to 
reconcile all pre-discharge medications with a residents' post-
discharge medication would be

[[Page 68744]]

necessary in a LTC facility, given that many individuals are there for 
long periods of time. The commenter suggested that this requirement 
would be more appropriate for a hospital. Also, one commenter noted 
that often ``pre-hospitalization medication'' is often inaccurate or 
not shared with the facility. Another commenter recommended that 
facilities include a rationale for all the medications that a resident 
is receiving in the discharge summary. The commenter notes that pre-
discharge medications are often not needed and hospitals do not 
reconsider the need for continuing medications after discharge or 
advise the next facility that certain medications could potentially be 
stopped, reduced, or changed. Similarly, another commenter recommended 
that the discharge summary should also include the rationale for 
interventions, not just the diagnosis for interventions that a resident 
received. The commenter indicated that providing the rationale provides 
a basis for the diagnosis and not just the conclusion. Another 
commenter recommended that facilities be required to provide the 
discharge summary in a written manner that is understandable by the 
resident.
    Response: We appreciate the feedback from commenters and agree that 
strengthening the discharge summary requirements will lead to better 
outcomes for residents post-discharge. We note that the discharge 
summary is intended to be a recapitulation of a resident's stay and 
final summary of the resident's status. We believe that including a 
rationale for the medications that a resident is receiving and the 
services that they received for care would be overly burdensome and 
unnecessary since this information is included in a resident's medical 
record and available upon request. In addition, regulations at Sec.  
483.10(g) of this final rule discuss the extensive requirements that 
facilities must meet related to providing residents with information. 
Specifically, the regulations require the facility to ensure that 
information is provided to each resident in a form and manner that the 
resident can access and understand, including in an alternative format 
or in a language that the resident can understand. These requirements 
would have to be met by the facility in regards to the discharge 
summary; therefore we believe the need to provide the discharge summary 
in a written manner that is understandable by the resident is already 
covered in the regulations.
    We note that while some residents may reside in the facility for 
lengthy periods, that is not always the case. Our regulations are 
developed in an effort to address the varying services provided by a 
LTC facility and the different individuals that may reside in the 
facility. We have not required facilities to reconcile ``pre-
hospitalization medication'' but rather those medications a resident 
was prescribed prior to being discharged from the facility to those 
they are prescribed when leaving the facility. We expect that this 
information is readily available and is maintained as a standard 
practice by a facility in order to provide sufficient care.
    Comment: One commenter indicated discontent with the requirements 
added by the IMPACT Act, stating that the requirement is problematic 
and unenforceable. Also the commenter noted that it would not be 
practical or pertinent to use the data mandated by the IMPACT Act. The 
commenter noted further that the most pertinent information to provide 
to residents and families about facilities they are being transferred 
to should include actual experience with care provided, such as case 
reviews of individuals sent to the facility. The commenter also 
questioned whether there could be a conflict of interest in requiring 
facilities to recommend others. Furthermore, the commenter questioned 
how facilities should use the data to inform residents and how 
surveyors should judge whether facilities have done so adequately.
    Response: We appreciate the feedback from the commenter and agree 
that additional information may prove to be valuable to residents and 
their families for purposes of effectively transitioning from one care 
setting to another. However, we have proposed the requirements 
specifically mandated by the IMPACT Act. Facilities have the 
flexibility to present residents with additional information as long as 
the statutory requirements are met. Once the requirements of the IMPACT 
Act are implemented we may consider additional ways to improve the 
information that residents receive. We expect that facilities will not 
use the data to recommend facilities, but rather present the data to 
residents and their families in order to assist them in making an 
informed decision regarding the selection of a post-acute care 
provider. We note that the data presented must be based on the 
individual goals and preferences of the resident. In addition, we 
expect that facilities will demonstrate compliance with this 
requirement by showing evidence that the relevant data was presented to 
a resident and their family for consideration. As with any regulation, 
this final rule will also have sub-regulatory guidance that provides 
additional resources for how these requirements can be met by 
facilities.
    Comment: A few commenters questioned whether the IMPACT Act 
requirements at proposed Sec.  483.21(c)(1)(viii) apply to SNFs only or 
both Medicare certified SNFs and Medicaid certified NFs. Another 
commenter recommend that the statement at proposed Sec.  483.21(c)(1), 
``transition of the resident from SNF to post-SNF care'', be revised to 
include NFs also.
    Response: The IMPACT Act specifically refers to requirements for 
SNFs and at this time we are aligning our regulations with the statute. 
Following the implementation of the IMPACT Act we may consider how 
these requirements may also be applied to NFs. We note that the all of 
the requirements in Sec.  483.21(c) apply to both SNFs and NFs with the 
exception of those requirements related specifically to the IMPACT Act 
at Sec.  483.21(c)(1)(viii). Therefore, to improve clarity, we have 
revised the text at Sec.  483.21(c)(1) by removing the reference to 
``post-SNF care''. We believe that this revision clarifies that the 
discharge planning process must focus on all residents.
    Comment: One commenter indicated that facilities should be required 
to assist, if requested, with tasks necessary for relocation, such as 
making phone calls, packing, and obtaining prescriptions.
    Response: As part of the discharge summary, regulations at Sec.  
483.21(c)(2)(iv) require that resident's receive a post-discharge plan 
of care that is developed with the resident, which will assist the 
resident to adjust to his or her new living environment. The post-
discharge plan of care must indicate where the resident 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. We 
believe that it would be overly burdensome for facilities to also be 
required to assist residents with relocation tasks such as packing. In 
addition, we do not consider packing and other relocation tasks to be 
``health services'' within the meaning of the Act and therefore these 
tasks would not be covered under Medicare and Medicaid.
    Comment: One commenter indicated that residents should be provided 
with copies of their discharge plans and the evaluation of the 
resident's discharge needs.
    Response: Existing regulations provide residents with the right to

[[Page 68745]]

obtain copies of their medical records, which would include their 
discharge plan. Specifically, the regulations at Sec.  483.10(g) 
discuss the extensive requirements that facilities must meet related to 
providing residents with information. In this final rule the 
regulations require facilities to allow the resident to obtain a copy 
of their 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. In addition, while we are not requiring the facility provide 
the resident with a copy of the discharge plan, existing provisions 
require the facility to provide the resident with a discharge summary 
when discharge is anticipated, including the post-discharge plan of 
care (see Sec.  483.21(c)(2) of this final rule).
    Comment: One commenter indicated that Sec.  483.21(c)(2)(iv) should 
be revised to not limit the additional individuals that may be included 
in the development of the post-discharge plan of care to just a 
resident's family. The commenter suggests revising the language to 
state that a resident's representative or family (as defined by the 
resident) should be involved.
    Response: We have removed the language ``his or her family.'' The 
text Sec.  483.21(c)(2)(iv) is revised to ``a post-discharge plan of 
care that is developed with the participation of the resident and, with 
the resident's consent, the resident representative (s), which will 
assist the resident to adjust to his or her new living environment.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     At Sec.  483.21(a), we have clarified that the facility 
must implement the baseline care plan.
     At Sec.  483.21(a)(3), we have added a new requirement 
that facilities must provide residents and their representatives with a 
summary of their baseline care plan.
     At Sec.  483.21(b), we have clarified that the facility 
must implement the comprehensive person-centered care plan.
     At Sec.  483.21(b)(1), we have replaced the word 
``timetables'' with ``timeframe.''
     At Sec.  483.21(b)(2)(ii)(E), we have removed the 
requirement for a social worker to participate on the IDT.
     At Sec.  483.21(c)(1), we have added that a facility must 
develop and implement a discharge planning process that is consistent 
with the discharge rights set forth at Sec.  483.15(b) as applicable. 
We have also removed the reference to ``post-SNF care'' to clarify that 
the discharge planning process applies to both SNFs and NFs.
     At Sec.  483.21(c)(2)(iv), we have removed the language 
``his or her family'' and replaced it with ``the resident 
representative(s).''

K. 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 LTC facility 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 LTC facilities. We proposed 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.
    First, we proposed to retitle this section ``Quality of Care and 
Quality of Life'' and revise the introductory paragraph to 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.
    Second, in Sec.  483.25(a), we proposed to address the residents' 
ability to perform activities of daily living (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, to the extent 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. We proposed to divide 
the requirements of existing Sec.  483.25(a)(1) into proposed Sec.  
483.25(a) and (b). We proposed to re-designate existing paragraphs 
Sec.  483.25(a)(2) and (a)(3) as Sec.  483.25(a)(1) and (a)(2), 
respectively. We proposed to add a new Sec.  483.25(a)(3) to clarify 
that 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.
    In Sec.  483.25(b), we proposed to establish those activities that 
we include as ADLs. These activities are currently listed in Sec.  
483.25(a)(1)(i) through (v). We proposed to update the language of that 
list, although the underlying activities remain unchanged. We proposed 
to 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.
    In Sec.  483.25(c), we proposed to relocate the current 
requirements related to an activities program as required in existing 
Sec.  483.15(f). We proposed 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.
    We also proposed a new Sec.  483.25(d), ``Special Care Issues,'' 
which we revised, re-located, and added 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. As many of the concerns in this section were 
previously included in Sec.  483.25, we discuss here only the 
provisions we proposed to add or modify.
    Specifically, we proposed to re-designate and revise Sec.  
483.13(a), ``Restraints,'' as Sec.  483.25(d)(1). In the proposed rule, 
we indicated that while we 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 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 proposed to 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.
    We proposed a new Sec.  483.25(d)(2) to establish specific 
requirements when a facility uses bed rails on a resident's bed. 
Specifically, we proposed 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

[[Page 68746]]

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.
    We also proposed 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.'' In this section, we proposed 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 proposed to address mobility both range 
of motion and other limitations of mobility. We proposed 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 proposed 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. We proposed to retain, 
unchanged, colostomy, ureterostomy, and ileostomy care in Sec.  
483.25(d)(7). In Sec.  483.25(d)(8), we proposed 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 proposed to include 
gastrostomy tubes with nasogastric tubes, both percutaneous endoscopic 
gastrostomy and percutaneous endoscopic jejunostomy. We also proposed 
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 proposed 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 proposed 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.
    In Sec.  483.25(d)(9), we proposed to address only parenteral 
fluids. We included enteral fluids in Sec.  483.25(d)(8), our proposed 
provisions on assisted nutrition and hydration, as discussed earlier.
    We proposed to add a new Sec.  483.25(d)(13) to ensure that 
residents receive necessary and appropriate pain management. We 
proposed 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 proposed 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 proposed 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 proposed 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 proposed 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 later in our 
section on pharmacy services.
    Comment: Some commenters support our proposed changes to Sec.  
483.25, particularly requiring facilities to take into account a 
resident's comprehensive assessment, their preferences and choices in 
activities program and to provide activities that are designed to 
encourage independence and interaction in the community; and including 
oral care as a component of a basic hygiene activity of daily living 
(ADL). One commenter particularly supports proposed regulatory 
revisions related to nasogastric tubes and assisted nutrition and 
hydration and notes the importance of nutritional assessment, nutrition 
and hydration, and eating assistance to the physical and emotional 
well-being of residents. The commenter further supports sufficient 
regulatory flexibility to enable incorporation of new theories and 
emerging research into practice. One commenter recommended more 
specificity related to the use of nasogastric tubes. Other commenters 
support the addition of CPR, oral care, fecal incontinence, foot care, 
mobility, pain-management and/or trauma informed care.
    Response: We thank the commenters for their support. In our 
proposal, we added requirements that support person-centered care as 
well as those that support the resident in attaining or maintaining his 
or her highest practicable well-being.
    Comment: Many commenters objected to our restructuring of this 
section and felt that it was very important that quality of life be 
recognized in its own regulatory section. One commenter strongly 
opposed combining Quality of Life and Quality of Care into a single 
requirement, believing that it would distort and erase the focus on 
quality of life intended by the Nursing Home Reform Law. One commenter 
suggested we restore Quality of Life as its own section that includes 
language from the beginning of proposed rule Sec.  483.11; (treat each 
resident with respect and dignity, etc.); self-determination language 
from proposed rule Sec.  483.11(e); social services provisions 
(proposed rule Sec.  483.40(d)); and safe environment language 
(proposed rule Sec.  483.11(g), in addition to the language in the 
proposed rule about activities. One commenter believed that the 
proposed rules diluted the strength and power of the current quality of 
care regulations and recommends we keep totally intact the quality of 
care regulations as a separate

[[Page 68747]]

requirement. Another commenter stated that deleting quality of life 
sends a strong message that quality of life is not essential. Some 
commenters stated that they are troubled by the fact that CMS has 
scattered the provisions included in the current Quality of Life 
section throughout the proposed regulations and the only provision 
remaining in the proposed Quality of Care and Quality of Life section 
is proposed Sec.  483.25(c), ``Activities''. These commenters object 
to, for example, moving requirements about unnecessary drugs to the 
section on pharmacy services. These commenters recommend that Quality 
of Life be restored as its own section that includes language from 
self-determination (proposed Sec.  483.11(e)), social services 
(proposed Sec.  483.40(d)), and safe environment (proposed Sec.  
483.11(g)).
    Response: We have retained our proposed restructuring that moves 
the statements of resident rights previously contained in the Quality 
of Life section to the Resident rights section, Sec.  483.10. This 
section now also includes all of the provisions in proposed Sec.  
483.11, Facility responsibilities. However, we have separated quality 
of life and quality of care by establishing a new Sec.  483.24, Quality 
of life, which will establish quality of life as a separate overarching 
principle in the delivery of care to residents of LTC facilities. 
Section 483.24 contains proposed Sec.  483.35(a), (b), and (c), which 
addresses requirements related to activities of daily living, basic 
life support, and activities programs. Proposed Sec.  483.25(d), 
special care issues, is retained in Sec.  483.25, ``Quality of care''. 
With regard to other specific sections, please also see our discussions 
at sections N. ``Behavioral health services'' (Sec.  483.40) and O. 
``Pharmacy services'' (Sec.  483.45) of this preamble.
    Comment: Some commenters suggested CMS require additional training 
topics related to quality of care and quality of life for facility 
staff. One commenter also recommended that facilities be required to 
use a standardized care needs assessment tool that the public has an 
opportunity to comment on prior to adoption. The commenter recommends 
that this tool should include a specific space for facility staff to 
document why the loss of functioning was ``demonstrably unavoidable''; 
and facility should set up an internal review process that reviews this 
section to determine if more training is needed on conditions that 
could have been improved or maintained with current standards or 
assistive technology or mental health services and supports.
    Response: Please see our discussion of Sec.  483.95 in section Z. 
of this preamble for comments and responses related to training, 
including recommendations for additional training topics.
    Comment: A number of commenters felt that CMS should further 
address staffing. One commenter stated that residents cannot maintain 
or improve their highest level of well-being without good staffing 
practices and stated that CMS should reinforce the need for strong 
staffing practices in the proposed rule. Commenters suggest that good 
staffing practices include adequate numbers of competent, consistently 
assigned staff working well with the whole care team. Some commenters 
suggested mandating consistent or dedicated staffing. One commenter 
suggested regulatory language requiring staffing practices that 
maximize competency, continuity, and coordination of care.
    Response: Please see section K. ``Nursing services'', for our 
discussion of staffing.
    Comment: Some commenters recommend wording changes to make the 
language less institutional.
    Response: We have reviewed and considered each suggested wording 
change, but do not address each one individually. Where we felt the 
wording change improved clarity, we have accepted it. In one case, we 
added the term ``walking'' in addition to the word ``ambulation'' 
rather than as a replacement because, while ``walking'' is a less 
institutional term and therefore may be preferable, ``ambulation'' has 
other meanings, such as in reference to a resident in a wheelchair, 
where it means the ability to move around.
    Comment: One commenter expresses concerns about ``odd 
terminology'', stating that CMS gives ``titles'' to activities of daily 
living (ADLs), proposed Sec.  483.25(b)--for example, ``hygiene'' to 
refer to bathing, dressing, grooming, and oral care. The commenter 
stated that the term ``hygiene'' does not provide further explanation 
of the requirements and interferes with ease of reading and 
understanding. The commenter further suggests that the new modifiers 
for activities of daily living are unnecessary and should be deleted.
    Response: We believe the titles are useful to group similar 
activities and have retained them as proposed.
    Comment: One commenter stated that moving ``activities'' at 
proposed Sec.  483.25(b) from ``quality of life'', Sec.  483.15(f), to 
this new section, with its broader language, is not objectionable, but 
listing professional credentials in this regulation is odd. The 
commenter stated that all requirements for staff credentials should be 
located in a single section and recommended that we retain proposed 
Sec.  483.25(b)(1), but move proposed Sec.  483.25(b)(2) to a new 
section addressing staff credentials. Another commenter supported 
language added to this section regarding an ongoing program to support 
residents in their choice of activities, both group and individual, and 
the requirement for a facility to encourage independence and 
interaction in the community.
    Response: We often list credentials for specific staff in the 
sections that address the care the staff provide. For example, we do 
this for Food and Nutrition Services, Infection Control, and for 
certified nursing assistants under Nursing Services. We believe it is 
appropriate to include the credentials for an Activities Director in 
the section where the activities program is addressed. However, we will 
evaluate the suggestion for a single section to address all staff 
credentials and consider it for future rule-making.
    Comment: Many commenters recommended that we add board certified 
music therapist to the list of qualified professions who could serve as 
an activities program director. These commenters stated that the 
educational requirements for a music therapist prepare them to become 
excellent activities directors. Others suggested that an individual 
with a Master's degree in gerontology or aging studies, or other 
degree-based qualifications, be added to the list of qualified 
professionals who could serve as an activities program director. Some 
commenters did not want us to change the requirements, fearing that 
this would eliminate qualified candidates. Some commenters wanted to 
ensure that we did not change the requirements to specify a specific 
recognized accrediting body, while others suggested specifying a 
specific recognized accrediting body. Additional suggestions and 
options were offered as well.
    Response: We thank all the commenters for responding to our 
solicitation of comments regarding whether the requirements for the 
director of the activities program remain appropriate and what should 
serve as minimum requirements for this position. We have reviewed all 
of the comments and believe we need additional time to further evaluate 
the many suggestions we received. We are not making any changes at this 
time.
    Comment: A commenter felt that the section on ADLs needed an 
introductory statement as to the expectations for the facility related 
to the ADL list.
    Response: We have added introductory language to state that the

[[Page 68748]]

facility must provide care and services in accordance with paragraph 
(a) for the listed activities of daily living
    Comment: One commenter stated that in proposed Sec.  483.25(d) CMS 
has gathered an odd collection of care concerns and labeled them as 
``special care issues,'' some of which are issues common to most 
residents while other issues are truly ``special,'' in the sense of 
less common. The commenter recommends that care requirements common to 
all or most residents should be separately identified, without the 
modifier of ``special care needs'' and the term ``special care issues'' 
should be restricted to issues that are truly special, in the sense of 
uncommon. The commenter suggests that the subsections under the 
``Quality of Care'' requirement should be retained in the order that 
they are in current Sec.  483.25 and language in proposed Sec.  
483.25(a) should be incorporated into the preliminary language of the 
regulation so that the current order can be retained.
    Response: In order to more clearly express our intention, we have 
eliminated the modifier ``special care needs'' and revised this section 
in consideration of this and other comments.
    Comment: Some commenters felt that CMS should provide more 
information/clarification related to colostomy, ureteostomy, or 
ilesostomy; parenteral fluids; prosthesis; pain management; and 
dialysis. In addition, two commenters stated that ``urostomy'' is the 
correct terminology and should be used instead of ureterostomy.
    Response: We thank the commenter for their suggestion. We have 
changed ``ureterostomy'' to ``urostomy.'' We have also added language 
to final sections (f) ``Colostomy, urostomy, or ileostomy care,'' (h) 
``Parenteral fluids,'' (j) ``Prostheses,'' (k) ``Pain management,'' and 
(l) ``Dialysis.'' For each section, we have specified that care must be 
provided consistent with professional standards of practice applicable 
to that care. We defer to sub-regulatory guidance for additional 
detailed discussion.
    Comment: Some commenter suggested CMS add other documents besides 
advance directives to the requirements relating to providing basic life 
support.
    Response: We have added related physician orders to paragraph 
(a)(3). We defer to sub-regulatory guidance for additional discussion.
    Comment: One commenter requested that CMS clarify that, where CMS 
proposes that a resident receive care that is consistent with 
professional standards of practice, a standard of care that is 
``consistent with professional standards of practice'' is not to be 
interpreted as a maximum standard or to limit care options for 
residents with complex conditions or unique needs. The commenter urged 
CMS to clarify that when providing care that is consistent with 
professional standards of practice, the care also take into account 
individual residents' needs and complexity of individual residents' 
conditions.
    Response: The requirement that that care be provided in accordance 
with professional standards of practice is neither a maximum standard 
nor a limitation on care options. We would expect the resident and/or 
his or her representative to be informed about care and treatment as 
required by Sec.  483.10(c), as contained in the comprehensive care 
plan. The care and services provided to the resident must be provided 
in a manner that meets the professional standards and principles that 
apply to such care and services and to the professionals that provide 
those services.
    Comment: One commenter stated that some provisions are already 
incorporated into the current survey process and can be implemented one 
year following adoption of the final rule, including proposed Sec.  
483.25(a)(3), and (d)(13).
    Response: We deliberately included a number of provisions in the 
regulations that were previously in sub-regulatory guidance as we felt 
that doing so strengthens the requirements for some very important 
issues. Please refer to our discussion in Section B, Implementation, 
for additional information.
    Comment: Some commenters expressed concern that facilities would 
have to hire additional staff in order to meet proposed requirements 
that residents be assisted to make appointments and to arrange for 
transportation to appointments.
    Response: While we have revised and reorganized this section, the 
requirement to provide residents with assistance in making appointments 
and arranging transportation is an existing obligation. Similarly, 
while prior regulations did not explicitly require that facilities 
assist individuals to make podiatric appointments, facilities were 
already required to ensure that residents received proper treatment and 
foot care. Furthermore, we understand that some facilities have 
arrangements to provide these services on site, providing added comfort 
and convenience for residents while negating the need for at least some 
work to make transportation arrangements. We do not agree that our 
revised requirements impose a significant new burden.
    Comment: Several commenters commented on our proposed requirements 
regarding bed rails. One commenter stated that proposed Sec.  
483.25(d)(2), as written, declares that the existence of a side or bed 
rail is a deficient practice and recommends we amend the provision to 
read ``engaging'' a side or bed rail rather than ``installing'' a side 
or bed rail. The commenter stated that deficient practice is reflected 
by not implementing/attempting alternatives prior to the use or 
engagement of a side or bed rails. Another commenter was concerned that 
this provision lacks adequate qualifiers to all for various real-life 
situations and puts the facility in violation of the requirement when 
no viable alternative exists and suggests specific revisions to the 
regulatory language. Other commenters recommended extensive provisions 
addressing bed rails as restraints and the criteria to use bed rails 
when not used as a restraints. Some commenters objected to our 
including requirements related to bed rails. One stated that there was 
no clinically justifiable reason to use bed rails. Others stated that 
few LTC facilities use bed rails. Other commenters stated that some 
beds have quarter rails to house the bed and TV controls and it would 
be burdensome to take these on and off as residents are admitted and 
discharged. Many commenters supported the requirement that facilities 
try alternatives to bed rails.
    Response: We thank the commenters for their suggestions and 
support. Proposed paragraph (2) sets out several requirements to be met 
before the bed or side rail is installed. We believe these requirements 
are important for resident safety before installation can create an 
expectation of use. We have re-designated this as paragraph (n) and, 
based on a combination of commenter suggestions, revised it to require 
that the facility must attempt to use appropriate alternatives prior to 
installing a side or bed rail, then to require that if a side or be 
rail is used, such use must meet specific requirements. In addition, we 
have reworded the provision so that the bed's dimension is appropriate 
for the resident's size and weight rather than the resident's size and 
weight being consistent with the bed's dimension, as recommended by a 
commenter. We defer additional discussion to sub-regulatory guidance. 
We expect that surveyors will conduct a fair and consistent review of 
these situations based on the facts of each case.

[[Page 68749]]

    Comment: One commenter objected to the addition to proposed Sec.  
483.25(d)(8)(i) of ``or resident preferences indicated otherwise'' and 
recommended we delete it. The commenter was concerned that a facility 
could use this as a means to not meet a resident's nutritional needs. 
The commenter stated that the facility would need to demonstrate that 
it served nutritious and appetizing food; identified the resident's 
food preferences; offered appropriate alternative foods to the 
resident; had sufficient numbers of trained staff to assist the 
resident in eating; maintained a pleasant environment for meals; 
provided assistive devices, as needed; addressed the resident's mental 
health needs; had received a medical determination from the resident's 
physician that the resident's medical condition indicated that weight 
loss was unavoidable; and took other necessary steps before it could 
justify not meeting a resident's nutritional needs.
    Response: This provision addresses assisted nutrition and 
hydration, and, like all treatments, residents have the right to accept 
or refuse. Accepting a resident's refusal, or deferring to their 
documented preferences, does not absolve a facility of its 
responsibilities to provide adequate nutrition or permit the facility 
not to meet a resident's nutritional needs. It does recognize that a 
competent resident has the right to make choices about assisted 
nutrition and hydration and that there are circumstances where failure 
to maintain acceptable parameters of nutritional status are not a 
reflection of failure(s) of care.
    Comment: Several commenters supported our proposal to add trauma-
informed care at Sec.  483.25(d)(15). Some commenters suggested 
additional related requirements, including adopting trauma informed 
care approaches, and requiring facilities to provide training regarding 
trauma informed care to all staff at all levels. Some commenters 
recommended deleting this provision entirely. One commenter stated that 
providing ``trauma-informed care'' is prudent and extremely important 
for those individuals who have experienced trauma in their lives and 
continue to live with residual effects from these experiences, but had 
several concerns about the requirement. The commenter noted that the 
link to the SAMHSA guidance does not work, and furthermore, SAMHSA's 
mission is focused on recovery and resilience. In addition, the 
reference to utilizing ``professional standards of care'' does not 
provide specific professional standards of care for individuals who are 
trauma survivors. Without specific identification of recognized and 
acceptable standards, determining compliance with this requirement will 
be varied and subjective. Furthermore, there was no clear definition 
provided for the term ``culturally competent care.'' Another commenter 
stated that there are other issues and concerns that are equally or 
more important to other individuals with other conditions that are not 
specified in regulation or mentioned in guidance.
    Response: Culturally-competent and trauma-informed care are 
approaches that help to minimize triggers and re-traumatization, 
including care that addresses the unique needs of Holocaust survivors 
and survivors of war, disasters, and other profound trauma are an 
important aspect of person-centered care for these individuals. We 
noted in the proposed rule that 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. We were 
able to access this document via the link provided; alternatively, it 
is available through the SAMSHA.gov Web site by clicking on 
``publications'' on the upper right and searching for SMA 14-4884. As 
discussed in our comments and responses section H, ``Comprehensive Care 
Planning,'' we do not believe that a definition of trauma-informed care 
should be added to the ``Definitions'' section, but note that the 
interpretative guidelines and the resource noted previously will 
provide further information regarding culturally-competent and trauma-
informed care. In addition, as with all of our requirements, surveyors 
will use uniform sub regulatory guidance and surveyor training will be 
provided to promote consistent enforcement. Please see our discussion 
of trauma-informed care in section J. ``Comprehensive care planning.'' 
We note in the comments and response for that section that one 
commenter provided resources for facilities to refer to for information 
and material addressing culturally competent and trauma-informed care. 
The resources include The Council on Social Work Education (see http://www.cswe.org), NASW's standards and indicators for cultural competence 
available at http://www.socialworkers.org/practice/standards/index.asp, 
and The National Standards for Culturally and Linguistically 
appropriate Services in Health and Health Care developed by the Office 
of Minority Health in HHS (see https://www.thinkculturalhealth.hhs.gov/index.asp).
    Comment: One commenter recommended we amend the requirement to 
provide trauma-informed care, Sec.  483.25(d)(15), to say ``When a 
facility is aware that a resident/patient is a trauma survivor, the 
facility must ensure these residents/patients receive care that takes 
into account the residents' experiences and preferences in order to 
eliminate or mitigate triggers that may cause re-traumatization of the 
resident.''
    Response: We do not agree with adding the qualifier ``when a 
facility is aware'' nor do we agree with deleting reference to 
culturally competent, trauma-informed care in accordance with 
professional standards of practice. Please see our earlier discussion 
in this section as well as the discussion in section J, ``Comprehensive 
Care Planning.''
    Comment: One commenter suggested that any requirements related to 
trauma-informed care have a 5-year phase in period.
    Response: Please see our discussion of implementation deadlines in 
section II.B, ``Implementation.''
    Comment: One commenter stated that the current regulation, at Sec.  
483.25(c)(1), begins with the statement that the resident who enters 
the facility without pressure ulcers should not develop them unless the 
resident's clinical condition demonstrated that they were unavoidable, 
but the proposed Sec.  483.25(d)(4)(i)(A) omits that language entirely, 
beginning with the requirement that the facility provide care to 
prevent development of pressure ulcers. The commenter stated that 
current language should be restored as a new (A) with the proposed 
subsections (A) and (B) moved to (B) and (C), respectively.
    Response: The commenter is correct that the proposed language omits 
the statement ``the resident who enters the facility without a pressure 
ulcer.'' The remaining language is included in the proposed provision. 
Any resident at any time who does not have a pressure ulcer, even if 
the resident had one upon admission and it has resolved, must receive 
care and services to prevent the formation of pressure ulcers unless 
the resident's clinical condition demonstrates that the development of 
pressure ulcers was unavoidable. Similarly, any resident who has a

[[Page 68750]]

pressure ulcer, no matter when or why it developed, must receive care 
and services to promote healing, prevent infection, and prevent new 
ulcers from developing.
    Comment: One commenter stated that proposed paragraph (d)(5) 
mobility should be correctly title ``range of motion'' as in the 
current rule.
    Response: We disagree. Range of motion, defined as the full 
movement potential of a joint, is important to mobility, but it does 
not encompass the full extent of the proposed provision. Proposed 
paragraph (d)(5) includes in (i) and (ii) requirements to ensure that a 
resident does not lose range of motion and, if the resident has a 
limited range of motion, receives services to, at a minimum, maintain 
existing range of motion and, if feasible, to improve range of motion. 
The proposed provision goes on to address mobility, defined as the 
ability to move, and to require that residents with limited mobility 
receive appropriate services to maintain or improve his or her 
mobility. Each of the three provisions is about a resident's ability to 
move, thus we have included them together is a provision about 
mobility.
    Comment: A number of commenters expressed concern about our 
provisions related to the use of restraints in facilities. One 
commenter stated that although new language about using the least 
restrictive alternative for the least amount of time and documenting 
ongoing evaluation of the need for the physical and chemical restraints 
was helpful, the proposed regulation does not adequately protect 
residents. Several commenters suggested a separate section specifically 
addressing restraints. Some commenters recommended additional 
requirements such as reporting any death which may have resulted from 
the use of a restraint; an environmental assessment; an in-person 
evaluation by a physician; informed consent; an in-person evaluation by 
the resident's physician; one-on-one monitoring; or release and 
monitoring when the use of restraints is indicated. Some commenters 
noted that there are more extensive requirements for other provider 
types (community mental health centers, hospitals). Some commenters 
requested that we explicitly include bed rails as restraints and 
strengthen our provisions related to bed rails. Some commenters 
suggested we only allow the use of bed rails if the resident requests 
them for mobility or other assistance and any time a bed rail is 
considered, a safety assessment be conducted using protocols that 
require an evaluation of residents and bed systems by an 
interdisciplinary team that includes specific professional staff. Some 
commenters requested that regulations more explicitly address chemical 
restraints and that we specifically address the use of wheelchairs as a 
restraint. One commenter suggested we relocate requirements related to 
restraints and bed rails to the section on facility responsibilities 
because inclusion here could imply they were a special treatment or 
care. The commenter also recommended addressing bed rails as restraints 
because not doing so implies that bed rails are not restraints. One 
commenter stated that restraint should be a requirement separate from 
quality of care because restraints are not an appropriate method for 
providing care. Other commenters discuss restraints in the context of 
trauma-informed care.
    Response: We acknowledge the commenter's concern that including 
restraints in this section could create an impression that the use of 
restraints is acceptable. We have relocated this provision to Sec.  
483.12(a) and added a cross reference to Sec.  483.12(a)(2) in Sec.  
483.10(e)(1) to ensure that the resident's right to be free of 
restraints is considered in the context of the requirement now in Sec.  
483.12(a)(2). We will continue to review our provisions related to 
restraints and will consider adding additional, more prescriptive 
requirements through future notice and comment rule-making.
    We considered similarly relocating our provision regarding bed 
rails, but do not believe that these requirements as clearly belong in 
Sec.  483.12. Therefore, we have retained this provision as Sec.  
483.25(n).
    Comment: One commenter suggested we retain assisted nutrition and 
hydration, prostheses, dialysis, and trauma-informed care as special 
care issues and move the rest of the issues to another part of the 
section.
    Response: We thank the commenter for their suggestion. We have 
modified this section based on other comments, however, believe it is 
appropriate to retain all of the proposed requirements in the section.
    Comment: One commenter recommended adding a separate section on 
honoring sleep.
    Response: We thank the commenter for their suggestion. We currently 
address sleep and wake times at Sec.  483.10(f)(1). We defer additional 
discussion to sub-regulatory guidance.
    Comment: Commenters supported the added specificity of proposed 
requirements regarding skin integrity, foot care, incontinence, and 
enteral feeding.
    Response: We thank the commenter for their support. We believe the 
proposed additions will assist in ensuring that LTC facility residents 
receive necessary care.
    Comment: One commenter suggested that in proposed paragraph (d)(4) 
we clarify that the standard is professional current clinical standards 
of practice.
    Response: We do not agree that this clarification is necessary. The 
statement ``professional standards of practice'' applies whether or not 
the issue is clinical, as in direct care delivery, or non-clinical, 
such as some administrative or physical plant concerns might be 
considered. In addition, ``professional standards of practice'' 
inherently means the professional standards that apply at the time that 
the care or service is delivered.
    Comment: Some commenters supported our proposed provision (d)(6) 
regarding incontinence. One commenter stated that the urinary tract 
includes more than just the bladder (that is, kidneys, ureters, 
urethra, prostate) and that various conditions and factors (for 
example, delirium, metabolic disorders, functional impairments, 
diuretic use) may affect continence. The commenter suggested that 
proposed (d)(6)(ii)(C) be revised to more accurately reflect that the 
goal is to try to improve continence by stating that the resident who 
is incontinent of bladder receives appropriate treatment and services 
to prevent urinary tract infections and to restore continence to the 
extent possible. Another commenter suggested we require that if a 
resident becomes incontinent, a determination regarding why be made. A 
different commenter recommended requiring that a resident's bathroom 
needs be anticipated and met to reduce the development of incontinence 
on because the resident did not get the help she or he needed to get to 
the bathroom on time.
    Response: We thank the commenters for their suggestions. We have 
modified proposed Sec.  483.25(d)(6)(ii)(C), finalized at paragraph 
Sec.  483.25(e)(2)(iii), to focus on continence as suggested. We 
require that a resident who is continent of bladder receives services 
and assistance to maintain continence unless his or her clinical 
condition is or becomes such that continence is not possible to 
maintain. We believe that in order to meet this requirement, both 
assistance to use the bathroom to prevent incontinence in a continent 
resident and an assessment of the cause of new incontinence would be 
necessary. We defer additional discussion to interpretive guidance.
    Comment: One commenter noted that nutrition status is complex and

[[Page 68751]]

recommended revising paragraph (d)(8) to include total parenteral 
nutrition, to eliminate protein levels as a parameter of nutritional 
status based on recent research, to add electrolyte balance as a co-
equal concern to hydration, and to add the qualifier ``unless the 
resident's clinical condition demonstrates that this is not possible or 
resident preferences indicate otherwise.'' The commenter stated that 
serum protein levels have significant limitations as a parameter of 
nutritional status and should not be listed as a measure. The commenter 
further stated that hydration maintenance is about more than just 
providing fluids, and should consider electrolyte balance as well and 
that some dehydration is unavoidable such as occurs with residents on 
palliative care who are not eating and drinking. Another commenter 
stated that this proposed provision inappropriately combines two 
existing sections, mislabeling them, and minimizing the critical 
importance of nutrition and hydration for residents. The commenter 
stated that CMS should restore the original two separate regulatory 
requirements.
    Response: We thank the commenters for their suggestions and agree 
that nutrition status is complex. We have eliminated the requirement 
for protein levels and added electrolyte balance. We believe it is 
appropriate to address parenteral fluids separately, as this involves 
the intravenous infusion of fluids. We also believe the requirements, 
as proposed, acknowledge the potential for unavoidable variations and 
recognize the resident's right to refuse treatment. We defer any 
additional discussion to sub-regulatory guidance. We disagree that 
nutrition and hydration should be two separate sections. Fluids are a 
source of nutrition and food is a source of hydration.
    Comment: One commenter stated that the proposed change in Sec.  
483.25(j) from providing sufficient fluids to offering sufficient 
fluids is objectionable.
    Response: This change was proposed in response to anecdotal 
accounts of fluids being placed in a resident room without ensuring 
that the resident was actually able to drink them. While residents' 
have the right to refuse to drink the fluids, it is not enough for a 
facility to simply place fluids in a resident room. We would expect 
that the fluids actually be offered to the resident and assistance 
provided so that the resident can drink, if they so desire.
    Comment: One commenter recommended that proposed Sec.  483.25(c) be 
amended to read: ``Based on the comprehensive assessment and care plan 
and the preferences of each resident, the home/community must provide 
ongoing opportunities for engagement with life or meaningful engagement 
via group, individual and independent opportunities 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.'' This change in language would remind 
everyone that individual resident preferences for engagement in 
meaningful ways should be identified and followed.
    Response: We agree and thank the commenter for their support. We 
have incorporated the commenter's suggestion and are finalizing this 
provision at Sec.  483.24(c)(1).
    Comment: One commenter suggested addressing the use of personal 
bed, chair, floor mat and laser alarms as devices with restraint 
qualities.
    Response: We discuss alarms in section E of this preamble. As noted 
there, if such devices are used as restraints, their use must comply 
with our requirements related to restraints.
    Comment: One commenter requested that we clarify that a new 
intervention is not required after each fall or incident, but that a 
root cause analysis should be conducted.
    Response: We agree that the response to a fall or incident should 
be episode specific, that a new intervention may not always be 
necessary, and that frequently a root cause analysis will be necessary. 
We defer to sub-regulatory guidance for additional discussion.
    Comment: One commenter supported our proposed change that a 
resident be offered a therapeutic diet instead of mandating a 
therapeutic diet.
    Response: We thank the commenter for their support and note that 
this change is consistent with our person-centered approach.
    Comment: Some commenters suggested that CMS address wheelchair use, 
including need, premature use, a plan of care for maintaining strength 
and mobility, and other concerns.
    Response: We thank the commenter for these suggestions. We believe 
that these issues should be addressed in the person-centered plan of 
care. However, we will further evaluate these concerns and consider 
them for inclusion in future notice and comment rule-making.
    Comment: Some commenters requested that we add a new section to 
special care issue to address dementia care. Others suggested that 
requirements for dementia care be added to the quality of care 
requirements. Commenters offered suggestions for such a section, 
including current language from sub-regulatory guidance.
    Response: We thank the commenters for these suggestions. We 
considered, but did not propose dementia-specific provisions for this 
rule. We agree that residents with dementia have specific needs as a 
result of their disease. Resident rights, person-centered care 
planning, and other provisions of this subpart work together to require 
that the individual's needs be met. Even among residents who have this 
diagnosis in common, needs may differ significantly. Residents with 
different diagnoses may benefit from similar care. We expect all 
residents to receive care to meet their needs, based on a 
comprehensive, person-centered care plan that reflects the resident's 
needs, goals, and preferences. We believe that the person-centered 
approach to care reflected throughout these regulations will best serve 
individual residents based on individualized diagnosis and needs. We 
will continue to evaluate this issue and may consider it for inclusion 
in future notice and comment rule-making.
    Comment: One commenter discussed the importance of a culture of 
safety and recommended that we incorporate a new section to address 
worker and resident safety issues, including safe resident handling and 
lifting, hazard protections, workplace violence, and other safety 
issues.
    Response: We thank the commenter for their suggestions. A culture 
of safety and worker safety are important issues. However, many of the 
suggestions provided are outside the scope of this regulation and many 
are already regulated by the Occupational Safety and Health 
Administration. Moreover, our statutory authority is limited to 
regulations that protect the health and safety of residents; we hope 
that our rules also protect the safety and well-being of staff and 
employees, but such results cannot be the basis for our authority. We 
will continue to evaluate the best way to identify and incorporate 
those elements that may be appropriate for incorporation into 
requirements for participation and consider them in future rule-making.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We have established Sec.  483.24, Quality of life, which 
contains proposed Sec.  483.35(a), (b), and (c) re-designated as Sec.  
483.24(a), (b), and (c), respectively, and revised the introductory 
language to clarify that quality of life applies to all care and 
services provided to facility residents.
     We have added an introductory statement to new paragraph 
Sec.  483.24(b).

[[Page 68752]]

     We have added the word ``walking'' in addition to 
``ambulation'' at Sec.  483.24(b)(2).
     We have revised the title of Sec.  483.25 to read 
``Quality of care,'' eliminated the modifier ``special care issues,'' 
revised the introductory language to clarify that quality of care 
applies to all care and services provided by the facility, and re-
designated Sec.  483.25(d)(3) through (15) as Sec.  483.25(a) through 
(m), respectively.
     We have added ``related physician orders'' to paragraph 
Sec.  483.24(a)(3) regarding the provision of basic life support.
     In Sec.  483.25, we removed (d)(1) relating to restraints 
and relocated it at Sec.  483.12(a)(2).
     We have re-designated proposed Sec.  483.25(d)(2) Bed 
rails as paragraph Sec.  483.25(n), added an appropriateness qualifier 
to the regulatory text and reworded the provision about the bed's 
dimension for clarity.
     We have re-designated Sec.  483.25(d)(6)(ii)(C) as Sec.  
483.25(e)(2)(iii) and revised it to state ``restore continence to the 
extent possible.''
     We have added language to Sec.  483.25(f), (h), (i), (j), 
(k), and (l) to require that care be provided consistent with 
professional standards of practice applicable to that care as well as 
the comprehensive person-centered care plan, and the residents' goals 
and preferences.
     In Sec.  483.25(g)(1), we have eliminated the reference to 
protein levels as a nutritional parameter and add reference to 
electrolyte balance.

L. Physician Services (Sec.  483.30)

    Under the reorganization discussed earlier, requirements regarding 
physician services currently located at Sec.  483.40 were proposed to 
be moved to new Sec.  483.30. We proposed to retain the current 
requirements but proposed a few additions as discussed below.
    We proposed to revise the introductory text of 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.
    We also proposed 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.
    At Sec.  483.30(f)(2), we proposed 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.
    Similarly, at Sec.  483.30(f)(3), we proposed 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.
    Comment: We received a comment in support of our revision to the 
introductory language to Sec.  483.30 allowing a physician, physician 
assistant, nurse practitioner, or clinical nurse specialist to write 
orders for a resident's immediate care and needs upon admission. The 
commenter stated that they believed this would help ensure more 
immediate access to care.
    Response: We thank the commenter for his support. We understand 
that the time period around a transition of care, including admission 
to a facility, can pose added risk. We expect that this provision will 
help ensure that the resident receives care for his or her specific 
needs until a comprehensive assessment and care planning can be 
completed.
    Comment: We received a significant number of comments on our 
proposal 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. Although a few 
commenters supported the proposal, the majority disagreed with the 
proposal, for a variety of reasons. The comments reflected significant 
concern about the burden this requirement would place on facilities, 
particularly small and rural facilities. Some commenters were concerned 
about added expense and suggested this requirement could not be 
implemented without payment reform. Beyond the cost issue, many 
facilities were concerned about the impact this requirement would have 
on their ability to recruit physicians, NPs, PAs, and CNS's to fill 
this role. In particular, rural facilities suggested that this 
requirement could not be met in areas where there are professional 
shortages. Further, some commenters suggested that this requirement 
would drive practitioners of all types away from working in LTC 
facilities and would ultimately result in reduced access and reduced 
quality of care and safety for residents.
    In addition, some commenters felt that this proposal would result 
in delayed access to care, resulting in harm to patients. Some 
commenters also felt that this requirement could conflict with resident 
rights, specifically, the resident's or resident representative's right 
to request such a transfer. One commenter stated that, in many 
circumstances, a practitioner can make an adequate assessment over the 
phone and that CMS had shown no reason to adopt this requirement, and 
facilities already have incentives to avoid unnecessary hospital 
transfers. Many commenters asked what was wrong with the current system 
of the nurse and physician speaking about the plan of care over the 
phone, stating that this is sufficient. Finally, some commenters stated 
that this proposal failed to recognize an appropriate role for 
registered nurses, in coordination with a practitioner. Commenters 
suggested we allow this requirement to be completed through a 
telehealth mechanism or using registered nurses.
    Response: The intent of this provision was to encourage the 
identification of opportunities to treat residents in their facilities, 
reducing the risks associated with the transfer to a hospital. In 
August of 2012, CMS launched ``The Initiative to Reduce Avoidable 
Hospitalizations Among Nursing Facility Residents'' (see https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/InitiativetoReduceAvoidableHospitalizations/AvoidableHospitalizationsamongNursingFacilityResidents.html). This 
effort aims to improve the quality of care for people residing in 
nursing facilities by reducing avoidable hospitalizations. Under the 
initiative, CMS supports enhanced care & coordination provider 
organizations that each partner with a group of nursing facilities to 
implement evidence-based clinical and educational interventions that 
both improve care and lower costs. The initiative is focused on long-
stay nursing facility residents who are enrolled in both the Medicare 
and Medicaid programs, with the goal of reducing potentially avoidable 
inpatient hospitalizations. CMS announced a second phase of ``The 
Initiative to Reduce Avoidable

[[Page 68753]]

Hospitalizations among Nursing Facility Residents'' on August 27, 2015. 
Under the new phase, a new funding opportunity will allow the 
organizations currently participating in the initiative to apply to 
test whether a new payment model for nursing facilities and 
practitioners, together with the clinical and educational interventions 
in place under the current initiative, will improve quality of care by 
reducing avoidable hospitalizations while also lowering combined 
Medicare and Medicaid spending (see https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/InitiativetoReduceAvoidableHospitalizations/AvoidableHospitalizationsamongNursingFacilityResidents.html). After 
consideration of the comments and pending the outcome of the second 
phase of the initiative discussed above as well as in order to allow 
further time to evaluate suggested alternatives, we have decided not to 
finalize this requirement at this time. Therefore, we are withdrawing 
proposed Sec.  483.30(e) as well as our proposal to redesignate 
paragraphs (e) and (f) as (f) and (g).
    Comment: A commenter noted that existing Sec.  483.40(f) states 
that at the option of the State, any required physician task in a NF 
(including tasks which the regulations specify must be performed 
personally by the physician) may also be satisfied when performed by a 
nurse practitioner, clinical nurse specialist, or physician assistant 
who is not an employee of the facility but who is working in 
collaboration with a physician. We proposed to re-designate existing 
Sec.  483.40(f) as Sec.  483.30(g). The commenter recommended that we 
remove the phrase ``who is not an employee of the facility but'' from 
the language in Sec.  483.30(g). Another commenter noted that the 
provision creates a difference between SNFs and NFs and suggests that 
the requirement should apply to both SNFs and NFs.
    Response: We proposed to re-designate Sec.  483.40(f) as Sec.  
483.30(g) but did not propose any changes to the language contained in 
the current requirement. Therefore, we cannot make any changes at this 
time, but will evaluate these comments and consider them for future 
regulatory proposals. Section 1919(b)(6) of the Act permits States to 
give NFs the discretion to allow a nurse practitioner, clinical nurse 
specialist, or physician assistant who is ``not an employee of the 
facility'' but working in collaboration with a physician to supervise 
the provision of healthcare at an NF. We do not have the authority to 
modify this.
    Comment: We received comments in support of our proposal to allow 
physicians to delegate the authority to write dietary orders to 
dietitians acting within their scope of practice under state law and 
under the supervision of the physician. One commenter noted that these 
professionals may actually know the resident better than the attending 
physician. Another stated that this would allow better use of 
professional's time. One commenter suggested that this authority should 
be limited to the attending physician or his or her designee. Another 
suggested that a physician, physician assistant, nurse practitioner, or 
clinical nurse practitioner should be able to make this delegation.
    Response: We appreciate comments in support of this proposal. We 
agree that it would be appropriate to limit this authority to the 
attending physician, as that individual retains primary responsibility 
for the care of the resident. We have modified the regulatory text at 
proposed Sec.  483.30(f)(2) and Sec.  483.30(f)(3) accordingly and 
finalize these provisions at Sec.  483.30(e)(2) and Sec.  483.30(e)(3).
    Comment: We received comments objecting to our proposal to allow 
physicians to delegate writing orders to qualified dietitians or other 
clinically qualified nutrition professionals and to qualified 
therapists for diets and therapy, respectively. One commenter felt that 
these proposals were focused on reimbursement concerns or amounted to 
condoning violation of current regulations. The commenter goes on to 
state that CMS should not authorize the physician to shift all 
authority to the therapist and that this would exacerbate the abuse of 
therapy. Another commenter suggested that such orders could be written 
without adequate consideration of the whole picture.
    Response: Our proposal is intended to improve responsiveness to a 
resident's needs and is implemented at the discretion of the physician. 
It does not allow a physician to shift all authority to either a 
dietitian or a therapist, as the qualified professional to whom the 
task is delegated must not only be acting within their scope of 
practice under state law, they must also be under the supervision of 
the physician. Nothing in this provision would permit ordering of 
inappropriate or excessive therapy. As professionals acting within 
their scope of practice and having more frequent direct contact with 
and observation of the resident, therapists may be able to be more 
responsive to a resident's needs and to changes in a resident's 
condition. This could actually reduce the amount of inappropriate 
therapy. Furthermore, as noted above, the resident's care remains under 
the supervision of the physician. As one commenter noted, our proposal 
provides for both oversight and accountability. Finally, based on other 
comments, we have modified this proposal to limit this authority to the 
attending physician who is responsible for the care of the resident and 
who should be aware of the full spectrum of issues and concerns 
regarding the resident.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We have withdrawn proposed Sec.  483.30(e).
     We have removed our proposal to redesignate paragraphs (e) 
and (f) as paragraphs (f) and (g).
     We have modified the regulatory text at Sec.  483.30(e)(2) 
and Sec.  483.30(e)(3), respectively, to specify that it is the 
attending physician who has the authority to delegate to a qualified 
dietitian or other clinically qualified nutrition professional the task 
of writing dietary orders, and to delegate to a qualified therapist the 
task of writing therapy orders, to the extent that these professionals 
are permitted to perform these tasks under state law.

M. Nursing Services (Sec.  483.35)

    Under the proposed reorganization, requirements for nursing 
services currently located at Sec.  483.30 were proposed to be 
relocated to Sec.  483.35. The current regulations at Sec.  483.30 
address certain aspects of LTC facility 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.
    We proposed a competency-based staffing approach that requires the 
facility to evaluate its population and its resources in accordance 
with 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. In Sec.  483.35, we proposed to clarify that the 
facility must take into account its assessment of all residents as well 
as the skill-sets of individual staff when making staffing decisions. 
We also proposed revisions to improve the logical order and readability 
of these regulatory provisions. In the proposed rule, we included a 
robust discussion regarding the long-standing interest in increasing 
the required hours of nurse staffing per day and the various

[[Page 68754]]

literature surrounding the issue of minimum nurse staffing standard in 
LTC facilities (See 80 FR 42199). We refer readers to the proposed rule 
for this background information.
    We proposed to clarify at Sec.  483.35(a)(1)(ii) that NAs are 
included in the term ``other nursing personnel.'' We proposed 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 
proposed 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.
    Consistent with our clarification that NAs are included in the term 
``other nursing personnel,'' we proposed to move most of the provisions 
relating to NAs previously located in Sec.  483.75 to proposed Sec.  
483.35. Specifically, we proposed to re-designate Sec.  483.75(f) 
``Proficiency of Nurse Aides'' as Sec.  483.35(c). We proposed 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. We proposed to re-designate the 
regulations at Sec.  483.75(e) to Sec.  483.35(d)(2) and address non-
permanent employees. Non-permanent caregivers are expected to meet 
competency, knowledge and skill requirements to the same extent as 
permanent personnel. We also proposed 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.
    Comment: Some commenters agreed that CMS should not impose 
mandatory staffing ratios, including the requirement for a 24/7 
registered nurse on the premises. These commenters acknowledged the 
importance of staffing levels but did not feel that such mandates were 
the best way to clarify ``sufficient'' and felt that mandatory staffing 
ratios are not supported by empirical evidence. Some commenters felt 
that current oversight of staffing was already burdensome. A number of 
commenters stated that it was often a daily struggle to ensure that the 
appropriate number and level of staff was available while striving to 
maintain quality of care and that our proposed requirements would only 
makes that struggle more difficult.
    Response: We thank these commenters. We concur that staffing is 
important. We continue to be concerned that a mandated ratio could 
result in unintended consequences, such as staffing to the minimum, 
input substitution (hiring for one position by eliminating another), 
and task diversion (assigning non-standard tasks to a position), as 
well as stifling innovation, and would not result in the improved 
quality and person-centered care that we seek in facilities. However, 
we continue to believe that our proposed requirement is necessary to 
address concerns about inadequate staffing and resulting harm to 
residents.
    Comment: Some commenters supported CMS's proposed competency-based 
staffing approach, but felt that it should be in addition to minimum 
staffing standards. One commenter noted that minimum staffing levels 
and a competency-based approach are not necessarily mutually exclusive. 
For example, a facility may meet minimum staffing levels and further 
increase its staffing based on the results of the facility assessment 
referenced below. This commenter urged CMS to give further serious 
consideration to these issues. One commenter stated that they recognize 
the many diverse skills nurses need and the responsibility to have 
nursing staff with demonstrated competency to care for residents. Their 
skills need to match resident needs and the scope of services they are 
expected to provide.
    Response: We thank these commenters. We did re-consider our 
approach, but, ultimately, returned to our original proposal. We agree 
that staff competency, in addition to sufficient numbers of staff, is 
critical to quality of care and resident safety. We continue to have 
concerns about establishing appropriate minimum standards as well as 
concerns that facilities will justify staffing to the minimum standard 
even when more are required in the context of a competency based 
approach. We further address comments regarding minimum staffing ratios 
below.
    Comment: Many commenters stated that CMS needs to establish and 
require minimum staffing levels and require a registered nurse to be in 
the LTC facility 24 hours a day, 7 days a week. One commenter stated 
that CMS is fully aware that facilities are understaffed and that 
understaffing harms and kills residents and that CMS must do more to 
strengthen nurse staffing requirements. The commenter further stated 
that CMS's assertion that it needs more accurate payroll-based staffing 
data is disingenuous and that CMS's refusal to set nurse staffing 
ratios and, as the Institute of Medicine recommended in in 1996 and 
again in 2001, to require a registered nurse 24 hours per day, seven 
days a week will mean that many residents will continue to receive 
inadequate, life-threatening care. Other commenters reviewed the 
literature supporting the need for and value of increasing staffing and 
RN presence. Several commenters provided examples of instances where 
insufficient staffing resulted in harm or where sufficient staffing 
prevented harm. Several commenters provided information on the fiscal 
impact of insufficient staffing and the cost savings associated with 
sufficient staffing. One commenter provided information on the changing 
nature of the LTC facility industry and the advent of for-profit LTC 
facilities, the purchase of LTC facilities by private equity firms, and 
the move towards Medicaid managed long-term services and support, all 
of which create incentives to staff at the lowest possible levels.
    Several commenters specifically advocated for CMS to require a 24-
hour registered nurse (RN) in every facility. One commenter stated that 
the current Requirements of Participation only mandate that facilities 
use a RN 8 continuous hours each day, 7 days a week. These 8 hours 
would not have to be spent providing care; they could be used to carry 
out any type of administrative tasks. Registered nurses by training and 
licensure have skills that are essential for timely assessment, 
intervention and treatment. The commenter noted that three Institute of 
Medicine studies have recommended that at least one RN be on duty at 
all times. They state that 24-hour RN coverage is essential because the 
acuity level of LTC facility residents has increased dramatically since 
the federal law was passed and expert nursing skills are required to 
anticipate, identify and respond to changes in condition; ensure 
appropriate rehabilitation, and maximize the chances for a safe and 
timely discharge home. In addition, a resident's condition can 
destabilize or deteriorate at any time. When that occurs, the 
individual must be immediately assessed and a determination made about 
whether the resident needs to go to the hospital for treatment or 
whether he or she can be properly cared for in the LTC facility. 
Because physicians do not have to be on-site, registered nurses are 
often the only medical personnel in a LTC facility with the education 
and licensure to conduct the assessment required. The commenter noted 
that substantial evidence that RN staffing is a key element for safe 
and effective resident care in U.S. LTC facilities has grown 
substantially over the last 2 decades, typically using quality measures 
or

[[Page 68755]]

deficient practice from the CMS survey data and that higher levels of 
RN time are associated with positive outcomes, such as reduced 
unnecessary hospitalizations, lower antipsychotic use and other 
improved outcome measures (pressure ulcers, restraint use, cognitive 
decline; reduced incidences of catheterizations, urinary tract 
infections, and antibiotic use; and less decrease in function and 
weight loss). The commenter stated that only 11 percent of nursing 
facilities nationwide report to CMS that they do not have enough RNs on 
staff for 24-hour RN coverage, therefore it is reasonable to expect the 
remainder to do so. The commenter's calculation is based on 2012 CMS 
Expected Staffing Data, assuming, in part, that a minimum of four RNs 
(A DoN and an RN on each shift) would provide the necessary RN 
staffing.
    Another commenter who advocated mandating a 24/7 RN stated that, as 
a result of SNF Value-based purchasing and because of the effect of RNs 
in decreasing unnecessary hospitalizations of LTC facility residents 
cited above, they anticipate that LTC facilities themselves will be 
seeking to employ RNs around-the-clock.
    Response: We agree that sufficient staffing is necessary, along 
with the need for that staff to be competent in delivering the care 
that a resident requires. We also agree that all of these factors are 
associated with quality of care. However, we do not agree that we 
should establish minimum staffing ratios at this time. As discussed in 
the preamble to the proposed rule, this is a complex issue and we do 
not agree that a ``one size fits all'' approach is best. We have re-
evaluated the literature and commenters concerns and remain convinced 
that additional data will be helpful in determining if and what such 
ratios should be. Our approach would require that facilities take into 
account the number of residents in the facility, those residents' 
acuity and diagnoses. We believe the added specificity of this approach 
precludes facilities from making staffing decisions based solely on 
fiscal considerations, without taking these other factors into account. 
We further believe that this approach can strengthen evaluation of 
staffing during the survey process. We also agree that RNs are a 
valuable resource in LTC facilities, however, we are not mandating a 
24/7 RN presence in each facility at this time. We note that the 
current regulatory requirements parallel statutory requirements. While 
we would have the discretion to impose a more stringent requirement 
regarding RN presence, we do not have the discretion to eliminate the 
waiver option, as it is statutory. See sections 1819(b)(4)(C)(ii) and 
1919(b)(4)(C)(ii) of the Act. While there are no current RN waivers in 
effect, such a mandate could result in an increase in such requests. We 
are also concerned that imposing such a requirement could negatively 
impact the development of innovative care options, particular in 
smaller, more home-like settings, for a subset of residents who might 
benefit from and be appropriate for such a setting. We are also 
concerned that, while the RN supply overall might be sufficient, 
geographic disparity in supply could make such a mandate particularly 
challenging in some rural and underserved areas. Finally, to the extent 
that facilities may already be moving in this direction, payroll based 
reporting, discussed previously in our responses, may give us a better 
picture of the extent to which increased RN staffing is occurring, 
although, at this time, we will still lack information on the extent to 
which this results in 24 hour coverage. We have noted elsewhere in our 
responses to comments that there are concerns about the validity of 
self-reported staffing data in accurately reflecting how a facility is 
staffed throughout the year. This, in concert with our inability to 
determine to what extent adequate RN hours equate to 24 hour RN 
coverage, impacted the assumptions we made regarding the number of 
facilities that would be impacted by imposing a 24/7 RN mandate. Thus 
our estimate of the number of facilities that would be required to hire 
additional RN staff is much higher than the commenters'.
    We have reviewed the recommendations of the Institute of Medicine 
in its 2004 report ``Keeping Patients Safe: Transforming the work 
Environment of Nurses.'' That report reiterates prior recommendations 
for a mandatory RN presence in LTC facilities and mandatory minimum 
staffing requirements, although it does not recommend a specific ratio. 
The report states, in part, that
    ``Patient safety requires staff resources that are sufficient to 
prevent an inappropriately high rate of untoward events that could be 
avoided with adequate staffing levels. For such a standard to be 
reasonable, it must at least be based on the number of residents in the 
LTC facility and address NAs, who provide most of the care to LTC 
facility residents. Such minimum staffing standards are not a precise 
statement of how many staff are required to fully meet the needs of 
each specific group of residents on each unit, nor are they a quality 
improvement tool to optimize quality in each LTC facility. Rather, a 
minimum staffing level is one that avoids placing individual residents 
unnecessarily at risk because of insufficient numbers of staff to 
provide even the most basic care.''
    The report discusses CMS's 2001 Report to Congress 
``Appropriateness of Minimum Nurse Staffing Ratios in Nursing Homes--
Phase II Final Report'' and states:
    ``With respect to the recommendation that DHHS specify staffing 
standards in regulations that would increase with the number of 
patients and be based on the findings and recommendations of the Phase 
II DHHS report to Congress on the appropriateness of minimum staffing 
ratios in nursing homes, the committee notes that the thresholds 
identified in that study above which no further benefit from staffing 
ratios could be identified are above the staffing levels of 75 to 90 
percent of facilities, depending on the type of staff. However, a 
minimum standard set by DHHS need not approach the threshold level 
above which there is no further benefit. In fact, such a standard would 
go beyond the expectation for a minimum, which is intended to identify 
situations in which facilities unequivocally place residents at an 
unacceptable level of risk. The challenge is that there is no absolute 
minimum level of risk for untoward events that is considered 
acceptable.''
    The IOM report further states:

    ``The study does not propose a specific minimum standard for 
RNs, licensed nurses, and NAs because agreement must first be 
reached about what is an unacceptable level of risk. However, data 
exist from this national study with which to determine the staffing 
levels for each type of staff that are associated with any level of 
risk for untoward events.''

    Finally, the IOM report states:

    ``At the same time, a number of nursing organizations, policy 
experts, and HCOs [health care organizations] point out the 
limitations of staffing ratios. While they may help ensure a 
baseline level of staffing in HCOs that may be outliers, they are 
poor instruments for achieving optimal staffing. Depending on the 
skill mix and expertise of nursing staff and patient acuity, minimum 
ratios may still not provide the needed levels of safety. Moreover, 
counts of patients needed to calculate nurse staffing levels 
consistent with a ratio must be taken at a point or points in time. 
Yet patient admissions, transfers, and discharges are frequent; 
therefore, an adequate nurse-to-patient ratio at 7 a.m. may be 
inadequate at 10 a.m., and an organization that has satisfied a 
nurse-to-staffing ratio at one point in time may still have 
inadequate staffing at another point. Thus, while staffing ratios 
can help protect against the most egregious staffing deficiencies, 
HCOs will need to employ more sensitive approaches internally to 
fine-tune staffing levels.''

    We include only a few portions of this report to highlight the 
complexity of

[[Page 68756]]

this issue and our concerns about determining a ``right'' number for 
any staffing ratio. CMS has begun mandatory, payroll-based collection 
of staffing information from long-term care facilities, to include 
registered nurses, licensed practical or vocational nurses, certified 
nursing assistants, or other types of medical personnel as specified by 
CMS, along with census data, data on agency and contract staff, and 
information on turnover, tenure and hours of care provided by each 
category of staff per resident day. We believe this information, once a 
sufficient amount is collected and analyzed, could greatly assist us in 
re-evaluating this issue. In addition, other elements of this 
regulation, such as QAPI, Infection Control, Compliance and Ethics, and 
Training, are also intended to put in place systemic process to prevent 
placing individual residents unnecessarily at risk.
    Comment: One commenter was pleased that the proposed regulations 
require that facilities ``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 wellbeing of each 
resident '' However, this commenter as well as other commenters 
expressed concern about the proposed mechanism for determining what 
constitutes ``sufficient staff,'' with the ``appropriate competencies 
and skills.'' The proposed regulations require the facility to conduct 
an assessment, at least annually, to determine the appropriate level 
and type of staffing needed. This proposal is of concern because it 
relies on the facility's own assessment of staffing needs without any 
enforcement mechanisms or safeguards to ensure that the facility is 
indeed objectively assessing resident needs, acuity, and other 
important factors and not unduly relying on other factors such as cost 
and convenience. The commenter felt that that this proposal requiring a 
``facility assessment'' is not materially different from what nursing 
facilities currently do to determine staffing levels--a method which 
has produced serious staffing and quality deficiencies. Other 
commenters felt that the proposal was insufficient in its explanation 
of expectations. Other commenters were concerned that our proposal did 
not allow sufficient flexibility for facilities to determine how they 
staff nursing units. Some commenters stated that a facility's ability 
to care for residents should be based on outcomes of care, such as 
annual survey results, quality measures, and the 5-star rating system.
    The commenter agreed with CMS that the regulations must not 
encourage facilities to set staffing levels based solely on regulatory 
minimum requirements and in lieu of actual resident needs and acuity 
levels of the residents they serve. They further agreed that the 
facility assessments should take into consideration all the factors set 
out in the proposed regulation in Sec.  483.70(e) and that each 
facility should conduct this assessment itself. However, the commenter 
suggested that CMS require that the facility assessment be audited by a 
facility surveyor and that the surveyor be empowered to require, under 
threat of graduated monetary penalties, the facility to provide 
additional nursing resources if he or she disagrees with the facility's 
assessment. Lastly, the commenter believed that the facility should be 
required to seek and use input from the Long-Term Care Ombudsman, the 
resident and family groups, and family caregivers when conducting its 
assessment.
    Another commenter noted that instead of establishing a minimum 
staffing standard or requiring 24-hour RN coverage, CMS proposed a 
competency-based staffing approach that stems in part from a facility 
assessment and stated that this assessment appeared to be put forth as 
the answer to requiring a specific number of staff or hours of nursing 
care. The commenter was concerned that this would not require 
facilities to do anything different than they have been doing and that 
this simply maintains the status quo. The commenter believed that the 
facility assessment could be useful in addition to a minimum staffing 
standard if revised to include staffing practices and used as a factor 
to consider in adjusting staffing levels upward based on resident 
needs.
    Response: We appreciate the commenters concerns and we have re-
reviewed the literature as well as additional information. There is no 
question that staffing and quality are associated, and we direct 
readers to our concerns about mandatory ratios in the previous 
response. As one of the commenter notes, the proposed facility 
assessment is in line with current industry practice. However, our 
approach would require that facilities document the assessment and take 
it into account, including the number of residents in the facility, and 
those residents' acuity and diagnoses, when making staffing decisions. 
Several commenters have noted that a primary driver of understaffing is 
that facilities make staffing decisions based solely on fiscal 
concerns. We believe the added specificity of this approach precludes 
facilities from making staffing decisions based solely on fiscal 
considerations without taking resident specific factors and needs into 
account. Further, the facility assessment is conducted at the facility 
level and it must be used in making staffing decisions, precluding 
staffing decisions from being made solely at a corporate level based on 
fiscal considerations and without taking facility- and resident-
specific factors into consideration. We believe this approach provides 
facilities adequate flexibility while still requiring that there be 
sufficient staff to care for residents. As noted earlier, we also 
believe that this approach can strengthen evaluation of staffing during 
the survey process. We further address comments regarding the facility 
assessment in our discussion of comments received with respect to 
proposed Sec.  483.70.
    Comment: One commenter stated that, somewhere in the regulations, 
it is important to ensure that all facility staff, including non-
permanent employees, be determined by the facility to be competent to 
provide care to the residents. The commenter stated that they have seen 
where the facility counts on the contract agency to determine 
competency and training, and this has not actually been completed in a 
timely manner. When a deficiency is cited, neither the facility nor 
contract agency wants to be held responsible for the resultant care 
that was provided to the residents. Regardless of whether the 
individual is a permanent facility employee or a contract employee, the 
facility should remain accountable for the competency of the 
individuals who are providing care to the residents. Language should be 
added to hold the facility is accountable to ensure that the contract 
staff have received the regular in-service education required every 12 
months under Sec.  483.35 (d)(7), otherwise there is no way to ensure 
these individuals meet their annual in-service education requirements. 
Many other commenters stated that facilities should not be accountable 
for ensuring the competency of contract personnel. Many of these 
commenters stated that the agency that employs the individual should be 
accountable for their employees' competency. One such commenter stated 
that they hire the agency, not the nurse or CNA.
    Response: We agree that all staff providing care must have the 
skill sets and competencies to provide that care. Proposed Sec.  
483.35(a)(3) and (c) specifically require that licensed nurses and 
nurse aides, respectively, have the

[[Page 68757]]

competencies and skills necessary to provide care to residents in 
accordance with that resident's needs. These provisions are not 
conditioned on the manner by which the individual's services are 
obtained. Further, we establish in proposed Sec.  483.95, training 
requirements for all staff. Please see our responses for that section 
for additional information. Furthermore, we re-designated but did not 
otherwise change the requirements for the use of outside resources, 
which requires that the facility obtain services under an agreement 
that specifies, in writing, that the facility assume responsibility for 
obtaining services that meet the professional standards and principles 
that apply to professionals providing such services and are timely. 
Depending on a facility's needs, contract staffing may be used 
infrequently, routinely, and for extended periods of time. A facility 
can require in its agreement with a staffing agency that the personnel 
the agency sends to fill staffing needs meet certain requirements. The 
facility could use mandatory training requirements as well as its 
facility assessment, past experience, and other knowledge of its 
staffing needs to determine what requirements it would expect the 
staffing agency to ensure personnel have met prior to being sent to the 
facility. However, when a contract individual reports for duty, the 
facility must ensure that the work assigned to that individual is 
appropriate for his or her competencies and skill sets.
    Comment: One commenter recognized that nurses need many diverse 
skills, but felt the meaning of this proposed requirement is unclear. 
They asked whether we intended to require this of all of nursing in the 
aggregate, or every nurse individually. They asked whether we intended 
that each nurse have competencies for all the residents/patients under 
their care each day, or on the unit on which they work. The commenter 
felt that it was unclear about how surveyors would evaluate this 
requirement fairly and consistently, in order to judge a facility's 
compliance with this provision. The commenter recommended that Sec.  
483.35(a)(3) be revised to read: The facility must ensure that its 
licensed nurses collectively 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. Other 
commenters stated that competency and skill set requirements were 
unnecessary, as these are ensured by education and licensure, and 
covered by requirements that care meet professional standards of 
practice.
    A commenter also recommended that ``Proficiency of nurse aides'' 
should be revised to read: ``The facility must ensure that nurse aides 
have the basic skills and techniques necessary to care for residents' 
needs, as identified through resident assessments, and described in the 
plan of care.''
    Response: The individual providing the care must have the skills 
and competencies to deliver the care that they are expected to provide 
to the resident, consistent with the individual's position and, when 
applicable, their scope of practice under state law. We recognize that 
education and licensure provide many foundational skill sets. There are 
many common competencies that every staff member or every member of a 
specific job position (such as nurse aide) need. We would expect those 
competencies to be identified through the facility assessment. We 
understand that not every staff member can have every competency for 
every resident and that an individual facility, based on the population 
it serves, may have some unique needs. It is not enough, however, that 
the staff, collectively, have the competencies and skill sets to 
provide the care. That could imply that the requirement is met so long 
as one member of the staff has the required training or knowledge, 
regardless of whether or not that staff member actually provides the 
care or is even present in the facility when the care is delivered. The 
facility must ensure that the individual providing care to a resident 
has the skills and competencies necessary to deliver that care. For 
example, if a particular resident is on contact isolation as a result 
of a medical diagnosis, every individual caring for that resident must 
know how to comply with those procedures. Similarly, if a resident 
requires the use of a specialized eating implement, the individual(s) 
responsible for assisting the resident to eat must know the proper use 
of the implement. If the individual has to obtain guidance for such 
use, such guidance must be timely. It would not be enough for one 
individual to have the knowledge if that knowledge was not actually 
used in caring for the resident.
    Comment: One commenter felt that the language of proposed Sec.  
483.35(d)(2) was unclear and could be interpreted to mean that a 
facility could not have a temporary worker that did not meet the 
requirements but could have a permanent employee who did not meet the 
requirements.
    Response: Sec.  483.35(d)(1) addresses the use of nurse aides; 
paragraph (d)(2) establishes that facilities cannot avoid compliance 
with (d)(1) through the use of non-permanent employees. In context, 
this does not permit any employee to whom paragraph (d) applies to not 
meet the requirements. We are finalizing this provision as proposed.
    Comment: A commenter stated that traditional in-service education 
has been largely supplanted by other approaches and may have marginal 
value in imparting skills and attitudes and in improving performance. 
Self-education, computer-based training, real-time coaching, mentoring, 
and other forms of education and training and coaching are often more 
productive. Furthermore, ``in-service education'' is not defined and 
lacks pertinent standards. The commenter recommended revising the 
wording of (d)(7) to reflect more flexible, efficient, effective, and 
modern approaches to the issue. Otherwise, regulatory compliance is 
limited by the inflexible specific requirement for ``in-service 
education.''
    Response: ``Regular in-service education'' is required by sections 
1819(b)(5)(E) and 1919(b)(5)(E) of the Act. ``In-service'' training is 
generally understood to be training intended for those actively engaged 
in the profession or activity concerned. We agree with that there are 
multiple ways of providing ongoing training that assures that 
individuals used as nurse aides are competent to perform services as 
nurse aides. We would encourage facilities to use the most efficient 
and effective training methods available to them to achieve their 
training objectives.
    Comment: One commenter felt that the final regulation should 
clearly address a specific, replicable methodology for calculating 
nursing staff and assessing whether or not it is adequate to meet the 
needs of residents in each facility. The commenter urged CMS to examine 
whether the current methodology for the five-star rating system, which 
calculates expected staffing based on RUG values along with reported 
staffing levels, can be adapted for establishing rules or guidelines 
providing presumptive levels for facility assessments. Such an 
adaptation must be designed to incorporate the more robust payroll-
based staffing data that will be in place as a requirement for all 
certified SNFs and NFs by July 2016. The commenter felt that a 
competency-based assessment could easily ask for a determination of 
whether or not the facility has 24-hour RN coverage, and whether all 
LPNs and CNAs have sufficient training to be able to communicate with 
and respond to the needs of individual residents who have difficulty 
communicating, notably individuals with dementia. A

[[Page 68758]]

competency assessment could also ask for further details about initial 
and in-service training, including whether all nursing staff understand 
ethics and compliance and QAPI standards well enough to use them. 
Further, a competency assessment could inquire about the composition of 
interdisciplinary teams, and whether these care teams record and take 
into account the treatment preferences and quality of life goals that 
residents express during care planning. The commenter stated that the 
importance of regulators having clearer yardsticks to understand what 
constitutes ``sufficient'' staffing in different facilities in order to 
ensure resident well-being cannot be overstated. Careful oversight by 
nursing staff serving residents is a core fiduciary responsibility of 
LTC facilities and the direct responsibility of the Administrator and 
the Director of Nursing (DoN). This responsibility must be understood 
to extend to the adequacy of training and the operational deployment of 
nursing staff--at all times, including night and weekend shifts, and 
during holidays--regardless of the business structure of the facility, 
and independent of any policies promulgated by individuals or entities 
that may be operationally and/or financially connected to a given LTC 
facility. To be useful, therefore, an annual facility assessment must 
be able to establish that its staffing will remain adequate throughout 
the year, both with regard to levels of total nurse staffing, and with 
respect to the responsibility that certain types of staff, for example, 
RNs and LPNs, have in overseeing the medical management of residents 
with regard to medications, falls prevention, development of pressure 
ulcers, readmission to hospitals and other key areas.
    Response: We will consider the commenters' recommendation to 
examine whether the current methodology for the five-star rating 
system, which calculates expected staffing based on RUG values along 
with reported staffing levels, can be adapted for establishing rules or 
guidelines providing presumptive levels for facility assessments. 
Please see our discussion of Sec.  483.70 for further discussion of the 
facility assessment requirement.
    Comment: In advocating for mandatory staffing standards, some 
commenters addressed the high cost of poor care. One commenter noted 
that CMS itself has recognized these costs. The commenter further noted 
that nearly 25 years ago, the Senate Labor and Human Resources 
Subcommittee on Aging issued a report that addressed, and used the 
term, ``high cost of poor care''--that is, the costs that are incurred 
by the health care system when inadequate nurse staffing in LTC 
facilities leads to avoidable medical problems that the health care 
system spends money to try to correct. The report detailed several poor 
care outcomes, their causes, and their estimated costs, noting that the 
costs would be far higher in 2015 dollars and links avoidable 
hospitalizations to ``the insufficient number of adequately trained 
nursing staff.'' The commenter notes additional studies that further 
support this conclusion. The commenter also discussed the use of 
INTERACT (Interventions to Reduce Acute Care Transfers is a quality 
improvement program that focuses on the management of acute change in 
resident condition) to avoid inappropriate hospitalizations and to 
support hospitalization that is medically necessary. The commenter 
further stated that considerable research demonstrates that unnecessary 
and inappropriate hospitalizations can be avoided when nursing 
facilities have more health care professionals in place on a daily 
basis--physicians, physician assistants, and registered nurses. 
Finally, the commenter discussed other costs of insufficient staffing, 
such as staff injuries. Another commenter stated that the lack of a 
specific minimum staffing standard and 24-hour registered nurse 
coverage in the proposed regulations has been a major obstacle to 
quality care since the Nursing Home Reform Law was passed in 1987 and 
will continue to be until these standards are adopted. The commenter 
highlighted the relationship between staffing levels and quality and 
stated that CMS discounts the numerous studies that support the 
relationship between nursing staff and quality.
    Response: We do not discount the relationship between staffing 
levels and quality. We disagree that this requires that we set minimum 
staffing ratios and that we know what that minimum staffing ratio 
should be. As discussed previously, we believe that there are concerns 
about utilizing a minimum staffing standard and we do not necessarily 
find that the 4.1 hours per resident day (hrpd) is the right standard 
for every facility. LTC facilities are varied in their structure and in 
their resident populations. Some facilities are Medicare-only SNFs that 
focus on short term rehabilitation services. Others are primarily 
Medicaid facilities that include primarily long-stay residents. Many 
are both. Some facilities specialize in dementia care. Some facilities 
have pediatric residents, young adult residents, or ventilator 
dependent residents. The care needs of each of these populations are 
different. Facilities range in size from the very small to the very 
large. The capabilities of these facilities are likely to be different. 
As noted above, we discuss our concerns with establishing a minimum 
staffing ratio in prior responses. As stated in the proposed rule, 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.
    Comment: One commenter stated that while they believe recommended 
minimum staffing requirements should be implemented when the revised 
rules go into effect, an alternative approach would be to phase-in the 
staffing standards incrementally over a 5 year period. A number of 
states, such as Florida and Illinois, have used an incremental phase-in 
period. This approach would give facilities ample time to increase 
staffing to the required levels.
    Response: We are not finalizing a minimum staffing requirement at 
this time. We will consider a phased-in approach if we determine to 
impose minimum staffing standards through future rulemaking.
    Comment: Several commenters stated that, despite industry claims to 
the contrary, they believe it is not necessary for CMS to increase 
Medicare and Medicaid LTC facility payment rates if CMS requires 
minimum staffing standards. One commenter noted that the actual 
facility-reported average RN staffing levels increased to 0.85 hours 
per resident day (hprd), LVN staffing increased to 0.83 hprd, and total 
staffing steadily increased to 4.15 hprd in 2015. Because the average 
LTC facility staffing is already 4.1 total hprd and 0.8 RN hprd, most 
homes should be able to meet these standards without an increase in 
reimbursement rates. The commenter felt that the for-profit chains who 
in general report lower staffing levels are in the best position to 
increase staffing without additional reimbursement.
    Response: We thank the commenters for this information. We are 
aware of concerns that current, self-reported staffing data may not 
fully reflect a facility's staffing across time. We expect our 
understanding of how facilities are staffed on an ongoing basis to 
improve with the collection of payroll-based staffing data. Also, it is 
important to note that changes to these requirements

[[Page 68759]]

do not necessarily drive changes to Medicare or Medicaid payment rates.
    Comment: Several commenters questioned the accuracy of the cost 
estimates CMS presented for the proposed rule. They believe that the 
salary figures appeared to be overly inflated and asked CMS to review 
its cost estimates. The commenters suggested that CMS use the BLS OES 
wage data that are specific to SNFs and felt that the 48 percent fringe 
benefit and overhead factor appeared overly generous. Finally, the 
commenters stated that it would be helpful for CMS to provide 
additional information on the justification and methodology for 
determining the benefit factor and what the specific elements of 
overhead costs are.
    Response: We have reviewed our calculation and believe that we 
provide a good faith estimate of the cost of requiring 24/7 RN 
coverage. We note that the overhead percentage used in our calculations 
is based on guidance from the Office of Management and Budget. After 
eliminating facilities that already require a 24/7 RN, we estimate that 
there are 13,279 facilities that will likely need to `staff-up.' We 
believe that ``staffing-up'' would entail hiring an additional one to 
four RN FTEs to cover an additional two shifts per day (14 eight hour 
shifts per week) in the 13,279 facilities that are not currently 
required to have a 24/7 RN presence. Given the 2015 mean annual wage of 
$62,440 for an RN working in a nursing care facility (http://www.bls.gov/oes/current/oes291141.htm), and assuming either 48 percent 
or 100 percent overhead, we estimate the burden of implementing such a 
mandate to be $92,411 to $124,880 per additional RN, for a total of 
between $1.2 and $6.6 billion in addition to the current estimated 
first year costs of the proposed rule. Particularly given existing 
concern that current self-reported staffing data may be inflated, we 
believe that payroll based staffing data will help us better estimate 
the burden.
    One commenter suggested that we should use $42.82 hourly wage based 
on the BLS OES Median for NAICS 623100, inflated by 48 percent. If we 
used that number, assuming 40 hours per week for 52 weeks, we get an 
estimate of $1.1 to $4.7 billion for an additional one to four RNs at 
13,279 facilities. Some commenters believe that we have over-estimated 
the number of facilities that would need to hire one or more additional 
RNs. One commenter believes that 89 percent of facilities, already meet 
or exceed four RN FTEs per day (1 DoN and 1 RN on each shift), based on 
a calculation of RN hours per resident day and currently reported 
staffing data. That would mean only 1,777 facilities would need 
additional RN staffing. Using this estimate and the $42.82 median 
hourly wage, the burden estimate is $158 to $633 million for one to 
four additional RN at 1,777 facilities. However, we believe this 
calculation significantly underestimates the number of facilities that 
would be required to hire additional RNs. We based our estimate on the 
number of facilities that are not currently required to have an RN 24/
7.
    Comment: Several commenters stated that, given the relationship 
between staffing and outcomes, increased staffing levels could save the 
Medicare and Medicaid programs billions of dollars, and cite studies 
demonstrating the possible cost savings. They noted that, while the 
trauma inflicted upon LTC facility residents and their loved ones from 
understaffing could not be easily categorized and calculated, the 
financial costs are quantifiable.
    Response: We agree that improved staffing, as well as improvement 
as a result of several of our proposals, could result in savings to the 
Medicare and Medicaid programs. In developing our proposals, we 
considered possible cost savings from these proposals. Those cost 
savings were not included in our estimates as they were deemed to 
potentially be the aggregate result of more than one requirement or 
activity, as well as speculative in nature.
    Comment: Some commenters are concerned that our requirements 
related to the DoN can be waived and note that the role of the DoN is 
critical to quality resident care. The commenter stated that the DoN is 
responsible for administrative, clinical, educational, staff and public 
relations; the core competencies include such skills as conducting root 
cause analysis, setting benchmarks, directing change, and mentoring and 
teaching and, with the increased acuity level and medical complexity of 
LTC facility residents, a DoN with the expertise, training and skills 
of a RN is necessary. The commenter recommends that we delete the 
waiver so the regulation reads: ``The facility must designate a 
registered nurse to serve as the director of nursing on a full time 
basis.''
    Response: We agree that the position of DoN is very important and 
that an RN should fill this position. However, the waiver in question 
is established by statute and we do not have the discretion to 
eliminate it. We note that the waiver only applies to rural facilities 
where the supply of RNs is not sufficient, and only when specific 
conditions are met. Further, we note that no such waivers are currently 
in effect.
    After consideration of the comments we received on the proposed 
rule, we are finalizing these provisions as proposed.

N. 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 proposed to add a new section Sec.  483.40 to address this 
requirement as it relates to behavioral health services and include 
requirements for social workers. These provisions work in conjunction 
with other provisions we proposed, including those related to reducing 
the inappropriate use of psychotropic medications, to address the 
behavioral health care needs for residents.
    We proposed at 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). We proposed to specify in Sec.  483.40(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 proposed to 
specify that a resident whose assessment does not reveal or who does 
not have a diagnosis of a mental disorder 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 a mental disorder and intellectual 
disability are required in the resident's comprehensive plan of care, 
the facility must provide the required

[[Page 68760]]

services, including specialized rehabilitation services as required in 
Sec.  483.40(c)(1); or obtain the required services from an outside 
provider of specialized rehabilitative services in accordance with 
proposed Sec.  483.65(a)(2).
General Comments
    Comment: Some commenters were very supportive of our proposed 
requirements for behavioral health services, but noted that these 
requirements focused substantially on behavioral and psychiatric 
conditions. They supported the focus on sufficient direct care staff 
with the appropriate skills and competencies to provide the necessary 
care to residents with a mental disorder and cognitive impairment, 
including how to implement non-pharmacological interventions. Some 
commenters supported requiring facilities to provide social services to 
the residents and that all of the behavioral health services that are 
indicated in the resident's comprehensive plan of care must be provided 
by the facility.
    Response: We thank the commenters for their support. We believe 
these proposals, which have been finalized in this rule, are essential 
for residents who need behavioral health services. We also agree that 
having a focus on behavioral health through having a separate section 
on behavioral health with a focus on, among other things, sufficient 
direct care staff with the appropriate skills and competencies and non-
pharmacological interventions, emphasizes the importance of providing 
the behavioral health services residents need to obtain their highest 
practicable physical, mental, and psychosocial well-being. Facilities 
will be required to provide the behavioral health services indicated on 
the resident's comprehensive plan of care; however, Sec.  483.65(a)(2) 
also allows for the facility to have these services provided by an 
outside source.
    Comment: Some commenters were supportive of the proposed 
requirement for sufficient direct care staff with the appropriate 
skills and competencies to provide the necessary care to residents who 
need behavioral health services and for this to be determined by a 
facility assessment. However, the commenters were concerned that it was 
the facility itself that would conduct this assessment. Without any 
enforcement mechanism or safeguards to ensure that the facility is 
objectively assessing its residents' needs, acuity, and other important 
factors, the commenters were concerned that the assessment could be 
influenced or rely upon other factors, such as the cost or convenience 
to the facility. In addition, the commenters stated that this 
requirement was not materially different from what facilities currently 
do and that current practice has resulted in serious staffing and 
quality deficiencies. Some commenters proposed that we require the 
facility to seek out and use the input from outside sources and that a 
surveyor audit the facility assessment and impose monetary penalties if 
the auditor disagreed with the facility assessment.
    Response: We understand the commenters' concerns about facilities 
performing their own facility assessment to determine staffing and 
other resource requirements and that the assessments could be based 
upon factors other than the care needs of the resident population, such 
as justifying their current staffing and other resources, as well as 
taking into consideration the facility's cost and convenience. However, 
we believe that facilities need the flexibility to determine the best 
way to perform their facility assessments to comply with this 
requirement. The facility can certainly perform this assessment itself 
or it may choose to have an outside entity perform the assessment. We 
believe that if a LTC facility does not objectively assess its resident 
population and resources, surveyors will be able to detect this during 
the survey, not only from reviewing the facility assessment but also 
from the LTC facility's compliance with the other requirements in this 
final rule. For further discussion on the facility assessment, please 
see the discussion for Sec.  483.70(e) below.
    Comment: Some commenters were very concerned about not having 
sufficient resources that would be needed to comply with these 
requirements. Some commenters noted the shortage of behavioral/mental 
health providers in their areas, especially qualified psychiatrists. 
Others noted that Medicaid per diem rates do not include any 
compensation for specialized behavioral health services. Other 
commenters were concerned they would have insufficient resources to 
obtain additional staff and provide the training, both initial training 
and continuing in-services, that would be required to comply with the 
requirements.
    Response: We understand that there are concerns about how to comply 
with the requirements in this final rule. However, sub-regulatory 
guidance will be published for these requirements. This guidance should 
provide the detailed information that LTC facilities need to understand 
what is needed to comply with these requirements.
    Comment: Some commenters believed that complying with the proposed 
requirements is unrealistic and problematic due to the high staff 
turnover in LTC facilities. A commenter noted that in 2012 there was a 
median turnover rate of 43.9 percent turnover for all employees and 50 
percent or more for direct care RNs, and CNAs. The turnover rate for 
LPNs and LPNs was 36.4 percent.
    Response: We acknowledge that the high turnover rates for staff in 
LTC facilities present a challenge. However, as discussed in other 
areas of this rule, we believe that these requirements will not only 
improve the quality of care and life for residents but also the quality 
of the work environment for the staff. We believe that over time this 
will result in lower turnover rates for staff and savings for LTC 
facilities.
    Comment: Some commenters were supportive of the emphasis on 
behavioral health; however, they also recommended a more holistic 
approach to improve care for residents with behavioral and psychiatric 
impairments, including dementia. They noted that all psychiatric and 
behavioral disturbances have a significant medical and biological 
component. In addition, there were many reliable and reputable 
resources in medicine, neurology, psychiatry, and other disciplines 
that explain how health professionals, other than psychiatrists, should 
be able to properly assess, diagnose, and manage behavioral and 
psychiatric issues. They are concerned that these requirements would 
perpetuate ``silos'' of care, which is managing each body part or 
symptom by a particular discipline, which could undermine managing all 
of a resident's symptoms and conditions holistically. Some of the 
commenters believed that mental health professionals are not often 
needed and may actually be unhelpful for some residents. Some 
commenters did not believe that having consultants provide behavioral 
care is unlikely to improve vital staff and practitioner understanding 
and performance.
    Response: We agree with the commenters that behavioral health 
issues have a medical and biological component and that healthcare, 
including the healthcare in LTC facilities, requires a holistic 
approach. We proposed and have finalized this section, not to elevate 
the treatment of mental disorders and emotional issues above physical 
health issues, but to ensure that assessment and treatment of 
behavioral health issues are viewed with the same importance as the 
physical and receive the resources necessary to provide appropriate

[[Page 68761]]

treatment to residents in need of behavioral health services. This is 
why we have also finalized requirements for assessments, personalized 
care plans, the involvement of an IDT, the involvement of the resident 
or their representative in the resident's care, as well as other 
requirements. We also agree with the commenters that behavioral health 
care can be provided by healthcare personnel other that psychiatrists. 
In this final rule, we have not required that the individuals who 
provide behavioral health care and services have specific degrees or 
certifications; however, the facility must have sufficient staff with 
the appropriate competencies and skill sets to provide nursing and 
related services to residents in need of behavioral health care and 
services.
    Comment: Some commenters were concerned that the behavioral health 
section requirements appear to be implying that facilities would be 
responsible for ensuring that people with mental or emotional disorders 
maintain stable emotions and behaviors. They also believed that the 
proposed requirements appeared to imply that the facility would be held 
responsible if residents could not adjust or behave adequately in a 
social setting, or if they withdrew, got angry, or failed to interact 
well with others. However, commenters noted that many residents may 
have long-standing, and often misdiagnosed or inappropriately or 
inadequately managed, behavioral health problems prior to being 
admitted to a LTC facility. They asserted that this indicates how 
widespread the problem of inadequate behavioral health care is in our 
healthcare system.
    Response: According to Sec.  483.40, LTC facilities are responsible 
for providing each resident with the necessary behavioral health care 
and services for the resident to attain or maintain the highest 
practicable physical, mental, and psychosocial well-being, in 
accordance with his or her comprehensive assessment and plan of care. 
No healthcare provider, including a LTC facility, can guarantee any 
particular result for its residents. In addition, an LTC facility can 
only be responsible for the care they provide and not the care the 
resident received prior to admission. However, they can, and are 
expected to, properly assess residents, develop plans of care, and 
provide residents with the appropriate behavioral health services that 
they need to attain or maintain their highest practicable physical, 
mental, and psychosocial well-being.
    Comment: Some commenters stated that the requirements were 
increasingly mandating certain approaches and discouraging or 
prohibiting the use of others. Commenters believed there was an 
emphasis on non-pharmacological interventions over the judicious and 
appropriate use of medications. The commenters did not believe that the 
approach in the proposed rule was based upon sound clinical judgment. 
Some commenters were supportive of the efforts to reduce unnecessary 
anti-psychotic drug use in LTC facilities, but they also believed in 
the judicious use of medications for appropriate indications with 
adequate monitoring of efficacy and side effects. They were 
particularly concerned about what they perceived as an anti-medication 
orientation that was obsessive and counterproductive and could inhibit 
the appropriate use of necessary medications that can effectively and 
safely relieve symptoms such as distressing delusion, hallucinations, 
and self-harming behaviors. Commenters recommended the wording be 
changed to focus on objective support for all potentially useful 
interventions that could be used in the appropriate context after a 
clinically competent assessment has been performed.
    Response: We appreciate the commenters concerns; however, these 
requirements neither mandate specific techniques or care nor do they 
require facilities to forego the use of any medically acceptable drugs 
or techniques. The requirements finalized in this rule regarding 
behavioral and non-pharmacological interventions, as well as those 
concerning psychotropic and anti-psychotic drugs in Sec.  483.45, are 
all intended to encourage appropriate care for the residents. We 
disagree that these finalized requirements have an anti-medication 
orientation. The requirements regarding medications are intended to 
promote the safe and effective use of medications and discourage the 
inappropriate use of these medications. Non-pharmacological or 
behavioral interventions are required in an attempt to reduce or 
eliminate psychotropic medications, but only if these non-
pharmacological methods are not clinically contraindicated for the 
resident.
    Comment: Some commenters indicated that CMS failed to specify the 
elements of the facility assessment that would be required to determine 
the facility's direct care staff needs; the expectations CMS would have 
regarding how facilities would determine the competencies and skill 
sets necessary to provide behavioral health services; and whether 
facilities would need to ensure expanded access to outside professional 
behavioral health services, which are costly and already difficult to 
access in rural and geographically underserved areas. Numerous 
commenters recommended that we delay the behavioral health requirements 
due to their lack of specificity, especially what ``appropriate'' is, 
who will determine what the competencies should be, and who will 
determine if the staff meet the competencies.
    Response: We have not provided specific instructions on how to 
conduct the facility assessment. We believe that each facility needs to 
have the flexibility to decide the best manner in which to conduct that 
assessment, as long as it addresses or includes the factors or items 
set forth in Sec.  483.70(e). We understand that the commenters' 
concern about how to comply with the requirements in this final rule 
and how they will be surveyed. However, such specificity is not 
suitable for these requirements; this is more detailed information than 
is usually incorporated in the requirements and would likely need to be 
modified more frequently than the requirements. In addition, after this 
rule is published, sub-regulatory guidance on complying with these 
requirements will be published.
    Comment: Some commenters recommended that we reverse the order of 
proposed Sec.  483.40(b)(1) and (b)(2). They stated that the first 
statement is not expecting a resident who does not have behavioral 
health problem at admission to develop one, unless there is a medical 
reason specific to that individual that makes the problem unavoidable. 
This first statement would then be followed by the statement requiring 
a facility to provide appropriate care to a resident who needs the 
service.
    Response: We do not believe it is necessary to reverse the 
requirements. Thus, we will finalize those requirements as proposed.
    Comment: Some commenters supported our proposal that the facility 
have sufficient staff with ``the appropriate competencies and skill 
sets,'' but they believed that the behavioral needs of residents could 
not be met unless CMS also specified that each facility have staffing 
practices that include the number and types of staff, staffing 
assignments (such as rotating or consistent assignment), schedules, and 
systems that affect communication, teamwork, and participation. 
Commenters recommended specific language for such a provision.
    Response: We agree with the commenters that staffing practices are 
important. Some staffing practices, such as consistent assignment, are 
also best

[[Page 68762]]

practices. We encourage LTC facilities to use best practices with 
staffing when it is feasible. However, we have not mandated the use of 
specific practices in these requirements because we believe that LTC 
facilities need the flexibility to ensure they have sufficient staffing 
for their residents.
    Comment: Some commenters recommended that the final rule strengthen 
the requirements related to assessment of behavioral health and other 
psychosocial concerns. Commenters specifically recommended that the 
final rule require that there be a comprehensive psychosocial 
assessment and social history completed upon admission according to 
Sec.  483.21(b), with the assessment portion updated annually or when 
significant changes in the resident's health or behavioral health 
occur. They also recommended that care plans be required to address 
psychosocial and behavioral needs identified by the IDT assessments, 
social histories, and applicable sections of the MDS and associated 
Care Area Assessments.
    Response: According to Sec.  483.21(b), LTC facilities must develop 
a comprehensive care plan, which among other things, must include 
measurable objectives and timetables to meet a resident's mental and 
psychosocial needs that are identified in the comprehensive assessment. 
This comprehensive care plan must be reviewed and revised by the 
interdisciplinary team after each assessment, including both the 
comprehensive and quarterly review assessments. We believe that by 
complying with these requirements LTC facilities should be able to 
provide the behavioral health care their residents need.
    Comment: Some commenters agreed that mental health care and 
services are integral to the goal of assuring the highest practicable 
well-being for residents; however, they also believed that any 
discussion of the existing requirements or proposals required 
consideration of the history, structure, and function of LTC 
facilities. Commenters were particularly concerned about the suggestion 
that LTC facilities are appropriate settings to care for seriously 
mentally ill residents or perhaps even being required to admit these 
residents and provide the specialized behavioral care and services 
these residents need. They noted that historically LTC facilities were 
not expected to admit residents that required specialized behavioral 
health services. They noted that residents with psychiatric illnesses 
are complex and require a thoughtful plan and that LTC facilities 
should not be expected to fill in the gaps in the behavioral health 
care system.
    Commenters said that expectations regarding the mental health care 
that LTC facilities can provide must be balanced against these 
facilities' ability to provide those services and the possible 
ramifications for the residents with mental disorders and the remaining 
resident populations in those facilities. A serious unintended 
consequence could be frail, elderly residents with dementia being 
housed with residents with a serious mental disorder, which could 
result in a dangerous situation. Other commenters were concerned that 
they would be pressured to admit residents with serious, complex 
behavioral health needs that they could not meet.
    Response: These requirements do not mandate that a LTC facility 
admit any resident with a serious mental disorder. However, if a 
resident does have behavioral health issues, the LTC facility is 
responsible for providing the appropriate care for that resident. As 
discussed in the proposed rule, by 2012, more than 48 percent of LTC 
facility residents were estimated to have some form of dementia, 
including Alzheimer's disease, and/or depression (80 FR 42202) Thus, 
residents requiring behavioral health services are already being cared 
for in LTC facilities.
    Comment: Some commenters were confused about the intent of the 
behavioral health services requirements and what was expected of 
providers. They requested clarification and some recommended that CMS 
not finalize the proposed behavioral health requirements, but work with 
the state survey agencies and providers to address how residents with 
complex behavioral challenges can best be served.
    Response: We understand that some of the requirements related to 
behavioral health services are new and will require time and resources 
to comply with the requirements. We will also be publishing sub-
regulatory guidance to assist LTC facilities in complying with these 
requirements.
    Comment: Some commenters were concerned that some of the proposed 
requirements regarding behavioral health services were inconsistent 
with a proper, objective assessment of a resident. They believe that 
instead of emphasizing sound clinical reasoning and problem solving the 
proposed requirements would encourage inflexible ``cookbook'' 
approaches that impeded adequate consideration of causes and treatment 
options. Commenters were concerned that the proposed regulations are 
primarily psychosocial and focuses on psychosocial interventions while 
largely ignoring or underemphasizing the reality of dementia as a 
neurological disorder and the benefits of competent medical assessment 
and diagnosis. In addition, some commenters were concerned that the 
proposed rule emphasized non-pharmacological interventions over 
pharmacological treatments. Commenters noted that competent and 
reputable sources, such as the World Health Organization (WHO) have 
emphasized the judicious use of medications in appropriate situation to 
produce remarkable improvement in the function and quality of life for 
individuals. They believe that amounts to an attempt to influence 
clinical practice that is unlikely to promote an improvement in the 
quality of care provided to residents.
    Response: We disagree with the commenters. Person-centered care is 
a focus of these requirements. Each facility is responsible for 
assessing every resident and developing care plans upon admission and 
periodically thereafter in accordance with Sec.  483.20 and Sec.  
483.21 for each resident. Section 483.45 ``Pharmacy services'' includes 
safeguards concerning specific types of medication; however, it does 
not require or prohibit the prescription or use of any medically 
acceptable medication for a resident. In addition, although behavioral 
or non-pharmacological interventions are required for residents on 
psychotropic medication in an effort to discontinue these drugs, this 
is only required if it is not clinically contraindicated for the 
resident (Sec.  483.45(e)(2)). Hence, there is no ``cookbook'' approach 
for the care for any resident. We have specifically addressed dementia 
below.
    Comment: Some commenters were concerned about some of the language 
in Sec.  483.40(a) and (a)(1). They were concerned about identifying 
specific conditions, especially the language concerning residents with 
a history of trauma and/or post-traumatic stress disorder. They do not 
believe that these conditions are neither more nor less relevant than 
other psychiatric and behavioral disorders. This could divert attention 
away from other disorders and problems that are equally important. 
Commenters provided recommendations on specific changes to the 
regulatory text.
    Response: The inclusion of certain issues, such as ``history of 
trauma and/or post-traumatic stress disorder'' is not intended to 
exclude other types of disorders or problems. We believe that the 
remaining language in Sec.  483.40(b)

[[Page 68763]]

clearly indicates that those requirements pertain to other behavioral 
health issues.
    Comment: Some commenters recommended that the behavioral health 
requirements not be contained in a separate section. Instead, they 
recommended that these requirements be relocated into the quality of 
care requirements, under special services, since it appears to be the 
intent for these services for residents who have a mental disorder, 
psychosocial disorders, and trauma or post-traumatic stress disorders.
    Response: In the previous requirements, the requirements related to 
behavioral health services were integrated throughout the requirements. 
However, we became aware of concerns that behavioral health services 
were either not always being addressed or not addressed to the extent 
required, in LTC facilities. We proposed, and are finalizing, these 
requirements in a separate section to emphasize the importance of 
behavioral health and ensure that LTC facilities address these issues 
(80 FR 42203).
Definitions
    Comment: Some commenters were concerned about what care and 
services were encompassed within the behavioral health requirements. 
They recommended that there be a definition of behavioral health in the 
final rule.
    Response: We agree with the commenters that there should be a 
definition of ``behavioral health'' in this final rule. LTC facilities 
are also the residence for residents. Hence, we believe there needs to 
be a holistic approach to behavioral health and that it should 
encompass a resident's mental, emotional, and physical well-being. We 
believe this holistic approach should also encompass prevention. 
Additionally, we do not want to limit the behavioral health 
requirements to residents who have been diagnosed with mental or 
substance use disorders. Therefore, we have inserted the following 
definition into the stem statement at Sec.  483.40, ``Behavioral health 
encompasses a resident's whole emotional and mental well-being, which 
includes, but is not limited to, the prevention and treatment of mental 
and substance use disorders.''
    Comment: Some commenters were concerned about how ``direct care/
direct access'' staff would be interpreted. Some commenters also 
recommended that the wording be changed to, ``[t]he facility must have 
sufficient staff who provide direct services to residents and who have 
the appropriate competencies and skills to provide nursing, social 
work, and other services to assure resident safety and attain or 
maintain the highest practicable physical, mental, and psychosocial 
well-being . . .''
    Response: We acknowledge that there could be some confusion 
concerning the use of ``direct care/direct access'' staff. Depending on 
the setting, this term could be interpreted as applying to virtually 
every staff member in the facility or more narrowly to nursing staff 
and any applicable therapist. We believe that ``sufficient staff who 
provide direct services to residents'' is more appropriate language and 
have finalized that language in Sec.  483.40(a). Thus, the facility 
would be responsible for ensuring that every staff member that provided 
direct services to residents has the appropriate competencies and skill 
sets to provide nursing and other services. Those competencies and 
skill sets would depend upon the services the staff members were 
providing to the residents. However, we do not agree that ``social 
work'' needs to be specifically mentioned in this requirement. Although 
``social work'' is very important, other services are also important to 
the residents. In addition, ``social work'' is clearly included in 
``other services''.
Social Workers and Social Services
    Comment: Some commenters noted that we proposed to move the 
requirement that the facility provide medically-related social services 
from the previous quality of life requirement at Sec.  483.15(g), to 
Sec.  483.40(d). Commenters said that this implies that medically-
related social services were only for those with mental disorders or 
psychosocial adjustment difficulties, a history of trauma and/or post-
traumatic stress disorder. They indicated that social workers also 
provide services that benefit all residents, such as contributing to 
ongoing care planning, facilitating transitions of care, and advocating 
for residents' rights and helping facilities. These commenters believed 
that many residents could benefit from the services of social workers, 
in addition to those residents that have behavioral health or mental 
health issues. Other commenters wanted to move the behavioral health 
requirements to a stand-alone section on Quality of Care and Quality of 
Life requirement section.
    Response: We agree with the commenters and believe that this is 
already required. Section 483.40(d), both as proposed and finalized, 
requires the facility to provide medically-related social services to 
attain or maintain the highest practicable mental and psychosocial 
well-being of each resident. Thus, this requirement for medically-
related social services goes to all of the facility's residents, not 
just those with identified behavioral or mental health issues.
    Comment: Some commenters recommended that the requirement for 
medically-related social services be strengthened. They noted that the 
current requirement is for a full-time social worker in facilities with 
120 or more beds; however, smaller facilities also need clinical social 
workers to assist residents and their families with concerns about care 
and rights. Commenters noted that while non-clinical social services 
staff are also important for helping arrange for and coordinate 
services not provided by the facility, discharge planning, and 
identifying ongoing care and services for residents who are moving out 
of facilities, they thought it was important for the staff providing 
medically-related social services to have clinical credentials. Some 
commenters recommended that LTC facilities be required to employ 
sufficient numbers of social workers who are professionally 
credentialed to provide clinical services to residents. Some commenters 
also noted that the current inability of social workers to bill 
Medicare Part B had created a barrier to these services.
    Response: We agree with the commenters that residents in smaller 
facilities could also benefit from medically-related social services. 
However, the requirement that facilities with 120 or more beds must 
employ a full-time, qualified social worker is a statutory requirement 
(sections 1819(b)(7) and 1919(b)(7) of the Act). While we believe we 
have statutory authority to require facilities with fewer beds to 
employ full-time social workers, we did not propose changing this 
provision. We will retain these comments for consideration if there is 
future rulemaking concerning social workers or social work services.
    Comment: Some commenters noted that proposed Sec.  483.40(d), which 
reads, ``[t]he facility must provide medically-related social services 
to attain or maintain the highest practicable mental and psychosocial 
well-being of each resident.'' Commenters noted that ``physical'' was 
included in Sec.  483.40 and Sec.  483.40(a). They recommended that 
``physical'' be inserted before ``mental''.
    Response: We thank the commenters for pointing out that 
``physical'' was left out of Sec.  483.40(d). We have finalized that 
section so that the word ``physical'' is included.
    Comment: Some commenters stated that residents had limited access 
to

[[Page 68764]]

clinical social workers and that this posed a significant barrier to a 
facility's ability to meet residents' mental and behavioral health 
needs as identified in proposed Sec.  483.40. Commenters also stated 
that social work is essential to realize the goal of Sec.  483.40(a). 
Clinical social workers have either a master's or doctoral degree in 
social work, at least two years of post-degree supervised experience in 
a clinical setting, and a state-issued clinical social worker license, 
certification, or registration. They also noted that the Health 
Resources and Services Administration (HRSA) recognizes social work as 
one of the five core mental health professions. Commenters noted that 
some LTC facilities do employ clinical social workers to provide social 
services to residents and that this staffing pattern can certainly 
contribute to staff identification and response to residents' mental 
and behavioral health concerns. Commenters discussed how reimbursement 
contributes to this lack of access. Specifically, they stated that 
psychotherapeutic diagnosis and treatment is not included in the 
services covered by the SNF Part A resource utilization group payment. 
They also noted that even if these services were included in the 
payment, many clinical social workers employed in a social services 
capacity would not have the time or flexibility to provide the mental 
health services some residents would require. In addition, many LTC 
facilities contract with Medicare-certified independent practitioners 
to provide mental and behavioral health services to LTC facility 
residents. However, at this time, clinical social workers are only 
reimbursable under Medicare Part B if the resident is not receiving SNF 
benefits under Medicare Part A. The commenters believe that it was the 
implementation of the requirements in the Balanced Budget Act of 1997 
(Pub. L. 105-33), which bundled all social work services in the per-
diem SNF payment (section 4432 of the BBA), failed to distinguish 
between medical social work services provided to all SNF residents and 
discretionary psychotherapeutic services provided by clinical social 
workers with specialized needs. They argued that this revocation of the 
clinical social workers ability to bill Medicare Part B for 
psychotherapeutic services to SNF residents contrasts with the 
privileges retained by psychiatrists and psychologists, whose services 
are not bundled in the SNF per-diem rate. They recommended that 
correcting this discrepancy would reduce costs to both the 
beneficiaries and the Medicare program by helping to prevent 
unnecessary transfers to the emergency department or psychiatric 
hospital, as well as to decrease avoidable re-hospitalizations related 
to mental and behavioral health.
    Response: We agree with the commenters that social workers offer 
valuable services to residents. LTC facilities with less than 120 beds 
are not required to have a full-time social worker on staff. However, 
in this final rule, LTC facilities are required to have sufficient 
staff with the appropriate competencies and skill sets to provide the 
care needed by their residents. Thus, LTC facilities must ensure that 
their residents have the social services, including medically-related 
social services, they require. Policy governing billing and payment for 
the services of social workers is beyond the scope of this regulation.
Relationship to Other Requirements
    Comment: Some commenters requested clarification on how the 
behavioral health services section requirements intersect with the 
current pre-admission screening and resident review (PASARR) process, 
particularly with respect to the Level II screening when it results in 
a finding that a resident would require specialized behavioral health 
services.
    Response: According to Sec.  483.40, LTC facilities are required to 
provide the necessary behavioral health care and services to residents 
for those residents to attain or maintain their highest practicable 
physical, mental, and psychosocial well-being, in accordance with the 
comprehensive assessment and plan of care.
    Comment: Some commenters were concerned about LTC facilities being 
confused with Institutions for Mental Diseases (IMDs) or Institutions 
for Individuals with Intellectual Disabilities (IIDs). The primary 
focus of the regulatory design for LTC facility was based on meeting 
the nursing and/or medical needs of residents. While the commenters 
noted that we have progressed to a more holistic, person-centered 
approach, LTC facilities continue to lack the capability in terms of 
specialized staffing, access to resources and specialized care, and the 
overall character of their population, to provide the appropriate care 
for residents with serious mental disorders or who require long-term 
and intensive psychotherapy. Commenters also pointed out that there is 
a provision for mental health services under the Medicaid program that 
prohibits federal financial participation (FFP) to centers for services 
rendered in LTC facilities that CMS finds qualify as an IMD. Commenters 
described the criteria used to determine if a facility is an IMD, 
including whether more than 50 percent of the residents need to be in 
an institution as a result of a mental disorder and an unusually large 
proportion of the staff has specialized psychiatric/psychological 
training.
    Response: The requirements in Sec.  483.40 Behavioral health, as 
well as the other requirements on staffing finalized in this rule, do 
not require any LTC facilities to admit any resident for whom the 
facility cannot provide appropriate care. According to the requirements 
in this final rule, facilities must perform a facility assessment, 
which includes both their resident population and the resources the 
facility needs to care for their residents. The facility must then 
provide those resources, including the sufficient number of staff with 
the appropriate competencies and skill sets, to care for their resident 
population. We are not requiring that LTC facilities admit residents 
with behavioral health needs that the facility cannot meet. However, 
the facility must provide the appropriate care for the residents it 
does have.
Dementia
    Comment: Some commenters were very concerned about the proposed 
rule not having specific requirements that addressed dementia. Some 
noted that the word dementia was not even included in the behavioral 
health section; however, the preamble implies that the proposed 
regulation would apply to residents with diagnoses such as dementia and 
Behavioral and Psychological Symptoms of Dementia (BPSD). They insisted 
that nothing was more central to the purpose of LTC facilities than 
providing good care to individuals with dementia. Dementia is 
increasing among LTC facility residents and two-thirds of those dying 
with dementia are dying in LTC facilities. They also noted that 
consumers and advocates have said that the quality of care that is 
provided in LTC facilities to residents with dementia is frequently 
poor and these residents are often chemically restrained and deprived 
of needed care and not treated with dignity. These commenters believed 
that establishing standards for dementia care in LTC facilities is a 
necessity. Some of these commenters recommended that there be a 
separate section and new standards for dementia care. Other commenters 
recommended adding a requirement to Sec.  483.40(b)(1) stating, ``[a] 
resident whose assessment reveals a history of or potential for 
dementia-related behavior receives appropriate

[[Page 68765]]

care and interventions to prevent or de-escalate dementia-related 
behaviors.'' Some commenters recommended that we incorporate into the 
requirements the guidance on dementia contained in the survey and 
certification letter, ``Advanced Copy: Dementia Care in Nursing Homes: 
Clarification to Appendix P State Operations Manual (SOM) and Appendix 
PP in the SOM for F309--Quality of Care and F329--Unnecessary Drugs'' 
(S&C: 13-35-NH) that was published on May 24, 2013.
    Response: We believe and intended that dementia be included in our 
requirements that address behavioral health. However, we understand the 
commenters' concerns regarding the lack of specific requirements 
concerning the care of residents with dementia. The survey and 
certification letter recommended by some of the commenters (S&C: 13-35-
NH) does contain valuable guidance for LTC facilities concerning care 
for their residents with dementia. However, we did not propose specific 
requirements for the care of residents with dementia. We believe that 
this would require more research and discussion than we have completed 
at this time. However, we will retain these comments in case there is 
future rule-making concerning dementia. At this time, we can 
specifically include dementia as a condition that the facility must 
address. Thus, we have inserted at Sec.  483.40(b)(3), the following, 
``[a] resident who displays the signs of or is diagnosed with dementia, 
receives the appropriate treatment and services to attain or maintain 
his or her highest practicable physical, mental, and psychosocial well-
being.''
    Comment: Some commenters were concerned about the burden associated 
with these requirements. Some commenters were concerned about imposing 
additional reporting and documentation requirements. Others were 
concerned about whether facilities would need to ensure expanded access 
to outside professional behavioral health services, which are costly 
and already difficult to access in rural and geographically underserved 
areas. Some commenters also noted that facilities would incur 
potentially significant cost to provide required behavioral health 
training to their entire staff under the proposed Sec.  483.95(i).
    Response: We do not believe that the costs associated with the 
behavioral health services requirements are burdensome for LTC 
facilities. In the previous requirements, Sec.  483.25 ``Quality of 
care,'' LTC facilities were already required to ensure that, ``[e]ach 
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.'' In addition, concerning 
mental and psychosocial functioning, facilities were already required 
to ``ensure that--(1) [a] resident who displays a mental disorder or 
psychosocial adjustment difficulty, receives appropriate treatment and 
services to correct the assessed problem; and (2) [a] resident whose 
assessment did not reveal a mental disorder or psychosocial adjustment 
difficulty 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 such a pattern was 
unavoidable'' (former Sec.  483.25(f)). Hence, LTC facilities should 
already be complying with many of the requirements in this rule and 
that should reduce the costs associated with complying with these 
requirements.
    After considering the comments, we are finalizing as proposed, with 
the addition of the definition for ``behavioral health.''

O. Pharmacy Services (Sec.  483.45)

    The LTC requirements regarding pharmacy services were located at 
Sec.  483.60. We proposed to relocate these provisions to Sec.  483.45. 
Section 483.60(c) required a pharmacist to perform a drug regimen 
review (DRR) for each resident at least once a month. At Sec.  
483.45(c)(2), we proposed that the pharmacist be required to review the 
resident's medical record concurrently with the DRR 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. The previous LTC requirements at Sec.  483.25(l)(2) 
specifically identified antipsychotic drugs and provided specific 
safeguards for their use. We proposed to re-designate these 
requirements to Sec.  483.45(e) and at Sec.  483.45(c)(3) to expand the 
drugs to which Sec.  483.45(e) applies to include psychotropic 
medications (anti-psychotic drugs are included in the definition of 
psychotropic drugs). We proposed to use the definition of psychotropic 
drug used in the November 2001 OIG report, ``Psychotropic Drug Use in 
Nursing Homes'' (OEI-02-00-00490), which is a drug that affects 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.
    The previous LTC requirements also required the pharmacist who 
conducted the monthly DRR to report any irregularities to the attending 
physician and the director of nursing. The term ``irregularities'' was 
not previously defined in the regulation and no examples were given. We 
proposed at Sec.  483.45(c)(4) to define ``irregularities'' as 
including, but not limited to, the use of any drug that meets the 
criteria set forth in proposed paragraph (d) for an unnecessary drug. 
In addition, previously the pharmacist performing the monthly DRR was 
required to report any ``irregularities'' to the attending physician 
and the facility's director of nursing, and that these reports must be 
acted upon.
    We proposed that the medical director be added to the individuals 
who should be notified of irregularities identified by the pharmacist 
during the residents' DRRs. We also proposed 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 
identified. To ensure that the reported irregularities are acted upon, 
we also proposed that the attending physician must document in the 
resident's medical record that he or she has reviewed the report of the 
identified irregularity and what, if any, action has been taken to 
address it. If there is to be no change in the medication for which an 
irregularity was identified, 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. We proposed to relocate these requirements 
from Sec.  483.25 ``Quality of Care'' to proposed Sec.  483.45 
``Pharmacy services.''
    In addition, we proposed at Sec.  483.45(e)(3) that LTC facilities 
ensure that residents would not receive psychotropic drugs pursuant to 
a PRN order unless that medication was necessary to treat a diagnosed 
specific condition that was documented in the clinical record. In 
addition, at Sec.  483.45(e)(4), we proposed that every PRN order for a 
psychotropic drug be limited to 48 hours and not be

[[Page 68766]]

continued beyond that time unless the resident's primary care provider, 
for example, his or her physician, documented the justification for 
this continuation in the resident's clinical record.
General Comments
    Comment: Some commenters were generally supportive of the proposed 
requirements for pharmacy services. One commenter said the section 
strengthened the role of both the physician review and accountability 
in regards to psychotropic medications and added additional oversight 
by the pharmacists. One commenter believed CMS already had, and had 
used, its authority to enforce requirements concerning unnecessary 
drugs and inappropriate drug use.
    Response: We thank these commenters for their support for the 
proposed requirements for pharmacy services. Although CMS already 
exercises its authority to regulate the use of unnecessary and 
inappropriate drugs, we believe that the requirements finalized in this 
rule will strengthen the protections for residents concerning pharmacy 
services and improve our oversight of the drugs used in LTC facilities.
    Comment: Some commenters believed that our proposals were 
insufficient to protect residents from the inappropriate use of 
psychotropic medications or otherwise questioned the value of the 
proposals. Some commenters also recommended additional provisions, such 
as informed consent from the resident or resident representative prior 
to administering any psychotropic or anti-psychotic drug. Another 
commenter believed that LTC facility resources would be better spent on 
enforcing and reinforcing existing requirements, combined with an 
intensified focus on some of the key underlying reasons for problematic 
prescribing and use of medications (including medication-related 
problems during care transitions and acute changes of condition), 
regardless of the medication category or underlying medical condition.
    Response: We believe the requirements finalized in this rule 
strengthen the protections for residents from the use of inappropriate 
drugs. For example, the finalized requirements for the monthly DRRs, 
which include a requirement that each resident's medical record be 
reviewed in conjunction with the monthly DRR, should result in more 
frequent and thorough reviews of residents' drug regimens. Please see 
the section on DRRs below for further explanation. The requirement to 
copy the facility's medical director on the report of irregularities, 
in addition to the attending physician and the facility's director of 
nursing, should result in medical directors becoming more aware of, if 
not involved in, the residents' medication management. Requiring the 
attending physician to document his or her review and action taken with 
respect to any identified irregularity should ensure that the 
irregularity is reviewed, and that medication errors and potential 
adverse events related to medications are minimized. Expanding the 
requirements for antipsychotic drugs to psychotropic drugs will expand 
protections for residents prescribed drugs that have an increased 
potential for being prescribed inappropriately or for reasons other 
than the resident's benefit, such as for the purpose of a chemical 
restraint.
    Comment: One commenter disagreed with our proposals regarding 
pharmacy services because the proposals did not address the root cause 
of the medication issues in LTC facilities. The commenter stated that 
most medication management and related issues emanate from shortcomings 
in the care delivery process and clinical reasoning and diagnosis. They 
said that the proposed changes would only create another ``silo'' by 
reorganizing more requirements into the Pharmacy Services requirement. 
Since implementation is the primary challenge, the commenter stated 
that everyone's time and effort would be better spent in enforcing and 
reinforcing existing requirements, combined with an intensified focus 
on some of the key underlying reasons for problematic prescribing and 
use of medications (including medication-related problems during care 
transitions and acute changes of condition), regardless of the 
medication category or underlying medical conditions. They believe that 
the most effective approach would be to focus all providers and 
practitioners on a thorough evaluation of each resident to establish a 
clinically valid rationale for all current treatments, and to 
effectively use existing requirements and surveyor guidance to look for 
evidence of appropriate clinical care, documentation, and 
implementation.
    Response: The ``Pharmacy Services'' requirements are a part of a 
comprehensive update of the long-term care requirements. As finalized, 
we believe all of the requirements in this rule, including the 
``Pharmacy Services'' section, will work together to protect the 
residents' rights and improve the quality of care they receive in LTC 
facilities. For example, the pharmacist must do a medical record review 
when the resident is taking an antibiotic or any drug the facility's 
QAA committee has requested be included in the monthly DRR (42 CFR 
483.45(c)(2)(iii)). Reviewing the medical record concurrently with the 
MAR or other list of current medications during the monthly DRR if the 
resident is taking an antibiotic supports the infection control 
program, especially the antibiotic stewardship program (Sec.  
483.80(a)(3)). Since the QAA committee coordinates and evaluates QAPI 
activities under the QAPI program, the pharmacist reviewing the medical 
record for those residents taking a drug identified by the QAA 
committee also contributes to QAPI activities. Thus, the requirements 
finalized in this rule should work together to address the care 
delivery process and promote improved clinical care for the residents.
    Comment: Some commenters were concerned that the pharmacy services 
requirements appeared to place the primary responsibility for 
medication management, especially for antipsychotic or psychotropic 
drugs, on the pharmacist. They argued that other disciplines, 
especially prescribers and nursing, have the primary accountability for 
the residents' drug regimens. One commenter also noted that while the 
consultant pharmacist and the IDT provide input to the prescriber, it 
is the prescriber, not the consultant pharmacist, who determines which 
medications are appropriate, based on the resident's clinical 
condition, goals of care, and the risks, benefits and alternatives to 
specific medications.
    Response: It is the physician or the prescribing practitioner who 
is responsible for prescribing medication. Nurses also bear the 
responsibility for the medications they administer to residents. Hence, 
we disagree with commenter that the proposed requirements place the 
primary responsibility for medication management on the pharmacist. The 
pharmacist is performing a DRR designed to identify irregularities, 
which is within their scope of practice. When the pharmacist identifies 
an irregularity, he or she is identifying a medication that they 
believe presents an issue that needs to be addressed. However, it is 
not the pharmacist but the attending physician who would review the 
identified irregularity and the resident's medical record and then 
determine if there should be any change to that medication. Thus, the 
resident's medication regimen is the responsibility of the physician or 
the prescribing practitioner, not the pharmacist.

[[Page 68767]]

    Comment: Some commenters were concerned that the proposed 
requirements were intended to have an overall chilling effect on the 
prescription of psychotropic drugs in LTC facilities. One commenter 
asserted that the proposed requirements established a default position 
that basically psychotropic drugs were not to be prescribed and, if a 
resident was on one of these drugs, the facility was to do everything 
it could to get the resident off the drug. This could result in anti-
psychotic and other psychotropic medications not being prescribed even 
when they are appropriate and needed for the resident's health and for 
their benefit.
    Response: As we said in the proposed rule, ``[w]e 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 [with] a specific condition that 
requires these medications. Our proposed requirements are intended to 
protect LTC facility residents from drugs that are not being prescribed 
for their benefit'' (80 FR 42204). In addition, as described below, we 
have not finalized all of the requirements as proposed. As discussed 
below in responses to comments, we have made modifications in this 
proposed rule in response to such comments. We do not believe that the 
requirements finalized in this rule are so burdensome that any 
practitioner should be discouraged from using any psychotropic 
medication when it is appropriate for the resident and is being 
prescribed for the resident's benefit.
    Comment: Some commenters were concerned about reorganizing these 
requirements from the quality of care section to the pharmacy services 
section. They believed this created the impression that antipsychotic 
or other psychotropic drugs were not a matter for quality of care or a 
fundamental human right. They also expressed concerns about how this 
reorganization would affect the surveyor's ability to be able to extend 
surveys due to a finding of substandard care. Some commenters wanted 
the pharmacy requirements retained in the quality of care section. They 
believed that only requirements related to procedures, staff, 
credentials, and so forth should be included in the pharmacy services 
requirements. They were also concerned that it would create an 
undesirable ``silo''.
    Response: We acknowledge that there will need to be changes in the 
survey process due to some of the changes encompassed in this final 
rule. However, any changes to the survey process will be managed 
through sub-regulatory guidance. We disagree with the commenters 
regarding the reorganization. As we explained in the proposed rule, we 
believed that there needed to be improvements in the overall 
readability and logical order of the requirements (80 FR 42178). We 
believe that the requirements in the pharmacy services sections should 
logically be grouped together and their new location makes them more 
accessible, especially to individuals who are not familiar with the 
requirements.
    Comment: One commenter recommended that the pharmacy services 
section be re-written to specify the goal and purpose for the use of 
psychotropic medications. They suggested that we specify in the 
requirements that the goal of caring for individuals with cognitive 
impairment is to limit the use of psychotropic medications. They 
recommended that the classes of medications along with exceptions or 
drugs in those classes to which the requirements should not apply, be 
included in the sub-regulatory guidance.
    Response: The goal or purpose of the requirements finalized in this 
rule is not to limit the overall amount of psychotropic drugs used by 
the facility or to supplant the judgment of a physician or other 
prescribing clinician concerning the use of psychotropic medications. 
As stated above, the purpose of these requirements is to ensure that 
residents receive psychotropic drugs only when these medications are 
appropriate and intended for the resident's benefit. These requirements 
are intended to decrease, and hopefully eliminate, inappropriate 
psychotropic drug use and the use of medications for reasons other than 
the resident's benefit.
Drug Regimen Reviews
    Comment: Some commenters approved of the proposed requirements 
concerning drug regimen reviews (DRRs), especially the requirement for 
periodic review of residents' medical records and monthly reviews when 
the resident is taking certain medications or during transitions in 
care. One commenter believed that requiring a medical record review for 
residents taking drugs identified by the QAA Committee was a good idea. 
However, some commenters recommended that the requirements be 
strengthened by requiring the concurrent review of each resident's 
medical record during the monthly DRRs. Another commenter wanted to 
require that all residents have their medical records reviewed during 
the DRR at least quarterly, instead of every six months. Another 
commenter supported the proposed requirements for reviewing the medical 
record in conjunction with the DRR under the proposed circumstances; 
however, the commenter also noted their concern about polypharmacy. 
Some commenters even stated they believed that a DRR by definition 
implies review of the resident medical record. This would enable any 
issues with the resident's medications to be identified sooner.
    Response: After reviewing the comments we received concerning the 
proposed requirement for the pharmacist to review residents' medical 
records in conjunction with the monthly DRR under certain specific 
circumstances, we agree with the commenters that the pharmacist should 
review each resident's medical record during every monthly DRR. We also 
agree with the commenter that expressed concern over the large number 
of drugs that many residents are being prescribed or polypharmacy. In 
addition, we agree that reviewing the medical records for all residents 
with each monthly DRR would likely identify irregularities sooner. 
Identifying irregularities sooner could assist in preventing adverse 
medication reactions and aid in earlier identification of medication 
issues. Requiring that the pharmacist review the medical record for 
each resident during his or her monthly DRR provides residents with 
protection from inappropriate drug use without being burdensome for the 
facility. Thus, we will not be making the commenters' recommended 
changes to require monthly or quarterly review of medical records in 
conjunction with the DRR, but modifying Sec.  483.45(c)(2) by requiring 
that the monthly DRR include a review of the resident's medical record.
    Comment: Some commenters were concerned about situations in which 
there is no action concerning an irregularity identified by the 
pharmacist during the DRR. Some commenters recommended a requirement 
for the pharmacist to report the irregularity and the lack of any 
action concerning that irregularity to an outside authority, such as 
the state's office of the long-term care ombudsman, state licensing 
authority, or CMS, if the pharmacist's believes that the irregularity 
detected requires action.
    Response: While we appreciate the commenters' concerns for 
residents, we do not believe that it is appropriate to require 
pharmacists to report to an outside entity if they do not agree with 
the action or lack of action taken by the attending physician or other 
prescribing

[[Page 68768]]

practitioner. The attending physician is notified of the irregularity, 
as well as the facility's medical director and director or nursing. It 
is the attending physician's responsibility to review the identified 
irregularity and take any action, or no action, based upon his or her 
professional judgment. If there is no action and either the facility's 
medical director or DoN has questions or disagrees, we would expect 
that either or both of these individuals would follow-up with the 
attending physician. Unless specifically allowed under the relevant 
state law, it is outside the scope of practice for pharmacists to 
prescribe medication. The appropriate action to take after an 
irregularity is identified is the responsibility of the attending 
physician. However, we do believe that the resident's medical record 
should demonstrate that the attending physician has reviewed the 
identified irregularity and what, if any, action was taken. If no 
action was taken, the medical record should indicate why no action was 
appropriate. Thus, we have finalized Sec.  483.45(c)(4)(iii) that 
requires the attending physician to 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.
    Comment: Some commenters wanted there to be more transparency with 
the monthly DRR process. They recommended that the report of 
irregularities become part of the resident's medical record. Another 
commenter wanted the resident or the resident's representative to be 
notified of the irregularity.
    Response: According to the SOM, Appendix PP-Guidance to Surveyors 
for Long Term Care Facilities (Rev. 149, 10-09-15), the pharmacist's 
findings are part of each resident's active medical record. These 
findings should be maintained in the resident's medical record or in 
the facility where it is readily available for review. According to 
proposed Sec.  483.10(f)(3), finalized at Sec.  483.10(g)(2), the 
resident has the right to access any medical record that pertains to 
him or herself. Thus, the pharmacist's findings are already available 
to the resident or the resident's representative. However, we decline 
to require that the resident or their representative be notified of the 
pharmacist's findings. The irregularity identified by the pharmacist 
may require no action, updating or modifying documentation, or some 
other action that does not affect the quality of care for the resident. 
Unnecessary notifications could lead to confusion and anxiety for the 
resident. We believe that it is the responsibility of the attending 
physician to determine whether to notify the resident or their 
representative. In addition, each facility could also make that 
determination and address notification of the resident and the 
resident's representative in the policies and procedures for the DRR 
process that is now required at Sec.  483.45(c)(5).
    Comment: Some commenters expressed concerns over various aspects of 
the DRR. Some were concerned about the absence of timeframes concerning 
how much time the pharmacist should have after discovering an 
irregularity to submit a report of irregularities to the attending 
physician, medical director, and the director of nursing or how long 
the facility or attending physician has to take action on any 
identified irregularities. In addition, some commenters were concerned 
there were no requirements related to what a pharmacist should do if he 
or she believed the identified irregularity required urgent or 
emergency action to protect the resident. Some commenters also 
recommended that there be designated circumstances or triggers for an 
emergency review. One commenter proposed that the supervising or 
attending nurse should be able to request an emergency medical records 
review from the pharmacist for residents taking psychotropic drugs upon 
observation of adverse side effects, significant changes in the 
resident's condition, the absence of a diagnosis of a major mental 
disorder in the medical records, or the presence of a primary diagnosis 
of Alzheimer's Disease or another form of dementia. If the irregularity 
involved the inappropriate use of psychotropic drugs, the facility 
should be required to take immediate steps to gradually reduce the drug 
and implement behavioral intervention with the goal of discontinuing 
the use of the drug as soon as it is safe and practicable. Other 
commenters were concerned about the increased documentation required by 
physicians, especially in cases where physicians might have to 
repeatedly document rationales for the same medications for the same 
residents after a pharmacist noted the medication on the report of 
irregularities. These commenters recommended that accommodations be 
made in cases where there had been previous irregularities noted for 
the same medication for a particular resident and even provided 
specific language for the regulatory text. Other commenters recommended 
that the facilities have policies and procedures that cover different 
aspects of the DRR process.
    Response: We agree with the commenters that LTC facilities should 
have policies and procedures concerning the monthly DRR, including 
appropriate time frames. We also agree that pharmacists should have a 
procedure to follow so that the appropriate individuals are notified if 
the pharmacist believes that an irregularity needs to be reviewed 
immediately due to the potential for harm to a resident. However, we do 
not believe that we should establish those time frames. We believe that 
each facility should establish policies and procedures that address the 
entire DRR process, especially the timeframes for various actions in 
the process and a procedure for a pharmacist to follow when he or she 
believes the irregularity must be addressed immediately due to the 
potential for harm to the resident. We disagree with the commenter that 
recommended that the attending or supervising nurse be able to request 
that the pharmacist perform an emergency DRR for a resident under 
certain circumstances or, if the drug in question is a psychotropic, 
institute gradual dose reductions (GDRs). The facility should have its 
own policies and procedures for the nurse if she or he is concerned 
about any medication order. We generally believe that the nurse, not 
the pharmacist, should be contacting the attending physician or the 
prescribing practitioner if there are any questions concerning the 
safety or appropriateness of a medication for a resident.
    We also agree with the commenter that physicians should not be 
required to repeatedly document the same rationale in the resident's 
medical record, once a clinically acceptable rationale is already 
documented in the medical record for a specific medication. However, we 
believe that each facility should have the flexibility to determine the 
best manner in which to handle this situation. We encourage facilities 
to address this situation in their policies and procedures concerning 
the monthly DRR. Concerning the other recommendations, we believe that 
each facility needs the flexibility to determine how the monthly DRRs 
will be conducted and how the facility will comply with the 
requirements in this final rule. Thus, in this final rule we are adding 
a requirement at Sec.  483.45(c)(5) that the facility must establish 
and maintain policies and procedures that addresses the monthly DRR, 
including but not limited to, timeframes for the various steps in the 
process and procedures a

[[Page 68769]]

pharmacist is to take when he or she believes immediate action is 
required due to potential harm to the resident.
    Comment: One commenter disagreed with the amount of detail and 
specificity in the requirements for the DRR. They also did not believe 
the regulatory text was sufficiently flexible to accommodate likely 
changes related to medication usage without modification. One commenter 
stated that with the increasing adaptation of e-prescribing real time 
reviews will become more frequent. With these types of reviews, some of 
the pharmacy requirements will become outdated. They recommended more 
general language, such as that in the preamble. They suggested we amend 
Sec.  483.45(c)(2) to read: ``[t]his review must occur on a regular 
basis including more frequent targeted reviews for medications that may 
be associated with an increase of adverse events or overutilization as 
well as when the resident experiences transitions in care or when 
requested by the facility.'' Written communication, they believed, did 
not allow for new and more effective methods of communication. By 
specifying specific elements, it would not provide for new data 
elements. Some commenters also argued that there was too much 
specificity concerning when the medical record review must be done in 
conjunction with the DRR.
    Response: We do not believe that the preamble language cited by the 
commenter would be appropriate for the regulatory text. The regulatory 
text must be specific enough to inform the facility of what activities 
are necessary to comply with the requirement. While it may be 
appropriate under certain circumstances to use more general language 
such as that suggested by the commenter, we do not believe it is 
appropriate for the monthly DRR. The inappropriate use of drugs has the 
potential to be very dangerous for residents. We believe that there are 
specific times when the medical chart must be reviewed concurrently 
with the DRR to ensure a thorough review of the resident's drug regimen 
and provide the resident with protection from inappropriate drugs. We 
believe that the requirements are specific enough to clearly indicate 
what is necessary to comply with the requirement, but flexible enough 
to allow facilities to decide how to comply. Thus, we have finalized as 
proposed the requirements for when a pharmacist must review the 
resident's medical record in conjunction with the DRR and the report of 
irregularities.
    Comment: One commenter was concerned about adding the facility's 
medical director to the list of individuals to whom the report of 
irregularities must be forwarded. The commenter noted that by 
increasing the number of persons the report must be forwarded to, it 
increased the likelihood of miscommunication and errors. Other 
commenters wanted the report forwarded to the appropriate prescribing 
practitioner, not just the attending physician.
    Response: We believe that it is crucial that the facility's medical 
director be notified of any irregularities detected by the pharmacist 
in the monthly DRRs. The medical director is responsible for the 
medical care provided in the facility. In addition, as a physician, the 
medical director is in the best position to discuss the identified 
irregularity with the attending physician, especially if there are 
continuing concerns about the medication after the attending physician 
has reviewed and acted upon the identified irregularity. Concerning the 
report of irregularities, although the pharmacist is required to 
forward the report of irregularities to the attending physician and the 
facility's medical director and director of nursing, this does not 
preclude the facility from forwarding the report to any other 
individuals they believe is appropriate, such as a prescribing 
practitioner.
    Comment: Some commenters were concerned about conflicts of interest 
between the facility and the pharmacists who are conducting the monthly 
DRR. These commenters wanted us to address the issue of independence 
for these consulting pharmacists.
    Response: Requirements addressing the independence of the 
consulting pharmacist were not included in the proposed rule. 
Therefore, we will not address this issue in this final rule. However, 
we will consider these comments if there is any future rulemaking 
concerning this issue.
Definition of ``Psychotropic Drug''
    Comment: Some commenters supported the proposed definition of 
``psychotropic drugs.'' One commenter noted that use of inappropriate 
psychotropic medications is prevalent in nursing facilities. They 
indicated that psychotropic drugs are powerful and often given to 
sedate or control elderly people with behavioral challenges caused by 
dementia, rather than major mental disorders as defined at 42 CFR 
483.102. Thus, these drugs are not being prescribed or administered in 
accordance with the safeguards set out in the current regulation.
    Response: We thank the commenters for their support. We believe 
that the definition of ``psychotropic drug'' finalized in this rule 
will not only ensure additional scrutiny when prescribed, but will also 
enhance the protection for residents from inappropriate use of these 
and other medications not prescribed for the residents' benefit. 
However, based upon our review of the public comments, we have made 
some modifications to the definition as described below.
    Comment: Several commenters stated that the proposed definition was 
so expansive as to make the use of psychotropic drugs unmanageable. The 
commenters indicated that the proposed definition would also include 
medications that do not warrant the resident protection safeguards and 
additional scrutiny required when a psychotropic drug is prescribed for 
a resident. One commenter recommended we use the term 
``psychopharmacological medication'' instead of ``psychotropic drugs.'' 
One commenter said the new definition was unlikely to improve or 
correct process problems.
    Some commenters were especially concerned about the last part of 
the definition, ``any other drug that results in effect similar to the 
drugs listed'' in the previous sections. They believed this was too 
expansive and included nearly all medications, such as drugs for 
seizures and Parkinson's disease, NSAIDs, beta-blockers, and eye drops 
for glaucoma. Another commenter also argued that the proposed 
definition would include commonly used drugs that do not merit 
additional scrutiny, such as Compazine, which is used for nausea. 
Another commenter recommended we define the classes of drugs, but 
provide exceptions in sub-regulatory guidance.
    Response: After reviewing and analyzing the comments, we believe 
that the definition of psychotropic drugs should be modified. We share 
the commenters' concerns that the proposed definition for 
``psychotropic drugs'' at Sec.  483.45(c)(3) might include many drugs 
for which the additional requirements in this section would be 
superfluous and unnecessary. Hence, we have removed the last element in 
the proposed definition of ``psychotropic drug,'' specifically, ``(vi) 
Any other drug that result in effects similar to the drugs listed in 
paragraphs (c)(3)(i) through (v) of this section.'' We have also 
modified the language in Sec.  483.45(c)(3) to read, ``[e]xamples of 
these drugs, include but are not limited to, drugs in the following 
categories . . .'' We modified this language to clarify that the 
definition includes drugs from the four identified categories (anti-
psychotic, anti-depressant, anti-anxiety, and hypnotic)

[[Page 68770]]

and that CMS has the authority to add other drugs to the definition 
through sub-regulatory guidance.
    Comment: Some commenters support the goal of reducing the use of 
unnecessary psychotropic medications in long-term care facilities, but 
were concerned that the proposed requirements, including the drugs 
included in the definition, were so extensive that it could result in 
under-treatment of pain and other distressing symptoms and reduce the 
efficacy of palliative care and the overall quality of life for the 
residents. They argued that individuals suffering from pain have the 
right to be informed of, choose, and receive effective pain and symptom 
evaluation, management, and ongoing monitoring as part of basic medical 
care, even if such pain and symptom management may result in analgesic 
tolerance, physical dependence, or as an unintended consequence, 
shorten the individual's life. They believe that the inclusion of both 
antidepressants and opioid analgesics in the definition of 
``psychotropic drugs'' would inevitably cause LTC facilities to avoid 
the use of such interventions, because they would be scrutinized as 
closely as anti-psychotic drugs, which have too often been misused in 
long-term care settings. The proposed regulation could potentially 
cause not only under-treatment but also unnecessary hospitalizations 
due to necessary medication not being prescribed or lapses in 
prescriptions due to limitations on PRN prescriptions of psychotropic 
drugs. One commenter stated it would be difficult to survey facilities 
consistently, using that definition.
    Response: We agree with the commenters that the proposed definition 
of ``psychotropic drug'' is too broad. We especially agree with the 
commenters that objected to including opioid analgesics in the 
definition. We are particularly concerned about the possibility that 
including opioid analgesics in the definition could result in negative 
consequences for pain management, especially since they are usually 
given PRN and there could be interruptions in the prescriptions due to 
the proposed limitation on PRN prescriptions. Therefore, we have 
removed the drug category of ``opioid analgesics'' from the finalized 
definition of ``psychotropic drug.'' Although we have not removed anti-
depressants from the definition, we have made modifications to the PRN 
limitation that we believe addresses the commenters' concerns, which 
are discussed below.
    Although we are not finalizing ``opioid analgesics'' in the 
definition of ``psychotropic drug,'' it is not our intention to in any 
way to either diminish the importance of these drugs in the alleviation 
of pain nor the serious consequences of their inappropriate use. Opioid 
abuse is a serious public health issue with devastating consequences. 
Currently, the United States is in the midst of a prescription opioid 
overdose epidemic. According to the Centers for Disease Control (CDC), 
in 2014, more than 28,000 people died from opioid overdose, and at 
least half of those deaths involved a prescription opioid. Many more 
became addicted to prescription and illegal opioids.\1\ Overall, 
overdose deaths from opioids, including prescription opioids and 
heroin, have nearly quadrupled since 1999.\2\ In response to this 
crisis, HHS has made addressing the opioid epidemic a top priority.
---------------------------------------------------------------------------

    \1\ Centers for Disease Control and Prevention. Increases in 
Drug and Opioid Overdose Deaths--United States, 2000-2014. MMWR 
2015; 64;1-5.
    \2\ CDC. Wide-ranging online data for epidemiologic research 
(WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 
2016. Available at http://wonder.cdc.gov.
---------------------------------------------------------------------------

    HHS continues to build upon current efforts to combat the opioid 
abuse epidemic, including continuing to help health professionals to 
make the most informed prescribing decisions by:
     Teaching medical professionals how and when to prescribe 
opioids by working with lawmakers on bipartisan legislation requiring 
specific training for safe opioid prescribing and establishing new 
opioid prescribing guidelines for chronic pain;
     Supporting data sharing for safe prescribing by 
facilitating prescription drug monitoring programs (PDMP) and health 
information technology integration and further adoption of electronic 
prescribing practices;
     Increasing investments in state-level prevention 
interventions, including PDMPs, to track opioid prescribing and support 
appropriate pain management.
    In addition, HHS supports efforts that encourage the increased use 
of naloxone, which reverses potentially fatal overdoses caused by 
opioids, and expand the use of Medication-Assisted Treatment (MAT), 
which combines behavioral therapy and medications to treat substance 
use disorders. In addition, we strongly encourage prescribing 
practitioners to follow CDC guidelines for prescribing opioids for 
chronic pain. The CDC guidelines provide recommendations which focus on 
the use of opioids in treating chronic pain (pain lasting longer than 3 
months or past the time of normal tissue healing) outside of active 
cancer treatment, palliative care, and end-of-life care. The CDC 
guidelines are available at the following Web site: http://www.cdc.gov/drugoverdose/prescribing/guideline.html. We note that additional 
information and guidance on the CDC guidelines, as well as guidance on 
how practitioners can help to combat opioid abuse, will be included in 
the sub-regulatory interpretive guidance, which will be available after 
the publication of this final rule.
    We believe that the requirements we have finalized in this rule 
provide residents with the protections they need from the inappropriate 
use of drugs, including opioids. However, we will continue to assess 
the opioid epidemic and will consider whether to propose additional 
requirements for providers in future rulemaking.
    Comment: One commenter said that good medical practice requires 
that all issues and conditions be viewed and managed in the proper 
context, and not as isolated conditions or risks. Singling out certain 
topics actually limits and reverses the current requirement, because it 
distracts attention from other equally or more important issues. 
Facilities learn only to address those medications that are on the 
radar screen, resulting in problematic use of many medications that are 
not under intense scrutiny.
    Response: The pharmacy services requirement at Sec.  483.45 in this 
final rule addresses all medications. Although any drug could be used 
inappropriately, we believe that certain medications, such as 
psychotropic drugs, do have more potential for inappropriate use. Such 
drugs also merit additional scrutiny for the protection of the 
residents. Hence, we are finalizing the requirements related to 
psychotropic drugs, as modified by this rule.
    Comment: One commenter recommended that instead of the proposed 
definition of psychotropic drug and the PRN limitation, CMS should 
instead take steps to develop palliative care quality indicators 
focused on assuring that the care received is in accordance with 
resident and family priorities.
    Response: We did not propose the development of palliative care 
quality indicators in the proposed rule. This comment is beyond the 
scope of this rule. However, we will keep this comment in mind if there 
is future rulemaking on this issue.
    Comment: Some commenters stated that while psychotropic drugs are a 
problem in LTC facilities, they opposed including anti-psychotic drugs. 
They argued that combining anti-psychotic drugs into a new category 
called

[[Page 68771]]

psychotropic drugs dilutes or takes attention away from anti-psychotic 
drugs, which are harmful and deadly when given to most LTC facility 
residents, who have dementia but no psychosis. There is less evidence 
that other psychotropic drugs are as frequently prescribed 
inappropriately or are as harmful for LTC facility residents. Some 
suggested that the current requirements for anti-psychotic drugs be 
maintained or expanded and that a separate section for psychotropic 
drugs be finalized. One commenter supported expanding the definition of 
drugs of concern, but also supported continued collection of data 
specific to anti-psychotics. Some expressed the belief that the 
proposed requirements actually diminished or reduced the focus on 
antipsychotic drugs.
    Response: We do not believe that expanding the requirements that 
previously only applied to anti-psychotic drugs to all psychotropic 
drugs would diminish or dilute the attention given to antipsychotic 
drugs. Antipsychotic medications are included in the definition of 
``psychotropic drugs,'' and are a focus for CMS. Since 2012, CMS has 
partnered with other federal and state agencies, LTC facilities, other 
providers, advocacy groups, and caregivers to form the ``National 
Partnership to Improve Dementia Care in Nursing Homes'' (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/National-Partnership-to-Improve-Dementia-Care-in-Nursing-Homes.html, accessed December 30, 2015). The initial 
focus of this partnership was to encourage reduction in the use of 
anti-psychotic medications. Since the launch of this initiative, there 
have been significant reductions in the use of anti-psychotic 
medications in LTC facilities. For specific information on the National 
Partnership to Improve Dementia Care in Nursing Homes, see their Web 
site that can be accessed at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/National-Partnership-to-Improve-Dementia-Care-in-Nursing-Homes.html. We also 
disagree with the commenter that other medications should not receive 
the same scrutiny as anti-psychotic drugs. However, we do agree that 
anti-psychotics do merit more scrutiny under some circumstances. Anti-
psychotic drugs continue to be a particular concern for us due to the 
serious side effects, including death, to elderly residents. In 
response to comments, we have modified the general PRN limitation on 
psychotropics specifically with respect to anti-psychotic drugs, which 
is discussed below. We are finalizing the definition of ``psychotropic 
drugs'' to include four specific categories of drugs, including anti-
psychotic drugs.
    Comment: Some commenters expressed concern that the proposed 
pharmacy services requirements do not include sufficient protection 
against antipsychotic and psychotropic medications being used as 
chemical restraints. They noted that there are epidemic levels of 
chemical restraints in LTC facilities. They also expressed their belief 
that there was likely underreporting of the residents who were being 
given antipsychotic drugs, despite the significantly increased risk of 
death from these drugs. Some commenters recommended a new section, 
which would specifically address chemical restraints and the 
unnecessary use of psychotropic drugs and one commenter suggested the 
regulation be based on a proposed rule published in 1992 by HHS 
(``Medicare and Medicaid Programs: Omnibus Nursing Home Requirements'', 
57 FR 4516, February 5, 1992). Some commenters also recommended that 
the final regulation establish a presumption that chemical restraints 
are harmful, require written informed consent before the use of 
psychotropic drugs, strengthen rather than diminish focus on misuse of 
anti-psychotic drugs, require physicians to both examine residents 
before prescribing antipsychotic drugs and justify that the potential 
benefits clearly outweigh the potential harmful effects. Another 
commenter expressed concerns about the current enforcement of the right 
to be free from chemical restraints by the state survey agencies and 
CMS. A commenter wanted to define ``chemical restraint'' as the 
unnecessary use of a psychotropic drug.
    Response: Residents have the right to be free from chemical 
restraints imposed for purposes of discipline or convenience and not 
required to treat the resident's medical symptoms, as already specified 
in Sec.  483.12. We do not believe that a separate section on chemical 
restraints is necessary. We also believe that the special requirements 
previously imposed on anti-psychotics should be applied to psychotropic 
medications to protect residents from inappropriate use, especially to 
ensure that these medications are not used as chemical restraints and 
are only used for the benefit of the resident. In addition, we do not 
believe that it would be appropriate to characterize the unnecessary 
use of a psychotropic drug as a chemical restraint. Concerning the 
proposed rule published by HHS in 1992, we reviewed that rule during 
our research for this proposed rule (80 FR 42168). We did not re-
propose some of the requirements in the 1992 proposed rule because we 
believed they were too prescriptive. We do not agree that the 
unnecessary use of a psychotropic drug should be defined as a 
``chemical restraint.'' Some psychotropic drugs could be used 
unnecessarily or have some other type of irregularity associated with 
their use, and this would still not be considered a chemical restraint. 
For example, a facility could fail to properly monitor a resident who 
is taking a psychotropic drug; however, if this is the only 
irregularity, its use would not qualify the drug as a chemical 
restraint.
Specific Requirements Related to Psychotropic Drugs
    Comment: Some commenters were concerned about the requirement for 
gradual dose reductions (GDRs) and behavioral interventions for all 
psychotropic drugs. Commenters argued that GDRs are not appropriate for 
many residents on psychotropic drugs. The commenters argued that GDRs 
are not appropriate for, among others, residents with mental disorders 
who are stable on their current drug regimen, such as residents 
diagnosed with depression, schizophrenia or bi-polar disorder or 
residents with seizure disorders. Another commenter stated that the 
term ``behavioral interventions'' is dated and misleading. One 
commenter recommended a broader requirement that ``[n]ursing homes 
should be required to use individualized care, services, attention and 
environmental modifications that are directed specifically towards the 
elimination or modification of the symptoms and distress for which the 
drugs are prescribed.'' Another commenter questioned why the proposal 
assumed that any psychotropic drug started prior to admission to the 
LTC facility was appropriate and did not require the documentation but 
that all of them would need a GDR along with behavioral intervention, 
unless contraindicated.
    Response: We agree with the commenters that GDRs are not 
appropriate for all residents taking psychotropic drugs. Based upon the 
comments, it is apparent there was confusion about this proposal. The 
requirements finalized in this rule are intended to reduce the 
inappropriate use of psychotropic drugs and the use of these drugs for 
reasons other than the resident's benefit. This is consistent

[[Page 68772]]

with one of the central themes of this final rule, which is person-
centered care (see Sec.  483.21). For many residents, psychotropic 
drugs are clearly appropriate to address a diagnosed disorder, 
necessary for their health, and prescribed for their benefit. For those 
residents taking psychotropic drugs, we expect that each resident would 
be evaluated by their attending physician to determine whether GDRs and 
behavioral interventions for a psychotropic drug are clinically 
contraindicated. If GDRs and behavioral interventions for a particular 
psychotropic drugs are clinically contraindicated, the physician should 
document that in the resident's medical record. Many of the examples 
provided by commenters would likely be determined to clinically 
contradict GDRs and behavioral interventions. For example, a resident 
who is taking an anti-anxiety or anti-depressant medication for a 
diagnosed condition and who was prescribed the medication for their 
benefit and who is stable would likely not need these interventions. 
Otherwise, we would expect that the attending physician, in conjunction 
with the IDT (Sec.  483.21((b)), to consider GDRs and behavioral 
interventions and institute a plan that is appropriate for that 
resident. For that reason, we are finalizing as proposed the 
requirement for GDRs for residents taking psychotropic drugs, ``unless 
clinically contraindicated'' (Sec.  483.45(e)(2)).
    Concerning the recommendation that we not finalize the term 
``behavioral interventions,'' we note that facilities may use any 
terminology they choose to describe these activities; however, we 
believe that behavioral interventions is a commonly used term that is 
universally understood. Thus, we have finalized this requirement using 
the term ``behavioral interventions.''
    We disagree with the commenter that said our proposal assumed that 
any psychotropic drug prescribed prior to admission to the LTC facility 
was appropriate and did not require the same documentation. Section 
483.45(e) requires that residents who have not used psychotropic drugs 
not be given those drugs unless the medication is necessary to treat a 
specific condition as diagnosed and documented in the clinical record, 
but that all resident who received psychotropic drugs receive GDRs and 
behavioral interventions, unless clinically contraindicated, in an 
effort to discontinue these drugs. This requirement does not assume 
that psychotropic drugs that were prescribed prior to admission are 
appropriate. It is intended to ensure that residents are not put on 
psychotropic drugs without there being a diagnosed and documented 
condition for which they are appropriate. Then, all residents who are 
on psychotropic drugs must then receive the GDRs or behavioral 
interventions, unless they are clinically contraindicated, as discussed 
above.
    Comment: One commenter recommended that psychotropic drugs should 
only be administered to a resident after the facility obtained informed 
consent from the resident or their representative.
    Response: We have finalized the requirement for comprehensive 
person-centered care planning, which requires that the participation of 
the resident and the resident's representative, to the extent 
practicable (Sec.  483.21(b)). The resident and their representative 
should be involved in the resident's care. We believe that requiring a 
separate informed consent solely for psychotropic drugs would be 
burdensome for the facilities and unnecessary. It could also interfere 
with the resident's care if the resident needs a psychotropic drug 
urgently.
    Comment: One commenter recommended that we require that 
psychotropic medications be used for FDA-approved conditions without 
limitations. We understand this to mean that the commenter wants to 
have psychotropic medications used only for the conditions set out in 
the medication's FDA approval. Alternatively, they suggested we change 
the language to either define ``antipsychotic use in dementia'' or 
``psychotropic in dementia to treat'' whatever condition or disorder 
the drug is intended to treat the resident.
    Response: We do not believe that the additional language 
recommended by the commenter is necessary. In addition, restricting the 
ability of health care practitioners to prescribe medication for uses 
other than those that have received FDA approval could violate the 
prohibition against interference with the practice of medicine at 
section 1801 of the Act.
    Comment: Some commenters were concerned about the effects these 
requirements could have on the facility. Another commenter was 
concerned that with such an increase in documentation requirements, 
some LTC facilities could unintentionally be out of compliance, with 
our requirements, resulting in a cascading sequence of penalties. The 
additional time and resources to correct any non-compliance would take 
away from resident care.
    Response: We believe that the requirements in this final rule are 
reasonable and necessary. We also believe that these requirements are 
not overly burdensome for the LTC facilities. Additional sub-regulatory 
guidance to assist LTC facilities in complying with the requirements in 
this final rule will be provided after this final rule is published.
Limitations on PRN Prescriptions of Psychotropic Drugs
    Comment: Many commenters were concerned about the 48 hour 
limitation on PRN prescriptions for psychotropic drugs. One commenter 
wanted to prohibit PRN orders for all anti-psychotic drugs. The 
commenter stated that physicians should not delegate the responsibility 
for PRN order for psychotropic drugs to the nursing staff. They 
believed that it was inappropriate to have the nursing staff determine 
when and for how long anti-psychotics and other psychoactive drugs were 
to be administered to a resident.
    Response: Based upon our own experience with LTC facilities, as 
well as other comments, there are situations in which PRN prescriptions 
for psychotropic drugs are appropriate for residents. Some residents 
may require a therapeutic trial to determine if a particular medication 
addresses the diagnosed disorder and what the correct dosage should be. 
In addition, some residents may only require a psychotropic drug for 
intermittent symptoms. We are also concerned that prohibiting PRN 
prescriptions for psychotropic drugs could result in either 
overmedication from physicians prescribing these drugs on a specific 
schedule when a PRN order would be appropriate or under medication from 
physicians not prescribing drugs they believe are needed for the 
resident's health. In addition, we believe that it is appropriate, and 
within their scope of practice, for nurses to make decisions on when 
drugs prescribed via PRN orders should be administered, including 
psychotropic medications. We also believe that prohibiting PRN orders 
for psychotropic drugs could violate the Act's prohibition against 
interference with the practice of medicine at section 1801 of the Act. 
Thus, we will not prohibit the PRN prescription of psychotropic drugs.
    Comment: Many commenters stated that the 48-hour limitation on PRN 
prescriptions for psychotropic drugs could result in serious unintended 
consequences. Some commenters argued that the 48-hour limitation could 
be difficult, if not impossible to comply with, especially in rural 
areas which may have limited access to physicians or other prescribers. 
Some commenters stated that the physicians or other health care 
practitioners who covered

[[Page 68773]]

their facilities, such as nurse practitioners, not only covered their 
facilities but also had their own private practices or covered other 
facilities. By increasing the burden to these providers, it could 
become more difficult to locate providers who would be willing to 
provide services in their facilities. Other facilities also noted 
having limited access to a physician or other health care practitioner 
who could renew a prescription for a psychotropic drug every 48 hours. 
Unless the physician was coming to the facility, the nurse would likely 
have to call the physician and get a verbal order to renew the 
prescription. Depending upon the number of these prescriptions, this 
could be time-consuming for both the nurse and the physician. This 
requirement also does not provide for the physician to assess the 
resident in person. If the prescription was renewed over the phone, 
there might be minimal, if any, assessment of the resident before the 
prescription would be renewed. Commenters indicated that the proposed 
requirements could also result in more frequent transfers to the 
emergency room due to interruptions in residents' drug regimens of 
essential drugs, such as could happen if the resident was on 
antipsychotic drugs or pain medication. Since it could require longer 
than 48 hours to assess a resident's response to some medication, such 
as during therapeutic trial or GDR, this proposed requirement could 
result in numerous renewals of the same prescription before the 
physician would have time to reasonably assess whether there should be 
any change in the prescription. In some cases, physicians might avoid 
this limitation in cases in which they believe it is not appropriate by 
writing the prescription for regular intervals when they would 
otherwise determine that a PRN prescription would be appropriate for a 
resident. Other commenters suggested a longer timeframe, such as 72 
hours or 7 days. One commenter recommended at least 7 days and some 
commenters recommended CMS delete the limitation on PRN medications 
entirely. One commenter stated that the current surveyor guidance 
defines an acute psychiatric situation and allows use of 
psychopharmacological medications for up to a week before additional 
documentation is needed. One commenter suggested there be a requirement 
that facilities develop policies with the medical director and/or 
medical staff to define the review process for all PRN medications, 
including timing of the review and documentation expectations. Another 
commenter recommended an exception for residents who are expected to be 
in the facility for a short-term, since these residents are expected to 
return to their primary care providers upon discharge.
    Response: We agree with the commenters that our proposal for a 48-
hour limitation on PRN prescriptions for psychotropic drugs could 
result in unintended consequences that could be detrimental to the 
residents' health in some cases and might also be burdensome for some 
facilities. In addition, based on our experience with LTC facility 
residents and comments we received, there are cases in which it is 
appropriate for a particular drug to be given PRN for a prolonged 
period of time. For example, some residents could require anti-
depressants or anti-anxiety medications long-term but only 
intermittently based upon the resident's symptoms. As described above, 
we believe that some of the commenters' concerns have been addressed by 
the modifications made to the definition of ``psychotropic drugs'' in 
this final rule, especially by not finalizing opioid analgesics as a 
category of drugs to be included. However, we continue to be concerned 
about PRN prescriptions. As we were conducting research for the 
proposed rule, we became aware of concerns about residents remaining on 
PRN prescriptions for prolonged periods of time when it might not be 
appropriate. Based upon comments, we now believe that a 48-hour 
limitation is overly restrictive and burdensome.
    As finalized in this rule, all residents, including those on 
psychotropic drugs, will have their medical records reviewed by a 
pharmacist in conjunction with their monthly DRR. This requirement 
provides additional review, which we believe is beneficial; however, we 
are concerned that a resident that is, for instance, treated for 30 
days with a psychotropic drug, especially on a PRN basis, could be 
receiving treatment that was inappropriate or detrimental. We proposed 
a 48-hour limitation on PRN orders of psychotropic drugs to address 
this concern. However, as noted above, many commenters disagreed with 
the 48-hour limitation. Some commenters recommended different 
limitations, such as a 72-hour or 7 day limitation on PRN prescriptions 
of psychotropic drugs. Another commenter suggested at least 7 days. We 
are concerned that the recommended 72-hour or 7 day limitation could be 
detrimental to some residents and still be burdensome for facilities 
that have limited access to physicians and other prescribing 
practitioners. When a facility has limited access to physicians and 
other prescribing practitioners, there could be an interruption in a 
resident receiving necessary medication due to a PRN prescription 
expiring before the prescribing practitioner could renew or write 
another prescription. This interruption could be detrimental to the 
resident. For example, as one commenter pointed out, an interruption in 
anti-anxiety medications could result in the resident experiencing 
withdrawal symptoms. Based on the limited access some facilities have 
to physicians and other prescribing practitioners and the potential for 
detrimental effects to residents from interruptions in their medication 
regimen, we believe the limitation on PRN prescriptions for 
psychotropic drugs should be longer and agree with the commenter that 
recommended at least a 7 day limitation. As finalized in this rule at 
Sec.  483.45(c)(2) all residents will have a pharmacist reviewing their 
drug regimen monthly. However, a physician is only required to visit a 
resident at least once every 30 days for the first 90 days after the 
resident is admitted to the facility and every 60 days after that (42 
CFR 483.70(c)). We believe that 30 days is too long for a resident to 
be on a psychotropic drug on a PRN basis without the physician or other 
prescriber having to evaluate whether the resident should continue on 
the subject drug according to the PRN order. Thus, we are establishing 
a 14-day limitation on psychotropic drugs. By establishing this 14-day 
limitation, each resident who is taking a psychotropic drug will have 
his or her prescription reviewed by the physician or prescribing 
practitioner every 14 days and also by a pharmacist every month. Since 
there was no previous limitation on PRN prescriptions for psychotropic 
or anti-psychotic drugs, this will provide residents receiving this 
type of medication on a PRN basis additional protections against 
unnecessary drugs, drugs with another type of irregularity, and drugs 
that might be prescribed for reasons other than the resident's own 
benefit. We also believe that a 14-day limitation on PRN prescriptions 
for psychotropic drugs should not be burdensome for facilities. 
Therefore, we have finalized a 14-day limitation on PRN prescriptions 
for psychotropic drugs, subject to the exceptions discussed below.
    We are also aware that some residents might require psychotropic 
drugs on a PRN basis for prolonged periods of time. Thus, we have 
established an exception to this 14-day limitation. For psychotropic 
drugs that the attending physician believes a PRN prescription

[[Page 68774]]

for longer than 14 days is appropriate, the attending physician can 
extend the prescription beyond 14 days for the resident by documenting 
their rationale in the resident's medical record. However, we believe 
this exception would be inappropriate for anti-psychotic drugs. If the 
attending physician believes that the resident requires an anti-
psychotic drug on a PRN basis for longer than 14 days, he or she will 
be required to write a new PRN prescription every 14 days after the 
resident has been evaluated. Detailed requirements for this evaluation 
will be developed in sub-regulatory guidance.
    Concerning the recommendation that we require a facility to have 
policies and procedures regarding PRN prescriptions and the facility's 
review of these prescriptions, we disagree with the commenters. 
Facilities need to have the flexibility to determine the policies and 
procedures they require, consistent with this rule and other sub-
regulatory guidance, to manage their facility. We believe that the 
requirements finalized in this rule are sufficient to provide the 
scrutiny psychotropic drug prescriptions require to protect residents. 
However, we encourage facilities to develop their own policies and 
procedures concerning PRN prescriptions for their facility.
    Concerning an exception for short-term residents, we disagree with 
the commenter. All of the requirements in this final rule, as well as 
other requirements and sub-regulatory guidance, apply to all residents, 
regardless of the length of their stay in the facility. Short-term 
residents deserve the same quality of care and protection of their 
rights as any other resident in a facility.
    Comment: One commenter recommended that LTC facilities be required 
to draft and complete an Antipsychotic Drug/Dementia Care Compliance 
Report for each resident taking an antipsychotic drug. The facility 
would be required to identify the resident's diagnoses, all attempted 
non-pharmaceutical interventions, consent, and recommendations for, and 
physician response to, consultant pharmacists' recommendations for 
gradual dose reductions. These reports would be signed by all members 
of the IDT, certifying compliance with all federal requirements. 
Surveyors would then review these as part of the annual survey or any 
relevant complaint survey.
    Response: We believe that the requirements in this final rule 
provide the necessary scrutiny and protections residents need from 
inappropriate drug use. We also believe that requiring a separate 
report, especially with all the requirements suggested by the 
commenter, would be overly burdensome for some facilities. However, 
facilities themselves could choose to prepare such reports.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We have added Sec.  483.45(c)(5) to require LTC facilities 
to develop and maintain policies and procedures for the monthly DRR, 
which include but are not limited to, timeframes for the various steps 
in the process and procedures a pharmacist must take when he or she 
believes immediate action is required to protect the resident.
     We have modified the definition of a psychotropic drugs in 
Sec.  483.45(c)(3) by removing paragraphs (v) and (vi).
     We have modified the limitation for PRN prescriptions of 
psychotropic drugs by extending the time for PRN prescription to 14 
days by modifying Sec.  483.45(e)(4).
     We have added a specific limitation on PRN prescriptions 
for anti-psychotic drugs by modifying Sec.  483.45(e)(5).

P. 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. Following the reorganization of subpart 
B, we proposed to relocate and re-designate both Sec.  483.75(j) and 
Sec.  483.75(k) to a new Sec.  483.50 entitled, ``Laboratory, 
Radiology, and Other Diagnostic Services.'' This section includes 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 
proposed 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 proposed 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 were proposed to be located at 
Sec.  483.50(a)(2)(i) and (b)(2)(i), respectively. Furthermore, we 
proposed to allow for these orders only if the practitioners were 
acting in accordance with state law, including scope of practice laws 
and facility policy.
    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 proposed 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 proposed 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 proposed in Sec.  483.50(a)(2)(ii) to clarify 
that the laboratory would have to promptly notify the ordering 
professional if results fell outside of clinical reference or expected 
``normal'' ranges, unless the orders for the test or the facility's 
policies and procedures required otherwise.
    Comment: Commenters supported the proposal to clarify that a 
physician assistant, nurse practitioner, or clinical nurse specialist 
could order laboratory, radiology, and other diagnostic services for a 
resident in accordance with state law, including scope of practice 
laws. Commenters noted that this revision aligned with the literature 
that supports better quality with the use of non-physician 
practitioners and is consistent with state licensure laws. Commenters 
also supported the proposal to allow other practitioners to receive 
laboratory, radiology, and other diagnostic results if these 
practitioners ordered the tests. Commenters noted that this revision 
would help to provide results in a timelier manner and improve care to 
the resident.
    Response: We appreciate the feedback and support from commenters. 
We agree and believe that this revision will ultimately increase access 
to care and also reduce some of the burden on facilities.
    Comment: Some commenters opposed our proposal at Sec.  
483.50(a)(2)(ii) to clarify that the laboratory would have to promptly 
notify the ordering professional if results fell outside of clinical 
reference or expected ``normal'' ranges; the commenters were skeptical 
that the policy would improve the notification process. Commenters 
noted that the term ``promptly'' is not defined, and used multiple 
times throughout the regulation with varying timeframes. Commenters 
also did not believe there

[[Page 68775]]

was a need to notify practitioners of results that fell outside of the 
clinical reference range. Specifically, the commenters indicated that 
the proposed language was too broad, did not provide enough 
flexibility, and stated that the revision would actually increase 
unnecessary notification of practitioners and result in unnecessary 
repeat testing. One commenter recommended revising the language to 
require that practitioners be notified when results fall outside a 
``critical value'' because this term is defined by laboratories and 
would avoid unnecessary calls when a result was outside the clinical 
reference, but not critical and trending in the right direction. 
Another commenter noted that many abnormal lab values are not 
necessarily associated with any medical problems, nor do they require 
immediate intervention. The commenter recommended removing the phrase 
``lab values that fall outside of normal range'' and revising the 
language to require facilities to develop a policy and procedure for 
notifying the ordering practitioner of test results in a timely manner 
to assure that results requiring intervention or new orders are 
addressed. Another commenter also recommended replacing the term 
``promptly'' with ``timely''.
    In contrast, some commenters indicated that facilities should be 
urged to notify practitioners of abnormal results as soon as possible 
and recommended that the term ``promptly'' be replaced with 
``immediately''. Commenters noted that the standard of practice for 
nurses is to notify practitioners immediately of results that fall 
outside of clinical reference ranges regardless of facility policy or 
physician order. One commenter recommended further that the language be 
revised to remove the flexibility allowing notification to be based on 
facility policy or procedure. One commenter recommended that facilities 
also be required to notify the resident and their representative when 
they notify the practitioner of test results.
    Response: We appreciate the commenters' feedback, but disagree that 
the proposed language will increase unnecessary notifications of 
practitioners. In the proposed rule we indicated that the proposal 
would revise existing language at Sec.  483.75(k)(2)(ii) which stated 
that facilities must ``promptly notify the attending physician of the 
findings''. We believe that by specifying that the ordering 
practitioner be notified of the results, many ``unnecessary'' 
notifications will be eliminated by ensuring that results are received 
by the individual who requested the information. We also disagree that 
the proposed language is too broad and does not provide flexibility. 
The proposed language provides that notification of the ordering 
physician should align with facility policy and procedure. It is also 
common practice for health care settings to establish procedures for 
determining normal/abnormal lab values. Therefore, in situations that 
may provide an abnormal result, but do not warrant an emergency 
response or repeat test, facilities have the flexibility to address 
these situations in their policies and determine how notification 
should take place. In addition, we note that the interpretative 
guidance to this final rule may also provide more detailed information 
regarding how a facility may choose to establish guidelines for 
promptly notifying practitioners of test results.
    We do not believe that facilities should notify the resident and 
their representative of results when they notify the practitioner. As 
commenters have indicated, there are many aspects of a person's care 
and medical condition to balance when reviewing the results of 
laboratory tests. We believe that it would be inappropriate to 
prematurely notify a resident of results before a practitioner 
responsible for the resident's care has had an opportunity to assess 
the results. This action could cause unnecessary anguish or result in 
the delivery of improper information to the resident and their 
representative.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal without modification.

Q. Dental Services (Sec.  483.55)

    Under the reorganization of subpart B, requirements regarding 
dental services remain at Sec.  483.55. In the proposed rule, we 
indicated that section 1862(a)(12) of the Act states, in part, that 
Medicare does not cover dental services such as the care, treatment, 
filling, removal, or replacement of teeth or structures directly 
supporting teeth. Medicaid state plans, by contrast, 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. 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 proposed limited changes to update and clarify this section. 
First, we proposed 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. 
Second, we proposed 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 proposed 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. Finally, we 
proposed 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 also proposed 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.
    Comment: Several commenters recommended we include stronger 
requirements for dental care and oral hygiene, as good dental care and 
oral hygiene can result in cost savings.
    Response: We agree that dental care and oral hygiene are important. 
In the proposed rule we discuss the importance of dental care and oral 
hygiene (80 FR 42197). We have included requirements related to oral 
hygiene at finalized Sec.  483.25(a)(2), which requires that 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. With respect to dental care, as noted in the proposed 
rule, 80 FR 42205, pursuant to section 1862(a)(12) of the Act, Medicare 
does not cover many dental services. Medicaid states plans vary widely 
in providing dental services. In keeping with these limitations, we 
address facility responsibilities related to assisting residents in 
obtaining dental services in Sec.  483.55. We did not propose to change 
existing regulations at 42 CFR 483.55(a)(1)and (2) and (b)(1), which 
require facilities to provide or obtain dental services to meet the 
needs of each resident.
    Comment: One commenter suggested we explicitly recognize dental 
hygienists.
    Response: We thank the commenter for this suggestion, but decline 
to incorporate it at this time. We proposed and are finalizing changing 
references to

[[Page 68776]]

a ``dentist's office'' to ``dental services'' in order to recognize 
that dental care may be provided in dental clinics, dentals schools, or 
even on site. These requirements are broad enough to encompass dental 
services provided by a dental hygienist working within their scope of 
practice under state law.
    Comment: Some commenters stated that obtaining dental services for 
residents is difficult due to difficulty finding providers, limitations 
in Medicaid coverage, and resident preferences regarding dental care. 
Some commenters felt existing regulations already address dental 
concerns and our proposed revisions were unnecessary.
    Response: We thank the commenters for their information. A resident 
or, when applicable, their representative, has the right to determine 
what dental care they will consent to, just as they have the right to 
request or refuse treatment as specified in Sec.  483.10. Medicaid 
coverage of dental services is outside the scope of this regulation. We 
would expect a facility to document extenuating circumstances that 
delay obtaining necessary dental care. We disagree that our proposed 
revisions are unnecessary. Our proposed revisions address areas where 
we are aware problems have occurred or where we are aware of 
opportunities to improve access to care. We note that other commenters 
have suggested that these revisions are useful and that we do not go 
far enough in ensuring adequate resident protections in this area.
    Comment: One commenter recommended we modify proposed Sec.  
483.55(a)(3) and Sec.  483.55(b)(4) by adding ``A facility must have a 
policy identifying those circumstances when the loss or damage of 
dentures is the facility's responsibility . . .''
    Response: We agree that adding this statement adds clarity and have 
modified these provisions to state that the facility must have a policy 
identifying those circumstances when the loss or damage of dentures is 
the facility's responsibility.
    Comment: Commenters expressed concern that facility policies for 
lost or damaged dentures would be written in order to absolve the 
facility of any responsibility. One commenter stated that this would 
allow a facility to develop a policy that would allow staff to damage 
the resident's property and not replace it and this would affect the 
resident's ability to consume meals. Other commenters stated that the 
facility should not be held financially responsible when residents 
throw away, damage, or lose dentures or when the loss is a result of a 
resident's actions or failure to abide by facility policies.
    Response: As noted above, we have modified the proposed requirement 
to state that the facility must have a policy identifying those 
instances when the loss or damage of dentures is the facility's 
responsibility. We do not believe a blanket policy of facility non-
responsibility would meet the modified requirement. In addition, 
proposed Sec.  483.15(a)(2)(iii) prohibits facilities from requesting 
or requiring residents or potential residents to waive any potential 
facility liability for losses of personal property. We have also 
modified the provision to require that the facility not only document 
extenuating circumstances that cause a delay in making a referral for 
dental services, but also require that the facility document efforts to 
ensure that the resident is able to eat and drink adequately while 
awaiting the dental services. We believe that the cumulative effect of 
these provisions address the commenters' concerns. We defer additional 
discussion to sub-regulatory guidance.
    Comment: Some commenters objected to the three day time frame for 
making a referral for dental services to replace lost or damaged 
dentures, stating that it was unreasonable. One commenter asked that we 
clarify that the 3-day time frame applied to the referral, not to 
obtaining repaired or replaced dentures. One commenter suggested that 5 
to 7 business days would be a more appropriate time-frame for requiring 
a facility to make a referral.
    Response: The three-day time frame is to make the referral, not to 
complete the dental appointment, or obtain repaired or replaced 
dentures. We continue to believe that such a time frame is necessary to 
ensure prompt referrals and minimize avoidable delays, but understand 
that there may be circumstances that prevent a timely referral. 
Extenuating circumstances could include issues such as the resident's 
preferred provider's office not being open or the need to obtain an 
insurance pre-authorization. Facilities would be expected to document 
such circumstances.
    Comment: One commenter suggested the focus should be on ensuring 
that residents could eat and drink adequately while awaiting dental 
services.
    Response: We agree and have added this to the regulatory 
requirement. However, we do not believe that this should be in lieu of 
documenting extenuating circumstances and maintain our proposed 
requirement that facilities document extenuating circumstances that 
lead to delayed referrals.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We are adding a requirement at Sec.  483.55(a)(3) and 
(b)(4) that the facility must have a policy identifying those instances 
when the loss or damage of dentures is the facility's responsibility.
     We are adding a requirement at Sec.  483.55(a)(5) and 
(b)(3) that the facility must document what they did to ensure that the 
resident could eat and drink adequately while awaiting dental services.

R. Food and Nutrition Services (Sec.  483.60)

    We proposed the revisions described below in an effort to improve 
the nutritional status of LTC facility residents. In the proposed rule, 
we included a detailed discussion regarding dietary standards for 
residents of LTC facilities. We encourage readers to refer to the 
proposed rule for this discussion.
    We proposed to re-designate existing Sec.  483.35 ``Dietary 
Services'' as new Sec.  483.60 ``Food and Nutrition Services'' and 
revise the introductory language to include taking resident preferences 
into consideration. We proposed 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 Sec.  483.60(a)(1) we proposed to 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. We also proposed to require minimum qualifications 
for dietitians working in SNFs or NFs. We proposed 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. We also proposed to allow up to 5 years after the 
effective date of the regulation for dietitians hired or contracted 
prior to the effective dates of the revised regulations to meet these 
requirements.
    In re-designated Sec.  483.60(a)(2), we proposed to continue to 
require that, if a qualified dietitian or other clinically qualified 
nutrition professional was not employed full-time, the facility would 
have to designate a person to serve as the director of food and 
nutrition

[[Page 68777]]

services who would receive frequently scheduled consultation from a 
qualified dietitian. We proposed to require that the director of food 
and nutrition services, if hired or designated after the effective date 
of these regulations, would have to 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, we proposed that the director of food and 
nutrition services could 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, we proposed that the director of food and 
nutrition services could meet our proposed requirement if he or she met 
applicable state requirements to be a food service manager or dietary 
manager.
    In Sec.  483.60(a)(4), we proposed 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.
    We proposed a new Sec.  483.60(b) to specify that a member of food 
and nutrition services also participate in the IDT. At Sec.  
483.60(c)(1), we proposed to change ``Recommended Dietary Allowances'' 
to ``established national guidelines or industry standards.'' We also 
proposed 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.
    At Sec.  483.60(d), we proposed minor revisions to incorporate the 
addition of drinks, to clarify that ``proper'' meant 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.
    At new Sec.  483.60(e) ``Therapeutic diets,'' we proposed to retain 
the requirement in current Sec.  483.35(e) that therapeutic diets be 
prescribed by the attending physician. However, we proposed 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.
    We proposed to modify Sec.  483.35(f) in re-designated Sec.  
483.60(f) regarding frequency of meals. Specifically, we proposed to 
modify the requirement that facilities provide and residents receive 
three 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 proposed 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. Instead, we decided to focus on 
when residents prefer to eat and on ensuring that meal service is 
provided to meet residents' clinical and nutritional needs. We proposed 
to require 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 plans of care. We indicated in the 
proposed rule that ``suitable, nourishing alternative meals'' would 
mean that when a resident missed a meal or snack, an alternative of 
comparable nutritive value to the missed meal or snack would be 
provided.
    We proposed 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 proposed 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). 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.'' We proposed to eliminate the reference to the 
resident call system. We also proposed to have the IDT make the 
determination of whether a paid feeding assistant would be appropriate 
for a resident.
    We proposed to clarify in new Sec.  483.60(i)(1)(i) that facilities 
could procure food directly from local producers, farmers or growers, 
in accordance with state and local laws or regulations. We further 
proposed to clarify in new Sec.  483.60(i)(1)(ii) that this provision 
would not prohibit or prevent facilities from using produce grown in 
facility gardens, subject to compliance with applicable safe growing 
and handling practices, such as the use of pesticides in accordance 
with manufacturers' instructions. Consistent with Sec.  483.70(b), we 
proposed 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 proposed 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.
    Comment: One commenter suggested that we reference the new Dining 
Practice Standards agreed to by 12 national standard setting 
organizations.
    Response: We thank the commenter. We mentioned in the preamble to 
the proposed rule an August 2011 report by the Pioneer Network Food and 
Dining Clinical Standards Task Force but did not provide the location 
of that resource. We would encourage facilities and practitioners to 
read the report. It is available at http://www.pioneernetwork.net/Providers/DiningPracticeStandards/.
    Pioneer Network also has a ``how to'' resource called the ``Dining 
Standards Toolkit'' that may assist LTC facilities in their efforts to 
understand and meet the updated requirements. In addition, CMS produced 
a video related to these standards. The video can also assist LTC 
facilities in their efforts to understand and meet the updated 
requirements. The video is available at http://surveyortraining.cms.hhs.gov/pubs/VideoInformation.aspx?id=1101&cid=0CMSNEWDINPRSTAN.
    Comment: Some commenters felt that our proposed requirement that 
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) was subjective and not specific 
enough. Some

[[Page 68778]]

commenters felt that the term ``sufficient'' was unclear and impossible 
to objectively measure. One commenter requested that we define 
``support personnel'' or ``support staff''.
    Response: Our proposal specifically requires that a facility have a 
dietitian, a food service manager in facilities that do not have a 
full-time dietitian, and enough support staff with the appropriate 
competencies and skills to carry out the functions of the food and 
nutrition service. Facilities have widely varying populations, and 
census. Thus, we would expect a facility to use the newly required 
facility assessment to determine both the competencies and skills that 
are required to effectively carry out the functions of the food and 
nutrition services, as well as the number of support staff that are 
needed. Given the potential diversity of each facility, we continue to 
believe that a ``one-size-fits-all'' approach to food and nutrition 
services serves neither the residents nor the facility. A facility 
should have some flexibility to determine how to best meet its 
resident's needs in the area. Furthermore, a facility should be able to 
articulate how it made its staffing decisions and how various factors, 
including the facility assessment and resident-specific needs, are 
incorporated into that decision making.
    We note that the term ``sufficient support personnel'' is an 
existing term in the current requirements for long-term care 
facilities. It is defined in current sub-regulatory guidance as `enough 
staff to prepare and serve palatable, attractive, nutritionally 
adequate meals at proper temperatures and appropriate times and support 
proper sanitary techniques being utilized.'' It would include any staff 
in addition to the qualified dietitian or other clinically qualified 
nutrition professional and the food service manager that are needed to 
carry out the functions of the food and nutrition service and meet the 
requirements of this section. We disagree that the term ``sufficient'' 
is unclear and impossible to objectively measure. ``Sufficient'' staff 
would be mean an adequate number, or enough staff, who have the skills 
and knowledge to safely and effectively deliver the care that residents 
need and that is the responsibility of the food and nutrition service. 
Direct observation and interview questions can be used to determine if 
residents are receiving the food and nutrition services they require, 
in accordance with his or her plan of care, in a safe, timely, and 
effective manner. Factors such as timely meal service, food that is 
served at an appropriate temperature and in an appetizing form, 
available assistance for residents who require assistance to eat a 
meal, as well as resident-specific issues such as unintended weight 
loss and dehydration may all be indicators considered when determining 
if a facility has sufficient staffing. We believe that surveyor 
training on these requirements and questions such as those identified 
above will allow surveyors to make evidence-based decisions about 
whether or not a facility has or does not have sufficient staffing.
    Comment: One commenter suggested not referring to `alternative' or 
`substitute' meals, but instead refer to choices and options and ``at 
times of the resident's choosing.''
    Response: We agree and have revised the language at Sec.  
483.60(d)(5).
    Comment: One commenter recommended that we modify our proposal for 
therapeutic diets to allow the attending physician or that physician's 
covering physician to delegate the task a prescribing a resident's 
diet, including a therapeutic diet, to a registered or licensed 
dietitian to the extent allowed by state law.
    Response: Please see our discussion regarding section Sec.  
483.30(f). We are retaining the existing regulatory language which 
states that the attending physician must prescribe a therapeutic diet 
and we are finalizing our proposal, with some modification, to allow 
the attending physician to delegate this task to a qualified dietitian 
or other clinically qualified nutrition professional. We note that the 
qualified professional to whom the task is delegated must not only be 
acting within their scope of practice under state law, they must also 
be under the supervision of the physician.
    Comment: One commenter did not support our proposal to allow an 
attending physician to delegate the task of writing dietary orders to a 
qualified dietitian or other nutrition professional acting within the 
scope of state law. The commenter acknowledged that it has been a real 
challenge through the years of getting physicians to fulfill their 
responsibilities in this aspect of care but believed that there are 
alternatives to our proposal and that it is not in the interest of 
resident to put a blanket authorization in regulation with its 
potential for misuse to the detriment of the residents. Finally, the 
commenter stated that the development of protocols to allocate 
responsibility to those of other disciplines should be done on a 
facility level based on knowledge of staff capabilities and close 
oversight of who is allowed to write orders in consultation with a 
medical practitioner.
    Response: As we discussed earlier, our proposal is intended to 
improve responsiveness to a resident's needs and is implemented at the 
discretion of the physician. It does not allow a physician to shift all 
authority to either a dietitian or a therapist, as the qualified 
professional to whom the task is delegated must not only be acting 
within their scope of practice under state law, they must also be under 
the supervision of the physician. As one commenter noted, our proposal 
provides for both oversight and accountability. Given the limited time 
that many commenters have stated physicians spend in the facility, we 
believe that in appropriate circumstances, this flexibility will 
benefit both the physician and the resident. Furthermore, nothing in 
this rule precludes a facility from implementing many of the 
alternatives suggested by the commenter, such as more detailed 
assessments of resident appetite and weight issues, better 
communications to the attending physicians, facility use of reliable 
and comprehensive references on nutrition, and facility adoption of 
protocols based on reputable references and resources. We agree that 
facilities should be knowledgeable of staff capabilities and would 
expect an attending physician who chooses to delegate responsibility 
for writing any order would also be knowledgeable about the 
capabilities of the staff to whom responsibility is being delegated, 
particularly since the attending physician remains accountable.
    Comment: One commenter suggested we change the term ``skill sets'' 
to ``skills'' as the terms are synonymous.
    Response: We thank the commenter for their suggestion, however, we 
have retained the language as proposed as we do not believe that this 
change would substantially improve the clarity or intent of the 
provision.
    Comment: One commenter urged us to make a more straightforward 
statement in the final rule that each resident, unless medically 
contraindicated, must be afforded a choice of foods at all times. One 
commenter suggested we more specifically address pureed foods. Another 
suggested that we change the language at Sec.  483.60(f)(3) that 
currently states that ``Suitable, nourishing meals and snacks must be 
available for residents who want to eat at non-traditional times or 
outside of scheduled meal times, in accordance with the plan of care'' 
to eliminate ``in accordance with the plan of care'', as resident 
requests to dine outside of mealtime should not be required to be

[[Page 68779]]

documented on the plan of care, unless nutrition is a concern and is 
being monitored for specific reasons. Other commenters objected to this 
requirement on the basis that it would require extended kitchen hours.
    Response: We believe our proposal, as written, addresses the 
concerns implicated in the commenters' statements. We agree that a 
resident's request to eat outside of mealtime does not necessarily need 
to be documented in the plan of care, nor should a resident be able to 
eat outside of meal time only if it is required by the plan of care. 
However, where nutrition is a concern and being monitored for a 
specific reasons, or where there are dietary restrictions necessitated 
by a resident's medical condition(s), the provision of such snacks and 
meals must be consistent with the plan of care. We have modified the 
regulatory language to state ``Suitable, nourishing meals and snacks 
must be provided for residents who want to eat at non-traditional times 
or outside of scheduled meal times, consistent with the plan of care'' 
to focus on residents actually receiving these snacks or meal options, 
rather than focusing on the availability of such options. As discussed 
in the proposed rule, this requirement is not intended to require the 
availability of a 24-hour-a-day full service food operation (80 FR 
42208), but rather accommodate residents who cannot or choose not to 
eat at a scheduled mealtime.
    Comment: Some commenters supported our proposed revisions to the 
food and nutrition requirements. One commenter stated that they expect 
the proposed rules will improve the quality of life and health outcomes 
for residents in LTC facilities.
    Response: We thank these commenters. The intent of our proposals 
is, ultimately, to improve the quality of life and the health outcomes 
for LTC facility residents. We understand that residents may have 
varying and unique dietary and hydration needs. We also appreciate the 
commenters support for our proposals that require that facilities 
incorporate resident preferences in decisions about food and beverages 
as well as the need to acknowledge cultural and ethnic diversity in 
menus and the requirement to provide meals at times in accordance with 
resident needs, preferences, requests, and the plan of care.
    Comment: Some commenters objected to our requirement that menus 
reflect the religious, cultural, and ethnic needs of the residents, as 
well as input received from residents and resident groups. The 
commenters felt that this meant that every facility would have to meet 
all religious dietary requirements for multiple faiths and that this 
was not achievable. One commenter suggested that we add ``to the extent 
possible'' to the requirement.
    Response: This requirement does not mandate that every facility be 
able to provide every possible religious, cultural, or ethnic diet. 
However, a facility should consider these factors with respect to the 
population it serves, as well as input from residents and resident 
groups, when developing its menus. We have clarified this provision to 
state that menus should ``reflect, based on a facility's reasonable 
efforts, the religious, cultural and ethnic needs of the resident 
population, as well as input received from residents and resident 
groups;'' and defer additional discussion to sub-regulatory guidance.
    Comment: One commenter objected to the inclusion of the term 
``industry standards'' with regard to menus. One suggested we retain 
only the term ``national guidelines.'' The commenter expressed concern 
that ``industry standards'' could allow for poor quality foods.
    Response: We agree that including ``or industry standards'' could 
allow for menus that don't meet national guidelines and therefore have 
eliminated the term ``industry standards.''
    Comment: One commenter suggested that in paragraph Sec.  
483.60(c)(1) after ``in accordance with established national guidelines 
or industry standards'' we add ``in accordance to the individual per 
his or her comprehensive assessment and care plan. The commenter is 
concerned that many kitchen staff mistakenly think that they must offer 
the dietary guideline amounts, ignoring a resident's preferences such 
as smaller portions, as bigger portions may overwhelm some individuals. 
Another commenter suggested we make proposed Sec.  483.60(c)(7) 
stronger by revising it to read: `` The comprehensive assessment and 
care plan support resident choice and preference for larger or smaller 
portions''. The commenter asked that we make clearer that residents 
decide what they want to eat. They wanted to clarify that no resident 
should be made to eat or to believe that they should eat a certain 
amount of food, which is what happens when menus are built upon generic 
``recommended dietary allowances.''
    Response: We agree that an individual's preference for smaller 
portions or who are overwhelmed by large portions should have that 
preference or need accommodated. However, the section in question 
refers to the menu that is prepared for the facility as a whole, not 
how each meal is provided to the resident. We believe that the 
provisions as proposed require appropriate menu development at the 
facility level, but also clearly allow, and in fact require, that meals 
meet individual needs and accommodate resident preferences. 
Specifically, Sec.  483.60(c)(7), as finalized, states that nothing in 
this paragraph should be construed to limit the resident's right to 
make personal dietary choices and Sec.  483.60(d)(4) requires that each 
resident receive food that accommodates resident allergies, 
intolerances, and preferences. We would defer additional specificity, 
such as choice of portion size, to sub-regulatory guidance.
    Comment: Commenters requested that we eliminate paid feeding 
assistants. One commenter is concerned that feeding assistants have 
little training and are ill-equipped to help residents who may have 
swallowing difficulties or resist being fed. The commenter suggests 
such assistants need training and skills that CNAs have and that 
assigning such tasks to CNAs would promote continuity of care and 
support the CNA's relationship with the resident. Another commenter 
asked that we change the title to ``dining assistant.''
    Response: We did not propose to eliminate the role of paid feeding 
assistants and do not have the benefit of public comment on such a 
proposal. The requirements for paid feeding assistants were issued in 
2003 in response to demonstration programs that evaluated supplementing 
LTC facility staffing with this role in order to address a recognized 
problem that most LTC facility residents needing mealtime assistance 
did not receive enough feeding assistance to ensure adequate nutrition 
and hydration. A follow-up study by Abt Associates, Inc. in 2007 did 
not support concerns that paid feeding assistants would be poorly 
trained or that they would replace existing nurse aides or used for 
additional resident assistance. The study did raise a concern regarding 
facilities identification of residents who were assigned a paid feeding 
assistant. We proposed a requirement that the IDT identify residents 
who were appropriate for this program that assessment should be 
reflected in the comprehensive care plan. This would assist in ensuring 
that resident selection for paid feeding assistance is appropriate. We 
believe we would need to pursue notice and comment rule-making to 
eliminate this role. Further, we believe we need to further investigate 
the need to do so and

[[Page 68780]]

the implications of doing so. We will evaluate the concerns raised and 
consider this issue for inclusion in future rule-making.
    Comment: Some commenters supported the proposed requirements' 
enhanced focus on resident preferences, assessment and care planning in 
this section, including incorporating resident preferences, recognizing 
residents' religious, ethnic, and cultural diversity, flexible meal 
times, the addition of `drinks, including water and other liquids, and 
the inclusion of a member of food and nutrition services on the IDT. 
Another commenter strongly supported our proposed requirements in Sec.  
483.60(i)(1) to allow food to be obtained from local producers or grown 
on-site, subject to some safety requirements and to clarify that the 
requirements do not preclude residents from consuming foods not 
procured by the facility (that is, food brought in by visitors).
    Response: We appreciate the commenters' support. We agree that 
these efforts will improve facility responsiveness to the unique needs 
and preferences of residents while ensuring residents a greater sense 
of participation in their care.
    Comment: One commenter suggested that instead of requiring specific 
educational requirements for the director of food services or any other 
position, we require that a member of the food and nutrition services 
management team include a person credentialed in the manner we have 
proposed. The commenter stated that there are many highly capable 
professionals with many years of food service experience without 
specific credentials who may nonetheless be competent within a long-
term care environment. Another commenter suggested that our 
requirements for a food service manager were ``woefully inadequate'' 
specifically citing the fact that we included a degree in hospitality 
as an option.
    Response: Effective management and oversight of the food and 
nutrition service is critical to the safety and well-being of all 
residents of a nursing facility. Therefore, it is important that there 
are standards for the individuals who will lead this service. However, 
we agree that there are many highly capable professionals with many 
years of food service experience without specific credentials who may 
nonetheless be highly competent within a long-term care environment. It 
is for this reason that we have allowed sufficient time to meet the new 
requirements. With regard to our requirements for food service 
managers, we have modified the option of a degree in hospitality. Based 
on the comment that a degree in hospitality was a ``woefully 
inadequate'' qualification, we conducted additional research, and 
determined that not all hospitality degree programs specifically 
require food service management. However, based on our research, food 
service management/restaurant management is a common aspect of 
hospitality degree programs. Therefore, rather than eliminate a 
hospitality degree as an qualifying option for facilities, we have 
clarified to specify that, in order to qualify based on a degree in 
hospitality, the individual must have included food service management/
restaurant management in their degree program.
    Comment: Some commenters supported our proposed definition of 
`qualified dietitian' but recommended refinements. Other commenters 
opposed our definition of `qualified dietitian,' asserting that the 
proposed change would weaken professional standards and enable 
unqualified practitioners without the necessary training or skills to 
oversee facilities' food and nutrition services. They suggested that we 
define ``qualified dietitian'' consistent with the definition of 
``registered dietitian or nutrition professional'' set out at section 
1861(vv)(2) of the Act.
    Response: We based our proposal for the definition of a ``qualified 
dietitian'' in part on our experience in allowing hospitals to grant 
specific nutritional ordering privileges to qualified professionals. We 
discussed our rationale in the final rule ``Medicare and Medicaid 
Programs; Regulatory Provisions To Promote Program Efficiency, 
Transparency, and Burden Reduction; Part II; published on May 12, 2014 
(79 FR 27106).
    Section 1861(v)(2) of the Act defines a ``registered dietitian or 
nutrition professional'' as an individual who holds a baccalaureate or 
higher degree granted by a regionally accredited college or university 
in the United States (or an equivalent foreign degree) with completion 
of the academic requirements of a program in nutrition or dietetics, as 
accredited by an appropriate national accreditation organization 
recognized by the Secretary for this purpose, who has completed at 
least 900 hours of supervised dietetics practice under the supervision 
of a registered dietitian or nutrition professional; and is licensed or 
certified as a dietitian or nutrition professional by the state in 
which the services are performed; or, in the case of an individual in a 
state that does not provide for such licensure or certification, meets 
such other criteria as the Secretary establishes. The definition of a 
``registered dietitian or nutrition professional'' at Sec.  410.134 is 
closely aligned with this statutory definition, adding only that, in a 
state that does not provide for licensure or certification, the 
individual will be deemed to have met this requirement if he or she is 
recognized as a ``registered dietitian'' by the Commission on Dietetic 
Registration or its successor organization, or meets the degree and 
practice requirements specified by the statute. Section 483.94(e) of 
our rules defines a qualified dietitian as ``an individual who meets 
practice requirements in the State in which he or she practices and is 
a registered dietitian with the Commission on Dietetic Registration.'' 
We note that, according to the Academy of Nutrition and Dietetics, the 
credential ``registered dietitian nutritionist'' (RDN) is synonymous 
with ``registered dietitian'' (RD) and the two credentials have 
identical meaning and legal trademark definitions.
    We have reviewed state requirements for licensure or certification 
of dietitians and nutrition professionals and find those requirements, 
with a few exceptions, generally include, at a minimum, similar 
education and experience requirements to those forth by the statute and 
currently reflected in Sec.  410.134. Many also require an examination 
and/or defer to the national examination provided by the Commission on 
Dietetic Registration for qualification as a Registered Dietitian. A 
few states do not require or offer licensure or certification. One 
state repealed such requirements in 2014. In those states, our proposed 
definition would require that qualified dietitians or nutrition 
professionals must be a RD in the state they are providing services. 
However, we agree that there could be states whose licensure 
requirements are less than the statutory requirement and we cannot 
predict future changes in state licensure requirements. Therefore, in 
order to better align our definition with section 1861(v)(2) of the 
Act, we have removed our proposed definition and provide that a 
qualified dietitian or other clinically qualified nutrition 
professional is one who: Holds a bachelor's or higher degree granted by 
a regionally accredited college or university in the United States (or 
an equivalent foreign degree) with completion of the academic 
requirements of a program in nutrition or dietetics accredited by an 
appropriate national accreditation organization recognized for this 
purpose; has completed at least 900 hours of supervised dietetics 
practice under the

[[Page 68781]]

supervision of a registered dietitian or nutrition professional; and is 
licensed or certified as a dietitian or nutrition professional by the 
state in which the services are performed. In a state that does not 
provide for licensure or certification, the individual will be deemed 
to have met this requirement if he or she is recognized as a 
``registered dietitian'' by the Commission on Dietetic Registration or 
its successor organization, or has a bachelors' degree or higher and 
has completed at least 900 hours of dietetics practice.
    Comment: Some commenters assert that 5 years is too long to allow 
for facilities to come into compliance with the proposed qualifications 
for dietitians and food service managers. Some commenters suggest 2 
years as an alternative.
    Response: We appreciate the commenters concerns and considered 
shorter timeframes. However, as another commenter noted, there are many 
highly capable professionals with many years of food service experience 
without specific credentials who may nonetheless be highly competent 
within a long-term care environment. We do not want to penalize such 
professionals and want to ensure that they have sufficient time to meet 
the new requirements and remain an asset to their facility.
    Comment: Some commenters objected to the alternative qualifications 
for a food service manager and suggest that the food service manager 
must be a certified dietary manager who has obtained a ServSafe[supreg] 
certification. A number of commenters expressed concern about the 
existing supply of certified dietary managers. These commenters 
recommended we allow 6 to 18 months after the effective date of this 
final rule for facilities to hire new food service managers and give 
them time to complete the requirements to become a certified dietary 
managers.
    Response: We note that there are currently no regulatory 
requirements for a food service manager. The ServSafe[supreg] manager 
certification requires training in the importance of food safety, good 
personal hygiene, time and temperature control, preventing cross-
contamination, cleaning and sanitizing, safe food preparation, 
receiving and storing food, methods of thawing, cooking, cooling and 
reheating food, HACCP (Hazard Analysis and Critical Control Points), 
food safety regulations, and more. These are important topics. However, 
while ServSafe[supreg] manager certification is one way to ensure that 
food service managers are current in this knowledge, it is not the only 
way to ensure this. We have chosen to allow some flexibility in this 
regard. Given commenters' concerns regarding a potential workforce 
shortage of certified dietary managers, we agree it is reasonable to 
allow facilities 12 months from the effective date of this rule for a 
food service manager hired after the effective date of this rule to 
meet the updated qualifications.
    Comment: We received a number of comments both supporting and 
objecting to our proposal to eliminate the requirement that there be no 
more than 14 hours between meals. Those who object felt that our 
objective was not person-centered care, as we stated in the preamble, 
but rather an intent to limit the existing regulatory requirement that 
facilities ensure that appropriate food is available and provided to 
residents at reasonable times. These commenters saw no reason not to 
retain the current requirement and recommended doing so. Other 
commenters felt that our proposal would allow facilities to tailor 
their food service programs to the needs and desires of its residents 
and patients and would improve the resident's environment and quality 
of life.
    Response: The intent of our proposal was, as some commenters noted, 
to give facilities some flexibility and to focus their efforts on 
meeting the residents' needs and preferences. The proposal required 
that the facility provide three meals a day at ``regular times 
comparable to the community or in accordance with the resident needs, 
preferences, requests, and plan of care'' and that suitable and 
nourishing alternative meals and snack must (emphasis added) be 
available for residents who want to eat at non-traditional times or 
outside of scheduled meal service times. We believe these requirements, 
in combination with other requirements, including the requirements for 
food and drink in paragraph (d), ensure that each resident will receive 
adequate nutrition and will have in say in both what he or she eats and 
when. However, the requirement that there must be no more than 14 hours 
between a substantial evening meal and breakfast the following day, or 
up to 16 hours when a nourishing snack is served at bedtime, and a 
resident group agrees to this meal span, does not conflict with the 
proposed requirement and may prevent diminished availability of meal 
service. Therefore, we will not finalize our proposal to delete the 
requirement that there must be no more than 14 hours between a 
substantial evening meal and breakfast the following day, or up to 16 
hours when a nourishing snack is served at bedtime, and a resident 
group agrees to this meal span.
    Comment: Some commenters objected to our requirement that 
facilities establish a policy regarding use and storage of foods 
brought to residents by visitors to ensure safe and sanitary handling. 
These commenters felt they were not capable of policing this and that 
it was inappropriate to ask them to, but at the same time felt that 
foods from visitors were an enhancement to resident enjoyment.
    Response: We were deliberately flexible in establishing this 
requirement, to allow facilities to determine how to best balance 
resident enjoyment of such treats and food safety. For example, some 
facilities may have the capacity to provide refrigeration space for 
residents, while others will not. We continue to believe that having a 
policy which residents and visitors are aware of is an important 
safeguard.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We have modified our definition of ``qualified dietitian 
or other clinically qualified nutrition professional'' at Sec.  
483.60(a)(1) to more closely align with statutory requirements.
     Director of Food and Nutrition Services: We have modified 
Sec.  483.60(a)(2)(i)(D) to specify that the hospitality degree must 
include food service or restaurant management.
     Menus and Nutritional Adequacy: We have deleted the term 
``industry standards'' from our proposal at Sec.  483.60(c)(1) that 
menus must meet the nutritional needs of residents in accordance with 
established national guidelines. We also clarified that menus must 
reflect, based on a facility's reasonable efforts, the religious, 
cultural and ethnic needs of the resident population, as well as input 
received from residents and resident groups.
     Food and Drink: At 483.60(d)(5), we have replaced the 
terms ``substitutes'' and ``alternative'' with the terms ``options'' 
and ``different meal choice.''
     We have withdrawn our proposal at (f)(2) to delete the 
requirement that there must be no more than 14 hours between a 
substantial evening meal and breakfast the following day, or up to 16 
hours when a nourishing snack is served at bedtime, and a resident 
group agrees to this meal span.

S. 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

[[Page 68782]]

limited to, physical therapy, speech-language pathology, occupational 
therapy, and mental health rehabilitative services for a mental 
disorder. Following the reorganization of part 483 subpart B, we 
proposed to relocate these existing provisions to Sec.  483.65 with 
minor revisions. We proposed at re-designated Sec.  483.65(a) to 
specifically add respiratory therapy to the list of specialized 
rehabilitative services. The addition of this service explicitly 
requires facilities to provide or obtain these services when necessary 
and meet the needs of residents facing respiratory issues. However, 
this addition did not change coverage policy regarding respiratory 
therapy. At Sec.  483.65(a)(2), we proposed to clarify that when it is 
necessary for facilities to obtain these services from an outside 
source, the provider would have to be a certified Medicare and/or 
Medicaid provider.
    Secondly, we proposed to clarify the meaning of specialized 
rehabilitative services in relation to PASARR. We proposed to add in 
Sec.  483.65 a cross reference to the PASARR regulations at Sec.  
483.120(c) which set out the mental health or intellectual disability 
services a nursing facility must provide to all residents who need 
these services. In addition, we proposed to correct a typographical 
error deleting the redundant ``mental health'' before ``rehabilitative 
services for a mental disorder and intellectual disability''.
    Comment: Many commenters supported the inclusion of respiratory 
therapy in the list of specialized rehabilitative services. One 
commenter suggested that recreational therapy also be added since 
recreational therapy is recorded in the MDS 3.0 for LTC facilities 
under Section O.
    Response: We appreciate the feedback and support from commenters. 
We have chosen not to add recreational therapy to the list of 
specialized rehabilitative services at Sec.  483.65 because at this 
time we do not believe that we have the evidence as to the efficacy of 
such therapy to support the addition.
    Comment: One commenter indicated that it is unclear whether the 
proposed rule requires that respiratory therapy services be provided by 
a respiratory therapist. The commenter notes that it would be nearly 
impossible to find enough respiratory therapists to provide the 
services and noted further that a nurse with appropriate training could 
provide necessary respiratory services in most instances. Commenters 
requested that a regulatory definition of ``respiratory therapy'' and a 
clear discussion of the scope of respiratory therapy services that must 
be provided be included in the final rule. In addition, commenters 
noted that the final rule should include a discussion of the 
qualifications necessary for individuals to furnish these services to 
help providers better understand how to meet these requirements.
    Response: All specialized rehabilitative services are considered 
facility services and are included within the scope of facility 
services. Therefore, the facility must provide the necessary 
respiratory therapy services for all residents who need them, so that 
the needs of the resident are met and support the resident in attaining 
or maintaining their highest practicable physical, mental, and 
psychosocial well-being. In addition, the regulation requires that 
these services be provided in accordance with the resident's 
comprehensive assessment and plan of care. Regulations at Sec.  
483.70(f) discuss staff qualifications and specify that the facility 
must employ on a full-time, part-time or consultant basis those 
professionals necessary to carry out the provisions of the requirements 
for LTC facilities. This would include those services related to 
specialized rehabilitative services, including respiratory therapy. In 
addition, the regulations at Sec.  483.70(f) require that professional 
staff must be licensed, certified, or registered in accordance with 
applicable state laws.
    Comment: One commenter indicated concern regarding the difficulty 
smaller and more rural facilities may face when providing very complex 
respiratory therapy services such as mechanical ventilation. The 
commenter noted that it would be reasonable to permit facilities some 
flexibility in how the needs of these residents are met and requested 
that we include provisions describing what complex respiratory services 
could be excluded from those services the facility must provide. The 
commenter noted that rehabilitation agencies provide services that may 
be furnished in a home environment that is similar to a SNF, such as an 
assisted living facility or independent senior living residence and 
recommended that the regulations be revised to allow the appropriate 
flexibility for SNFs that is consistent with that permitted in other 
Medicare outpatient therapy provider settings.
    Response: We appreciate the commenter's feedback and understand 
that there are challenges that smaller and rural facilities may face 
when trying to obtain access to care and services for their residents. 
However, facilities must be able to provide, directly or under 
arrangement, the necessary care that their residents require. We urge 
facilities to use the facility assessment that was proposed at Sec.  
483.70(e) as a tool for appropriately assessing the resources necessary 
for providing care to its residents. Facilities should use this 
assessment to make decisions about their direct care staff needs as 
well as their capabilities to provide services to the residents in 
their facility.
    Comment: One commenter disagreed with our proposal to clarify that 
when it was necessary to obtain specialized rehabilitative services 
from an outside source, the provider would have to be a certified 
Medicare and/or Medicaid provider. The commenter noted that this 
revision limits access to providers and recommends that facilities 
continue to be permitted to obtain necessary services from a qualified 
therapy professional that is appropriately licensed or certified to 
practice in the state in which services are being furnished. The 
commenter recommended that services obtained from an outside resource 
should only be restricted to a provider who was not excluded from 
federally funded health care programs including Medicare and/or 
Medicaid.
    Response: We appreciate the commenter's feedback and have given 
much consideration to the implications that this revision may have on 
access to providers of specialized rehabilitative services. Our goal is 
to ensure that all LTC residents receive services from qualified 
professionals. Therefore, in an effort to balance the need to assure 
the safety of LTC residents against the concerns of facilities 
regarding obtaining access to providers, we have withdrawn our proposal 
at Sec.  483.65(a)(2) to require that an outside resource must be a 
Medicare or Medicaid provider. Instead we are revising the requirement 
to indicate that services obtained from an outside resource must come 
from a provider that is not excluded from any federally funded health 
care program. We believe that this revision supports our intent to 
assure that LTC facility residents receive services from outside 
resources that are both professional and safe, while maintaining the 
access to providers.
    Comment: Some commenters indicated that the use of the term 
``specialized rehabilitative services'' should be revised to 
``rehabilitative services and devices'' to be consistent with a CMS 
regulation entitled, ``Patient Protection and Affordable Care Act; CMS 
Notice of Benefit and Payment Parameters for 2016'' (80 FR 75487). 
Commenters noted further that the final rule should adopt a definition 
of ``rehabilitative services'' that includes explicit recognition and 
coverage of devices. Commenters noted that the

[[Page 68783]]

definition of ``rehabilitative devices'' should also include durable 
medical equipment, prosthetics, orthotics, and supplies (DMEPOS). In 
addition, commenters recommended that rehabilitative devices should be 
covered whether or not they are considered part of the SNF per diem 
rate or separately billable to the Medicare program.
    Response: We disagree with commenters and believe that the term 
``specialized rehabilitative services'' is appropriately used in the 
LTC setting. Sections 1819(b)(4)(A) and 1919(b)(4)(A) of the Act 
specifically use the term ``specialized rehabilitative services'' when 
discussing the provision of services that a facility must provide, 
directly or under arrangement, to the extent needed by residents to 
fulfill all plans of care. The CMS regulation discussed by commenters 
(``Patient Protection and Affordable Care Act; CMS Notice of Benefit 
and Payment Parameters for 2016'' (80 FR 75487)) applies to private 
insurance under the Affordable Care Act and does not have an impact on 
long-term care facilities that participate in the Medicare and Medicaid 
program. In addition, the coverage of rehabilitative devices under the 
Medicare program falls outside the scope of this regulation.
    Comment: A few commenters also recommended that the regulation be 
revised to ensure compliance with the decision in Jimmo v. Sebelius, 
which indicated that Medicare coverage for skilled services should not 
be denied based on the absence of potential for improvement or 
restoration. Commenters indicated that residents should not have to 
show improvement for rehabilitative services to be determined as 
reasonable and necessary.
    Response: We thank the commenters for highlighting the importance 
of the decision in Jimmo v. Sebelius. However, the Jimmo v. Sebelius 
settlement agreement did not modify or expand the existing eligibility 
requirements for receiving Medicare coverage and does not fall into the 
scope of this regulation. We note that CMS committed to conducting a 
number of activities in response to the settlement agreement to ensure 
that the existing Medicare policy is clear and that Medicare claims are 
adjudicated consistently and appropriately. Specifically, CMS planned 
to engage in the review of claims determinations, update program 
manuals, and educate contractors, adjudicators, and providers and 
suppliers on the policy clarifications. Readers may refer to the CMS 
Web site at https://www.cms.gov/medicare/medicare-fee-for-service-payment/SNFPPS/downloads/jimmo-factsheet.pdf for a fact sheet regarding 
the Jimmo v. Sebelius settlement agreement.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     At Sec.  483.65(a)(2), we are removing the requirement for 
outside resources to be Medicare and/or Medicaid providers of 
specialized rehabilitative services. We have clarified that the outside 
resource must be a provider of specialized rehabilitative services that 
is not excluded from participating in any federal or state health care 
programs pursuant to sections 1128 and 1156 of the Act.

T. Outpatient Rehabilitative Services (Sec.  483.67)

    We proposed 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 noted 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 proposed to require facilities that provide outpatient 
rehabilitative therapy services to meet requirements similar to those 
already established for hospitals. Specifically, we proposed to require 
in 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. At Sec.  483.67(a), we 
proposed that the organization of the service must be appropriate to 
the scope of the services offered. At Sec.  483.67(b), we proposed 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 proposed to require that 
the facility must have appropriate professional and nonprofessional 
personnel available at each location where outpatient services are 
offered. In addition, we proposed 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. At Sec.  483.68(c), we proposed to 
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 proposed to require that 
the provision of care and the personnel qualifications must be in 
accordance with national acceptable standards of practice.
    Comment: The majority of commenters indicated support for the 
addition of the requirements regarding facilities that provide 
outpatient rehabilitative services. Commenters noted that there has 
been inconsistent interpretation regarding how SNFs can furnish 
outpatient therapy services to non-residents and that steps towards 
standardization are needed. While a few of the commenters indicated 
that the new section provides adequate guidance for those facilities 
offering these services, other commenters raised concerns that the 
proposed requirements need further clarification and revision.
    Specifically, one commenter raised the issue of SNFs that provide 
outpatient rehabilitative services to non-residents at a location 
outside of the facility. The commenter requested that the regulations 
address SNFs that may furnish outpatient rehabilitative services in 
locations other than the facility and allow flexibility in how these 
services are provided. The commenter urged CMS to revise the 
regulations so that they are consistent with requirements imposed for 
other Medicare outpatient therapy providers. The commenter indicated 
that the outpatient therapy services furnished by SNFs resemble the 
delivery of services furnished through outpatient rehabilitation 
providers described under 42 CFR part 485 subpart H (referred to in the 
comment as rehabilitation agencies) and not those services furnished 
through outpatient hospital departments. The commenter noted that 
unlike a hospital, rehabilitation agencies may also provide outpatient 
therapy services to individuals in a home environment, such as to 
residents of independent senior living and assisted living

[[Page 68784]]

residents. In addition, the commenter noted a CMS memo from April 3, 
2015 entitled ``Clarification of Requirements for Off-Premises 
Activities and Approval of Extension Locations for Providers of 
Outpatient Physical Therapy and Speech-Language Pathology Services and 
Off-Premises Activities'' (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-33.pdf). The commenter requested that the 
provisions addressed in this memo regarding off-premise treatment 
activities be added as requirements for SNFs.
    A few commenters also recommended that the requirements be revised 
to ensure compliance with the decision in Jimmo v. Sebelius, which 
indicated that Medicare coverage for skilled services should not be 
denied based on the absence of potential for improvement or 
restoration. Commenters indicated that residents should not have to 
show improvement for rehabilitative services to be determined as 
reasonable and necessary. Also, a commenter raised concerns regarding 
inconsistences between the proposed requirements and Medicare Part B 
outpatient therapy payment policy. Lastly, commenters requested that 
the regulatory section be updated to replace the term ``patient'' with 
``resident''.
    Response: We appreciate the in depth feedback from commenters. 
Through our proposal, we intended to establish requirements for 
outpatient rehabilitative services provided to non-residents in the LTC 
facility to ensure that these services meet health and safety 
standards. We were informed that a number of facilities provide 
rehabilitative services on an outpatient basis and that these services 
may be paid for under Medicare Part B. We want to ensure that our 
requirements are fully and clearly developed in an effort to provide 
clarity to facilities and safety to those individuals that are 
receiving services. After carefully considering all of the comments we 
received, reviewing the comprehensive regulations for outpatient 
therapy providers found in part 485, and the CMS guidance regarding 
off-premise treatment activities recommended by commenters (https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-33.pdf); 
we believe that the practice of some LTC facilities providing 
outpatient rehabilitative services presents several additional complex 
issues that were not carefully and thoroughly considered during the 
development of the proposed regulations. Therefore, we have decided 
against finalizing the proposed requirements for outpatient 
rehabilitative services. We believe that it is necessary to study the 
issue further and consider proposals for future rulemaking.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modification:
     We have withdrawn this proposed section in its entirety.

U. Administration (Sec.  483.70)

Relocation of Existing Requirements
    We proposed to re-designate current Sec.  483.75 ``Administration'' 
as Sec.  483.70. At Sec.  483.75(c), we proposed 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 proposed to 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).
    We proposed to re-designate and revise existing Sec.  483.75(e) and 
(f), provisions regarding nurse aides, to Sec.  483.35 ``Nursing 
Services'' or Sec.  483.95 ``Training'', as discussed under these 
sections.
    We proposed 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. In addition, we proposed 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 did not receive any comments in response to these proposals and 
are finalizing as proposed except that we have added a reference to 45 
CFR part 92 in the list of regulations that facilities are required to 
comply with, based on a comment received with regards to Sec.  483.12.
Governing Body Sec.  483.70(d)
    At Sec.  483.70(d)(2)(i) we proposed to 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 proposed to add a new Sec.  
483.70(d)(2)(iii) to specify that the LTC facility administrator would 
report to and be accountable to the governing body. We also proposed 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).
    Comment: One commenter pointed out that deleting the phrase ``where 
licensing is required'' could result in confusion in states where state 
law allows administrators of hospitals which have a distinct part SNF 
not to be certified as LTC facility administrators.
    Response: We agree and withdraw this proposal.
    Comment: Some commenters supported the proposed changes to Sec.  
483.70(d)(2)(iii), which would require that the LTC facility 
administrator report to and be accountable to the governing body.
    Response: We thank the commenters. We believe this change will 
ultimately benefit LTC facility residents.
    Comment: One commenter was concerned about the proposed requirement 
at Sec.  483.70(d)(2)(iii) for the LTC facility administrator to report 
to and be accountable to the governing body. The commenter stated that, 
while they understand and appreciate the need for the governing body to 
be kept apprised of the operations and management of the facility, they 
do not support a regulatory requirement prescribing that the facility 
administrator report to and be directly accountable to the governing 
body. The commenter stated that many not-for-profit organizations have 
management structures that include a Chief Executive Officer (CEO) who 
is not the administrator of record of the LTC facility. Under the 
bylaws and governance structure of these organizations, the CEO is 
directly accountable to the board of directors and responsible for 
hiring and supervising the facility administrator and other executive 
staff. Requiring the administrator to report to and be directly 
accountable to the governing body in these circumstances would supplant 
the governance policies of these organizations and undermine the 
relationship of the CEO to the board of directors. The commenter 
recommended that this requirement be eliminated in its entirety. 
Alternatively, the commenter suggested the requirement could be 
modified to require that the organization's senior management keep the 
governing body apprised of the operations and management of the 
facility, while leaving it up to the organization to designate the 
individual

[[Page 68785]]

who would be responsible for this function.
    Response: As the commenter noted, we believe that it is important 
for the governing body to be kept apprised of the operations and 
management of the facility. Under current regulation, the governing 
body is already responsible for appointing the administrator who is 
responsible for the operations and management of the facility. The 
proposed provision would add that the administrator reports to and is 
accountable to the governing body. The new provision does not specify 
``directly'' and thus we believe that a governing body may appoint a 
designee, such as a CEO, to directly interface with an Administrator. 
However, the use of a designee does not change the Administrator's 
accountability to the governing body nor the governing body's 
responsibility to know and respond to concerns with the operation and 
management of the facility.
    Comment: One commenter stated that they appreciate that CMS would 
make the administrator report to and accountable to the governing body. 
They note that while this may be implied, the proposed specificity 
clarifies this point. Given the governing body's responsibility for 
implementing the management and operations of the facility, the 
commenter agrees with CMS that the administrator must keep the 
governing body informed and knowledgeable about these issues. The 
commenter also supports the governing body also being responsible and 
accountable for the facility's QAPI. This program cannot be successful 
unless the facility leadership is involved.
    Response: We agree. As noted above, we believe it is important that 
the governing body be kept apprised of the operations and management of 
the facility. Furthermore, should the governing body appoint an 
intermediary such as a CEO, the use of such an intermediary does not 
change the Administrator's accountability to the governing body nor the 
governing body's responsibility to know and respond to concerns with 
the operation and management of the facility.
Facility Assessment (Sec.  483.70(e))
    We proposed a new Sec.  483.70(e) to establish a new requirement 
for an annual facility assessment. We proposed 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, and 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.
General Comments
    Comment: Some commenters did not believe that the proposed 
requirement for a facility assessment would be a significant change 
from what is currently required. Commenters pointed to language in the 
proposed rule, where we first said, that the requirement for a facility 
assessment was ``a central feature'' of our revisions and that ``[t]his 
is similar to existing common business practices for strategic planning 
and capital budget planning'' (80 FR 42210). Commenters said that 
authorizing a practice that is already common does not appear to be a 
significant change. The current requirements already require resident-
centered and specific care plans designed to attain and maintain the 
resident's highest practicable physical, mental, and psychosocial well-
being. LTC facilities already use multiple sources of data, including 
the items listed in the proposed rule, in various ways to make 
operational decisions, including the number of staff and skills that 
staff need to provide care to the residents. Some commenters also noted 
that the current requirement to determine staffing levels was already 
producing serious staffing and quality deficiencies and did not see 
where the proposed changes would make any appreciable difference. They 
also said the reason for this assessment was completely unclear.
    Response: Based on our experience with LTC facilities, we believe 
that there is already some assessment of the resident population and 
the resources that would be required to care for that population. 
However, we do not believe that all facilities perform as thorough an 
assessment of their resident population or the facility's resources as 
is required by Sec.  483.70(e). In addition, we do not believe that 
most facilities have a formal process that is documented. We believe 
that the requirement for a facility assessment that must address the 
factors identified in Sec.  483.70(e)(1) through (3) will enable each 
LTC facility to thoroughly assess their resident population and the 
resources that are needed to provide the care they need. It will also 
enable the facility to determine the resources it has so that it can 
determine what resources it needs to competently care for its resident 
population. By having the facility assessment documented, it will also 
provide a record for staff and management in the future to understand 
the reasoning for decisions that were made on staffing and other 
resources. It will also provide a reference point for assessment when 
deficiencies are noted or when adverse events occur.
    Comment: Some commenters were very supportive of the requirement 
for a facility assessment, but wanted us to also require that self-
assessment plans include individual crisis plans for residents who may 
develop dementia-related or other behavioral crisis.
    Response: We understand the commenters concern for residents who 
have or may develop dementia-related or other behavioral crisis. As 
proposed and now finalized in this rule, Sec.  483.70(e) requires that 
facilities must, among other things, 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 and this assessment must address or include 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. Hence, 
LTC facilities must already consider the care that is needed for those 
residents who already have dementia-related or other behavioral crises 
or could develop these during an emergency. We have not required a 
specific methodology for LTC facilities to perform their facility 
assessments because we believe that

[[Page 68786]]

facilities need the flexibility to decide how they will conduct their 
assessments. Thus, we will not require that individual crisis plans be 
included; however, each facility must address the needs of all 
residents, including those who have or may develop dementia-related or 
other behavioral crises both during day-to-day operations and 
emergencies.
Facility Assessment Methodology
    Comment: Some commenters were supportive of LTC facilities 
conducting their own facility assessment and taking into consideration 
the factors set out in the proposed rule at Sec.  483.70(e). However, 
they were concerned about the facility being able to rely on its own 
assessment without there being any enforcement mechanisms or safeguards 
to ensure that the facility was objectively assessing its residents' 
needs, acuity, and other important factors and not relying unduly on 
other factors, such as costs or convenience. Some commenters were 
concerned that LTC facilities would simply produce assessments that 
indicated that their current staffing and other resources were 
sufficient to care for their resident population. Commenters 
recommended that facility assessments be validated in some manner.
    Response: We understand the commenters' concerns; however, we 
believe that in complying with the requirements finalized in this rule 
as set forth in Sec.  483.70(e), LTC facilities will have to conduct 
and document a thorough assessment and analysis of their resident 
population, staff and staff competencies, and resources to determine 
not only the resources they currently have but also the resources they 
need to obtain in order to care for their resident population 
competently. We will also be developing sub-regulatory guidance that 
will provide more information on how to comply with this requirement. 
If any LTC facility simply writes up a facility assessment to justify 
the resources it currently has, we believe that will be evident in the 
facility assessment, as well as in their performance on surveys.
    Comment: Some commenters were concerned about having the facility 
assessment developed by the LTC facility without requiring input from 
other sources. They recommended that the facility be required to seek 
and use input from the state's Office of the Long-Term Ombudsman, the 
resident and family groups, and family caretakers when conducting its 
assessment. However, other commenters believed that the facility 
assessment should be considered proprietary and that the facilities 
should not be required to either include input from sources outside the 
facility or share the assessment with them.
    Response: While we encourage LTC facilities to seek out and 
consider input from multiple sources, including residents, residents' 
representatives, families, and advocates, including the state Office of 
the Long Term Care Ombudsman, we disagree with the commenters that this 
should be required. As stated in the proposed rule, we encourage LTC 
facilities to seek input from multiple sources; however, ``[w]e 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'' (80 FR 42210 through 42211). We 
believe that each facility needs the flexibility to decide the best way 
to comply with this requirement. This is also the reason we have not 
required any specific methodology for facilities to use for the 
facility assessment.
    Comment: Some commenters believed that the level of detail in 
facility assessment requirement was unreasonable, complex, and would be 
extremely burdensome for the LTC facilities. However, other commenters 
were concerned about the lack of specificity for the facility 
assessment requirement. They said it was unclear what these assessments 
would look like or which staff members should be involved. Some 
commenters noted that there was insufficient information in the 
preamble and the regulatory text to evaluate the requirement for a 
facility assessment. Commenters were particularly concerned that this 
inevitable lack of consistency in methodology would result in the 
results not being comparable. Thus, the facility assessments would not 
provide any valid comparisons or provide any precedent over time 
sufficient to be beneficial for LTC facilities, advocates, regulators, 
surveyors, or researchers. Commenters also questioned whether these 
assessments could fail to comport with the OBRA '87 requirement that 
every facility have adequate staff in place to ensure that residents 
can achieve their maximum well-being.
    Response: We understand that the commenters have concerns and 
questions about what would be needed to comply with the requirement for 
a facility assessment. In proposed Sec.  483.70(e), we only included 
the elements that we believe are essential for a facility to assess and 
analyze its resident population and resources so that it can 
competently determine the resources it needs to care for its resident 
population. As we said in the proposed rule, ``[t]his 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'' (80 FR 42210). Thus, we believe that the basic elements 
for the assessment are included and do not believe that the 
requirements are unreasonable, complex, and would be extremely 
burdensome. As we indicated earlier, we believe that facilities are 
already performing some type of assessment, although it may not be as 
formal or documented. In addition, after this final rule is effective, 
additional sub-regulatory guidance will be published or disseminated to 
provide further detail on how to comply with these requirements.
    We acknowledge that there will likely be some variation in how LTC 
facilities will conduct and document their facility assessments. 
However, due to the significant variations in the types of LTC 
facilities, resident populations, and resources among the LTC facility 
facilities, we believe that the facilities need the flexibility to 
determine the best way for each facility to comply with this 
requirement. As to consistency among the facility assessments, we 
believe that the accuracy of the assessments is more important. 
However, over time we believe that some consistency will likely develop 
due to facilities sharing what has worked best for them with other 
facilities and their associations. In addition, if a facility complies 
with the requirements for the facility assessment finalized in this 
rule, we believe that facilities will be able to determine what 
constitutes sufficient staff for their facility, which would be in 
compliance with the requirement in OBRA '87 for sufficient staffing.
Annual and Other Updates
    Comment: Some commenters were concerned that facilities may 
potentially need to update their assessments frequently, such as every 
time their resident-mix changes, they hire new staff or a DoN, conduct 
any remodeling, etc. This continuous, or at least frequent, need to 
update the facility assessment could distract LTC facilities from 
improving resident care.
    Response: We do not believe that the facility assessment will need 
to be updated as frequently as the commenters suggest. We understand 
that the resident-mix may change frequently. However, the care that 
needs to be provided for the resident populations should not change 
that frequently. Once the facility completes its assessment, changes in 
its resident

[[Page 68787]]

population should not necessitate a change in the facility assessment 
unless the facility begins admitting residents that require 
substantially different care. For example, when a facility does its 
initial assessment, it might not have any morbidly obese residents who 
require special bariatric equipment, such as a bariatric wheelchair and 
walker. However, in the future, if the facility wants to admit morbidly 
obese residents who require that equipment, it would need to identify 
the care needs for morbidly obese residents, update the facility 
assessment, ensure that its staff have the relevant competencies, and 
obtain the other required resources. As long as the facility assessment 
encompasses the care and resources needed by the residents, admitting 
new residents with the same needs should not require an update of the 
facility assessment. Likewise, hiring new staff or a DoN or even 
remodeling should not require an update of the facility assessment, 
unless these are actions that the facility assessment indicated the 
facility needed to do. In that case, it should only require notation 
that the facility has taken the actions to satisfy a need the facility 
assessment identified.
    Comment: Some commenters questioned the requirement to perform the 
facility assessment annually. They said that appropriate staffing 
levels and the competencies that are required to care for their 
resident population change much more frequently than annually. 
Commenters said that the annual assessment must be able to establish 
that its staffing will remain adequate throughout the year, both with 
regard to levels of total nurse staffing, and with respect to the 
responsibility that certain types of staff, for example, registered 
nurses, licensed practical nurse, have in overseeing the medical 
management of residents with regard to medications, falls prevention, 
development of pressure ulcers, readmission to hospitals, and other key 
areas.
    Response: We believe that an annual assessment is needed to ensure 
that there have not been any substantial changes that will require the 
facility to update its facility assessment. The annual assessment is a 
minimum requirement. LTC facilities should update their facility 
assessment whenever they believe it is appropriate.
Number of Assessments
    Comment: Some commenters stated that a single facility assessment 
was insufficient. Some commenters said that the facility assessment 
requirement, as a single process, did not appear to serve long-range 
planning needs and, simultaneously, the changing day-to-day needs of a 
facility for staffing and other services, such as food and nutrition, 
rehabilitation, and housekeeping. Some commenters argued for two 
different assessments. One facility assessment would be limited to the 
day-to-day needs for the facility and another that would address 
emergency planning, strategic planning, and capital budget planning. 
Other commenters offered specific language for this type of 
requirement, with separate subsections: One for an annual strategic 
planning and capital budget assessment and another for a bi-weekly 
staffing and day-to-day operations assessment. For the bi-weekly staff 
and day-to-day operation assessment, commenters also recommended the 
individuals they believed should be involved in that assessment and 
that this assessment must also address emergencies.
    Response: The requirement for a facility assessment as finalized in 
this rule and set forth in Sec.  483.70(e) is a minimum requirement. If 
facilities choose to conduct another assessment or expand the facility 
assessment to include long-range planning needs or any other needs, it 
is free to do so as long as it complies with the minimum requirements 
in this final rule. We have not required the involvement of specific 
LTC facility personnel because we believe that the facility should have 
the flexibility to determine the appropriate individuals who should be 
involved in the facility assessment.
Use of Facility Assessment
    Comment: Some commenters stated that each LTC facility is a unique 
organization with its own values, goals, experiences, and other factors 
that drive how it operates. The commenters were concerned that the 
requirement for the facility assessment could result in organizational 
decisions and approaches being specifically directed or managed by CMS, 
which is contrary to the spirit of QAPI whereby the organizations 
operations should be shaped by the staff, residents, governing body, 
and other parties. However, other commenters wanted the facility 
assessment audited by a facility surveyor and that the surveyor be 
empowered to require, under threat of graduated monetary penalties, 
that the facility provide additional nursing resources if the surveyor 
disagrees with the facility's assessment.
    Response: The requirement for the facility assessment is intended 
to ensure that LTC facilities have appropriately assessed their 
resident population and determined the resources, including staff and 
their competencies, to competently care for their residents. The 
facility assessment will be performed and documented by the facility 
and not by CMS or any other entity. LTC facilities must comply with the 
long term care requirements; however, we have endeavored to allow for 
as much flexibility as possible for facilities to decide the best way 
for their facility to comply with these requirements. We also believe 
that the facility assessment could be very useful tool for QAPI, 
especially when assessing the facility's performance on the elements 
they are required to include in the assessment.
Implementation
    Comment: Some commenters said that there was no discussion on 
implementation of the findings in the facility assessment. They 
recommended including language that requires the facility to implement 
the competent staffing and resources determined necessary to care for 
the residents based on the results of the facility assessment.
    Response: There are many sections in this final rule, as in the 
proposed rule, that requires that the facility assessment be used to 
determine the resources the facility needs to devote to certain 
activities. For example, Sec.  483.35 requires that the facility have 
the appropriate staff with the appropriate competencies and skill sets 
for the resident population in accordance with the facility assessment. 
Section Sec.  483.40(a) requires that the facility have sufficient 
direct care staff with the appropriate competencies and skills sets in 
behavioral health for the residents in accordance with the facility 
assessment. Facilities must also establish and maintain their infection 
prevention and control programs based upon the facility assessment as 
set forth in Sec.  483.80(a)(1). In addition, we encourage facilities 
to use their facility assessment in any other activities that affect 
their resident population. We believe these requirements are sufficient 
to require facilities to use their facility assessments so we will not 
include the recommended specific language.
Alternatives
    Comment: Some commenters recommended that the proposal for the 
facility assessment not be finalized and that CMS form a stakeholder 
workgroup that could explore the potential use of ``facility 
assessments'' and unintended consequences or outcomes, as well as 
possible alternate approaches. Commenters wanted CMS to provide 
clarification on what it envisions for a facility assessment; provide 
evidence for the value of proposing a requirement for this facility 
assessment; and provide

[[Page 68788]]

evidence-based models of facility assessment and process. Other 
commenters questioned what evidence we had that supported the validity 
of this requirement.
    Response: As discussed above, we believe that LTC facilities 
already perform some type of assessment to determine staffing and other 
resources they will need to care for their resident population. For 
example, previous Sec.  483.30 ``Nursing services,'' required 
facilities to provide ``sufficient nursing staff to provide nursing and 
related services to 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.'' 
Also, previous Sec.  483.15 ``Quality of life,'' required facilities to 
``care for its residents in a manner and in an environment that 
promotes maintenance or enhancement of each resident's quality of 
life.'' The Veterans Administration is also using facility assessments 
in its strategy to improve its health care delivery system (``Restoring 
Trust in VA Health Care,'' 271 New Eng. J. Med. 295 (2014), accessed on 
Westlaw (2014 WLNR 20261329) on July 26, 2016). We believe that these 
requirements are necessary to ensure that the facility competently 
cares for its resident population by appropriately assessing its 
resident population and resources. The requirement includes specific 
elements that each facility must address that relate to its resident 
population, staff, and the resources the facility needs to care for its 
residents. It provides for not only a process but also provides a 
valuable tool for facilities to use for planning for and improving 
care. We do not believe that a stakeholder group is necessary prior to 
implementing the requirement for a facility assessment; however, we are 
always willing to review any information or comments that any member of 
the public wishes to send to us and will consider that information if 
there is any relevant future rulemaking.
    Comment: Some commenters did not want the requirement for a 
facility assessment finalized because they believed that the outcomes 
for residents under the existing requirements should stand as evidence 
of the adequacy of the facility's assessment. These commenters 
questioned the need to require LTC facilities to spend precious time 
documenting a facility-wide assessment that surveyors will use to 
interpret whether the facility has sufficient staff. The more 
appropriate way to assess allocation of resources is to assess whether 
or how the facility has met the individual needs of each resident 
rather than require another documentation endeavor.
    Response: The requirement for a facility assessment addresses 
different issues that the requirements for person-centered care for 
residents. In the facility assessment, LTC facilities should be 
proactive in assessing and analyzing the needs for the entire resident 
population. Individual care plans would certainly be a valuable 
resource in performing the facility assessment; however, the care plan 
would address the specific needs for a single resident. The facility 
assessment must address the care needed for all of the residents, as 
well as the resources needed to provide that care competently.
    Comment: Commenters urged that CMS examine whether the current 
methodology for the five-star system, which calculates expected 
staffing based on RUG values along with reported staffing levels, could 
be adapted for establishing rules or guidelines providing presumptive 
levels for facility assessments. An adaptation of this system must also 
be designed to incorporate the more robust payroll-based staffing data 
that will be in place as a requirement for all certified SNFs and NFs 
by July 2016.
    Response: As discussed above, we will consider the commenters 
recommendation to examine whether the current methodology for the five-
star rating system, which calculates expected staffing based on RUG 
values along with reported staffing levels, can be adapted for 
establishing rules or guidelines providing presumptive levels for 
facility assessments. In addition, we will also be reviewing the 
payroll-based staffing data that we will be receiving starting this 
year. However, proposals to use either of the above suggested methods 
would have to be developed. We will consider these recommendations if 
there is future rulemaking concerning the facility assessment or 
staffing.
Surveys/Surveyors
    Comment: Other commenters were concerned about how the facility's 
management might use the facility assessment or how surveyors would use 
the facility assessment in assessing a facility's compliance with 
various requirements. The general requirement for a facility assessment 
invites a tremendous amount of subjectivity into the survey process 
when surveyors already have requirements and other sub-regulatory 
guidance to determine whether there is non-compliance during a survey.
    Response: We understand the commenters' concern about how the 
facility assessment will be used by the facility and the surveyors. 
Facilities are required to use the facility assessment in determining 
how they need to comply with several requirements in this rule. 
However, facilities may also choose to use their assessments for other 
purposes. Concerning the surveyors, further guidance will be published 
or disseminated by CMS after this rule is published to provide 
additional information on what constitutes compliance with the 
requirements set forth in this final rule.
Medical Records (Sec.  483.70(i))
    We proposed to re-designate existing Sec.  483.75(l) as 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 proposed minor revisions in it to clarify that the 
medical record must contain the resident's comprehensive plan of care 
and physician's and other licensed professional's progress notes. We 
noted in the proposed rule that existing paragraph (m) will 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).
    Comment: One commenter was concerned about proposed Sec.  
483.70(e)(2)(i) using the term ``medical records,'' rather than the 
term in the current Sec.  483.75(l), which is ``clinical records.'' The 
commenter stated that the term ``clinical records'' appears to be 
broader than ``medical records'' and states that CMS offered no reason 
for the change. The commenter suggested CMS retain the current term 
``clinical records.''
    Response: We believe the commenter is referring to proposed Sec.  
483.70(i), which addresses medical records rather than Sec.  483.70(e), 
which addresses facility assessment. In the preamble to the proposed 
rule, we noted that we proposed 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). We did not specifically state that our 
change to the term `medical record' was related to achieving 
consistency with the HIPAA rules, but that was the impetus for the 
change. The HIPAA rules in 45 CFR part 164 use the term `medical 
record' rather than `clinical record'. We regard the terms as 
synonymous.
    Comment: One commenter suggested that we further clarify that the

[[Page 68789]]

comprehensive care plan and services provided includes records 
documenting activities of daily living care and services, bathing and 
skin inspections, and nutrition and fluid intake and output records.
    Response: We thank the commenter for their suggestion. We proposed 
that the medical record must include, in addition to the comprehensive 
care plan and services provided and other existing requirements, the 
reports of diagnostic testing and the progress notes of licensed 
personnel. We expect that this will address some of the commenters 
concern. However, we will consider further expanding this requirement 
in future rule-making, which would give us the opportunity to obtain 
further feedback on this issue.
    Comment: CMS proposed to incorporate, without change, the current 
requirements for medical directors, current Sec.  483.75(i). The 
commenter was concerned that, too often, the medical director also 
serves as the attending physician for most of the facility's residents. 
The dual roles of medical director and attending physician make it 
impossible for the medical director to perform the medical director's 
specific regulatory functions--implementing resident care policies and 
coordinating medical care in the facility. The medical director cannot 
``oversee'' the care he or she is providing to residents as attending 
physician. The commenter encouraged CMS to address this issue in final 
regulations. The commenter stated that, although there may be a need, 
in some limited instances, for medical directors to serve as residents' 
attending physicians, CMS needs to strengthen the regulatory standards 
for medical direction so that medical directors can, in fact, perform 
their critical management functions. The commenter suggested that, for 
example, CMS could mandate specific minimum numbers of hours per week 
or per month for medical direction functions; require certification for 
medical directors; limit medical directors from serving as medical 
director in more than two facilities; and prohibit medical directors 
from serving as the residents' attending physicians (with a limited 
exceptions process).
    Response: We thank the commenter for these suggestions. As noted by 
the commenter, we did not propose any changes to this provision, but 
are re-designating it as Sec.  483.70(h). We defer to sub-regulatory 
guidance for further discussion of the medical director's specific 
functions pertaining to resident care policies and coordinating medical 
care in the facility. In addition, while we are not addressing them in 
this final rule, we will continue to evaluate both the situation where 
the medical director is fulfilling the attending physician role and the 
oversight role and the need for additional standards for medical 
direction. We will consider addressing these concerns in future rule-
making.
Transfer Agreement (Sec.  483.70(j))
    In Sec.  483.70(j), ``Transfer Agreement, ''we proposed 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, consistent with state 
law and facility policy. We further proposed to specify here that the 
information exchange required by existing paragraph Sec.  
483.75(n)(1)(ii) be modified to require that the exchanged information 
include, at a minimum, the information we proposed to require under new 
paragraph Sec.  483.15(b)(2)(iii)(B). We proposed to incorporate 
existing Sec.  483.75(o), assessment and quality assurance, into 
proposed Sec.  483.75(c).
    Comment: Some commenters indicated support for our proposal to 
allow a practitioner other than the attending physician to determine 
that a hospital transfer is medically appropriate in an emergency 
situation, consistent with state law and facility policy.
    Response: We thank the commenters. We believe this change will 
ultimately benefit LTC facility residents.

Discussion of Sec.  483.70(l), (m), and (o)

    Provisions on disclosure of ownership, facility closure-
administrator, facility closure, and hospice services were proposed to 
be re-designated as paragraphs Sec.  483.70(k), (l), (m), and (o) 
respectively, and the cross-reference in (m) updated, but otherwise 
unchanged. We proposed to address training of paid feeding assistants 
in Sec.  483.95 ``Training requirements.''
    Comment: One commenter stated that they believe that Sec.  
483.70(l) is an adequate statement of a requirement for facilities to 
be judicious about hospitalizing and re-hospitalizing people. The 
commenter further stated that the additional structural requirements 
proposed elsewhere in the proposed regulations related to hospital 
transfers are warranted or that they will somehow correct what are 
essentially process problems due to diverse causes.
    Response: We address the commenters concerns about additional 
structural requirements related to transfer in our response to comments 
on proposed Sec.  483.15. Section 483.70(l) applies to requirements for 
the facility administrator in the event of a facility closure.
    Comment: A few commenters recommended we add notice and timing 
requirements related to facility closure, including notice to facility 
staff and any union representation.
    Response: Timing and notice requirements for facility closures are 
specified in final Sec.  483.70(l). We did not propose any changes, 
other than re-designation, to the requirements associated with facility 
closure. We will consider the commenters' suggestions for future rule-
making.
    Comment: One commenter was concerned that Sec.  483.70(o)(1)(ii) 
enabled LTC facilities to ``not arrange for the provision of hospice 
services at the facility through an agreement with a Medicare-certified 
hospice.'' The commenter stated that they understand that a resident 
cannot use both the SNF and hospice benefits at once and that SNF 
discharge may be needed for a resident to access hospice. However, the 
commenter feels this situation does not seem to be the intent of the 
requirement. Moreover, the commenter is concerned that, although a 
facility may assist the resident in transferring to a facility that 
will arrange for the provision of hospice services, as stated in the 
requirement, such a transfer disrupts a resident's care at a critical 
juncture. Care cannot be person centered, and a LTC facility cannot be 
considered a resident's home, if the resident is not able to access the 
services of a Medicare-certified hospice. The commenter urges CMS to 
delete subsection (o)(1)(ii).
    Response: We respectfully decline. While we understand the 
commenter's concern, such a change is outside the scope of this final 
rule, as we did not propose any changes to our hospice provisions and 
have not had the opportunity to obtain public feedback on this issue. 
We would need to carefully consider the implications for both hospice 
providers and long-term care facilities of mandating, without 
exception, that long-term care facilities contract for hospice 
services. There may be instances where an appropriate hospice provider 
is not available to the facility or there are other reasons that the 
facility is unable or unwilling to enter into a contractual 
relationship with a hospice provider or the hospice provider is 
unwilling or unable to enter into a contract with the facility. We 
would need to consider these issues carefully before mandating that 
nursing facilities contract for hospice services.

[[Page 68790]]

Binding Arbitration Agreements (Sec.  483.70(n))
    We proposed 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. We proposed 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 could not contain any language that prohibited or discouraged 
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). If a facility utilized an arbitration 
agreement, such facility would be required to inform the resident, at a 
minimum, that the resident was waiving his or her right to judicial 
relief for any potential cause of action covered by the agreement. The 
agreement could only be entered into by the resident voluntarily and 
would have to provide for the selection of a neutral arbitrator and a 
venue convenient to both parties, the resident and the facility. We 
indicated in the proposed rule that any agreement for binding 
arbitration could not be contained within any other agreement or 
paperwork addressing any other issues. It would have to be a separate 
agreement in which the resident made an affirmative choice to either 
accept or reject binding arbitration for disputes between the resident 
and the facility. We also proposed to specify that the guardians or 
representatives could not consent to an agreement for binding 
arbitration on the resident's behalf unless that individual was allowed 
to do so under state law, all of the other requirements in this section 
were met, and the individual acting on behalf of the resident had no 
financial interest in the facility. In addition, in the proposed rule, 
we solicited comments on whether binding arbitration agreements should 
be prohibited entirely.
    We received a significant number of public comments concerning this 
proposal. The commenters from the LTC facility industry overwhelmingly 
wanted us to withdraw our proposal. Other commenters, including members 
of the public, advocates, and members of the legal community, 
predominantly wanted a prohibition on ``pre-dispute'' arbitration 
agreements (that is, agreements made before any dispute had arisen). 
Some commenters believed that arbitration should not be allowed in LTC 
facilities under any circumstances. We also received numerous items of 
congressional correspondence concerning arbitration agreements. One 
letter signed by 34 senators urged CMS to ban pre-dispute arbitration 
clauses; another letter from three members of the House of 
Representatives argued that CMS lacked the authority to ban these 
agreements and, even CMS did have the authority, the agency should not 
prohibit them. Another senator urged us to seriously consider the 
concerns surrounding pre-dispute arbitration agreements and their 
consequences to residents. The senator noted that individuals seeking 
long-term care, many of whom are elderly or disabled, are basing their 
decisions on the cost of care and proximity to their loved ones, and 
that it would be difficult for these individuals to fully understand 
the gravity of contract terms and their legal rights to concerning 
potential future disputes between themselves and the facilities. This 
senator also noted that due to the limited grounds for appeal, it was 
imperative that both parties understand the terms of the agreement, 
especially in the long-term care setting, where individuals and their 
families are making choices that profoundly impact the health and 
safety of their loved ones.
    In addition, we received a letter signed by 16 state attorneys-
general stating that pre-dispute arbitration agreements were harmful to 
residents in LTC facilities and should be prohibited. Other commenters 
were concerned about particular aspects surrounding arbitration, such 
as: The conflict of interest in having the LTC facility explain and ask 
the resident to sign the agreement; the coercive nature of having the 
resident sign the agreement during the admission process, before any 
dispute has arisen; the arbitration process not actually being 
conducted by a neutral arbitrator or in a neutral environment; the 
costs of arbitration to the residents; and the secrecy of the entire 
arbitration process. Other commenters were not only against our 
proposed requirements but opposed any regulation concerning 
arbitration, including a ban on arbitration agreements. A summary of 
the comments and our responses are set forth below. We have grouped the 
discussion into issue areas raised by commenters.
Statutory Authority To Regulate Arbitration Agreements
    Comment: Some commenters argued that the federal government, 
through the Federal Arbitration Act (FAA) (9 U.S.C.A. Sec.  1 et seq.) 
favors arbitration and requires that arbitration agreements be enforced 
unless there are grounds that exist at law or in equity for the 
revocation of any contract, such as enforcing the agreement would be 
unconscionable (9 U.S.C.A. Sec.  2). They also pointed out that both 
Congress and the courts have repeatedly refused to regulate arbitration 
agreements between LTC facilities and their residents. They noted that 
Congress had failed to pass five different bills to regulate 
arbitration agreements in LTC facilities during [time period].\1\ 
Commenters also cited the Supreme Court's per curiam ruling in Marmet 
Health Care Center, Inc. v. Brown (132 S.Ct.1201, 1203 (2012)), which 
addressed on appeal a decision of the Supreme Court of Appeals of West 
Virginia. The West Virginia court had held that all predispute 
arbitration agreements pertaining to claims alleging personal injury or 
wrongful death were unenforceable in accordance with West Virginia's 
public policy. The Supreme Court reversed the decision, holding that 
``[w]hen state law prohibits outright the arbitration of a particular 
type of claim, the analysis is straightforward: The conflicting rule is 
displaced by the FAA.'' Id. at 1203 (quotations omitted).
---------------------------------------------------------------------------

    \1\ See Fairness in Nursing Home Arbitration Act of 2012, H.R. 
6351, 112th Cong.; Fairness in Nursing Home Arbitration Act of 2009, 
H.R. 1237, 111th Cong.; Fairness in Nursing Home Arbitration Act, S. 
512, 111th Cong.(2009); Fairness in Nursing Home Arbitration Act of 
2008, H.R. 6126, 110th Cong.; Fairness in Nursing Home Arbitration 
Act, S. 2838, 110th Cong. (2008).
---------------------------------------------------------------------------

    The commenters also pointed to cases in which courts rejected 
various federal agencies' attempts to prohibit the enforcement of 
arbitration agreements. The commenters argued that when Congress 
intends to give an agency authority to prohibit or impose conditions on 
the use of arbitration agreements it does so with unambiguous statutory 
language, and it did not do so in the Social Security Act. They also 
argued that there was no language in the Act that gave the Secretary 
statutory authority to interfere in commerce, and that Congress had in 
face expressed its opposition to such actions in creating the 
International Court of Arbitration of the International Chambers of 
Commerce (ICC) and the Federal Trade Commission (FTC). They argued that 
prohibiting the use of or regulating arbitration was contrary to legal 
policy and tradition favoring contract formation.

[[Page 68791]]

    In addition, they claimed that a previous survey and certification 
memorandum issued by CMS acknowledged that these agreements were 
between the facility and resident. They noted that former HHS Secretary 
Mike Leavitt had sent a letter dated July 29, 2008 addressed to the 
House Judiciary Committee, a letter that officially opposed the 
``Fairness in Nursing Home Arbitration Act of 2008'' that would have 
amended the FAA to render pre-dispute binding arbitration agreements 
between LTC facilities and their residents unenforceable.
    Some commenters pointed out that, in addition to the FAA, courts 
have upheld arbitration in many industries, and that many contracts in 
the health care field including but not limited to admissions contracts 
for LTC facilities, are on a take-it-or-leave it basis. Others argued 
that arbitration had been successfully used in LTC facilities for years 
and that further regulation was not necessary.
    Response: We disagree with the commenters' assertions that CMS 
lacks authority to issue regulations concerning arbitration agreements 
contained in LTC facility admissions contracts.
    First, we note that the plain language of the FAA applies only to 
existing arbitration agreements voluntarily made between private 
parties; it does not compel or require the use of arbitration between 
private parties.\2\ Because it does not prescribe circumstances in 
which arbitration agreements must be used, it does not impinge on 
federal agencies' rights to issue regulations regulating the conditions 
of adoption of such agreements, assuming that the Secretary otherwise 
has proper statutory authority. Consequently, we believe that the 
proper focus of this discussion is only on whether these rules have 
been properly issued under the Act and the procedural requirements of 
the Administrative Procedure Act. The proposed and final regulation 
would have no legal effect on the enforceability of existing pre-
dispute arbitration agreements between LTC facilities and patients, and 
therefore we believe that the terms of the FAA are not implicated. 
``(``[W]hen two statutes are capable of co-existence . . . it is the 
duty of the courts, absent a clearly expressed congressional intention 
to the contrary, to regard each as effective.'' (citation omitted)).'' 
Morris v. Ernst & Young LLP, __ F.3d __ (9th Cir., August 22, 2016) 
(2016 WL 4433080 at *8).
---------------------------------------------------------------------------

    \2\ The applicable provision of the FAA reads, in its entirety: 
``A written provision in any maritime transaction or a contract 
evidencing a transaction involving commerce to settle by arbitration 
a controversy thereafter arising out of such contract or 
transaction, or the refusal to perform the whole or any part 
thereof, or an agreement in writing to submit to arbitration an 
existing controversy arising out of such a contract, transaction, or 
refusal, shall be valid, irrevocable, and enforceable, save upon 
such grounds as exist at law or in equity for the revocation of any 
contract.'' 9 U.S.C. 2.
---------------------------------------------------------------------------

    We are finalizing this rule, which will prohibit facilities' use of 
pre-dispute arbitration agreements, as a requirement for participation 
in the Medicare and Medicaid programs. Under sections 1102(a) and 1871 
of the Social Security Act, the Secretary of Health and Human Services 
Section is authorized to issue such rules as may be necessary to the 
efficient administration of the functions of the Department. Section 
1866 of the Act requires all Medicare providers and suppliers to agree 
to certain conditions in order to participate in the Medicare program. 
Likewise, section 1902(a)(27) of the Act requires that Medicaid 
providers meet all the requirements set out in the Medicaid provider 
agreement; and section 1902(a)(28) of the Act requires that States 
ensure that Medicaid nursing facilities meet all provisions of section 
1919(b)-(d) of the Act (governing requirements for Medicaid nursing 
facilities).
    The Department regularly requires providers and suppliers of health 
care items and services to forgo certain rights they might otherwise 
have with respect to Medicare and Medicaid patients, such as the right 
to pursue the patient for payment when the patient has no way of 
knowing that services are not covered by Medicare (See Section 1879 of 
the Act); requirements that LTC facilities give Medicare beneficiaries 
written advanced notifications of non-covered services (See Skilled 
Nursing Facility Advance Beneficiary Notice (SNFABN) Form CMS-10055, 
accessed at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/CMS-Forms-Items/CMS019508.html, on September 19, 2016), limitation on the rights 
of insurers to market alternative products while potential Medicare 
advantage customers are placed on hold (or to upsell products to 
Medicare Advantage and Medicare Prescription Drug Plans (See Medicare 
Marketing Guidelines, accessed at https://www.cms.gov/Medicare/Health-Plans/ManagedCareMarketing/Downloads/2017MedicareMarketingGuidelines2.pdf, on September 19, 2016), specific 
limitations on the rights to provide patients with promotional 
information, including a prohibition on marketing Medicare Advantage 
and Part D insurance plans to Medicare beneficiaries residing in long-
term care facilities (including LTC facilities, assisted living 
facilities, board and care homes, etc.) without first receiving a 
specific request from the beneficiary (See Medicare Marketing 
Guidelines issued June 10, 2016, located at https://www.cms.gov/Medicare/Health-Plans/ManagedCareMarketing/Downloads/2017MedicareMarketingGuidelines2.pdf, accessed on September 19, 2016), 
and so on. These rules mandating that suppliers of health care items 
and services forgo contractual and other commercial rights they might 
otherwise have with respect to Medicare and Medicaid patients, evince a 
Congressional and administrative understanding that business 
arrangements with Medicare and Medicaid patients are not typical 
commercial contracts where both parties engage in arms-length 
bargaining. Given the unique circumstances of the LTC admissions 
process, coupled with the clear interest that Medicare and Medicaid 
have in protecting beneficiaries, a prohibition on the use of pre-
dispute arbitration agreements is not by its nature outside the 
permissible realm of conditions a facility must meet if it wishes to 
receive payment under the Medicare and Medicaid programs.
    In addition to the statutory authority of the Secretary to set 
general practice parameters for payment under Medicare and Medicaid, 
the Secretary, under the explicit authority of Congress, is charged 
with protecting the health, safety and welfare of LTC facility 
residents pursuant to specifically enumerated standards set out in 
sections 1819 and 1919 of the Act. In addition, Congress granted the 
Secretary explicit authority under sections 1819(d)(4)(B) and 
1919(d)(4)(B) of the Act to require LTC facilities to ``meet such other 
requirements relating to the health, safety, and well-being \3\ of 
residents or relating to the physical facilities thereof as the 
Secretary may find necessary.'' As set out below, there is significant 
evidence that pre-dispute arbitration agreements have a deleterious 
impact on the quality of care for Medicare and Medicaid patients, which 
clearly warrants our regulatory response.
---------------------------------------------------------------------------

    \3\ We note that section 1919(d)(4)(B) of the Act omits ``well-
being''.
---------------------------------------------------------------------------

    In addition, sections 1819(c)(1)(A) and 1919(c)(1)(A) of the Act 
create a host of specified rights for LTC facility residents, 
including, but not limited to, free choice, confidentiality, privacy, 
and the expression of grievances. These sections also include a broad 
grant authorizing the Secretary to establish ``any other right'' 
(sections 1819(c)(1)(A)(xi) and 1919(c)(1)(A)(xi) of the Act) as she 
may deem necessary. Based on the comments received in

[[Page 68792]]

response to this rulemaking, we are convinced that requiring residents 
to sign pre-dispute arbitration agreements is fundamentally unfair 
because, among other things, it is almost impossible for residents or 
their decision-makers to give fully informed and voluntary consent to 
arbitration before a dispute has arisen. We believe that LTC residents 
should have a right to access the court system if a dispute with a 
facility arises, and that any agreement to arbitrate a claim should be 
knowing and voluntary.
    With respect to the Supreme Court's opinion in Marmet, we believe 
the decision to be inapposite, because the matter under consideration 
involves the enforceability of an already-existing pre-dispute 
arbitration clause. As noted above, the rule we are issuing does not 
affect already-existing arbitration clauses, but prohibits Medicare-and 
Medicaid-participating LTC facilities from using them in the future, as 
a condition of participating in these programs. While we share the same 
public policy concerns about already-existing arbitration agreements, 
we are only addressing agreements reached after the effective date of 
this rule. Likewise, Compucredit Corp. v. Greenwood, 565 U.S. __ 132 
S.Ct. 665 (2012), a case involving consumer credit, considered whether 
a provision of the Credit Repair Organizations Act (15 U.S.C. 1679c(a)) 
(CROA) created a right to sue which would have the effect of rendering 
any arbitration clause unenforceable. The Supreme Court's opinion held 
that the statutory language of CROA failed to create an explicit right 
to have recourse to the courts that superseded the public policy 
concerns of the FAA. Because the case involved the interpretation of 
CROA's language, we do not believe it to create any meaningful 
restriction on the Secretary's statutory authority to prohibit 
facilities' future use of pre-dispute arbitration clauses as a 
condition of participation in Medicare and Medicaid.
    Concerning the survey and certification letter previously published 
by CMS, we do not believe the requirements in this final rule 
contradict that letter. Any agreement for binding arbitration is 
clearly between a facility and a resident, and this rule does not in 
any way prohibit the use of post-dispute arbitration agreements. The 
requirements in this final rule only ensure that the residents receive 
basic protections in signing an agreement for arbitration. Since 
facilities will only be able to approach residents to request them to 
sign an agreement for binding arbitration after a dispute has arisen, 
residents and their representatives will have the information necessary 
to make an informed decision, and should also be able to negotiate 
specific terms. Former HHS Secretary Leavitt's letter, dated July 29, 
2008 addressed to the House Judiciary Committee, officially opposedthe 
Fainess in Nursing Home Arbitration Act of 2008, which would have 
amended the FAA to render pre-dispute binding arbitration agreements 
between LTC facilities and their residents unenforceable. Again, we see 
no contradiction between the Secretary's letter and this final rule. 
The requirements in this rule do not prohibit arbitration between 
facilities and residents. After a dispute arises, facilities and 
residents could enter into agreements for binding arbitration and 
settle a dispute in arbitration. Our rule also does not affect any 
arbitration agreements signed before the effective date of the rule. 
Moreover, it does not purport to preempt or otherwise supersede 
arbitration agreements made after the effective date. We have only 
prohibited pre-dispute binding arbitration agreements between 
facilities and residents as a condition of participation in Medicare 
and Medicaid. If a facility wishes to continue to utilize pre-dispute 
agreements, it is free to continue in business without Medicare or 
Medicaid residents.
    We agree with the commenters that arbitration is clearly favored in 
the Federal courts and has been used in many industries, including the 
healthcare industry, successfully for years. As discussed in detail 
below, however, some of the key organizations whose members conduct 
nursing home arbitrations (including the American Bar Association, the 
American Health Lawyers Association, and the American Arbitration 
Association) have expressed concerns about the fairness of pre-dispute 
arbitration clauses in the LTC context. Thus, while the FAA contains a 
policy encouraging arbitration, it also recognizes that there may be 
situations where enforcing an arbitration agreement is improper. For 
example, the FAA's saving clause permits agreements to arbitrate to be 
invalidated by certain defenses, such as ``fraud, duress, or 
unconscionability,'' but not by defenses that apply only to 
arbitration.
    We recognize that an argument could be made that Medicare and 
Medicaid beneficiaries can assert in Court the FAA's saving clause if 
they believe that a pre-dispute arbitration agreement should not be 
enforced. However, the comments we have received have confirmed our 
conclusion that predispute arbitration clauses are, by their very 
nature, unconscionable. As one commenter noted, it is virtually 
impossible for a resident or their surrogate decision-maker to give 
fully informed or voluntary consent to such arbitration provisions. 
That same commenter also noted that refusing to agree to the 
arbitration clause, in most cases, means that care will be denied. 
Furthermore, Medicare and Medicaid beneficiaries are aged or disabled 
and ill. Many beneficiaries lack the resources to litigate a 
malpractice claim, much less an initial claim seeking to invalidate an 
arbitration clause. Rather than requiring Medicare and Medicaid 
beneficiaries to incur the additional fees, expense, and delay that 
would be the direct cost of opposing a motion to enforce arbitration, 
we have concluded that this is precisely the type of situation 
envisioned by the Congressional grant of authority contained in 
sections 1819(d)(4)(B) and 1919(d)(4)(B) of the Act authorizing the 
Secretary to establish ``such other requirements relating to the 
health, safety, and well-being of residents or relating to the physical 
facilities thereof as the Secretary may find necessary.''
    There is a significant differential in bargaining power between LTC 
facility residents and LTC facilities. LTC agreements are often made 
when the would-be resident is physically and possibly mentally 
impaired, and is encountering such a facility for the first time. In 
many cases, geographic and financial restrictions severely limit the 
choices available to a LTC resident and his/her family. LTC facilities 
are also, in many cases, the resident's residence. These facilities not 
only provide skilled nursing care, but also everything else a resident 
needs. Many of these residents may reside there for a prolonged period 
of time, some for the rest of their lives. Because of the wide array of 
services provided and the length of time the resident and his/her 
family may have interactions with the LTC facility, disputes over 
medical treatment, personal safety, treatment of residents, and quality 
of services provided are likely to occur. Given the unique 
circumstances of LTC facilities, we have concluded that it is 
unconscionable for LTC facilities to demand, as a condition of 
admission, that residents or their representatives sign a pre-dispute 
agreement for binding arbitration that covers any type of disputes 
between the parties for the duration of the resident's entire stay, 
which could be for many years.
    Comment: Some commenters stated that the proposed requirements 
concerning arbitration agreements violate the Non-Delegation and the 
Separation of Powers Doctrines (See Black's Law Dictionary, 7th ed., 
West

[[Page 68793]]

Group, MN (1999)). The Delegation Doctrine states that an agency may 
only act within the authority granted to it by Congress in the enacting 
legislation. The Separations of Powers Doctrine states that 
governmental authority is divided between the three branches of 
government--the legislative, executive, and judicial--each has its own 
duties and the other branches should not encroach on its duties. 
According to these commenters, CMS, is quasi-executive and quasi-
legislative. It is not part of the judicial branch and has no authority 
to act in a quasi-judicial function. They argue that the attempt to 
regulate arbitration amounts to interference in private contracts, 
which is contrary to legal policy and tradition favoring contract 
formation.
    Response: As discussed above, the Secretary has statutory authority 
to promulgate regulations for the residents' health, safety, and well-
being and administer the programs under the Act. In addition, the 
Secretary has the authority to create specified rights for LTC facility 
residents, including, but not limited to, free choice, confidentiality, 
privacy, and grievances. Sections 1819(c)(1)(A)(xi) and 
1919(c)(1)(A)(xi) of the Act also grant the Secretary authority to 
establish any other rights for residents. Thus, the Secretary, in this 
final rule, is acting well within her statutory authority, particularly 
given the concerns raised by commenters over the unfairness of pre-
dispute arbitration and the harm these agreements cause LTC facility 
residents. In addition, these requirements do not decide the validity 
of existing arbitration agreements, but establish protections for LTC 
facility residents prospectively by prohibiting pre-dispute binding 
arbitration agreements and establishing requirements for post-dispute 
agreements entered into after the provision's effective date. Insofar 
as the commenters are going beyond this to question the Secretary's 
right to issue legislative rules in general, we believe the Secretary's 
authority under the Social Security Act, authorizing her to promulgate 
legislative rules under the Administrative Procedure Act (5 U.S.C. 553) 
that protect the well-being of Medicare and Medicaid beneficiaries, is 
a matter of settled law.
Residents' Health, Safety, and Well-Being
    Comment: Some commenters acknowledged that the Secretary had 
authority to promulgate regulations for the health and safety of LTC 
facility residents; however, they indicated that our concerns about 
these agreements being detrimental to the residents' health and safety 
were theoretical and the proposals were not ``necessary.'' They also 
indicated that they were not aware of any incidents in which residents 
or their families were precluded from expressing quality-of-care 
concerns with governmental officials. In contrast, other commenters 
stated that they believed that some facilities use pre-dispute binding 
arbitration agreements to avoid responsibility for providing poor or 
substandard care to their residents. Some commenters believed that 
residents who did not sign pre-dispute binding arbitration agreements 
received better care than the residents who did sign these agreements. 
Many commenters expressed their belief that the proposed requirements 
did not go far enough to protect residents' rights. Most of these 
commenters wanted to ban arbitration agreements, especially pre-dispute 
arbitration agreements. However, some of the commenters said that post-
dispute binding arbitration agreements should be allowed.
    Response: In addition to reviewing the comments received, we 
conducted a literature review and also reviewed court opinions 
involving arbitration in LTC facilities. Many the articles we reviewed 
provided evidence that pre-dispute arbitration agreements were 
detrimental to the health and safety of LTC facility residents (See, 
e.g., Tripp, Lisa, ``A Senior Moment: The Executive Branch Solution to 
the Problem of Binding Arbitration Agreements in LTC facilities 
Admission Contracts'', Campbell Law Review Sym. 2009, 31 Campbell 
L.Rev. 157 (2009); Tripp, Lisa, ``Arbitration Agreements Used by LTC 
facilities: An Empirical Study and Critique of AT&T Mobility v. 
Concepcion'', 35 Am. J. Trial Advoc. 87 (2011); and Bagby, K. and 
Souza, S., ``Ending Unfair Arbitration: Fighting Against the 
Enforcement of Arbitration Agreements in Long-Term Care Contracts'', 29 
 J. Contemp. Health L. & Pol'y (2013)). These articles discuss, among 
other things, the unequal bargaining power between the resident and the 
LTC facilities; inadequate explanations of the arbitration agreement; 
the inappropriateness of presenting the agreement upon admission, an 
extremely stressful time for the residents and their families; negative 
incentives on staffing and care as a result of not having the threat of 
a substantial jury verdict for sub-standard care; and the unfairness of 
the arbitration process for the resident. Bagby and Souza note that 
``oftentimes, only after a nursing facility's negligence has caused a 
resident severe injury or death, does the resident or family member 
discover that, upon admission to the nursing facility or during their 
stay, the resident became bound to settle disputes in arbitration, 
ostensibly giving up the resident's constitutional right to a jury 
trial.'' (29 J. Contemp. Health L. & Pol'y 183). Tripp notes that 
``residents of nursing homes are frail and elderly people who are 
completely dependent on the facility and its employees for their safety 
and health. Thus, many residents and their families would not oppose 
the arbitration provision because they are fearful of antagonizing the 
facility'' (31 Campbell L.Rev. 157, p. 5). Tripp further notes that, 
``with so many operators selecting pre-dispute binding arbitration, 
this may have the effect of forcing some vulnerable elders suffering 
serious injury or even death to adjudicate their claims outside of the 
public court system with all of its safeguards, and into private 
arbitration without those protections'' (35 AM. J. Trial Advoc. 89).
    Additionally, a number of commenters stated that arbitration 
clauses have a detrimental effect on patient safety. One commenter, a 
healthcare provider who had previously treated LTC facility residents, 
stated that they had personally witnessed resident neglect and 
attributed it to facilities believing that they were immune to any 
legal consequences for their mistreatment because of the likelihood 
that they would prevail in binding arbitration. Another commenter, a 
large association of lawyers, asserted that permitting pre-dispute 
arbitration clauses creates an unnecessary shield that protects 
facilities. Other commenters stated that binding arbitration clauses 
generally cover all claims, including claims involving serious bodily 
harm and death, and allow facilities to escape accountability for 
neglect and abuse. We believe we have ample basis between the published 
research and the statements of commenters to support the connection 
between the use of pre-dispute arbitration clauses and the health and 
safety of LTC facility residents.
    Comment: Some commenters stated that proposed Sec.  483.70(n)(4), 
regarding communication with outside parties, was unnecessary because 
proposed Sec.  483.11(i) contained similar provisions. Proposed section 
483.70(n)(4) would require that the binding arbitration agreement could 
not contain any language that prohibited or discouraged the resident or 
anyone else from communicating with federal, state, or local officials, 
including but not limited to, federal and state surveyors, other

[[Page 68794]]

federal and state health department employees; and representatives of 
the Office of the State Long-Term Care Ombudsman, in accordance with 
Sec.  483.10(k).
    Response: Although the two requirements are similar, they are not 
identical. Proposed Sec.  483.11(i), which is being moved but otherwise 
finalized as proposed, states that facilities 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 and state health department employees, 
including representatives of the Office of the State Long-Term Care 
Ombudsman and the protection and advocacy system, regarding any matter, 
whether or not subject to arbitration or any other type of judicial or 
regulatory action. However, Sec.  483.70(n)(4) specifically addresses 
the arbitration agreement and applies both to the resident and anyone 
else who would like to, or chooses to, communicate with outside 
authorities. We wished to ensure that pre-dispute arbitration 
agreements could not be used to in any way prohibit or discourage 
anyone from contacting or communicating with outside authorities, while 
Sec.  483.10(k) simply addresses the resident's right to contact 
outside entities. We believe both requirements are necessary to protect 
residents' rights and have finalized both of these requirements in this 
rule.
Arbitration as an Appropriate Forum
    Comment: Some commenters believed that the proposed rule suggested 
that the arbitration proposals were being proposed due to recent 
changes in the business practices of LTC facilities, especially an 
increased prevalence of binding arbitration agreements in these 
facilities. These commenters stated that LTC facilities have been using 
these agreements for many years. These commenters also noted that 
residents can still obtain judicial review of an arbitration decision 
if the agreement was entered into as a result of corruption, fraud, or 
undue means or that an arbitrator was guilty of misconduct or exceeded 
his or her powers. They also pointed out that these agreements only 
establish the forum in which legal claims will be heard and not that 
residents are denied an opportunity to bring them. However, other 
commenters pointed out that the differences between arbitration and 
litigation did result in disadvantages to residents in addition to the 
lack of judicial review, such as, lack of choice of arbitrators, the 
venue for the arbitration, and limitations on discovery and damages, 
such as punitive damages, which might have been available if the 
dispute were settled in a court. Another commenter, a national 
association whose members included several groups dedicated to the 
protection of senior citizens and consumer rights, argued that these 
pre-dispute binding arbitration agreements and the associated 
disadvantages they have for residents actually deter many residents 
from pursuing claims and result in claim suppression.
    Response: Although arbitration has been an alternative dispute 
resolution strategy that has been in use for many years, based upon the 
comments we have received, as well as our literature review, it appears 
to us that the use of arbitration agreements has increased in LTC 
facilities in recent years (Tripp, Lisa. ``A Senior Moment: The 
Executive Branch Solution to the Problem of Binding Arbitration 
Agreements in LTC facilities Admission Contracts.'' Campbell Law Review 
Sym. 2009 31 Campbell L. Rev. 157 (2009); and Schleppenback, John R., 
``Something Old, Something New: Recent Developments in the 
Enforceability of Agreements to Arbitrate Disputes Between LTC 
facilities and Their Residents'', 22 Elder L.J. 141 (2014)). A number 
of commenters to this rulemaking also stated that there has been a 
marked increase in the use of binding arbitration agreements by LTC 
facilities in recent years. For example, one commenter, a large 
organization of attorneys, referenced a Wall Street Journal article 
that noted that LTC facilities became some of the biggest converts to 
binding arbitration after sustaining some very large jury awards in the 
1990s (Nathan Koppel, ``LTC facilities, in Bid to Cut Costs, Prod 
Patients to Forgo Lawsuits'' Wall Street Journal, April 11, 2008, 
available at http://www.wsj.com/articles/SB120786025242805879, accessed 
August 3, 2016). The Wall Street Journal article also stated that 
attorneys that litigate on both sides of LTC facility-resident disputes 
agreed that arbitration in LTC facilities was quickly becoming the rule 
rather than the exception in these cases.
    We disagree with the commenters who suggest that arbitration is 
merely a change of the forum and therefore, inconsequential. 
Arbitration changes the manner in which a dispute will be resolved by, 
among other things, waiving the right to a jury trial, and providing 
only limited grounds to appeal the arbitrator's decision. Some 
commenters noted that arbitration can be very expensive for the 
resident, with some agreements requiring the resident to bear some of 
the costs of the arbitration, and the limited discovery generally 
allowed puts the resident at a distinct disadvantage. However, due to 
contingency agreements with attorneys and the public funding of the 
court system, residents have a possibility of litigating a dispute with 
the LTC facility for little or no money. As noted, by entering into an 
arbitration agreement, both parties are waiving their right to a jury 
trial. There is no public forum and the arbitrator's decision will not 
usually be publically available, whereas a court decision would be a 
matter of public record. We believe that a public knowledge about a 
dispute and a public record of a decision are vitally important for 
checking the worst abuses of non-compliant LTC facilities.
    We also disagree with the implication that judicial review of an 
arbitrator's decision is adequate protection for beneficiaries. A 
resident cannot usually challenge an arbitrator's decision even if it 
is based on a mistake in the applicable law for the issue in dispute. 
In addition, even when there are grounds under the applicable state law 
to overturn the arbitrator's decision, this requires additional 
judicial proceedings, which adds additional time and expense to the 
litigation.
    We are also concerned about the possibility of claim suppression. 
If a resident or their representative does not believe that arbitration 
is a fair process, they may not pursue a claim despite its merit; the 
secretive nature of the process and decision only adds to the public 
perception that the forum may be biased against the resident. However, 
we believe that the requirements being finalized in this rule should 
mitigate some of commenters' concerns about claim suppression.
    Comment: One commenter pointed out that other Medicare and Medicaid 
healthcare providers use arbitration agreements. This commenter also 
stated that there was no factual or legal justification for imposing 
requirements for arbitration agreements on LTC facilities and not on 
these other providers.
    Response: We believe that the concerns about pre-dispute binding 
arbitration are applicable to any resident that signs one as a 
condition of receiving services, regardless of provider or supplier 
type. However, we have decided to make LTC facilities our first 
priority because many of the residents spend an extended period of time 
in these facilities, and as noted, these facilities often serve as the 
resident's residence. A number of commenters agreed with our 
conclusions. Whether arbitration

[[Page 68795]]

agreements should be prohibited for other providers and supplier types 
is beyond the scope of this rule. However, we will retain this comment 
for review in case there is future rulemaking in this area.
    Comment: One commenter made a Freedom of Information Act (FOIA) 
request asking for the comments that raised our concerns about 
arbitration agreements in LTC facilities. They noted that CMS' response 
was that there was only one document and that was a three-year old 
letter that had been submitted by a national organization for trial 
attorneys. The commenter stated that the letter contained an inaccurate 
portrayal of the use of arbitration agreements in LTC facilities.
    Response: We understand that the commenter may have different views 
from those expressed in the letter that raised the issue of arbitration 
agreements in LTC facilities. However, our proposed requirements for 
arbitration agreements were not based solely upon that letter. We 
performed a literature search and reviewed judicial decisions that 
involved arbitration agreements in LTC facilities. We also received 
input from healthcare providers with experience working in or surveying 
LTC facilities. Thus, our proposed requirements were based upon 
multiple sources of information, not just the letter described by the 
commenter. Moreover, as noted, we have received nearly a thousand 
comments on our proposal and reviewed substantial amounts of 
information supporting many different points of view.
    Comment: Many commenters argued that arbitration was beneficial for 
residents and their families as well as facilities. Disputes could be 
resolved more quickly and with less animosity and expense than 
litigation. Some commenters also argued that prohibiting these 
agreements would only benefit lawyers, result in protracted litigation, 
increase costs to the facilities, and increase the burden on an already 
overwhelmed court system. This would also result in resources for 
resident care being diverted for litigation. Other commenters argued 
that prohibiting arbitration could be detrimental to residents. If a 
dispute was not worth a sufficient amount of money, the resident or 
their representative might not be able to obtain a lawyer, which could 
result in the resident not being able to address the dispute with the 
facility. Some commenters discussed how arbitration agreements may 
include a prohibition against the individual pursing a class action. A 
class action arbitration or lawsuit may be the only opportunity an 
individual may realistically have to pursue their claim. If they could 
not join a class action, they could be effectively denied any avenue of 
redress for the dispute. Other commenters were concerned that we had 
not sufficiently assessed not only the costs of these proposals but 
also the real life, practical implications of these proposals within 
the long-term care community and the daily practice within this 
community. Other commenters disagreed with these arguments. Some argued 
that there could still be protracted litigation even within the context 
of pre-dispute arbitration agreements; and noted that arbitration could 
be very expensive for the resident.
    Response: There are both advantages and disadvantages associated 
with both pre-dispute arbitration agreements and arbitration itself. As 
finalized in this rule, residents and their representatives have the 
option of signing an agreement for binding arbitration with the 
facility after a dispute arises. In addition, residents can also use 
the facility's grievance process, as set forth at Sec.  483.10(j). 
However, arbitration agreements, particularly pre-dispute agreements 
provided to residents on a ``take-it-or-leave-it'' basis, present 
opportunities for facilities to include terms that undercut commenters' 
contention that arbitration is a neutral process that works to the 
benefit of both parties. A report of the American Bar Association 
noted, ``[c]lauses frequently specify that the provider can select the 
arbitration service and the location of the arbitration. Some include 
caps on damages, even for tragic and possibly preventable deaths. 
Moreover, some clauses or arbitration procedures restrict the discovery 
process-limiting the number of investigative interviews or the exchange 
of documents. `This could prevent an aggrieved consumer's lawyer from 
deposing all possible employees who might have witnessed an incident at 
a nursing home and gaining access to relevant records,' whereas the 
facility has the records and personnel at its disposal (Sturgeon, J., 
``Nursing Homes Use Arbitration As a Shield,'' The Roanoke Times, Aug. 
24, 2006). The resident may have to pay substantial fees for the 
arbitration.'' (American Bar Association, Commission on Law and Aging, 
Policy on LTC facility Arbitration Agreements 111B, page 4, February 
16, 2009, at http://www.americanbar.org/content/dam/aba/directories/policy/2009_my_111b.authcheckdam.pdf, accessed on September 15, 2016). 
By contrast, this final rule will allow residents to avail themselves 
of the benefits of arbitration once a dispute has arisen and the 
resident and/or his/her representatives can determine whether it may be 
an advantageous forum for them.
    Concerning class actions, we share the commenters' concerns about 
residents possibly not being able to pursue their claims. However, 
since we did not propose to address matters relating to class actions 
in our proposed rule, we are unable to address them in this final rule. 
We also note that to date, litigation against LTC facilities has 
involved primarily malpractice claims, which tend to be individual-
specific. Because class actions against LTC facilities remain rare, we 
believe that it is not yet clear that there is a problem that would 
require additional regulation. We will retain these comments and 
concerns about protection of class-action litigation and consider for 
future rulemaking.
    Comment: Some commenters pointed out the lawyers in their areas are 
already aggressively advertising for LTC facility litigation. Another 
commenter noted that some residents and/or their families are already 
dispositionally angry before they even arrive at the facility and may 
find fault with the facility despite the provision of quality care. 
Other commenters noted that depending upon the jurisdiction and the 
aggressiveness of the attorney, jury verdicts could be excessive; 
however, an arbitrator who is an impartial and experienced profession 
should be able to look at the dispute and make a rational decision. 
Some commenters noted that an important factor in determining liability 
insurance premiums was whether a facility used pre-dispute arbitration 
agreements and that prohibiting these agreements could result in a 
substantial increase in LTC facilities' insurance premiums. Other 
commenters expressed their concern that prohibiting pre-dispute binding 
arbitration agreements could result in a substantial increase in the 
cost of business without any commensurate quality in care. It would 
increase the amount of frivolous lawsuits because arbitration was 
effective in deterring those claims due to the lower damages generally 
awarded by an arbitrator. In addition, attorney fees are generally much 
lower in arbitration. This could result in costs becoming prohibitive 
and force some LTC facilities to close.
    Response: We agree with the commenters that arbitration offers 
advantages to both parties. We also realize that settling disputes in 
court might take longer and result in more costs to facilities. 
However, a resident or their representative's choice to engage in 
arbitration to settle a dispute should be informed and voluntary. This 
final rule does not prohibit binding

[[Page 68796]]

arbitration, only the use of pre-dispute binding arbitration 
agreements. Once a dispute arises between a resident and the facility, 
the parties can enter into an agreement for binding arbitration subject 
to the requirements in this rule. No resident, resident representative, 
or facility is being denied the opportunity to engage in arbitration to 
settle a dispute, and this rule has no effect on the enforceability of 
arbitration agreements in general.
    Comment: Some commenters have argued that CMS should not be 
interfering with a matter that is a private contract between the 
parties. They noted that some states have already passed legislation 
concerning arbitration. This legislation may directly concern 
arbitration, arbitration in LTC facilities, or tort reform. Commenters 
argued that these issues should be left to the states.
    Response: We disagree with the commenter's contention that LTC 
services are a private contractual matter between two independent 
parties. Unlike traditional arms-length commercial contracts that are, 
for the most part, business arrangements between two private 
individuals, the Medicare and Medicaid programs have a significant 
interest in both the services being delivered as well as the well-being 
of the beneficiary. In many cases, Medicare and Medicaid are the sole 
payors for the services. This is why, for example, Congress has 
required that the Secretary create a wide assortment of rules and 
regulations relating to quality of care and the delivery of services in 
the LTC context.
    Furthermore, because the Congress has expressed an clear interest 
in protecting the rights of Medicare and Medicaid beneficiaries in LTC 
facilities, it has granted the Secretary statutory authority to 
establish rights for residents (sections 1819(c)(1)(A)(xi) and 
1919(c)(1)(A)(xi) of the Act) and to protect the health, safety and 
well-being of residents in LTC facilities (sections 1819(d)(4)(B) and 
1919(d)(4)(B) of the Act). Because of overriding Congressional mandate 
that the Secretary protect the health and welfare of LTC residents, we 
believe that a federal uniform response is both necessary and 
appropriate.
When, How Arbitration Agreement Is Reached
    Commenters noted that residents or their representatives are 
typically asked to sign arbitration agreements during the admission 
process, and that the pre-dispute arbitration agreement is one clause 
in a contract comprising many pages. Since no dispute had yet occurred, 
the resident or their representative could not fully understand the 
rights they were waiving or how any future dispute would be handled. 
They might also not understand or be thinking about the possible 
problems that could occur during their stay, including substandard care 
that could result in serious injury or even death. It is also highly 
unlikely they would have consulted a lawyer about the agreement. 
Commenters noted that admission to a LTC facility is usually an 
extremely stressful time for the resident and his or her family. The 
resident may have a serious injury, surgery, or illness, is being 
removed from their usual living arrangements, and is being admitted to 
a facility for an indeterminate period of time.
    One commenter noted that one state, Georgia, has a statute that 
states, concerning medical malpractice claims, ``no agreement to 
arbitrate shall be enforceable unless the agreement was made subsequent 
to the alleged malpractice and after a dispute or controversy has 
occurred and unless the claimant is represented by an attorney at law 
at the time the agreement is entered into'' (Ga. Code Ann., Sec.  9-9-
62).
    Some commenters pointed out that in the state of Mississippi this 
proposal could result in neither the resident nor a healthcare 
surrogate being able to sign an agreement to arbitrate disputes with 
the facility. Miss. Code Ann. Sec.  41-41-211 allows for a healthcare 
surrogate to make healthcare decisions for another person if that 
individual's primary care physician determines that he or she lacks 
capacity and no agent or guardian has been appointed or the agent or 
guardian is not reasonably available. Commenters also cited a court 
case, Mississippi Care Center of Greenville, LLC. et al. v. Nancy 
Hinyub, 975 So.2d 211 (Miss. 2008) (Hinyub), a case in which the 
Mississippi Supreme Court held that a health care surrogate could not 
bind a party to arbitration unless the arbitration provision was an 
essential part of the consideration for the receipt of ``health care.'' 
The commenters noted that after Hinyub, Mississippi LTC facilities now 
require patients or their surrogates to sign pre-dispute arbitration 
agreements as a condition of admission and receipt of services. Some 
commenters noted that a facility's explaining an arbitration clause to 
a resident could be viewed as providing legal advice and therefore the 
unlicensed practice of law.
    Response: When a resident or his or her representative signs an 
agreement for binding arbitration, he or she is waiving the right to go 
to court and have a dispute decided by a judge and jury. We believe 
that any waiver of this right should be voluntary and informed. Would-
be residents are often presented a ``take-it-or-leave-it'' contract 
under circumstances where meaningful or informed consent for pre-
dispute arbitration is often lacking. Thus, we believe that voluntary 
post-dispute arbitration agreements are the best way to balance the 
policy favoring arbitration with the need to protect beneficiaries from 
unfairly waiving their rights to a jury trial. While we support the 
public policy behind the Georgia statute referenced by the commenter, 
we acknowledge that this provision was determined to have been 
preempted by the Federal Arbitration Act (see Triad Health Management 
of Georgia, LLC, III v. Johnson, 298 Ga. App. 204, 679 SE.2nd 785 
(2009) and suggests that leaving this policy to the discretion of 
states may not be an effective strategy. Consequently, this case, like 
others, illustrates the necessity of prohibiting pre-dispute 
arbitration agreements.\4\ With respect to the decision in Hinyub, we 
note that this rule will effectively moot the holding in this case, 
since LTC facilities will no longer be able to assert that pre-dispute 
binding arbitration agreement was an element of consideration in the 
admissions contract. To the extent that Hinyub would be applicable to 
surrogates' power to bind the resident to a post-dispute arbitration 
agreement meeting our requirements, we defer to state law on this 
matter.
---------------------------------------------------------------------------

    \4\ According to the complaint in Triad, ``as a proximate result 
of Triad's negligence, Johnson's father, Matthew Johnson, developed 
bed sores, which led to his development of sepsis and his subsequent 
hospitalization, illness, and death.'' 298 Ga. App. At 204.
---------------------------------------------------------------------------

    Comment: A few commenters were concerned about the requirement in 
proposed Sec.  483.70(n)(5)(iii) that indicated that another individual 
could sign the agreement for binding arbitration if, among other 
things, that individual had no interest in the facility. Commenters 
pointed out that some residents might have next-of-kin or 
representatives that work for the facility or are otherwise associated 
with, or have an interest in, the facility. This proposed requirement 
could result in representatives that might want to sign the agreement, 
but would be prohibited from doing so.
    Response: We understand that, in some circumstances, this could 
mean that a particular representative for a resident would not be able 
to sign an agreement for binding arbitration. However, we continue to 
believe that individuals who have a financial or employment interest in 
a facility have

[[Page 68797]]

an inherent conflict of interest and must not sign an agreement for 
binding arbitration for another person. We believe that the resident's 
family would be able to find an individual not associated with the 
facility for such purposes. In any case, the rare occasion when the 
representative of the patient also has a financial interest in the 
facility will not prevent us from implementing a provision that 
generally protects residents against conflicts of interest.
Unequal Bargaining Power
    Comment: Commenters noted that facilities would likely have 
experience with arbitrations, but not residents. The facility usually 
decides, and sometimes names in the arbitration agreement, how the 
arbitrator will be chosen and where the arbitration will be held. Some 
commenters argued that the arbitrator has a financial incentive to be 
favorable to the facility. It is unlikely that the resident will need 
to hire an arbitrator in the future; however, facilities are likely be 
involved in future arbitrations. Hence, the arbitrator will want 
facilities to select them for future arbitrations. Other commenters 
said that this potential bias could be addressed by educating residents 
and their representatives about local arbitrators. Other commenters 
believed that no regulation could overcome the problems with 
arbitration in LTC facilities, such as the facility's superior 
bargaining power, the risk that the resident or their representative 
will not fully understand the agreement, that signing the agreement 
would inherently be coerced, unfair, or unconscionable, and the 
inherent conflict of interest of having the facility explain the 
agreement (the potential future adversary in any dispute). Some 
commenters noted that facility may imply that the agreements were not 
voluntary such that the resident or their representative may not 
believe they have a choice on whether to sign it. As previously noted, 
arbitration agreements are often just one paragraph of an admissions 
package that generally that is quite extensive. The arbitration 
agreement may be a clause within another document or otherwise does not 
stand out. Thus, the resident or their representative may not even 
realize they are signing an arbitration agreement. The agreement may 
not be sufficiently explained so that the resident or their 
representative fully understands the rights they are waiving or the 
arbitration process. The facility employee admitting the resident may 
not even fully understand the agreement.
    Response: We agree with those commenters that asserted that there 
is unequal bargaining power between the residents and their 
representatives and the facilities. The resident's immediate need for 
nursing care and lack of experience with arbitration means that 
residents are unlikely to ask for time to seek legal advice concerning 
the agreement for binding arbitration. We believe that this unequal 
bargaining power cannot be alleviated with the protections we initially 
proposed. Thus, in this final rule, in response to a significant volume 
of public comment, we are prohibiting the use of pre-dispute binding 
arbitration agreements between residents and the facilities. After a 
dispute arises, residents or their representatives will have the time 
to seek legal advice, if they choose to, and evaluate the option to 
arbitrate the dispute with the facility.
    Three major legal or arbitration associations have made policy 
statements against pre-dispute binding arbitration agreements. In 2009, 
the American Bar Association (ABA) issued a policy statement that 
opposed the use of mandatory, binding, pre-dispute arbitration 
agreements between a long-term care facility and a resident or a person 
acting for the resident. That policy statement also indicated that the 
ABA supported enactment of federal regulations that would, among other 
things, invalidate such arbitration agreements (American Bar 
Association, Commission on Law and Aging, Policy on LTC facility 
Arbitration Agreements 11B, February 16, 2009, at http://www.americanbar.org/content/dam/aba/directories/policy/2009_my_111b.authcheckdam.pdf, accessed on August 3, 2016). The 
American Health Lawyers Association's Alternative Dispute Resolution 
Services Rules of Procedure for Arbitration, revised in May 2012, 
indicated that their ADR service would administer a ``consumer health 
care liability claim'' only if ``all of the parties agreed in writing 
to arbitrate the claim after the injury has occurred'' or arbitration 
is order by a judge (file:///G:/DIQS/LTC%20Facilities/Regulations/
Resources/AHLA%20Arbitration%20Procedures%20May%2031,%202012.pdf, 
citation added). (A later revision to the statement did not include 
this prohibition, but did include requirements to ensure, among other 
things, that a pre-dispute arbitration agreement was voluntary, could 
not be a condition for obtaining care, and included a right to revoke 
the agreement within 10 days after being signed.) (https://www.healthlawyers.org/dr/SiteAssets/Lists/drsaccordion/EditForm/Rules%20Effective%20April%207.pdf, accessed on August 3, 2016). In 
addition, in 2003, the American Arbitration Association issued a 
Healthcare Policy Statement that said ``it would not administer 
healthcare arbitrations between individual patients and healthcare 
service providers that relate to medical services, such as negligence 
and medical malpractice disputes, unless all parties agreed to submit 
the matter to arbitration after the dispute arose'' (file:///C:/Users/
PI47/Downloads/HC%20Policy%20Statement.pdf, accessed August 3, 2016).
    After a dispute arises and residents or their representatives have 
the opportunity to seek legal counsel and review their options, we 
believe they can make a rational and informed decision about 
arbitration. Thus, while the bargaining power between LTC facilities 
and residents will undoubtedly never be equal, we believe that the 
requirements finalized in this rule will provide residents with the 
protections they need to preserve their rights, while still preserving 
the option of arbitration if both parties decide to arbitrate a 
dispute.
Confidentiality of Arbitration Process and Decisions
    Comment: Several commenters indicated that the arbitration process 
is usually confidential and secretive. Most, arbitration agreements 
have confidentiality clauses that prohibit both parties from discussing 
the dispute and what happens during the arbitration process, including 
the decision, with outside parties. Some of the commenters were 
concerned that arbitration regarding disputes involving abuse and 
neglect shields facilities from having their poor quality or dangerous 
conditions exposed to the public and prevented judges who would hear 
the case if it were decided in court from making findings of fact and 
conclusions of law that would influence future nursing facility 
conduct. One commenter stated that not only did arbitration and its 
secrecy result in substandard care for residents but also that 
facilities had incentives to, and did, provide better care to residents 
who did not sign the pre-dispute arbitration agreements. Other 
commenters asked how CMS would be able to survey facilities for 
compliance with arbitration requirements.
    Response: We agree that the secrecy surrounding the arbitration 
process is a substantial concern. We are also concerned that the 
arbitration process, especially the secrecy it involves, could

[[Page 68798]]

result in some facilities evading responsibility for substandard care. 
We are finalizing the proposed requirement at Sec.  483.70(n)(4) that 
the agreement cannot contain any language that prohibits or discourages 
the resident or anyone else from communicating with federal, state, or 
local officials. When any dispute involves any allegations that relate 
to our long-term care requirements, especially the health care provided 
by the facility or instances of abuse or neglect, we believe it is 
necessary for the protection of the health and safety of residents that 
federal, state, and local health and regulatory officials have access 
to the relevant information and be able to conduct an investigation as 
appropriate. Anything that could interfere with federal, state, or 
local health and regulatory officials or LTC advocates from learning 
of, or restricting the investigation of, instances of substandard care 
or other serious instances affects the health and safety of residents. 
When a surveyor discovers substandard care or another violation of the 
LTC facility requirements of participation and cites the facility with 
a deficiency, the surveyor would cite the deficiency on a Form CMS-
2567, which is filed with both the state surveyor agency and CMS. This 
form is available to the public and can be accessed on the LTC Facility 
Compare Web site at https://www.medicare.gov/nursinghomecompare/search.html. Concerning CMS' ability to survey for compliance with the 
requirements in this final rule, we have also inserted a requirement 
that when the facility and a resident resolve a dispute with 
arbitration, a copy of the signed agreement for binding arbitration and 
the arbitrator's final decision must be retained by the facility for 5 
years and be available for inspection upon request by CMS or its 
designee. This will provide surveyors and CMS the opportunity to learn 
how often and under what circumstances arbitration is occurring at a 
facility, as well as the outcomes of any arbitrations. In addition, CMS 
will be publishing sub-regulatory guidance for surveyors concerning the 
requirements. Although arbitration proceedings will not have the 
potential publicity of a trial, arbitrations in LTC facilities will no 
longer be confidential and secret. CMS will be monitoring the use of 
arbitration in LTC facilities through the survey process, not only 
through the normally scheduled surveys but also through the complaint 
process.
General Comments
    Comment: Some commenters argued that it was inconsistent for CMS to 
describe the problems associated with the use of binding arbitration 
agreements but nonetheless authorize their use in LTC facilities. Some 
commenters also believed the proposed arbitration requirements were 
inconsistent with other proposed requirements in the proposed rule. 
Specifically, commenters noted that Sec.  483.15(a)(2)(iii), which 
prohibits facilities from requesting or requiring residents ``to waive 
potential facility liability for losses of personal property'' could be 
deemed to be at cross-purposes with binding arbitration. In addition, 
the commenters noted that proposed Sec.  483.10 confirms the residents' 
rights to exercise rights as citizens or residents of the United 
States.
    Response: We agree with the commenters that indiscriminate use of 
arbitration agreements in LTC facility contracts can create a risk of 
improperly insulating facilities from liability or loss of property, 
and they, likewise, create a risk of residents unwittingly waiving 
their rights. We also recognize, however, there are legal and policy 
reasons supporting post-dispute arbitration. We believe a balance be 
struck between protecting residents' rights and conducting arbitration 
when appropriate. We do not believe that the requirements identified by 
the commenters are inconsistent with the arbitration requirements. In 
cases where residents or their representatives sign arbitration 
agreements, they still have the right to pursue claims for losses of 
personal property. However, the dispute would be handled through 
arbitration, rather than in court. Section 483.10, which confirms the 
residents' rights to exercise their rights as citizens or residents of 
the United States, is also consistent with the arbitration 
requirements. The arbitration requirements in no way denigrate the 
residents' rights as citizens or residents of the United States. We 
will continue to monitor arbitration agreements to ensure that 
residents' rights are, in fact, protected.
    Comment: Some commenters argued that our proposed requirements 
concerning arbitration were inconsistent with the positions taken by 
the legal community and other federal agencies. One commenter said that 
one legal scholar has called on the Department of Health and Human 
Services to declare arbitration agreements by LTC facilities 
unconscionable and to ``prohibit federal funding of LTC facilities that 
use them'' (citing Lisa Tripp's ``A Senior Moment''). They pointed to 
the 2009 Midyear Meeting of the American Bar Association, in which the 
House of Delegates adopted Resolution 111B, which was introduced by the 
ABA Commission on Law and Aging and co-sponsored by the Section of 
Dispute Resolution. The Resolution, which became official policy of the 
ABA, ``supports the enactment of federal, state, and territorial 
legislation and regulations that oppose the use of mandatory, binding, 
pre-dispute arbitration agreements between a long-term care facility 
and a resident of such facility or person acting on behalf of such 
resident'' accessed at http://www.americanbar.org/content/dam/aba/directories/policy/2009_my_111b.authcheckdam.pdf, on September 19, 
2016). In addition, the commenters discussed an initiative of the 
Consumer Financial Protection Bureau (CFPB), which initiated rulemaking 
on arbitration agreements, and, in March 2015, issued a 
Congressionally-mandated report, which found that arbitration 
agreements limit consumer relief in disputes. Some commenters pointed 
to examples in which arbitration was specifically prohibited for 
specific types of claims. For example, commenters cited a 2009 
amendment to the Department of Defense Appropriations Act, which 
imposed a restriction on the ability of certain DOD contractors and 
subcontractors to enter into or enforce mandatory arbitration 
agreements with their employees in cases of discrimination or sexual 
assault (Section 8116, Pub. L. 111-118 December 19, 2009). According to 
the commenters, since its passage, the amendment has been successfully 
implemented by the Department of Defense, the government's largest 
federal contracting agency. (See 48 CFR 252.222-7006 Restrictions on 
the Use of Mandatory Arbitration Agreements). Another example was from 
2014, when President Obama issued an Executive Order (E.O.) aimed at 
ensuring safe workplaces and fair pay for American workers. Among its 
protections, the E.O. mandates that companies with federal contracts of 
$1 million or more cannot require their employees to enter into pre-
dispute arbitration agreements for any disputes arising out of Title 
VII of the Civil Rights Act or from torts related to sexual assault or 
harassment. E.O. 13673, Section 6, 79 FR 45309 (July 31, 2014).
    Response: While we recognize that some members of the legal 
community and other federal agencies may have taken different 
approaches to this issue,

[[Page 68799]]

each situation is different, and the legal and policy issues are unique 
to each particular agency and program. While some commenters have 
requested that we ban all arbitration, we have determined, at this 
point, to implement a policy that strikes a balance between banning 
arbitration in all situations and allowing unfettered use of 
arbitration clauses with no restrictions on their terms or usage. We 
are aware of attempts to regulate arbitration taken by these agencies, 
and we are also aware of the positions taken by some groups against 
arbitration and pre-dispute arbitration agreements. The regulations 
finalized in this rule prohibit pre-dispute binding arbitration 
agreement and are intended to protect residents from many of the 
problems identified by critics of arbitration. We also note that many 
groups do not call for an outright ban on arbitration in LTC facility 
contracts but, rather, encouraged us to add limits on arbitration 
agreements. For example, as noted above, the American Bar Association's 
comments stated that, while arbitration can be a viable means of 
resolving LTC facility resident-facility disputes, it is only 
appropriate after the dispute has arisen and each party knows the 
contours and seriousness of the claims. See the ABA's Position 
Statement 111B at http://www.americanbar.org/content/dam/aba/directories/policy/2009_my_111b.authcheckdam.pdf, accessed on August 1, 
2016. The other requirements finalized in this rule also work to 
protect the rights of the residents and prohibit many of the unfair 
practices that have been identified by the commenters. We will continue 
to monitor this issue in order to ensure that the requirements 
implemented by these regulations adequately protect resident' rights 
and, if we determine that they do not, we may revisit the issue of 
banning arbitration or adding additional protections for residents.
    Comment: Some commenters pointed out that the proposed requirements 
could adversely affect residents' legal positions in litigation 
regarding the enforceability of arbitration agreements in general. 
Facilities could use their compliance with the requirements to argue 
that the resident or their representative fully understood the 
agreement and voluntarily choose to sign the agreement. The 
requirements could also be interpreted as in some way condoning or 
authorizing binding arbitration agreements in facilities. It could make 
it more difficult for residents to challenge the arbitration.
    Response: These regulations are not meant to limit or provide 
standards for courts to use in determining if an arbitration agreement 
should be enforced in, for example, a motion to compel arbitration. 
These requirements are minimum requirements for ensuring fairness for 
LTC facility residents. By addressing these agreements in this rule, we 
are not condoning them, but simply acknowledging that they are used by 
LTC facilities. The requirements will provide residents with the 
minimum protections they need and we intend that these rules will allow 
residents to make an informed and voluntary choice. With respect to the 
litigation posture of parties that might have wished to challenge a 
facility's motion to compel arbitration under our proposed rule, we 
believe that this concern has been mooted by our decision to prohibit 
the use of pre-dispute arbitration agreements entirely. Insofar as a 
party would wish to challenge a post-dispute arbitration agreement, we 
believe the existing jurisprudence interpreting the FAA would be 
applicable under such circumstances.
    Comment: Commenters disagreed with our contention that the proposed 
requirements ensured that residents and their representatives would be 
offered a ``voluntary'' choice concerning binding arbitration. The 
commenters stated that both arbitration and mediation are alternatives 
to litigation and options for alternative dispute resolution (ADR). If 
arbitration is the only ADR option offered to residents and their 
representatives, it is a forced substitute rather than an alternative 
that is voluntarily and knowingly entered into by the parties.
    Response: We agree that ADR consists of multiple options in 
addition to arbitration. However, we are only addressing arbitration in 
this rule. Rules regarding mediation are not within the scope of this 
rulemaking.
    Comment: Some commenters cited Hinyub for the proposition that it 
is permissible for LTC facilities to require residents or their 
surrogates to sign arbitration agreements as a condition of admission 
and receipt of services. Commenters claim that, if these agreements 
were not part of the admissions contracts, there may be no one to sign 
them, which would deny the resident the option to choose arbitration, 
which would be a violation of the FAA.
    Response: Although the commenters cite Hinyub as support for the 
legality of mandatory arbitration agreements under Mississippi law, to 
the contrary, this case illustrates the Secretary's concerns about the 
fundamental fairness of making arbitration agreements a mandatory 
condition for admission to a LTC facility. The dispute in Hinyub 
included, among other things, claims against a LTC facility and others 
for malpractice, negligence, fraud, breach of fiduciary duty, and 
wrongful death. The response of Mississippi's LTC facilities to require 
arbitration agreements as an organic part of the agreement, illustrates 
our underlying concerns about the incentives such agreements provide to 
deliver substandard care. Under our final rule, Mississippi LTC 
facilities that require new residents to agree to pre-dispute 
arbitration as a condition of admission will not be deemed to be in 
compliance with our requirements and will be subject to termination.
    Comment: One commenter recommended that any regulations concerning 
arbitration be delayed. The commenter believed that there was 
insufficient evidence of what problems, if any, existed with 
arbitration in LTC facilities. The commenter noted that Congress has 
considered various pieces of legislation concerning this issue and not 
passed any of them; this demonstrates that the issues are not well 
understood or no optimal solution has yet to be determined. They 
recommended that CMS not finalize any requirements concerning 
arbitration until Congress has more fully explored this issue and 
determined what, if any, actions are appropriate.
    Response: We disagree with the commenter. In response to the 
proposed rule, we received almost 1,000 comments about our proposed 
arbitration requirements. In addition, we believe that our review of 
case law and the literature, including law review articles, amply 
demonstrates the importance of the issues surrounding arbitration in 
LTC facilities. Because we believe that further monitoring of the 
effects of this rule are necessary, we are requiring that LTC 
facilities retain a copy of the signed agreement for post-dispute 
binding arbitration and the arbitrator's final decision for 5 years to 
that it can be inspected by CMS or its designee upon request. This will 
enable us to gather information on arbitrations that have taken place 
in LTC facilities to determine if the requirements finalized in this 
rule are providing the protections resident need.
    We also note that although no specific legislation has passed, 
Congress has not been silent on this issue. Several hearings have been 
held on this issue, and there is a voluminous legislative record 
evidencing the need for action on this matter. We also note that there 
is broad support for protecting residents of LTC facilities. For 
instance, in a Joint Hearing of the Senate Judiciary Subcommittee on 
Antitrust, Competition, and Consumer Rights and

[[Page 68800]]

the Special Committee on Aging, Sen. Gordon Smith (R-OR) stated, ``The 
Federal Arbitration Act was enacted in 1925 as a means to ensure a 
framework for the enforcement and to determine the validity of 
arbitration agreements. . . . Today, however, we are talking about a 
particularly vulnerable population. And when we talk about such 
populations, we must ensure an additional level of scrutiny to 
guarantee that their rights are protected, as they may not be in a 
position to protect themselves.'' (Senate Special Committee on Aging, 
``S. 2838, the Fairness in Nursing Home Arbitration Act'', 110th 
Congress, June 18, 2008, accessed at http://www.aging.senate.gov/hearings/s2838-the-fairness-in-nursing-home-arbitration-act September 
15, 2016).
    Comment: One commenter, an association of elected officials, 
believed that it was important that consumers be informed of the 
potential impact of binding arbitration agreements on LTC facility 
residents. They suggested that HHS develop a public information 
campaign concerning these agreements and tools to assist consumers to 
understand the implications of these agreements and how they would 
affect their rights as consumers.
    Response: We understand and appreciate the commenter's concern that 
consumers, especially facility residents and their representatives, be 
informed about binding arbitration agreements, their implications, and 
how they affect consumer rights. However, such a campaign is beyond the 
scope of this rule.
Final Decision
    We are adding a requirement to proposed Sec.  483.70(n) to provide 
that Medicare and Medicaid-participating LTC facilities can no longer 
enter into pre-dispute binding arbitration agreements with their 
residents or their representatives. We are retaining the proposed 
requirements and specifying at paragraph (n) that they will apply if a 
facility chooses to ask a resident to sign a post-dispute arbitration 
agreement. We have also revised proposed Sec.  483.70(n)(3) to provide 
that an LTC facility cannot require the resident to sign a post-dispute 
arbitration agreement as a condition of the resident's continuing to 
stay at the facility. Finally, to address commenters' concerns 
regarding the confidentiality of the arbitration process and its 
negative effects on patient health and safety, we have added a new 
paragraph (n)(2)(vi) to provide that when the facility and a resident 
resolve a dispute with arbitration, a copy of the signed agreement for 
binding arbitration and the arbitrator's final decision must be 
retained by the facility for 5 years and be available for inspection 
upon request by CMS or its designee. Although the arbitration 
proceedings themselves could still be confidential, this requirement 
will enable us to evaluate whether agreements for binding arbitration 
and the impact of arbitration in the long-term care industry is having 
desired effects for both the residents and the facilities.
    We emphasize that this final rule does not prohibit all arbitration 
agreements between residents and the LTC facilities in which they 
reside, and does not have any effect on existing arbitration agreements 
or render them unenforceable. It has no effect on LTC facilities that 
do not participate in the Medicare or Medicaid programs. It does not 
create any new standard for determining whether an arbitration 
agreement is unconscionable. It only affects Medicare and Medicaid LTC 
facilities insofar as they wish to ask their residents if they wish to 
voluntarily enter into arbitration. After a dispute arises, the 
resident and the LTC facility may voluntarily enter into a binding 
arbitration agreement if both parties agree and comply with the 
relevant requirements set forth in Sec.  483.70(n) of this final rule.
Social Worker (Sec.  483.70(p))
    We proposed to relocate the requirement for and qualifications of a 
social worker from the current Sec.  483.15(g)(3) to Sec.  483.70(p). 
In addition, there is a list of human services fields from which a 
bachelor's degree could provide the minimum educational requirement for 
a social worker. We proposed to add ``gerontology'' to that list of 
human services fields.
    Comment: Commenters were very supportive of and expressed their 
belief in the importance of social workers in LTC facilities. Some 
commenters were very concerned about the qualifications for social 
workers in LTC facilities, especially the education that is required. 
Some commenters disagreed with allowing individuals with bachelor's 
degree in a human services field other than social work, which is a 
human services field, to work as social workers in LTC facilities and 
believed that the minimum requirement for a social worker in a LTC 
facility should be a bachelor's in social work. Other commenters wanted 
a bachelor's or master's degree in social work as a minimum education 
requirement and that the degree be from a program accredited by the 
Council On Social Work Education (CSWE). Other commenters' objected to 
using the title of ``social worker'' for anyone who does not have a 
bachelor's (BSW), master's (MSW) or doctorate in social work. 
Commenters pointed out that individuals with a bachelor's in a human 
services field do not have the same education as social workers. Social 
workers, at both the bachelor's and master's degree levels, receive 
training in interviewing and psychosocial assessment, care planning, 
and intervention. Individuals with other human services degrees may not 
be adequately prepared to identify and address psychosocial issues. In 
addition, some commenters specifically disagreed with the proposed 
addition of ``gerontology'' to the examples of human services degrees 
that could qualify someone as a social worker. Commenters noted that 
CSWE-accredited programs provided competency-based education that 
integrates and applies knowledge, skills, and values and are based on 
nine competencies and that these competencies are congruent with the 
competency based emphasis in the proposed rule. They also noted that 
these programs provide for field placements that are under the 
supervision of professional social workers. They noted their concerns 
about CMS recognizing degrees in psychology, rehabilitation counseling, 
sociology, special education, and other ``human services'' as 
sufficient preparation for LTC facility social work. They were also 
concerned with the de-professionalization of LTC facility social work 
and cited to a study that indicated that 20 percent of social services 
director did not have even a bachelor's degree and only 50 percent held 
a bachelor's in social work. Commenters also noted that the educational 
preparation for BSWs and MSWs prepares individuals to fulfill the 
requirements in the proposed rule, such as, promoting quality of care 
and quality of life for all residents (Sec.  483.25), advocating for 
residents' rights and helping facilities uphold those rights (Sec.  
483.10), preventing and addressing abuse, neglect, and exploitation of 
older adults and other LTC facility residents (Sec.  483.12), and 
facilitating transitions of care and discharge planning (Sec.  483.15 
and Sec.  483.20). Commenters also pointed to other areas that 
professional social workers were well-equipped to perform in the 
facility, such as, strengthening communication among residents, 
families, and facility staff; facilitating financial and medical 
decision making, including advance care planning; and providing 
individual, family, and group education and counseling related to

[[Page 68801]]

illness, disability, treatment, interpersonal relationships, grief, 
loss, dying, and death. Commenters also agreed with the one year of 
supervised social work experience in a health care setting working 
directly with individuals.
    Response: We understand the commenters' concern for the 
qualifications for social workers in LTC facilities. However, pursuant 
to sections 1819(b)(7) and 1919(b)(7) of the Act, for skilled nursing 
facilities and nursing facilities, respectively, with 120 or more beds, 
the facility must have a full-time social worker with at least a 
bachelor's degree in social work or similar professional qualifications 
employed to provide or assure the provision of social services. This is 
a statutory requirement. Thus, we cannot remove the requirement that an 
individual with similar professional qualifications can provide or 
assure the provision of social services. Individuals with a bachelor's 
degree in a human services field, including but not limited to, 
sociology, special education, rehabilitation counseling, and psychology 
can be qualified social workers under the current requirements for 
long-term care facilities. We believe that LTC facilities need the 
flexibility to hire individuals who are qualified and have the 
competencies and skill sets to perform the jobs they are hired to do. 
According to this final rule, LTC facilities must conduct a facility 
assessment, which assesses, among other factors, the care required by 
the resident population and the staff competencies necessary to care 
for that resident population (Sec.  483.70(e)), and, must have 
sufficient direct care/direct assess staff with the appropriate 
competencies and skills 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 (Sec.  
483.40(a)). If the LTC facility does employ an individual with a human 
services degree as a social worker, that individual must have the 
competencies and skill sets to perform the duties and responsibilities 
the LTC facility determines are needed for the social worker position 
in their facility. Thus, we are finalizing the social worker 
qualifications at Sec.  483.70(p) as proposed, with ``gerontology'' as 
an example of a human services field that an individual with a 
bachelor's degree could qualify as a social worker in a LTC facility.
    Comment: Some commenters wanted to delete the exemption for a full-
time social worker in LTC facilities with 120 or fewer beds and require 
that all LTC facilities, regardless of size, be required to employ a 
full-time social worker. Other commenters recommended a ratio of one 
full-time equivalent (FTE) social worker for the first 50 residents and 
one FTE social worker for up to an addition 12 residents. Commenters 
noted that this is the ratio proposed by the National Nursing Home 
Social Work Network's Policy Committee. They believe that all LTC 
facility residents need the services of social workers because of their 
importance in ensuring residents' quality of care and quality of life 
and that there must be a sufficient number of social workers in each 
facility. Commenters also noted that the new requirements in the 
Mandatory Data Set (MDS) increased the social workers' workload and has 
already affected the quantity and quality of psychosocial services they 
can provide and the launch of MDS 3.0 will increase that workload. In 
addition, some commenters argued that the 120-bed rule was incompatible 
with the current and proposed requirements to provide person-centered 
care.
    Response: As discussed above, the requirement for one full-time 
social worker for LTC facilities with more than 120 beds is statutory 
(sections 1819(b)(7) and 1919(b)(7) of the Act). One of the focuses of 
this final rule is person-centered care (see Sec.  483.21 
``Comprehensive person-centered care planning''). Social services are 
essential; however, the requirements for social workers will vary 
depending up the needs of the resident population, as well as the staff 
and the facility itself. Smaller LTC facilities might not need a full-
time social worker. Larger LTC facilities or facilities with residents 
with complex needs might require either more than one full-time social 
worker or more staff to assist the social worker. As discussed above, 
the facility assessment performed by the LTC facility should identify 
the social services the resident population requires (Sec.  483.70(e)). 
The LTC facility should then determine how to ensure that those social 
services are provided. Hence, we will be finalizing the requirement for 
the social worker as proposed.
    Comment: Commenters noted that some LTC facilities might decide to 
hire social services staff to fulfill administrative function, such as 
completing financial paperwork, or meeting some of the residents' 
needs, such as arranging appointments or locating lost items. The 
commenters wanted these individuals to be called ``social services 
assistants'' and not be counted as ``qualified social workers,'' 
especially for any minimum staffing ratio.
    Response: As discussed above, we are finalizing the qualifications 
for a ``qualified social worker'' as proposed. Hence, the facility may 
refer to anyone who meets those qualification as a ``qualified social 
worker'' regardless of the duties and responsibilities they are 
assigned. In addition, as discussed above, we will not be establishing 
any minimum staffing ratios for LTC facilities, including ratios for 
social workers.
    Comment: Some commenters stated that social work practitioners with 
more experience providing quality psychosocial care could provide 
consultation to BSWs and MSWs, especially those with little experience, 
to ensure that residents receive high-quality psychosocial care. The 
commenters recommended that LTC facilities provide expert social work 
consultation to social work directors. This consultation should address 
practice, administrative, and organizational issues along with program 
planning and professional development. A consultant could also provide 
consultation to the facility administration and staff concerning 
program planning, policy development, and priority setting related to 
social work services; case consultation concerning the psychosocial 
needs of residents and their families; and in-service education on 
selected topics.
    Response: We agree with the commenters that many LTC facilities and 
their residents could benefit from consultation with an expert in 
social work. However, we do not believe that we should require that 
consultation in this final rule. As discussed above, LTC facilities 
must perform a facility assessment and determine what resources it 
needs to care for its residents. LTC facilities need the flexibility to 
not only assess the needs of the resident population but determine how 
to satisfy those needs. When a LTC facility determines that it is 
deficient in the social services it needs to provide its residents, and 
perhaps the staff or facility itself, then we would encourage them to 
obtain consultation concerning social services. However, we will not 
require that consultation.
    Comment: Some commenters acknowledged that some facilities had 
reported difficulties in locating an adequate number of BSWs or MSWs. 
These commenters offered some suggestions on how LTC facilities could 
recruit and retain BSWs and MSWs. These suggestions included partnering 
with social work degree programs, chapters in social work associations, 
and state associations that are concerned about the care provided by

[[Page 68802]]

LTC facilities to recruit social workers. Commenters also believed that 
LTC facilities could enhance their recruiting and retention of social 
workers by making their jobs more appealing and noted some of the 
challenges social workers encounter in LTC facilities, such as low 
wages, large caseloads, professional isolation, and assigned tasks 
being below their skill level. Commenters also recommended that CMS 
provide extra resources to support social worker recruitment and 
retention efforts for LTC facilities, especially for frontier and rural 
areas.
    Response: We appreciate the commenters' suggestions. We encourage 
LTC facilities to consider these suggestions for recruiting and 
retaining social workers. However, requiring LTC facilities to follow 
these suggestions will not be included in this final rule. In addition, 
providing more resources is beyond the scope of this rule. LTC 
facilities are expected to comply with these requirements within the 
funding that is provided.
Mandatory Submission of Staffing Information Based on Payroll Data in a 
Uniform Format (Sec.  483.70(q))
    Finally, we indicated that in the proposed rule entitled ``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 contract staff, based 
on payroll and other verifiable and auditable data in a uniform format 
according to specifications established by the Secretary. We proposed 
to re-designate Sec.  483.75(u) (as set out in the April 20, 2015 
proposed rule at 80 FR 22044) to Sec.  483.70(q). We note that the 
proposed rule was finalized on August 4, 2015 (see 80 FR 46389) and we 
are finalizing the re-designation of the requirement in the final rule 
at Sec.  483.75(u) to Sec.  483.70(q) in this final rule.
    As a result of comments received, we are finalizing this section as 
proposed, with the following revisions:
     We have added 45 CFR part 92 to the regulations 
specifically referenced in Sec.  483.70(c) ``Relationship to other HHS 
regulations.''
     We have withdrawn our proposal to delete the phrase 
``where licensing is required'' from Sec.  483.70(d)(2)(i).
     In Sec.  483.70(n), we have modified paragraph (1) to 
prohibit the use of pre-dispute agreements for binding arbitration 
between any resident or their representative and the facility and allow 
post-dispute agreements for binding arbitration, if the facility 
complies with the requirements in this section.

V. 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 all 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 standards are issued, 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. In accordance with the QAPI provisions of the 
Affordable Care Act, we proposed to establish these 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. We proposed to retain the 
substance of the existing QAA requirements at Sec.  483.75(o) and 
pursuant to the requirements of the Affordable Care Act, we proposed a 
revised Sec.  483.75 entitled, ``Quality Assurance and Performance 
Improvement.''
    At Sec.  483.75(a), we proposed to 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 proposed that the facility's governing body, or 
designated persons functioning as a governing body, would ensure that 
the QAPI program is defined, implemented, and maintained and addresses 
identified priorities. Therefore, we proposed at Sec.  483.75(a)(1) 
that the facility maintain documentation and demonstrate evidence of 
its QAPI program. This would include, but would not be limited to, the 
QAPI plan. We proposed at Sec.  483.75(a)(2) that the facility would be 
required to submit the QAPI plan to the State Agency or federal 
surveyor, as the agent of the Secretary, at the first annual 
recertification survey 1 year after the effective date of these 
regulations. In addition, we proposed at 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. Further, we proposed at 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, would consider 
such plan in making its certification recommendation and providing 
evidence to the CMS Regional Office for a compliance determination.
    At Sec.  483.75(b), we proposed requirements for the design and 
scope of the QAPI program. We proposed to 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 always include clinical care, 
quality of life, and resident choice. It would also require LTC 
facilities 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

[[Page 68803]]

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 proposed at Sec.  483.75(c) to establish requirements for QAPI 
program feedback, data systems and monitoring. We proposed at new Sec.  
483.75(c)(1) that, as part of its QAPI process, the facility must 
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. 
At Sec.  483.75(c)(2), we proposed 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. At Sec.  483.75(c)(3), we proposed to 
require that the policies and procedures include a description of the 
methodology and frequency for developing, monitoring, and evaluating 
performance indicators. Finally, at Sec.  483.75(c)(4), we proposed 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. We indicated in the 
proposed rule that this would include methods by which the facility 
obtains information on adverse events and potential adverse events from 
residents, family and direct care/direct access staff, and how the 
facility addresses and investigates the adverse event or potential 
adverse event and provides feedback to those same individuals.
    We proposed to establish a new Sec.  483.75(d) to address QAPI 
program systematic analysis and systemic action. We proposed 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 proposed 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 mode and effects 
analysis, for example) to determine underlying causes of problems 
impacting larger systems.
    At Sec.  483.75(e), we proposed to establish requirements for 
program activities. Specifically, we proposed to require at 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 proposed 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, we proposed to require that the QAPI program 
activities include Performance Improvement Projects (PIPs). Under the 
proposal, the facility is required to 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. We proposed that each 
facility 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.
    Finally, at Sec.  483.75(f), we proposed to require that the 
facility ensure, through the governing body or executive leadership, 
that an ongoing QAPI program would be 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, we proposed 
that 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 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.
    We proposed to re-designate Sec.  483.75(o) as Sec.  483.75(g). At 
Sec.  483.75(g)(1), we proposed revisions to clarify that the QAA 
committee membership requirements would be a minimum requirement. We 
also proposed the requirement that the Infection Control and Prevention 
Officer (ICPO) would participate in the quality assessment and 
assurance committee.
    At Sec.  483.75(g)(2), we proposed that the quality assessment and 
assurance committee would 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 proposed that the committee 
would coordinate and evaluate activities under the QAPI program, 
including performance improvement projects, and that the committee 
would 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).
    We proposed to add a new Sec.  483.75(h) to address disclosure of 
information. We proposed 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 proposed to 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 
proposed to re-designate Sec.  483.75(o)(4) as Sec.  483.75(i).
    In the proposed rule we included a discussion regarding technical 
assistance, materials, and resources available to LTC facilities on the 
development of best practices relating to QAPI (80 FR 42168, July 16, 
2015). We encourage readers to review that discussion and take 
advantage of the tools available.
    Comment: Many commenters stated that they generally support QAPI in 
facilities. One commenter stated that they were pleased that we have 
proposed standards for QAPI.
    Response: Thank you. These standards build on our experience 
requiring QAPI for other providers and, importantly, on the knowledge 
gained during the CMS QAPI demonstration project in LTC facilities. We 
believe facilities are familiar with the principles we are using and 
expect that some facilities have or are in the process of developing 
QAPI programs using the materials developed during the project and now 
available through the CMS Web site.
    Comment: Some commenters felt that mandating QAPI in facilities was 
unnecessary due to current voluntary

[[Page 68804]]

activities in hospitals and managed care, including quality improvement 
efforts to reduce unnecessary re-hospitalizations, and value-based 
purchasing.
    Response: We disagree. Effective QAPI programs are critical to 
improving the quality of life, and quality of care and services 
delivered in facilities. Furthermore, QAPI in LTC facilities is 
mandated by Section 6102 (c) of the Affordable Act and CMS does not 
have any discretion to not implement the provision.
    Comment: One commenter requested that we not use the word 
``program'' to encourage facilities to make QAPI part of the everyday 
life and operations of the facilities.
    Response: We thank the commenter and agree that QAPI should be part 
of the everyday life and operations of the home; however, the statute 
specifically refers to the ``QAPI program'' and, for clarity and 
consistency, we have chosen to remain consistent with statutory 
language.
    Comment: One commenter supported our focus on ``high-risk, high-
volume, or problem-prone areas'' and suggested we not include a list of 
areas that each facility must address. If we were to provide such a 
list, the commenter suggests that inclusion of topics addressing 
psychosocial well-being, mental and behavioral health, and quality of 
life are crucial. They specifically note that a positive approach that 
focuses on improving long-term residents' everyday experience, 
promotion of short-term residents' decision making, and improving 
palliative and end of life care would be particularly useful. One 
commenter stated that ``each organization should be able to determine 
their own areas of focus based on the collection of data, trends, and 
comparable benchmarks vs arbitrary mandates.''
    Response: We are not adding a specific list of QAPI topics or 
required performance improvement projects at this time. We want to 
allow facilities the flexibility to determine what issues should be 
prioritized for their QAPI program based on the needs of the facility 
and its residents. If we decide to require specific topics or 
performance improvement projects in the future, we will consider the 
topics suggested by the commenter as well as other comments we may have 
received.
    Comment: One commenter felt that the proposed requirements exceeded 
our authority, and suggested that we withdraw our proposal and replace 
it with the statutory language. Some commenters felt that the proposed 
requirements are very detailed, too prescriptive, and significantly 
exceed the requirements for other providers. One commenter believes 
that the number of system areas that must be minimally included is too 
large. Some commenters expressed general concern that our proposed QAPI 
provisions lack specific requirements or stated that additional 
guidance is necessary. One commenter suggested regional sharing of 
program development, training, program evaluation and other resources.
    Some commenters suggested that we allow a 5 year implementation 
period during which the facility would show progress in its 
implementation process during the annual standard survey, while other 
commenters suggested a 2 to 3 year phase-in for the QAPI provisions.
    Response: We appreciate the commenters concerns regarding both the 
need for sufficient specificity to meet requirements and sufficient 
flexibility. We have worked to achieve a balance between specificity 
and flexibility in recognition of the wide diversity that exists among 
LTC facilities. We have re-evaluated our proposal to determine if we 
can be less prescriptive in some areas, and have modified our language 
accordingly. For example, we have eliminated the specific methodologies 
listed in proposed Sec.  483.75(d)(2)(i), as these may be more 
appropriate in sub-regulatory guidance. We do not agree that we have 
exceeded our authority and should include only the statutory language 
as suggested.
    In addition, we have received many comments regarding the overall 
implementation of this rule and address that issue in section II.B. 
Implementation. With regard specifically to QAPI, we note that the 
statute requires at 1128I(c)(1) of the Act that the QAPI plan be 
submitted to the Secretary not later than one year after the date on 
which the requirements are issued. We have modified our regulatory 
provision to mirror the statutory language. We would expect facilities 
to show their efforts to effectuate the QAPI plan, on an ongoing basis 
thereafter, with no fixed start or end date.
    QAPI is intended to be a continuous part of the everyday life and 
operations of the home. We note that facilities have been expecting 
these regulations for a number of years, since publication of the 
Affordable Care Act in 2010. In developing our proposal, we relied 
heavily on the experiences gained in the CMS QAPI demonstration project 
which was conducted from Sept 2011 through Sept 2013. Resources and 
tools were developed as a result of that pilot, were rolled out on June 
7, 2013 (see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-37.pdf) and remain available on the CMS Web site (see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/NHQAPI.html). In addition, QIOs are currently using these tools in 
their work with LTC facilities and additional resources are under 
development. We would encourage facilities to share best practices and 
other resources as they develop their QAPI programs. Furthermore, this 
proposal, while tailored to long-term care facilities, is consistent 
with our requirements (Conditions of Participation and Conditions for 
Coverage) for QAPI for other providers, such as community mental health 
centers (Sec.  485.917), end stage renal disease facilities (Sec.  
494.110), hospitals (Sec.  482.21), hospices (Sec.  418.58), organ 
procurement organizations (Sec.  486.348), and transplant centers 
(Sec.  482.96) as well as proposed requirements for home health 
agencies (79 FR 61164).
    Comment: One commenter supports the concept of an effective QAPI 
program, but feels we have over-emphasized data and outcomes and do not 
adequately acknowledge the qualitative processes such as clinical 
reasoning, correct diagnoses, and the nuances of selecting 
individualized treatments that are the foundation of high-quality 
results. They further state that any requirements about QAPI programs 
should focus attention on improving processes and practices, including 
those related to both clinical and nonclinical decision making, 
reasoning, and problem solving. The commenter is concerned that 
excessive emphasis on data and results distracts attention from 
improving the basis for those results, that available quality measures 
and data only represent a small part of the many aspects of quality 
care, and that aggregate results may not faithfully reflect the quality 
of the overall care of individual residents. The commenter suggests 
language to strike a better balance between looking at data and 
focusing on practices and processes that need optimized regardless of 
the data. The commenter also suggests that the QAPI requirements 
specifically include case review.
    Response: We believe that our focus on outcomes is appropriate. We 
agree that QAPI should focus on improving processes and practices, and 
believe that data is a necessary element in doing so. Data is used to 
identify problems in processes and practices and to set goals related 
to improving those processes and practices. It is then used to validate 
that a change is successful in improving

[[Page 68805]]

that process or practice and subsequently to monitor that the change is 
sustained. Using data involves critical reasoning and analytical 
thinking; these are not mutually exclusive. We agree that case review 
is one tool that can be used to identify problems and collect data. We 
would defer specificity regarding such tools to sub-regulatory 
guidance.
    Comment: One commenter suggests we use the term ``information'' 
instead of ``data.'' They note that ``information'' includes data as 
well as other knowledge, whereas data could exclude other information.
    Response: We agree that information other than data may be useful 
in the QAPI process, but we also believe that data-facts, measurements, 
and statistics collected for analysis and planning are an integral part 
of the QAPI process. Rather than substitute one term for the other, we 
have, where appropriate, used both.
    Comment: One commenter believes the regulations should be more 
flexible with regard to performance improvement projects (PIP) and that 
the proposal is overly prescriptive. The commenter notes that there are 
many performance project activities that would not be considered a PIP 
but are activities that could be built into everyday activities and 
real-time problem solving. They state that the PIP requirement is 
problematic and these regulations need a better balance of diverse 
methods including qualitative reasoning and real-time problem solving.
    Another commenter suggested that each facility be required to have 
at least three PIPs in place at a time, reflecting different areas of 
concern and at least one reflecting residents' rights and quality of 
life. The commenter further suggests that a facility cited with 
immediate jeopardy deficiency(ies) be required to initiate a PIP in the 
area where the immediate jeopardy was cited.
    One commenter suggests that CMS develop and annually update a list 
of a dozen mandatory PIPs reflecting issues that CMS has identified as 
significant quality of care and quality of life issues. Each facility 
would then be required to choose at least one PIP from that list 
annually.
    Response: The comments regarding the PIP requirements reflect 
opinions advocating for both less and more specificity in our PIP 
requirements. One of the critical elements of QAPI is to give 
facilities the flexibility to use QAPI to best meet their own needs. In 
order to give facilities this flexibility, we believe that a less 
prescriptive approach to PIPs is appropriate. However, this flexibility 
must occur in the context of a QAPI program that addresses the full 
range of care and services provided by the facility. Accordingly, we 
limited our proposal to require only one PIP annually, and declined to 
establish mandatory PIPs at this time.
    We agree that not all improvement activities are PIPs and believe 
that our proposed regulatory language is inclusive of these activities. 
(See Sec.  483.75(e)). In addition, we have reviewed our proposals and, 
where appropriate, have expanded our references to PIPs to include 
other improvement activities. While we agree that areas in which an 
immediate jeopardy deficiency is cited require immediate action, we are 
not certain that a PIP will always be an appropriate response, and 
therefore have not adopted this recommendation at this time.
    Comment: One commenter stated that they were pleased that the 
medical director or his or her designee is specifically listed as a 
member of the QAA committee. They support medical director and other 
medical practitioner involvement in the development and assessment of 
the QAPI program.
    Response: Thank you. We agree that medical director involvement in 
QAPI is an important leadership element. We also believe that the 
involvement of other medical practitioners can contribute to the 
success of a QAPI program.
    Comment: Some commenters suggested that we needed to ensure 
resident, resident representative, and staff participation in the QAPI 
program. The commenters raised concerns and suggested additional 
language that would address resident, resident representative, and 
staff involvement in the QAPI program.
    Response: Our proposed requirements include obtaining and using 
feedback and input from staff, residents and resident representatives. 
We are finalizing this particular requirement as proposed.
    Comment: Some commenters recommend adding staffing and worker 
safety elements to the QAPI requirements.
    Response: The QAPI program is required to address the full range of 
care and services provided by the facility. This would include staffing 
as well as a number of other areas. We defer additional specificity to 
sub-regulatory guidance. While facilities could certainly include 
worker safety in their QAPI processes, we have not specifically 
included worker safety in this regulation as we believe worker safety 
is more appropriately the purview of other federal agencies such as 
HRSA and OSHA.
    Comment: One commenter suggested that we require effective 
collaboration training for members of the QAA committee.
    Response: We agree that effective collaboration training could be 
useful for members of a QAA committee, as well as individuals in other 
positions. However, we do not mandate any specific trainings for QAA 
committee members and do not believe that we should mandate this 
specific training for all QAA committee members. There are many 
trainings that could be equally beneficial, and some that might be a 
greater priority, based on prior training and experience of the members 
of the QAA committee. We will defer such decisions to the facility.
    Comment: One commenter recommended that we require a contracted 
consultant pharmacist sit on the Quality Assessment and Assurance 
Committee. The commenter stated that adverse medication events, 
including medication errors, remain a serious problem in LTC 
facilities.
    Response: We appreciate the commenters' suggestion, but, while we 
would agree that this would be a good practice, we are not adopting 
this recommendation at this time. As part of the update of these 
requirements, we have updated our requirements related to pharmacy 
services and mandated adverse event monitoring as a part of the QAPI 
program. We believe that these requirements will help reduce adverse 
medication events. Mandatory membership on the Quality Assessment and 
Assurance Committee reflects a minimum standard and facilities can add 
members based on the needs and priorities of the facility.
    Comment: Several commenters supported our proposed requirements 
regarding disclosure of QAPI information to demonstrate compliance with 
the requirements for the QAPI program. One commenter stated that they 
believed it would improve facility compliance with the requirements and 
would assist in federal and state oversight. Another stated that the 
purpose of the quality assurance provisions is to ensure that LTC 
facilities identify and act on information about neglect, abuse, and 
other adverse events, not that they be able to hide this information by 
making it part of a QAPI record. Another asked that we clarify that 
documents and reports used or relied on by QAPI are not confidential 
and that non-disclosure applies only to minutes, internal working 
papers, or statements of conclusions of QAPI and

[[Page 68806]]

QAA. They further stated that we should clarify that records and 
materials submitted to the QAA committee for review are not 
confidential solely because they are used or reviewed by the QAA 
committee. Others stated that the QAPI plan should be made available to 
residents, resident representatives, and staff.
    Other commenters objected to our proposed provisions regarding 
information disclosure to demonstrate compliance with the QAPI 
requirements. One commenter stated that this requirement could be 
misconstrued. Several suggested that these requirements could have a 
chilling effect on advancing QAPI efforts and should be deleted or 
substantially modified. Several commenters felt that the proposed rules 
for QAPI would discourage open and honest evaluation of areas of 
concern without fear of negative consequences. A number of commenters 
were concerned that disclosing quality assurance records to surveyors 
would expose providers to increased risk of sanctions and litigation. 
One commenter stated that surveyors should not have broad access to 
facilities' QAPI data or deliberations. Another commenter stated that 
they believe that the proposed regulations exceed the statutory 
authority granted to CMS. The commenter stated that we have 
significantly expanded upon the statutory mandate by requiring a 
``laundry list'' of requirements related to the QAPI program, including 
requiring the disclosure of, or potentially requiring a facility 
provide access to, a plethora of QAPI-related documents and records. 
They further stated that proposed 42 CFR 483.75(a)(4), requiring 
facilities to present documentation and evidence of its ongoing QAPI 
program's implementation and the facility's compliance with the 
requirements to a State Agency, Federal surveyor, or CMS upon request 
exceeds the permissibly required disclosures under the statute. One 
commenter stated that these provisions are contrary to state law. 
Finally, they believed that proposed Sec.  483.75(h) is internally 
inconsistent.
    Response: We thank those commenters who support our proposal 
regarding the need to provide documentation demonstrating compliance 
with the QAPI requirements. We have attempted to strike an appropriate 
balance between concerns about inappropriate use of QAPI materials and 
our obligation to provide effective oversight of Medicare and Medicaid 
participating facilities.
    We do not agree with commenters who believe that we have exceeded 
our authority in establishing these requirements. Under section 
1128I(c) of the Act, as added by section 6102 of the ACA, Congress 
required the Secretary to establish and implement a quality assurance 
and performance improvement program for facilities. The Secretary is 
also required to set forth standards for QAPI and provide technical 
assistance to develop best practices for facilities to meet those 
standards. The expectation that facilities will implement a QAPI 
program that meets those standards is clear, and facilities must be 
able to demonstrate that they have implemented their QAPI plan and have 
an effective, ongoing QAPI program. The standards, the best practices, 
and the tools to support facilities as they implement their plan to 
meets those standards were developed in the course of the QAPI 
demonstration project conducted by CMS. We also consider our 
experiences with requiring QAPI programs from other providers such as 
community mental health centers (Sec.  485.917), end stage renal 
disease facilities (Sec.  494.110), hospitals (Sec.  482.21), hospices 
(Sec.  418.58), organ procurement organizations (Sec.  486.348), and 
transplant centers (Sec.  482.96) as well as proposed requirements for 
home health agencies (79 FR 61164).
    QAPI is intended to be one aspect of a LTC facility's operations 
that helps to maintain and protect the health and safety of the 
residents of the facility. Section 1819(f)(1) of the Act states that it 
is the duty and responsibility of the Secretary to assure that 
requirements which govern the provision of care in skilled nursing 
facilities under Title XVIII, and the enforcement of such requirements, 
are adequate to protect the health, safety welfare, and right of 
residents and to promote the effective and efficient use of public 
moneys. Therefore, we have an obligation to ensure that the QAPI plan 
becomes more than a paper exercise. To that end, we proposed 
requirements that would demonstrate that a facility has not only 
written a plan that meet the established standards, but has actually 
implemented that plan. In our proposed requirements, we stated that the 
facility must present its QAPI plan at its annual recertification (or 
in the case of a new facility, during its initial certification) after 
the effective date of this regulation and at every annual survey 
thereafter, as well as during other surveys or upon our request. We 
included this ongoing requirement because we understand that a QAPI 
plan will need to be updated and modified as a facility implements it 
and learns from the QAPI program. We proposed that the facility would 
have to present documentation and evidence of its ongoing QAPI 
implementation to reflect the ongoing nature of the QAPI program.
    It is not our intent that a facility lose existing protections for 
QAA documents, including those established under state law, nor do we 
intend to create a punitive environment or increase litigation. At the 
same time, we cannot ignore our obligation to ensure that facilities 
implement their QAPI plan, and continue to modify and implement that 
plan over time. What we require is satisfactory evidence that a 
facility is implementing its QAPI plan and maintaining an ongoing QAPI 
program. We further articulated in the proposed rule what sort of 
evidence and documentation we believe may be necessary to demonstrate 
compliance. We retain the proposed requirement, as required by statute, 
that a State or the Secretary may not require disclosure of a QAA 
committee's records except insofar as such disclosure is related to the 
compliance of such committee with the requirements of the statute. 
Clearly, this requirement recognizes that, in some cases, such records 
will be necessary to evaluate compliance. However, much information 
relating to the implementation of the QAPI plan could be available 
outside of the QAA committee's records. Further, we do not believe that 
every document, piece of information, or data reviewed or generated in 
the course of implementing QAPI is a ``record of the QAA committee.''
    We also retain the proposed requirement that ``Good faith attempts 
by the committee to identify and correct quality deficiencies will not 
be used as a basis for sanction.'' This requirement is not new; 
however, it now also includes QAPI activities. As is currently the 
case, surveyors are instructed not to cite as a deficiency for a 
requirement other than the QAPI requirements a concern that would not 
have been identified but for a review of QAPI materials for the purpose 
of determining compliance with the QAPI regulations. That said, nothing 
in this section would preclude a surveyor from citing a concern that is 
identified based on a review of materials or on observations separate 
and apart from an assessment of QAPI compliance. Excluding such a 
concern simply and only because it has also been identified by the QAPI 
program would be irresponsible of CMS. We understand that the ability 
to discern when and how a deficiency is identified is of concern to 
facilities. We have and will continue to educate surveyors on the 
parameters of this provision and the need to not

[[Page 68807]]

inappropriately request or use QAPI documentation.
    With regard to concerns about increased litigation, we reiterate 
that our purpose is neither to inappropriately make documents public 
nor to expose facilities to litigation risk. In fact, section 1106 of 
the Act specifically states that, for health programs established by 
titles XVIII and XIX, reports (including program validation survey 
reports and other formal evaluations of the performance of providers of 
services) made public by the Secretary or the State Agency shall not 
identify individual patients, individual health care practitioners, or 
other individuals. Our obligation to conduct effective oversight is not 
waived in the face of litigation fears. We have attempted in these 
regulations to establish an appropriate balance between ensuring that 
QAPI can be conducted in an open, non-punitive environment and ensuring 
that we can provide effective oversight of requirements necessary to 
protect the health and safety of LTC facility residents. We have re-
evaluated our proposed language and made some modifications in order to 
be less prescriptive and duplicative. In order to address the 
commenters concerns about internal consistency and overreach, we have 
moved the language regarding the information that may be necessary to 
demonstrate compliance to section (a)(1) and eliminated, as potentially 
overbroad, proposed paragraph (iii) which stated ``other documentation 
considered necessary by a State or Federal surveyor in assessing 
compliance.'' We are finalizing as proposed the requirement that 
facilities must provide documentation and information that demonstrates 
that they are effectively implementing their QAPI plan, on an ongoing 
basis, and surveyors must have sufficient information to evaluate if a 
facility is in compliance with the requirements of this section.
    Comment: One commenter supported our proposed QAPI provisions and 
stated that QAPI must be among the services disclosed to residents on 
the notice of services. The commenter suggested that there be some 
method for a resident to ``trigger'' a QAPI performance improvement 
project (PIP).
    Response: Our requirements include obtaining and using feedback and 
input from staff, residents and resident representatives. While not all 
such input would trigger a PIP, it is important that it be included in 
the facility's assessment of concerns and priorities.
    Comment: One commenter asked if using programs such as Abaqis or 
PCC are sufficient to meet the QAPI regulation.
    Response: Programs such as PointClickCare and Abaqis may assist 
facilities to meet the QAPI requirements, but using them is neither 
necessary nor sufficient for compliance. Facilities must evaluate their 
use of such tools and ensure that they comply with the QAPI 
requirements.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We have modified paragraph (a)(2) to mirror the statutory 
language to indicate that the facility must present its QAPI plan to 
the State Survey Agency not later than one year after the date the 
regulation is issued.
     We have added the term ``information'' in paragraphs 
(c)(2) and (f)(4).
     In paragraph (e)(3), we have referenced performance 
improvement activities in the context of our PIP requirement.
     We eliminated the parenthetical examples in paragraph 
(d)(2)(i)
     We have moved the language in proposed Sec.  483.75(h)(2) 
regarding the information that may be necessary to demonstrate 
compliance to section (a)(1) and eliminated proposed paragraph (iii) 
which stated ``other documentation considered necessary by a State or 
Federal surveyor in assessing compliance.''

W. Infection Control (Sec.  483.80)

    As part of our overall reorganization of these regulations, we 
proposed to re-designate the provisions under existing Sec.  483.65 as 
Sec.  483.80. We proposed 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 proposed to revise 
paragraph (a) to read ``Infection prevention and control program'' 
(IPCP) and add new Sec.  483.80(a)(1), (2) and (3) to specify the 
elements of the IPCP. We proposed to require that the program must 
follow accepted national standards, be based upon the facility 
assessment conducted according to 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 proposed to 
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. We also proposed that the facility be 
required to train staff related to the IPCP as specified in Sec.  
483.95.
    We proposed 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 proposed to add a new paragraph (b) to require that the 
facility designate an infection prevention and control officer (IPCO) 
who is responsible for the IPCP and who has received specialized 
training in infection prevention and control. We proposed that the IPCP 
be a major responsibility for the individual assigned as the facility's 
IPCO. We proposed to require that the IPCO be a healthcare professional 
with specialized training in infection prevention and control beyond 
their initial professional degree. At Sec.  483.80(c), we proposed to 
require that the IPCO be a member of the facility's Quality Assessment 
and Assurance (QAA) committee.
    We proposed 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 proposed to add a new Sec.  483.80(f) to require that the 
facility review its IPCP annually and update the program as necessary. 
We also proposed 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

[[Page 68808]]

we proposed using the term ``resident representative'' instead of 
``legal representative.'' Finally, we proposed moving the requirement 
concerning linens from the current Sec.  483.65(c) to the proposed 
Sec.  483.80(e).
Infection Prevention and Control Program (IPCP)
    Comment: Many commenters agreed that infection control is very 
important for residents in LTC facilities and commended CMS for 
proposing to significantly enhance the infection control requirements 
given the physical harm and financial cost of HAIs. One commenter said 
the proposed measures are an important step forward.
    Response: We would like to thank the commenters for their support. 
We agree that infection control is very important for residents, as 
well the staff and other individuals who work or visit the facility. We 
believe the requirements that are finalized in this rule will 
contribute to the reduction in HAIs, which should result in a reduction 
in physical harm to residents and others, as well as a decrease in the 
associated health care costs.
    Comment: One commenter expressed a concern that the infection 
control efforts could not be effective without adequate numbers of 
consistently assigned, well-trained and well-supervised direct care 
nursing staff. Nurses and nursing assistants are essential for 
infection control prevention, detection and intervention. The commenter 
recommended a minimum staffing standard of at least 4.1 hours of direct 
care nursing per resident day, 24-hour registered nurse coverage for 
the facility, and staffing practices to promote successful infection 
prevention.
    Response: We agree with the commenter that for the infection 
control requirements finalized in this rule to be effective, the 
facility would need a sufficient number of trained and supervised 
direct care nursing staff. However, we disagree that this final rule 
should establish a minimum staffing standard for LTC facilities. In 
this final rule, each facility must conduct and document a facility-
wide assessment to determine what resources are necessary to care for 
it residents competently during both day-to-day operations and 
emergencies (Sec.  483.70(e)). That assessment must include, among 
other things, the resident population and the care required by that 
population considering the types of diseases, conditions, physical and 
cognitive disabilities, overall acuity, and other pertinent facts that 
are present in that population, as well as the staff competencies that 
are necessary to provide the level and types of care needed by that 
population. This assessment must then be used to determine what is the 
number of sufficient nursing staff and the competencies and skill sets 
the nursing and related staff must have to care for their resident 
population (Sec.  483.35). Based on these requirements, as well as the 
infection control requirements finalized in this rule, each facility 
will need to determine the resources it needs to devote to its 
infection control program.
    Comment: Commenters recommended that the guidelines from the 
Centers for Disease Control and Prevention be inserted into Sec.  
483.80(a)(1), so that it reads, ``staffing practices, and following 
accepted national standards including, but not limited to guidelines 
from the Centers for Disease Control and Prevention; . . .''
    Response: We disagree with the commenters. We believe that 
facilities need the flexibility to determine which national standard 
they are going to follow. We also believe it is appropriate for the 
different types of national standards that are acceptable to CMS to be 
included in the sub-regulatory guidance for this rule. Although we are 
not requiring that LTC facilities follow the CDC guidelines, we agree 
with the commenters that the CDC is an excellent resource for 
guidelines, as well as other information on infection control, and 
encourage LTC facilities to consider the CDC guidelines. For example, 
the CDC has a Web site for information on infection control in LTC 
facilities, ``New CDC Infection Control Web site for Nursing Homes and 
Assisted Living,'' (http://www.leadingage.org/Infection_Control_Website.aspx). Other organizations also have 
information available on their Web sites, such as The Society of 
Healthcare Epidemiology of America (SHEA) (http://www.shea-online.org/
), Infectious Diseases Society of America (IDSA) (https://www.idsociety.org/Index.aspx), and the Association for Professionals in 
Infection Control and Epidemiology (APIC) (http://www.apic.org/).
    CDC and CMS are also exploring opportunities to develop and 
implement infection prevention and control training specific for LTC 
facility clinical personnel. We expect that this would provide training 
on a variety of infection control topics relevant for LTC facility 
staff developing and sustaining an IPCP. We expect that any training 
would be widely available for all providers, surveyors, and other 
partners. We are also exploring opportunities for continued education, 
dissemination of promising practices, and ensuring that new infection 
prevention and control guidance and information for LTC facility staff 
can be shared widely. CMS is pleased to be collaborating with CDC on 
this type of comprehensive training for providers. CMS has previously 
developed specific surveyor training on infection control topics in 
2014 and 2015. CMS is also exploring processes for reviewing infection 
prevention and control practices in the context of transitions of care. 
Please see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-16-05.pdf for additional information about that pilot.''
    Comment: One commenter stated that the detail in the scope and 
components in the infection control program went well beyond what is 
required in the hospital CoPs. They noted that hospitals are a setting 
with much greater risk of infections and individuals at higher risk of 
adverse events from infections. They recommended adopting more general 
language similar to that used in the hospitals CoPs and specify the 
details in interpretive guidance that should be developed in 
partnership with stakeholders. They noted that referring to the goal 
and purpose of the infection control program along with following 
national standards allows the goal and intent to be accomplished. This 
affords the providers greater flexibility and creativity in how to 
achieve the goals also provides CMS flexibility to provide additional 
suggested approaches in interpretative guidance. They also noted that 
modifying and updating the guidance as new and better practices are 
identified over time is preferable to the long and arduous formal 
rulemaking process to update the requirements.
    Response: We disagree with the commenters. As we discussed in the 
proposed rule, it is estimated that there are between 1.6 and 3.8 
million HAIs in LTC facilities annually (80 FR 42215). These infections 
result in an estimated 150,000 hospitalizations; 388,000 deaths; and 
healthcare costs between $673 million to $2 billion. In addition, 
residents may be more susceptible than individuals in other types of 
healthcare facilities due to malnutrition, dehydration, comorbidities, 
or functional impairments, such as urinary and fecal incontinence, or 
medications that diminish immunity or mobility. Also, due to the length 
of their stays, there is more opportunity for exposure to infectious 
agents from the socialization between residents. This clearly indicates 
that infection prevention and control is a critical issue for LTC 
facility residents. In addition,

[[Page 68809]]

due to transfers between hospitals and LTC facilities, infection 
control in LTC facilities directly affects hospitals as well. The LTC 
facility resident with an infection today maybe the patient that the 
hospital must treat tomorrow when he or she arrives in the hospital's 
ED.
    Concerning the level of detail in the infection control 
requirements, we disagree with the commenter. Hospitals and LTC 
facilities are different types of facilities. LTC facility residents 
generally stay much longer than patients in hospitals and generally 
require care for chronic conditions instead of acute illnesses, 
injuries, or surgeries. In addition, there must be sufficient detail in 
the regulatory text so that LTC facilities know what will be needed to 
be in compliance with requirements. We believe there is sufficient 
detail in the infection control requirements so that LTC facilities and 
the public understand what is expected for compliance. We also note 
that CMS published a proposed rule on June 16, 2016 entitled, 
``Hospital and Critical Access Hospital Changes to Promote Innovation, 
Flexibility and Improvement in Patient Care (CMS-3295-P) (81 FR 39448). 
These proposed regulations update and add specificity to the infection 
prevention and control requirements for hospitals.
    Concerning the commenter's recommendation that referring to the 
goal and purpose of the infection control program along with following 
national standards allows the goal and intent to be accomplished. We do 
not believe this is needed in the regulatory text. However, further 
direction will be provided in sub-regulatory guidance. Concerning the 
use of interpretative guidance, sub-regulatory guidance for this final 
rule will be developed and published as soon as possible. That guidance 
will contain more specific direction for long-term care facilities, 
surveyors, and others concerning compliance with these regulatory 
requirements. Thus, we believe that the level of detail in the 
infection prevention and control requirements in this final rule are 
appropriate and ensure that LTC facilities are aware of what is 
required to comply with these requirements.
    Comment: One commenter was concerned about the specificity of the 
language in the infection control comments. They recommended specific 
language changes to remove much of the detail in this section and 
suggested using ``should'' instead of ``must'' to allow more 
flexibility for both the providers and CMS when legitimate exceptions 
are identified or new and better practices are identified.
    Response: We disagree with the commenter. While the commenter is 
correct that the use of ``should'' would convey more flexibility, that 
is not the purpose of these requirements. This final rule contains 
requirements for LTC facilities, not suggestions. LTC facilities must 
be in compliance with these requirements. In addition, further guidance 
will be provided through sub-regulatory guidance. As practices change 
in the future, we would appreciate comments from the commenter, as well 
as any other individuals, on any recommended changes to these 
requirements.
    Comment: One commenter supports the efforts to address antibiotic 
stewardship; however, they noted that the problem is not isolated to 
LTC facilities. For example, hospital emergency departments (EDs) will 
usually obtain a urine analysis on residents who are sent to the ED. 
Over 50 percent of these tests will show asymptomatic bacteria which 
would not meet the Society for Healthcare Epidemiology of America 
(SHEA) criteria for giving antibiotics. However, the ED frequently 
starts the resident on antibiotics before the resident returns to the 
facility. In addition, a State Survey Agency will cite a facility for 
an adverse event when the LTC facility does not begin an antibiotic 
based upon an asymptomatic urinalysis but the resident later develops 
an infection. The commenter noted that this has occurred across the 
country over the past several years as providers have attempted to 
follow the SHEA criteria. If the proposed requirements are finalized as 
proposed, the commenter requested that language be added that indicates 
that providers will not be cited if an infection develops when the 
provider has followed nationally accepted guidelines for antibiotic 
use, such as SHEA. The commenter recommended that the hospital CoPs 
also be modified to prevent citation for an adverse event under these 
circumstances.
    Response: We agree with the commenter that antibiotic stewardship 
is not an issue for LTC facilities alone and as noted above, we have 
published a proposed rule with requirements for antibiotic stewardship 
programs for hospitals (81 FR 39454 through 39459). However, it is 
crucial that LTC facilities establish an infection prevention and 
control program that contains an antibiotic stewardship program. As we 
discussed in the proposed rule, antibiotic resistance has become a 
national concern and both the inappropriate and even appropriate use of 
antibiotics contribute to this problem (80 FR 42215). In addition, LTC 
facilities are part of the overall healthcare system. With the growth 
in the short term resident population, more residents with complex 
healthcare issues are coming from the hospital into the LTC facility. 
Residents with infections in the LTC facility may become patients in 
the hospitals ED. In addition, residents also may go to other 
healthcare facilities for care, such as ambulatory surgical centers 
(ASCs) and dialysis centers. Therefore, the facility's IPCP, and its 
antibiotic stewardship program, also affects other facilities and 
individuals throughout the healthcare system. Therefore, we are 
finalizing the requirement for LTC facilities to establish and maintain 
an IPCP, which must include, among other things, an antibiotic 
stewardship program that includes antibiotic use protocols and a system 
to monitor antibiotic use.
    Regarding the commenter's concern about being cited by a surveyor 
for following national standards and modification of the hospital CoPs, 
we will be working on developing sub-regulatory guidance and training 
for the surveyors that should address situations that the commenter 
described.
    Comment: One commenter expressed concerns about Sec.  
483.80(a)(2)(iv), which requires ``(2) [w]ritten standards, policies 
and procedures, which must include, but not limited to: . . . (iv) 
[w]hen isolation should be used for a resident.'' The commenter said 
they had heard directly from residents, families and ombudsmen about 
situations where facilities have barred all visitors from accessing 
residents for a significant period of time due to the outbreak of 
certain infectious viruses among residents and/or facility staff. The 
commenter noted that the practice of facilities restricting visitation 
as part of an infection control protocol has been regularly reported in 
the news. The commenter noted that the current interpretive guidelines 
already recognize the potential adverse psychological impact on 
residents when instituting any precautions to control outbreaks. 
According to the guidelines, ``because of the potential negative impact 
that a resident may experience as a result of the implementation of 
special precautions, the facility is challenged to promote the 
individual resident's rights and well-being while trying to prevent and 
control the spread of infections,'' and it is appropriate for 
facilities to ``use the least restrictive approach'' to infection 
control while adequately protecting the residents and others.'' The 
commenter recommended that the language from the interpretive 
guidelines be inserted in the rule to strike a balance between 
protecting the

[[Page 68810]]

health of the residents and their psychological well-being. They 
recommended the following language, ``[t]he facility must isolate 
infected residents only to the degree needed to isolate the infecting 
organism. The method used must be the least restrictive possible:''
    Response: We agree with the commenter that isolation should only be 
used when necessary to control the spread of infections and should be 
the least restrictive as possible to the resident. The current 
interpretative guidelines contain language about using the least 
restrictive approach possible that adequately protects both the 
resident and others and that maintaining isolation longer than 
necessary my adversely affect the resident's psychosocial well-being, 
We also agree that there should be more detailed requirements for 
isolation in the regulatory text. Thus, in this final rule we have 
modified the text of Sec.  483.80(a)(2)(iv) to read: ``When and how 
isolation should be used for a resident, including but not limited to, 
(A) the type and duration of the isolation depending upon the 
infectious agent or organism involved, and (B) that the type and 
duration of the isolation should be the least restrictive possible for 
the resident under the circumstances.''
Infection Prevention and Control Officer (IPCO)/Infection Preventionist 
(IP)
    Comment: Some commenters were concerned about the requirement for 
an IPCO. They question whether the requirement was even viable, 
particularly in areas that already lack adequate numbers of registered 
nurses. They indicated that for many locations, particularly rural 
areas, individuals with this expertise are simply not available. The 
commenter also expressed concern that the requirement was mandating 
structure instead of focusing on process expectations, which left 
little to no opportunity to accomplish the objectives of infection 
prevention and control through means other than those prescribed by the 
structure-related regulation.
    Response: We disagree with the commenters. We do not believe that 
requiring an IPCO is unrealistic. We believe it is necessary to have 
one or more individuals responsible for the infection control program 
in each facility. However, as discussed below, we have modified this 
requirement based upon other comments.
    Comment: Some commenters recommended that the requirement for the 
IPCO, allow two or more individuals to be responsible for the IPCP. 
Another commenter noted that the director of nursing (DoN) is often the 
part-time infection prevention and control officer for the facility. 
When the DoN is unavailable because he or she is on vacation or busy 
with other responsibilities, there is no one to address the infection 
prevention and control responsibilities. The commenter recommended that 
we not allow the DoN to be the primary IP.
    Response: After reviewing the comments, we agree that LTC 
facilities should have the flexibility to determine if more than one 
individual should be designated to be responsible for the facility's 
IPCP. We also believe that LTC facilities should ensure coverage 
whenever the designated IP(s) is unavailable. However, we disagree with 
the commenter that recommended that we prohibit the DoN from being an 
IP. We believe that each facility should have the flexibility to 
determine how their facility should comply with the requirements in 
this final rule, including which individuals should be designated as 
the IP(s). Therefore, we have modified the requirements at proposed 
Sec.  483.80(b) to allow for more than one individual to be responsible 
for the IPCP and be the designated IP.
    Comment: Some commenters argued that the requirement for the IPCO 
was inconsistent with our assertion in the proposed rule, ``[w]e 
considered prescriptive approaches, such as requiring specific numbers 
and types of staff . . .'', but instead decided on a ``competency-based 
approach.'' The commenters recommended that a more reasonable approach 
that would be to provide detailed standards for the infection control 
activities and procedures, and then allow LTC facilities to make the 
determination as to whether the individual responsible for this 
function possesses the competency and expertise to function effectively 
in the role to accomplish the defined processes.
    Response: We disagree with the commenters. The language referenced 
by the commenters in the proposed rule (80 FR 42175) is located under 
our discussion of the facility assessment and competency based approach 
taken in the proposed rule and finalized in this rule. It pertains to 
the approach we have taken towards staffing. We noted in the proposed 
rule that we wanted to ensure that our requirements would ``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'' (80 FR 42175). However, 
regardless of the facility assessment, each LTC facility must have an 
IPCP. As we said in the proposed rule, ``[w]hile all staff 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'' (80 FR 42216). As discussed above, we are not 
finalizing ``major'' to describe the IP's responsibility due to the 
burden it would impose on nursing facilities. However, we continue to 
believe that it is essential at least one individual be designated the 
IP for each LTC facility. In addition, we have modified this final rule 
so that LTC facilities can designate more than one individual as an 
ICPO. Thus, requiring that at least one individual be responsible for 
the IPCP is consistent with the facility assessment and competency-
based approach in this final rule.
    Comment: Commenters disagreed with using the term ``officer'' for 
the infection prevention and control officer (IPCO). The commenter said 
that officer was ill-defined and its rationale is unclear. The 
commenter recommended that the term ``coordinator'' or infection 
prevention and control coordinator (IPCC).
    Response: We understand that different terms are used to identify 
the individual or individuals who are responsible for the facility's 
infection control program. For example, in Appendix A-Survey Protocol, 
Regulation and Interpretive Guidance for Hospitals, (Rev.151,11-20-15), 
it states that the individual(s) ``responsible for the infection 
control program may be called a hospital epidemiologists (HEs),'' 
``infection control professionals (ICPs)'' or ``infection 
preventionists (IPs).'' In the Appendix PP-Guidance to Surveyors for 
Long Term Care Facilities in the SOM, accessed on January 28, 2016), 
the interpretative guidelines refer to an ``infection Preventionist 
(IP)'' or an ``infection control professional (ICP)''. Regardless of 
the title used by the facility, we are referring to the individual who 
is responsible for the facility's IPCP. However, to prevent any 
confusion, we have modified this final rule to use the term ``infection 
preventionist'' or IP. Therefore, there must be at least one individual 
who is responsible for the facility's infection control program.
    Comment: Some commenters were concerned about the qualifications 
for the ICP. Some commenters asked who would be included in the term 
``clinician'' and asked that it be defined. Other commenters were 
concerned about the requirement that the IPCO

[[Page 68811]]

(now IP) to have specialized training in infection prevention and 
control beyond their initial professional degree. One commenter noted 
that APIC provides specialized training in infection prevention and 
control and also provides the opportunity for individuals to become 
certified. Some were unsure what training would qualify, while others 
believed it would difficult for facilities to find qualified staff with 
this training or get the training for their staff due to availability 
or cost.
    Response: We understand that there is a substantial amount of 
concern and confusion about the qualifications for the IP. We also 
understand that many LTC facilities currently have individuals who are 
responsible for infection control who might not qualify under the 
proposed requirements, but who have been performing their duties 
exceptionally well. These individuals may have obtained their knowledge 
through training at the facility or other experience. Thus, we have 
modified the requirements to allow for flexibility and for individuals 
with a broader range of experience to be a qualified IP. Specifically, 
we have removed the term ``clinician'' and instead provide at Sec.  
483.80(b) that the IP's primary professional training must be in 
nursing, medical technology, microbiology, or epidemiology, or other 
related field and that IPs can be qualified by education, training, 
experience or certification.
    Comment: Commenters supported the requirement for a LTC facility to 
designate an IP for whom the IPCP is their major responsibility and who 
serves as a member for the facility's QAA committee. However, other 
commenters argued that it is unrealistic to specify that the IPCP must 
be a ``major responsibility'' for the IP and that this requirement was 
unclear. The commenter said that this could easily be interpreted as 
0.50 FTE or more. This lack of clarity will lead to confusion and 
inconsistencies for providers and surveyors, resulting in technical 
misunderstandings that will undermine the intent of the requirement. 
One commenter pointed out that the hospital CoPs do not require the 
IPCP as a major responsibility of the IP or require the IP to have 
specialized training in infection prevention and control. The commenter 
recommended that the word ``major'' not be finalized. If the 
requirement is finalized, the meanings of ``major responsibility'' and 
``specialized training'' should be clarified. However, other commenters 
wanted the requirement strengthened by changing ``major'' to 
``primary'' responsibility.
    Response: Depending upon the facility, we understand that there is 
a substantial variation in the amount resources required for the IPCP, 
especially the amount of time the IP needs to devote to those 
responsibilities. For some facilities, especially small and rural LTC 
facilities, it may not be feasible or even necessary to have one staff 
person devote a substantial amount of their time to the IPCP or have it 
be their primary responsibility. Hence, we have modified the 
requirement for the IP by removing the language at Sec.  483.80(b) 
indicating the IPCP must be a major responsibility for the IP. However, 
we expect that each facility will review their facility assessment they 
conducted according to Sec.  483.70(e) to determine the resources it 
needs for its IPCP and ensure that those resources are provided for the 
IPCP to be effective. In addition, we are finalizing the requirement 
that the IP work at the facility at least part-time.
    Comment: One commenter questioned whether the reference in proposed 
Sec.  483.80(a)(1) to Sec.  483.75(e) should be Sec.  483.70(e).
    Response: We would like to thank the commenter for pointing out 
this discrepancy in the reference. Yes, the reference should be to 
Sec.  483.70(e). We have inserted the correct reference to that section 
in this final rule.
Influenza and Pneumococcal Immunizations
    Comment: Some commenters disagreed with many of the requirements 
related to influenza and pneumococcal immunizations. They noted, among 
other things, that no justification had been provided for a different 
process for immunizations in LTC facilities as compared to other 
healthcare facilities and that it was unclear why these particular 
vaccines should have these detailed requirements when other vaccines 
may have higher side effects. They also noted that the requirements did 
not recognize electronic medical records (EMRs). They noted that 
specifying the date ranges is not consistent with good public health 
practices and that the level of detail makes it more difficult to 
modify or update standards. The commenter recommended that most of the 
section be removed and that the facility should be required to develop 
policies and procedures to ensure that all residents and employees with 
direct patient care contact be offered and receive the influenza 
vaccine, unless they decline, per CDC guidance and that all residents 
be offered and receive the pneumococcal vaccine, unless they decline, 
per CDC guidance. Other commenters expressed concerns about the 
recommended dates for immunizations since this may change or vary in 
different regions. The commenter saw no valid reason to be so 
prescriptive about the exact date range and stated that doing so may 
make the regulations obsolete in the future. One commenter agreed with 
informing residents and/or their representatives about influenza and 
pneumococcal immunizations. However, since it is impossible to identify 
or judge whether they were sufficiently ``educated,'' the commenter 
recommended that the wording be changed.
    Response: We disagree with the commenters. As we explained in the 
proposed rule, we reorganized the requirements for influenza and 
pneumococcal immunizations for their previous location at Sec.  
483.25(n) to where it is now finalized, Sec.  483.80(d). With few 
exceptions, it is the identical requirement. We eliminated the 
exception that was set out at Sec.  483.25(v), which provided 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 because this was no longer the standard of care (80 FR 
42216). We replaced the term ``legal representative'' with ``resident's 
representative'' because we believe it is a broader term and 
encompasses individuals whom the resident has personally identified as 
their representative (80 FR 42216 through 42217). We believe that 
reorganizing this requirement to the infection control requirement was 
appropriate. According to the CDC, a vaccine is a product that 
stimulates the immune system to produce immunity to a specific disease 
(Immunization: The Basics, located at http://www.cdc.gov/vaccines/vac-gen/imz-basics.htm, accessed on January 26, 2016). Based upon our 
experience with LTC facilities, these immunizations are generally given 
by nursing personnel. Therefore, we believe that the infection control 
section is the most appropriate place for the requirements related to 
influenza and pneumococcal immunizations.
    Concerning the other comments on requirements for the pneumonia and 
pneumococcal immunizations, we did not propose any changes to these 
requirements. Influenza and pneumococcal immunizations are crucial for 
the resident populations. Due to the higher morbidity and mortality 
rates, we believe it is crucial that these immunizations be offered to 
the resident

[[Page 68812]]

population. Thus, we believe it is appropriate to specifically address 
these immunizations in these requirements. We also believe that the 
details, including dates and documentation, are also necessary to 
ensure appropriate immunizations for the residents. Although EHRs are 
not specifically addressed in this requirement, we do discuss health IT 
in other sections of this final rule. We expect that LTC facilities 
that use EHRs will include documentation concerning immunizations in 
those EHRs, as LTC facilities that use paper charts are expected to 
include the immunization documentation in the paper record. We have 
decided to retain the wording about ``education'' in the requirement. 
We believe further details concerning this requirement are best 
addressed in sub-regulatory guidance, which we will be producing for 
this final rule after it is published.
Implementation
    Comment: One commenter recommended that LTC facilities be allowed a 
minimum of two and up to three years to meet the requirements for a 
healthcare professional with additional training to serve as an IP and 
that there be a waiver process when the facility can not comply when 
due diligence has been followed but such a person is not available. 
They also recommend a minimum of two years and up to three years for a 
LTC facility to fully develop and implement the IPCP.
    Response: We understand that for some facilities, especially the 
smaller and rural LTC facilities, coming into compliance with the 
infection control requirements in this final rule may require an 
extended period of time. We are finalizing a phased in delay of the 
implementation date for these requirements. We refer readers to Section 
II. B for a detailed discussion regarding the implementation deadline 
for these specific requirements.
Costs
    Comment: Commenters pointed out that the proposed infection control 
requirements, especially those concerning the IP, are unnecessary and 
will increase costs.
    Response: We agree that coming into compliance with the infection 
control requirements in this final rule will require additional 
resources for many facilities. However, we have modified the 
requirements for the IP, now the infection control professional or ICP, 
which we believe will decrease the burden associated with this 
provision and address many of the commenters' concerns related to 
increased costs.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We have modified Sec.  483.80(a)(1) by changing the 
reference from Sec.  483.75(e) to Sec.  483.70(e).
     We have modified Sec.  483.80(a)(2)(iv) by inserting 
after, ``[w]hen and how isolation should be used for a resident,'' the 
following language, ``including but not limited to, (A) the type and 
duration of the isolation depending upon the infectious agent or 
organism involved, and a requirement that the isolation should be the 
least restrictive possible for the resident under the circumstances.''
     We have modified Sec.  483.80(b) to change the infection 
prevention and control officer (IPCO) to an infection preventionist 
(IP).
     We have modified Sec.  483.80(b) to allow LTC facilities 
to designate more than one IP.
     We have modified Sec.  483.80(b)(1) and (2) to establish 
that IPs must have primary professional training in nursing, medical 
technology, microbiology, epidemiology, or other related field and can 
be qualified by education, training, experience or certification.
     We have modified Sec.  483.80(b) by removing the 
requirement that the IPCP be a major responsibility for the IP.

X. 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) of the 
Act 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. In the proposed rule we 
included a robust discussion regarding several industry-specific 
guidance documents on compliance issued by the DHHS OIG. In addition, 
we also included a detailed discussion regarding a September 23, 2010 
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), to which we received feedback through public comment 
regarding compliance program requirements that are required by both 
sections 6102 and 6401(a) of the Affordable Care Act. We encourage 
readers to review the proposed rule for this background information.
Proposed Sec.  483.85(a) and Sec.  483.85(b)
    At Sec.  483.85(a), we proposed to define the terms ``compliance 
and ethics program,'' ``high-level personnel'', and ``operating 
organization.'' We proposed 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 Sec.  483.85(c). We did not propose using the term 
``managing employee'' that is contained in the current LTC facility 
requirements, but rather proposed to retain the use of the term ``high-
level personnel'', which is used in the Affordable Care Act. We 
proposed 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. We indicated that 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 also proposed 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 LTC facilities are part of 
corporate chains, there are still some LTC facilities that are owned by 
an individual or a small group of individuals. Therefore, we proposed 
to add ``individual(s)'' to the definition to make it clear that all 
LTC facilities, regardless of their legal structure, are required to 
comply with these requirements.
    In Sec.  483.85(b), we proposed that the operating organization for 
each facility must have in operation a compliance and ethics program 
(as defined in Sec.  483.85(a)) that meets the requirements of this 
section beginning on the date

[[Page 68813]]

that is one year after the rule's effective date.
Proposed Sec.  483.85(c)
    In Sec.  483.85(c), we proposed 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. First, at Sec.  485.85(c)(1) we proposed that the 
operating organization must 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. Second at Sec.  483.85(c)(2), we proposed that the operating 
organization must 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)). At Sec.  483.85(c)(2), we 
proposed that the program must 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.
    Next at Sec.  483.85(c)(4), we proposed that the operating 
organization is 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.
    We also proposed at Sec.  483.85(c)(5) that the operating 
organization 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 include, but are not 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.
    Next at Sec.  483.85(c)(6), we proposed that the compliance program 
must 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 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. We also 
proposed at Sec.  483.85(c)(6) that the operating organization 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. We proposed that an operating organization is 
required to consistently enforce its standards and procedures through 
appropriate disciplinary mechanisms.
    Lastly, at Sec.  483.85(c)(8) we proposed that after an operating 
organization detected a violation, it must 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. We noted in the proposed rule that in sections 1128I(b)(3)(F) 
and (G) of the Act, which correspond to Sec.  483.85(c)(7) and (8), the 
term ``offense,'' is used instead of ``violation'' and that the 
previously described components are mandatory for all of the SNF and NF 
operating organizations' compliance and ethics programs.
Proposed Sec.  483.85(d)
    At Sec.  483.85(d), we proposed to 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 must report directly to the governing body for the 
operating organization. We also proposed that all operating 
organizations designate a compliance and ethics program contact.
    In addition at Sec.  483.85(d), we proposed 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)).
Proposed Sec.  483.85(e)
    Lastly, at Sec.  483.85(e), we proposed 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.
General Comments
    Comment: Some commenters were very supportive of the proposed 
requirements for compliance and ethics programs, especially the 
components that are required for all facilities. Some commenters also 
appreciated the recognition of the different levels of resources that 
were available to smaller and larger operating organizations to 
develop, implement, and maintain compliance and ethics programs.
    Response: We thank the commenters for their support. We do 
recognize that there would be varying levels of resources available to 
smaller and larger organizations. Although the requirements for 
compliance and ethics programs finalized in this rule go to all 
operating organizations. with additional requirements for those with 
five or more

[[Page 68814]]

facilities, we would expect that all operating organizations would also 
use the facility assessment they developed according to Sec.  483.70(e) 
in developing and maintaining their programs. For example, the 
operating organization must provide, among other things, sufficient 
resources to reasonably assure compliance with the program's standards, 
policies, and procedures (Sec.  483.85(c)(3)). In addition, operating 
organizations must also take steps to effectively communicate the 
standards, policies, and procedures of its program to its entire staff, 
individuals providing services under contractual arrangements; and 
volunteers, consistent with their expected roles (Sec.  483.85(c)(5)). 
This can be accomplished by mandatory training, orientation programs, 
or disseminating information that explains in a practical manner what 
is required under the operating organization's program (Sec.  
483.95(f)). Operating organizations should use the facility assessment 
to determine the resources they need to devote to their compliance and 
ethics programs to reasonably assure compliance with the requirements 
finalized in this rule.
    Comment: Some commenters supported the proposed requirements, but 
also recommended certain individuals who they believed should be 
involved in developing and maintaining the facility's compliance and 
ethics program. Some commenters said that professional social workers, 
who are guided by the National Association of Social Work (NASW) Code 
of Ethics (2008), would be well equipped to contribute to and help to 
lead such programs.
    Response: We appreciate the commenters support for the proposed 
requirements. We also agree that social workers could play an important 
role in compliance and ethics programs. However, not all LTC facilities 
are required to have a full-time social worker on staff so we cannot 
require that a social worker be involved in developing, implementing, 
and maintaining these programs. We also believe that each facility 
needs the flexibility to determine how it will comply with the 
requirements finalized in this final rule, including choosing the 
individuals who will be involved in compliance and ethics programs.
    Comment: Some commenters noted there were definitions for some 
terms used in proposed Sec.  483.85, including ``compliance and ethics 
program'', ``high-level personnel'', and ``operating organization''; 
however, there was no definition for ``reasonable'' or ``reasonably''. 
They also noted that CMS did ask for comments on how to evaluate 
``reasonableness'' in the proposed rule (80 FR 42221). The commenters 
supported our statement that ``reasonableness'' may depend on the 
applicable facts and circumstances. Some commenters also recommended 
that the term ``reasonable'' be defined and that we use the Black's Law 
Dictionary definition of ``reasonable person'' as it is often used in 
other areas of the law, such as, an ordinary person who exercises care 
while avoiding extremes of boldness and carefulness.
    Response: We do believe that reasonableness depends upon the 
applicable facts and circumstances surrounding any particular 
situation. As stated in the July 16, 2015 proposed rule (80 FR 42168), 
the terms ``reasonable'' and ``reasonably'' were used in the section 
6102 of the ACA and consequently used in proposed Sec.  483.85(c)(1), 
(6), and (8). We did not propose a definition of these terms in the 
proposed rule, but did state that ``[w]e 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 (80 FR 42221). We 
will not be finalizing a definition of ``reasonable'' or ``reasonably'' 
in this rule. However, we will be publishing further sub-regulatory 
guidance on how to determine reasonableness for these requirements''.
    Comment: Some commenters were concerned about including contractual 
staff and volunteers in some of the requirements. Specifically, 
proposed Sec.  483.85(c)(1), (5), and (6) that state that LTC 
facilities must establish ``disciplinary standards,'' communicate ``the 
standards, policies, procedures . . . includ[ing] . . . mandatory 
participation in training or orientation programs and/or dissemination 
of information,'' and ``ensure that reasonable steps were being taken 
to achieve compliance'' by the facility's staff, and ``individuals 
providing services under a contractual arrangement; and volunteers, 
consistent with the volunteers' expected roles.'' They argued that it 
would not be a good use of the facility's time and resources and that 
some LTC facilities could find it burdensome to train and orient 
contractor staff and volunteers to their compliance and ethics program. 
It should be the contractor that it responsible for training the 
contract staff and the LTC facility should only be responsible for 
orienting the contract staff to the nuances in their program. In 
addition, they argued that training for these individuals could be 
inconsistent with the best practices that are currently in place for 
LTC facilities, which is to educate contractors or volunteers about the 
facility's compliance program, seven core elements of an effective 
compliance program, code of conduct, reporting processes (hot line 
numbers and other alternative reporting mechanisms) and correction 
processes by furnishing written materials to contractors or volunteers 
to review and having them attest to reviewing the materials. The 
contracting agency should be discussing compliance and ethics matters 
with their employees and this is often covered in their contracts with 
the LTC facilities. It should be understood that the LTC facility would 
be responsible for orienting contractual staff to the individual 
nuances of the compliance and ethics program for the facility. The 
commenters recommended that LTC facilities not be required to provide 
full training and education to volunteers and contractor agency 
personnel but that the facilities be required to provide these 
individuals with an overview of their programs.
    Response: For any operating organization's compliance and ethics 
program to be effective, it is crucial that all of the organization's 
staff, including those who are providing services under contract, and 
volunteers, consistent with their roles, need to understand the 
standards, policies and procedures for that program. If these 
individuals do not understand the program's requirements and their 
responsibilities under that program, they will not be able to comply 
appropriately and that will severely reduce, or perhaps eliminate, the 
effectiveness of the program. Operating organizations with four or less 
facilities ``must effectively communicate'' to the operating 
organization's entire staff; individuals providing services under a 
contractual arrangement; and volunteers, consistent with their expected 
roles. It could be formal training, but they could also comply with 
this requirement through dissemination of materials, as the commenters 
noted above. For operating organizations with five or more facilities, 
annual training is required. However, these requirements do not specify 
how the training or dissemination of information is to be performed. 
Further, as set forth in Sec.  483.95, it states that ``[a] facility 
must determine the amount and types of

[[Page 68815]]

training necessary based on a facility assessment as specified at Sec.  
483.70(e).'' We believe that each operating organization needs to have 
the flexibility to determine the best way for each of them to comply 
with this requirement and this final rule provides them that 
flexibility to determine what kind of dissemination of information or 
training they need to provide. In addition, it is the training or 
dissemination of the information that is crucial. For example, the 
operating organization could choose to arrange with the contractor to 
have the contractor provide the required training or dissemination of 
information for the compliance and ethics program as some commenters 
indicated happens today.
    Comment: Some commenters recommended that LTC facilities be 
required to integrate the information from the compliance program into 
the facility's QAPI program. The commenters believed that compliance 
must be coordinated into the current ongoing activities so that the 
primary focus remains on doing the right thing in the right way 
routinely, and on proper clinical reasoning and problem solving, with 
regulatory and legal compliance always kept in mind but not as a 
separate or predominant activity. They were concerned that an excessive 
or separate focus on compliance could potentially result in clinically 
questionable activities in the name of ``compliance'' that could be 
inconsistent with desirable care approaches.
    Response: We agree that the information and data obtained through 
the facility's compliance and ethics program should be integrated into 
the facility's QAPI program. However, the QAPI requirements finalized 
in this rule already provide for this integration. The facility must 
design its QAPI program to be ongoing, comprehensive, and to address 
the full range of care and services provided by the facility and must 
address, among other things, all of the systems of care and management 
practices (Sec.  483.75(b)(1)). In addition, each facility must 
establish and implement written policies and procedures for feedback, 
data collections systems, and monitoring (Sec.  483.75(c)). Also, the 
QAA committee must regularly review and analyze data and act on 
available data to make improvements (Sec.  483.75(g)((2)(iii)). Thus, 
LTC facilities should be integrating the information and data they 
collect or arises out of their compliance and ethics programs into 
their QAPI program.
    The requirements for compliance and ethics and the QAPI programs 
should work together or be coordinated to not only ensure compliance 
with the requirements in this final rule but also improvements in the 
quality of care provided to the residents. Also, we do not believe this 
will result in an excessive or separate focus on compliance or result 
in negative consequences to the residents, staff, or facility.
Additional Requirements for Operating Organizations With Five or More 
Facilities
    Comment: Some commenters were concerned that our proposal for 
additional requirements for operating organizations with five or more 
facilities was imposing additional requirements on certain operating 
organizations based upon an arbitrary number of facilities. Some 
commenters recommended that only operating organizations with 15 or 
more facilities be required to comply with the additional requirements.
    Response: We proposed additional requirements for operating 
organizations with five or more facilities, because section 
1128I(b)(2)(B) of the Act, as added by section 6102 of the ACA (Pub. L. 
111-148 (2010), states that ``with respect to specific elements or 
formality of a program, in the case of an organization that operates 5 
or more facilities, vary with the size of the organization.'' Since the 
statutory language specifically indicates that the compliance and 
ethics programs for operating organizations with five or more 
facilities should be a more formal program or have more elements, we 
will be not finalize Sec.  483.85(d) to apply to operating 
organizations with 15 or more facilities. Hence, we have finalized that 
section so that the additional requirements apply to operating 
organizations that have five or more facilities.
    Comment: Other commenters were very supportive of the proposed 
additional requirements for operating organizations with five or more 
facilities as set forth in Sec.  483.85(d): Mandatory annual training 
programs on the operating organizations' compliance and ethics programs 
that meet the requirements set forth in Sec.  483.95(f); designated 
compliance officers for whom their operating organization's compliance 
and ethics program is a major responsibility; and designated compliance 
liaisons located at each of the operating organization's facilities.'' 
These commenters recommended that all operating organizations, 
regardless of size, be required to comply with these additional 
requirements.
    Response: We appreciate the commenters support for these additional 
requirements. However, in developing requirements, we must balance the 
necessity of the requirement for the health and safety of the residents 
with the burden of that requirement to the operating organization. We 
believe that the additional requirements are necessary for larger 
operating organizations to develop and maintain effective compliance 
and ethics programs. Larger organizations will generally be caring for 
more residents and have more locations for which they are responsible. 
We believe this requires that the larger operating organizations have a 
compliance officer. Since that compliance officer will be responsible 
for the organization's program at five or more facilities, we believe 
he or she will need someone at each facility, the compliance liaison, 
to assist them with the program at each facility. In addition, 
considering the number of facilities, we believe this requires annual 
training to ensure that all staff, including those who are providing 
services under a contract and volunteers, consistent with their roles, 
are knowledgeable about the operating organization's program and how 
they are expected to comply with its standards, policies, and 
procedures. For operating organizations with four or fewer facilities, 
we believe they can develop and maintain a compliance and ethics 
program that is effective in preventing and detecting criminal, civil, 
and administrative violations under the Act as required by section 
1128I(b)(1) of the Act without the additional requirements for larger 
operating organizations. However, we would encourage operating 
organizations with four or fewer facilities to incorporate these 
additional elements if their facility assessments indicate that they 
are necessary to ensure that their compliance and ethics programs are 
effective. Thus, we will not be extending the addition requirements set 
forth in Sec.  483.85(d) to all operating organizations.
    Comment: Some commenters were concerned about the requirement for 
designated compliance liaisons at each facility for operating 
organizations with five or more facilities (Sec.  483.85(d)(3)). They 
did not believe it was good policy to appoint someone at each facility 
who does not have the critical experience, education, or knowledge of a 
compliance officer. It is also not feasible to expect that each 
facility could hire someone with the background or expertise to be a 
compliance officer in the operating organization's compliance and 
ethics program.
    Response: Compliance liaisons are not compliance officers. In the 
proposed rule, we did not define ``designated compliance liaison'' but 
stated that

[[Page 68816]]

``[w]e 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 . . . [a]t 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'' (80 FR 42220). We believe that each operating organization 
needs the flexibility to determine what the qualifications, duties, and 
responsibilities that these compliance and ethics program liaisons 
should have in their organization. Thus, it is the operating 
organization with five or more facilities that will develop its own 
definition for the position of ``designated compliance liaison'' and 
determine the qualifications, duties, and responsibilities for the 
individuals in this position.
    Comment: Some commenters noted that compliance officers could not 
to be subordinate to the general counsel (GC), chief financial officer 
(CFO) or chief operating officer (COO) in proposed Sec.  483.85(d)(2). 
They were very supportive and noted that in many large organizations 
the GC is the compliance officer and is often the best qualified to 
address potential legal violations and other areas of concern. In 
addition, the commenters noted that in many mid-sized organizations the 
GC, CFO, or COO is the compliance officer because the organization 
cannot financially support a full-time compliance officer. Some 
commenters recommended that we insert a sentence that specifically 
indicates that the GC, CFO, or COO may serve as the compliance officer. 
Other commenters recommended that the compliance officer also not be 
subordinate to the facility's chief executive officer (CEO) or the 
administrator.
    Response: We agree with the commenters that it is very important 
that the compliance officer not be subordinate to certain individuals 
in the operating organization. We agree that the compliance officer 
should also not be subordinate to an administrator; however, we believe 
that the compliance officer would be within the operating 
organization's staff and not located at an individual facility to avoid 
any interference or influence of the compliance officer by an 
administer. We do not agree that the compliance officer could not be 
subordinate to the CEO, who is generally the highest ranking officer in 
an operating organization. For these reasons, we did not propose that 
the compliance officer could not be subordinate to the CEO or an 
administrator. The compliance officer must be able to communicate with 
the governing body without being subject to any coercion or 
intimidation. This is why we proposed Sec.  483.85(d)(2) that states 
that the compliance officer must be able to report directly to the 
governing body. Thus, we have finalized Sec.  483.85(d)(2) as proposed. 
We believe any further detail on who can and cannot serve as the 
compliance officer should be provided in the sub-regulatory guidance 
for this requirement. We refer facilities to additional guidance the 
OIG has published for nursing home compliance programs, ``OIG 
Supplemental Compliance Program Guidance for Nursing Facilities'' (73 
Fr 56832) (https://oig.hhs.gov/compliance/compliance-guidance/docs/complianceguidance/nhg_fr.pdf).
Implementation and Costs
    Comment: Some commenters were concerned about the 1-year timeframe 
for implementation of the compliance and ethics programs. Commenters 
wanted at least 2 years for LTC facilities to develop their compliance 
and ethics programs. They based the 2 years on both the statutory 
language in ACA that stated that the Secretary had 2 years to 
promulgate regulations for compliance and ethics programs and to allow 
adequate time to change and adjust current compliance and ethics 
programs allow adequate time to change and adjust current processes and 
procedures and to reconfigure facility budgets.
    Response: We appreciate the commenters' concerns about the 
implementation of the requirements for compliance and ethics programs. 
We are finalizing a phased in delay of the implementation dates for 
this final rule. We refer readers to Section II.B. for a detailed 
discussion regarding the implementation deadlines for these 
requirements. The estimated costs for complying with these requirements 
are discussed in sections V. Collection of Information Requirements and 
VI. Regulatory Impact Analysis (RIA).
    Comment: Some commenters believed that the requirements for the 
compliance and ethics program were unduly prescriptive and costly and 
could impose an unnecessarily onerous burden on some LTC facilities. 
However, some of these commenters also indicated that a major 
organization for long-term care facilities had already been educating 
its membership on the requirements in ACA for compliance and ethics 
program in LTC facilities and had educational tools on its Web site.
    Response: Section 6102 of the ACA mandated compliance and ethics 
programs in LTC facilities. Hence, these are not discretionary 
requirements. In developing these regulations, we have established the 
requirements contained in the ACA and have been mindful of the burden 
which will be required to comply with these requirements. In finalizing 
these requirements, we strived to avoid not only any unnecessary burden 
but also to provide maximum flexibility for operating organizations to 
comply with the requirements established in ACA.
Surveys
    Comment: Some commenters were concerned about how the LTC 
facilities would be surveyed for the compliance and ethics program 
requirements. Some commenters wanted a tangible observational process 
established for the surveyors, which would validate that facilities are 
providing compliance and ethics policies and procedures to the staff 
and that governing bodies are implementing those policies and 
procedures.
    Response: We understand that commenters have concerns about how 
surveyors would determine compliance with these requirements. As 
discussed above, we will be developing and publishing or disseminating 
sub-regulatory guidance, including interpretative guidelines (IGs), 
before surveyors begin to survey LTC facilities for these requirements. 
That guidance will provide the detailed information surveyors need to 
determine compliance with these requirements.
    After consideration of the comments we received on the proposed 
rule, we are finalizing the requirements as proposed.

Y. Physical Environment (Sec.  483.90)

    In the proposed rule we indicated that 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 recently 
published a final rule which adopts many provisions of the 2012 LSC 
``Medicare and Medicaid Programs; Fire Safety Requirements for Certain 
Health Care Facilities,'' (81 FR 26871, May 4, 2016). As part of our 
comprehensive review and restructuring, we 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'' are unchanged, including new provisions 
related to the requirement that long term care

[[Page 68817]]

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 Sec.  483.90(c) ``Space and equipment'', we proposed 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. We 
proposed to eliminate the word ``essential'' from Sec.  483.90(c)(2) 
(re-designated from Sec.  483.70(c)(2)). In addition, we proposed 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.
    Currently, in existing Sec.  483.70(d), the regulations allow for 
bedrooms that accommodate up to four residents. We proposed to require 
at 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. We indicated in the 
proposed rule that 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 also proposed 
to require that the bed size and height be not only convenient for the 
resident's needs, but also safe.
    Section 483.70(e) currently requires that each bedroom be equipped 
with or located near toilet and bathing facilities. We proposed at 
Sec.  483.90(e) to add the requirement that, for facilities that 
receive approval of construction or 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 proposed 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. We 
indicated in the proposed rule that 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.
    At Sec.  483.90(f) (proposed to be re-designated from Sec.  
483.70(f)), a resident call system is required. We proposed to revise 
this revision and 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.
    At Sec.  483.90(g) (proposed to be re-designated from Sec.  
483.70(g)) we address dining and activity rooms and include a 
requirement to designate non-smoking areas. We proposed to eliminate 
the language ``with non-smoking areas identified''.
    We also proposed to add a new paragraph at Sec.  483.90(h)(5) 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, including but 
not limited to non-smoking residents.
    Comment: One commenter asked that we adopt the 2012 Life Safety 
Code.
    Response: This concern has been addressed through separate rule-
making. As noted above, we published the final rule, ``Medicare and 
Medicaid Programs; Fire Safety Requirements for Certain Health Care 
Facilities,'' which would adopt many provisions of the 2012 LSC on May 
4, 2016 (81 FR 26871).
    Comment: Some commenters recommended that CMS consider adopting the 
``Guidelines for Design and Construction of Residential Health Care and 
Support Facilities,'' produced by the Facilities Guidelines Institute, 
in addition to and in the same manner as we currently adopt the Life 
Safety Code.
    Response: We thank the commenters for their suggestion. We will 
evaluate this suggestion further and consider it for future rulemaking.
    Comment: Some commenters disagreed with our proposed requirement 
regarding bed rails. One stated that their facility already had a 
process in place and this would require an additional inspection that 
would take away from their ability to complete other maintenance tasks. 
Another stated that our requirements were inadequate given the risks 
posed by bed rails, citing concerns about the availability of 
manufacturer information and guidance. One commenter recommended 
strengthening our requirements including adding additional detailed 
requirements, especially to safeguard against entrapment.
    Response: We agree that resident safety in important when 
considering the use of bed rails. However, detailed guidance regarding 
the use of bed rails is more appropriate in interpretive guidance. As 
noted in the proposed rule, additional resources are available at 
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/HospitalBeds/default.htm. If a 
facility already conducts regular inspections of all bed frames, 
mattresses, and bed rails, no new process would be required as long as 
the requirements at Sec.  483.25(n) and Sec.  483.90(c) were met. If a 
facility was unable to identify a manufacturer and access manufacturer 
information and guidance for bed rails that they used, they would not 
be meeting requirements to follow the manufacturers' recommendations 
and specifications for installing and maintaining bed rails set forth 
in Sec.  483.25(n)(4).
    Comment: Several commenters supported our proposal to limit the 
number of residents in a room to two. Many suggested that the 
requirements do not go far enough. Several suggested that this 
requirement should apply to all facilities, not just newly constructed, 
certified, or renovated. Others suggested that private rooms should be 
the standard, with a few double rooms to accommodate couples or those 
desiring a roommate. A few commenters objected to the requirement. Some 
commenters stated that this requirement was burdensome and would 
discourage new construction and renovation. Some commenters felt that 
this requirement should apply to new construction only and were 
concerned about the definition of reconstruction. One commenter stated 
that their facility had large rooms and putting an occupancy limit on 
all rooms regardless of considering the size of the rooms would be 
unreasonable.
    Response: We have taken into account all of the comments received, 
both supportive comments and those pointing out concerns with our 
proposal to limit room occupancy only in newly constructed, 
reconstructed, or newly certified facilities and considered multiple 
alternatives. We believe that semi-private rooms are far more 
supportive of privacy and dignity. We recognize that for many 
residents, a private room would be ideal. However, for others, a spouse 
or other roommate is desirable. We note that many states have physical 
environment requirements that exceed our requirements. These 
requirements vary widely, but many states include a

[[Page 68818]]

requirement for no more than two beds per resident room or establish a 
minimum percentage of rooms that must be private or semi-private. 
Individual facilities can choose to offer private rooms as well. 
However, as these regulations apply to every Medicare- and Medicaid- 
certified facility, we must also consider the potential for our 
requirements to discourage innovation, new construction, or 
reconstruction and to negatively impact access to care. Therefore, at 
this time, we believe our proposal represents an appropriate balance 
among the concerns voiced and we are finalizing this requirement as 
proposed. With regard to the definition of reconstruction, we have 
stated that this 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 would clarify that, for 
reconstruction, the requirement applies to the reconstructed area, so 
that where reconstruction involves a limited area within a building, we 
would not expect the entire building to upgrade to the new 
requirements. This should not deter facilities from making needed 
renovations. We defer additional discussion to sub-regulatory guidance.
    Comment: One commenter noted that residents benefit from being 
outdoors, not just in the facility. The commenter suggested that CMS 
should establish goals that help pave the way to more universal 
standards for facilities that are person-centered in all aspect, 
including physical environment that recognizes the needs of residents 
for privacy, dignity and personal choice and included should look to 
models such as Green House[supreg] to ``borrow'' as appropriate. 
Another commenter recommended that we include a requirement that the 
facility provide sufficient outdoor space that is accessible to 
residents and where residents can sit and move around as independently 
as possible.
    Response: We thank the commenter for their suggestions. We agree 
that some residents may benefit from access to outdoor spaces. Such 
access, of course, must be balanced with safety and supervision 
concerns, which may vary significantly across resident populations. In 
addition, such requirements would need to be equally applicable to all 
long-term care facilities, whether urban, suburban, or rural, or small, 
medium, and large. We are aware of the Green House[supreg] and other 
models and will continue to evaluate these models and new innovations, 
including requirements for outdoor space, and consider their 
application in future rule-making.
    Comment: A couple of commenters asked that we consider using terms 
other than ``toilet facilities'' or other terms that reflect an 
institutional mindset.
    Response: We appreciate the comment and have modified language at 
Sec.  483.90(e).
    Comment: Several commenters objected to our proposal to include a 
shower, in addition to a toilet and sink, in rooms that are renovated, 
or newly constructed or certified after the effective date of the final 
regulation. A number of commenters suggested that not only would such 
showers be under-utilized, they would present a safety hazard. Some 
commenters raised, in particular, safety concerns related to residents 
with dementia having unsupervised access to a shower. One referred to a 
shower as ``costly, wasted space'' and another stated that ``it has 
been our experience . . . that current showers in private rooms go 
unused.'' Some commenters suggested this requirement should not apply 
to facilities being renovated, as this would discourage needed upgrades 
to facilities. A commenter suggested that building configuration and 
existing spaces would not be conducive to adding showers, given other 
square footage and code requirements applicable to resident spaces. 
Further, showers in these rooms would need to be of substantial size to 
accommodate specialized equipment when necessary, resulting in reduced 
living space for the resident. Some commenters suggested that 
construction costs may make this prohibitive for many companies to 
build new facilities, resulting in reduced construction at a time when 
additional facilities may be needed due to demographic factors or that 
such costs would create a disincentive to update and modernize resident 
rooms. Other commenters supported the inclusion of a shower for each 
resident room, stating that this would eliminate residents needing to 
go down the hall to a common bathing room. Another suggested that 
portable showers could serve the intended purpose but avoid some of the 
concerns that have been raised.
    Response: We have taken into account all of the comments received, 
both supportive comments and those pointing out concerns with our 
proposal. We considered suggestions to require facilities to install 
safety features or special monitoring in bathrooms. We acknowledge 
concerns about safety as well as the disincentive for facility upgrades 
that our proposal could create, particularly in light of space 
requirements for a safe, effective shower. Given these concerns, at 
this time, we have decided to modify the proposed requirement at Sec.  
483.90(e) to require that resident rooms have a toilet and sink in 
facilities that receive approval of construction plans by state and 
local authorities or are newly certified to participate in Medicare 
and/or Medicaid after the effective date of this rule. Facilities 
continue to have the option to exceed our requirements, in keeping with 
the health, safety and quality of life of its residents.
    Comment: Several commenters supported our proposal to require that 
each resident room must have its own commode and sink. Some commenters 
objected to our requirement that each room must have its own commode 
and sink. Several commenters stated that existing facilities are likely 
not to have adequate space to accommodate this requirement and believed 
that this would prevent facilities for undertaking renovations. One 
commenter asked if a bathroom shared between two resident rooms would 
be permissible.
    Response: Our requirement states that each resident room must have 
its own bathroom. A shared bathroom would not meet this requirement. We 
have considered commenters concerns about cost and the lack of 
available space to add additional bathrooms deterring upgrades to 
existing facilities and have revised this requirement to apply only to 
facilities that receive approval of construction from State and local 
authorities or are newly certified after the effective date of this 
rule. Furthermore, we believe removing the requirement for each 
bathroom to include a shower substantially reduces the burden, both 
financial and in terms of space, that this requirement imposes on 
facilities subject to the heightened requirement.
    Comment: One commenter asked that it be made clear that ``newly 
certified'' does not include facilities where there has been a change 
of ownership. Other commenters echoed similar concerns about 
certification after change of ownership.
    Response: When facilities change ownership, the new owners have the 
option of accepting the existing provider agreement. In this case, the 
facility would not be ``newly certified.'' However, when a new owner 
does not accept the existing provider agreement, the facility does 
require a ``new certification'' and these requirements would apply. We 
considered explicitly exempting all changes of ownership from this 
requirement, however, there is the potential for significant abuse of

[[Page 68819]]

such an exemption and we believe that to do so is not appropriate.
    Comment: One commenter objected to our inclusion of smoking 
cessation in proposed paragraph (h)(5). The commenter stated that while 
smoking cessation is a noble cause, it should not be required in every 
center's policies, particularly if a facility has adopted a policy for 
non-smoking. They further stated that smoking cessation programs are 
appropriate for some facilities but not for all. Finally, the commenter 
stated that the requirement, as written, was confusing and should also 
reference electronic cigarettes. Another commenter stated that smoking 
should not be considered a resident right and that accommodating 
smoking takes CNAs away from caring for residents.
    Response: We appreciate the commenter's thoughtful suggestions. We 
have revised the provision to remove the reference to smoking 
cessation, and improve clarity. We did not at this time add electronic 
cigarettes, but will evaluate whether or not electronic cigarettes 
should be included in this provision in the future. We agree that a 
smoking cessation program may not be appropriate for some facilities, 
such as those facilities that are ``smoke-free.'' However, even 
``smoke-free'' facilities may admit residents who smoke. Smoking 
cessation support should be offered to residents who smoke and 
addressed in their person centered plan of care. Smoking is not 
addressed as a resident right; rather, we require that facilities have 
policies and procedures to safeguard residents, whether smoking or non-
smoking, if and where smoking occurs.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     We have modified our proposal at Sec.  483.90(e) to 
require that, for facilities that receive approval of construction or 
are newly certified after the effective date of this final rule, each 
resident room must have its own bathroom with at least a commode and a 
sink.
     We have modified our proposal at Sec.  483.90(h)(5) to 
state that facilities must establish policies in accordance with 
applicable Federal, State, and local laws and regulations regarding 
smoking, smoking areas, and smoking safety that also take into account 
non-smoking residents.

Z. Training Requirements (Sec.  483.95)

    We proposed to add a new Sec.  483.95 to subpart B which sets forth 
training requirements. We proposed 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 proposed 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 proposed at Sec.  483.95(a) to include effective communications 
as a required training topic for direct care personnel. We did not 
propose to require a specific amount of time, specific communications 
topics, or specific training mechanisms to meet this requirement. We 
proposed 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. At Sec.  483.95(c) we proposed 
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 proposed 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.
    At Sec.  485.95(d), we proposed to require that a facility must 
provide mandatory QAPI training to its staff that outline the elements 
and goals of the facility's QAPI program. At Sec.  483.95(e) we 
proposed 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.
    At Sec.  483.95(f)(1), we proposed 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 did not specify how a facility should develop this 
training; however we indicated in the proposed rule that 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 
proposed to require that if the operating organization operates five or 
more facilities, it must include mandatory training annually.
    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.'' We proposed to amend the LTC requirements by 
requiring that the current mandatory on-going training requirements for 
NAs include dementia management and resident abuse training.
    We also proposed to relocate the training requirements for NAs at 
Sec.  483.75(e)(8) to Sec.  483.95(g). Specifically, we proposed 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 
proposed 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 Sec.  483.95(g)(3), we proposed 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). 
In addition, 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 proposed to relocate this provision without change 
to proposed Sec.  483.95(h).
    Lastly, we proposed 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), 
we proposed that the facility be responsible for using their facility 
assessment to determine the behavioral health related needs of their 
residents. Then the facility must ensure that their staff is provided 
with behavioral health training that correlates with the needs of their 
residents.
    Comment: Many commenters applauded the addition of the training 
section and the inclusion of the various required topics of training. 
Commenters noted that all trainings should be conducted in an 
environment that encourages participation and open discussion with the 
freedom to ask questions.
    Response: We appreciate the feedback from commenters. We believe 
that requiring facilities to develop, implement, and maintain an 
effective training program for staff will help to prepare staff and 
improve outcomes. In addition, we believe that appropriately training 
staff can improve resident safety, create a more person-centered 
environment, and reduce the number of adverse events or other resident 
complications. We agree that training activities should encourage 
participation and allow for open dialogue among participants in order 
to

[[Page 68820]]

be productive. We encourage facilities to allow for this type of 
interaction and anticipate that the interpretive guidance to this 
regulation will further provide ideas and best practices for how to 
implement these training requirements.
    Comment: While commenters supported the training topics named in 
the proposed rule, many commenters provided suggestions for additional 
topics to be required for all facility staff members who provide 
services directly to residents. Suggested topics included advance care 
planning, cultural competence, end-of-life care, geriatrics and 
gerontology, working with young and middle-aged adults, grief and loss, 
interdisciplinary collaboration, person-centered care, specialized 
rehabilitative therapy, and intellectual disability. In addition, one 
commenter recommended that the training section be expanded to require 
training on additional CMS requirements, such as resident choice and 
quality of life and care. One commenter indicated that staff should be 
educated on the aging process and have an understanding of how human 
beings change as they grow older.
    Response: We appreciate the feedback from commenters. Given the 
volume of the proposed requirements and the concerns raised by 
commenters regarding the time needed to implement all of the 
requirements, we believe it would be overly burdensome to increase the 
number of required training topics at this time. We will continue to 
evaluate each of the suggested topics raised by commenters and consider 
them for future rulemaking. In addition, we note that while the 
regulations require specific training topics, facilities have the 
flexibility to add more topics to their training programs, in 
accordance with their facility assessments.
    Comment: A couple of commenters recommended that the requirement 
for communication training specifically address the content that should 
be discussed in the training. One of the commenters recommended that 
the content specifically address individuals with dementia, individuals 
who are non-verbal, and individuals with hearing and/or vision 
impairments. Another commenter indicated that the requirement for 
communication training should specify the number of hours required for 
the training. One commenter indicated that the regulations should 
specifically require staff to pass exams as part of their training 
program.
    Response: We appreciate the recommendations from commenters, but 
ultimately we recognize that training needs are likely to change over 
time. We believe that it is necessary for facilities to 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. To ensure that the training 
provided is facility specific and most beneficial to the residents 
receiving care in the facility, we believe that it is best not to limit 
the training requirements to too many specifics. We expect that the 
surveyor guidance associated with this final rule will provide 
facilities with additional guidance for how to meet these requirements. 
In addition we encourage readers to refer to the proposed rule 
discussion (80 FR 42222) for resources available for providing 
effective communication training including the Agency for Healthcare 
Research and Quality's (AHRQ) Team STEPPS Long Term Care communication 
training for front line staff in LTC facilities (http://www.ahrq.gov/qual/ptsafetyltc/index.html).
    Comment: Many commenters recommended that caring for residents with 
dementia should be highlighted as a training topic for all nurse 
staffing personnel, not just nurse aides. Commenters noted that there 
are an overwhelming number of individuals with a diagnosis of 
Alzheimer's or another dementia-related illness in LTC facilities and 
the use of interdisciplinary teams to deliver care is on the rise. One 
commenter indicated that simple ideas such as sensory stimulation be 
used for communicating with an individual who has dementia and that 
this type of care does not need to be the province of just one type of 
staff who is caring for the individual. Another commenter noted the CMS 
``Hand in Hand'' curriculum (http://www.cms-handinhandtoolkit.info/) as 
an excellent resource and highlighted a report developed by the 
Dementia Action Alliance entitled, ``Living Fully with Dementia: Words 
Matter'' (http://daanow.org/living-fully-with-dementia-words-matter/) 
as an additional resource for interested parties.
    Response: Given the encouragement from commenters to extend 
dementia management training beyond just NAs, we have revised our 
proposal in this final rule. We agree that expanding the requirement 
for dementia management training to all staff will only further improve 
the care that is provided. Therefore, at Sec.  483.95(c) we are adding 
a provision to require that all new and existing staff, individuals 
providing services under a contractual arrangement, and volunteers 
receive dementia management and abuse prevention training, consistent 
with their roles in the facility. We are not proposing that facilities 
develop a separate training from that required for nurse aides and 
given that the dementia management training will already be developed, 
it will not be overly burdensome for facilities to expand the training 
to all staff. In addition, we encourage facilities to utilize the free 
training materials available to facilities, such as the CMS ``Hand in 
Hand'' curriculum as well as the additional resources highlighted by 
commenters.
    Comment: One commenter recommended that the term dementia 
management be replaced with ``appropriate care of residents living with 
dementia'' to be more person-centered.
    Response: We appreciate the recommendation; however, dementia 
management is the language used in the Affordable Care Act and at this 
time we are using the same term for consistency.
    Comment: One commenter indicated that all or part of the abuse, 
neglect, and exploitation training should be performed by an individual 
or agency that is not associated with the LTC facility.
    Response: The regulations do not specify that a member of the 
facility has to conduct the training activities and facilities have the 
flexibility to work with outside entities to provide the training. We 
encourage facilities to leverage any resources available to assist with 
developing and implementing their training program.
    Comment: One commenter recommended that all staff be required to 
receive an orientation to the LTC facility within their first two weeks 
of employment that includes training in at least residents' rights, 
aging, dementia, abuse reporting requirements, emergency procedures, 
and the policies of the LTC facility.
    Response: We agree that new staff members should also receive 
training and have specified at Sec.  483.95 that training must be 
provided to both new and existing staff. As discussed in a previous 
comment, we believe it would be burdensome to require additional 
training topics at this time.
    Comment: One commenter recommended that all staff be required to be 
certified as nursing assistants. The commenter indicated that all staff 
should be able to assist residents with all activities of daily living 
without having to wait for a CNA.
    Response: We agree that all staff should be able to assist 
residents with activities of daily living. However, we do not believe 
that having this capability is dependent on being a nursing assistant 
and therefore do not believe that it is necessary to require all

[[Page 68821]]

staff to be certified as nursing assistants. Instead we believe that 
facilities should assess their resident population including, among 
other things, the care required by the resident population considering 
the overall acuity that are present within the population. We proposed 
at Sec.  483.70(e) to require facilities to conduct an annual facility 
assessment that addresses the staff competencies that are necessary to 
provide the level and types of care needed for the resident population. 
We believe that facilities will be able to use this information to 
appropriately staff their facilities and provide residents with the 
care and attention that they need.
    Comment: One commenter recommended that those facilities with 
residents diagnosed with dementia should be required to conduct an 
annual assessment of all direct care staff that includes observation, 
to ensure that staff are providing adequate dementia care and abuse 
prevention. The commenter recommends further that for those staff 
members who exhibit caregiver stress, the facility should be required 
to have a plan in place to identify and support these individuals.
    Response: The in-service training requirement for nurse aides 
specifies that the training must be no less than 12 hours per year. 
Therefore, following the implementation of this final rule nurse aides 
who provide direct care to residents will be re-trained in dementia 
management, as proposed at Sec.  483.95(g)(2), at least annually. In 
addition, we note that in response to comments in this final rule we 
are expanding the requirement for dementia management and abuse 
prevention training to all direct care staff. As discussed previously, 
by direct care staff we are referring to those individuals who, through 
interpersonal contact with residents or resident care management, 
provide care and services to allow residents to attain or maintain the 
highest practicable physical, mental, and psychosocial well-being. 
While we appreciate that recommendation to provide staff members with 
support for caregiver stress, we believe that it would be overly 
burdensome to place this additional responsibility on facilities. We 
encourage those facilities that are capable to consider developing some 
type of employee assistance program that can be utilized by those staff 
members that may be exhibiting caregiver stress.
    Comment: One commenter disliked the use of the phrase ``dementia 
management'' and suggested the use of the phrase ``dementia care'' 
indicating that this phrase is more person-centered.
    Response: We appreciate the commenter's feedback, however dementia 
management is the phrase used in the statute and at this time we are 
aligning the terminology in our regulation with that of the statute for 
consistency.
    Comment: A few commenters recommended increasing the number of on-
going in-service training hours for nurse aides. Commenters provided 
various recommendations for the number of hours increased from 12 to 24 
hours. Another commenter recommended that CMS evaluate the current in-
service training provided to nurse aides in order to determine a 
minimum requirement for hours to enhance the continued competency of 
staff.
    Response: We appreciate the feedback from commenters and agree that 
additional consideration should be given to increasing the number of 
in-service training hours required for nurse aides. We will continue to 
review the commenters and as recommended by commenters, review the 
current in-service training for nurse aides in order to determine a 
minimum number of training hours that will help to enhance the 
continued competency of staff.
    Comment: One commenter recommended that the in-service training for 
nurse aides be expanded to include training in end-of-life care, 
teamwork, and problem solving. Another commenter recommended that nurse 
aides should also be trained to recognize situations where licensed 
nursing staff are needed and how to initiate immediate contact with 
them.
    Response: We appreciate the feedback from commenters and believe 
that their concerns are already covered in the regulations. We proposed 
at Sec.  483.95(a) to include effective communications as a required 
training topic for direct care personnel, which includes NAs. We 
believe that effective communication is important for reducing 
unnecessary hospitalizations as well as for improving a resident's 
overall quality of life and quality of care.
    Comment: One commenter questioned whether employees of the LTC 
facility must develop the training materials. The commenter indicated 
that many facilities use consultants or contractors to develop 
training. In addition, a commenter indicated that the proposed rule did 
not clearly define the type of training that volunteers should receive. 
Also, the commenter indicated that the requirement for facilities to 
train all individuals under a contractual arrangement is unreasonable.
    Response: Facilities have the flexibility to determine the 
materials to use for providing training and determining the appropriate 
individuals to be responsible for providing the training. In the 
proposed rule we indicated that training should be provided for new and 
existing staff, individuals providing services under a contractual 
arrangement, and volunteers consistent with their expected roles. We do 
not agree that requiring individuals under a contractual arrangement be 
trained is unreasonable. Facilities have a responsibility to ensure 
that the individuals they employ, whether directly or under contract, 
have their appropriate competencies and capabilities to provide 
services in their facility.
    Comment: Commenters indicated concern regarding the financial and 
administrative burdens associated with requiring expansive training 
requirements. Commenters noted that it is already challenging to 
address the currently imposed training requirements. Also, commenters 
indicated that facilities need the flexibility to determine how to 
training staff on the proposed training topics. One commenter 
recommended that the proposed training topics be evaluated by a 
workgroup comprised of both CMS and providers and that any new training 
topics be implemented based on a 5 year phased-in schedule.
    Response: We did not propose a specific training mechanism to meet 
the training requirements, therefore facilities have the flexibility to 
determine how to appropriately train staff. Given the overall 
comprehensive revision to the LTC requirements we are finalizing a 
phased in implementation schedule for this regulation. We defer readers 
to section II.B. Implementation for a detailed discussion regarding the 
implementation timeline for the training requirements, as well as the 
other requirements finalized in the rule.
    Comment: One commenter noted that there are many ways to provide 
training such as computer based training, self-directed learning, 
mentoring and coaching.
    Response: We appreciate the feedback from commenters and agree that 
there are many effective training mechanisms available to facilities to 
meet the training requirements including those recommended by the 
commenter.
    After consideration of the comments we received on the proposed 
rule, we are finalizing our proposal with the following modifications:
     Adding a new requirement at Sec.  483.95(c)(3) to require 
that staff

[[Page 68822]]

receive dementia management and abuse prevention training.

III. Provisions of the Final Regulations

    In this final rule, we are adopting the provisions of the July 16, 
2015 proposed rule with the following revisions:
     In Sec.  483.5, we are revising the definition of 
``abuse'' to ``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. 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.''
     In Sec.  483.5, we are revising the definition of 
``exploitation'' to ``taking advantage of a resident for personal gain 
through the use of manipulation, intimidation, threats, or coercion.''
     In Sec.  483.5, we are adding ``registered respiratory 
therapist or certified respiratory therapy technician'' to the 
definition of ``licensed health professional.''
     In Sec.  483.5, we are adding a definition of 
``mistreatment'' and define it as ``inappropriate treatment or 
exploitation of a resident.''
     In Sec.  483.5, we are revising the definition of 
``neglect'' to ``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 emotional 
distress.''
     In Sec.  483.5, we are revising the definition of 
``resident representative'' to (in accordance with 45 CFR 1324.1), 
``(1) An individual chosen by the resident to act on behalf of the 
resident in order to support the resident in decision-making; access 
medical, social or other personal information of the resident; manage 
financial matters; or receive notifications; (2) A person authorized by 
State or Federal law (including but not limited to agents under power 
of attorney, representative payees, and other fiduciaries) to act on 
behalf of the resident in order to support the resident in decision-
making; access medical, social or other personal information of the 
resident; manage financial matters; or receive notifications; (3) Legal 
representative, as used in section 712 of the Older Americans Act; or 
(4) The court-appointed guardian or conservator of a resident. (5) 
Nothing in this rule is intended to expand the scope of authority of 
any resident representative beyond that authority specifically 
authorized by the resident, State or Federal law, or a court of 
competent jurisdiction.''
     In Sec.  483.10, we have consolidated proposed Sec.  
483.10 and proposed Sec.  483.11 into Sec.  483.10, ``Resident rights'' 
and removed or updated all cross-references as appropriate.
     In Sec.  483.10, we have replaced the term ``verbal'' with 
``oral'' throughout this entire section.
     In Sec.  483.10, we have moved introductory language from 
proposed Sec.  483.10 and proposed Sec.  483.11, as well as Sec.  
483.11(a)(2) to Sec.  483.10(a) ``Resident Rights.''
     In Sec.  483.10, we have consolidated proposed Sec.  
483.10(a)(1) through (5), and proposed Sec.  483.11(a)(1), and (a)(3) 
through (5) into Sec.  483.10(b), ``Exercise of rights.''
     In Sec.  483.10, we have revised Sec.  483.10(b)(3) to 
incorporate previously existing language clarifying that the provision 
applies to residents who have not been adjudged incompetent by a State 
court.
     In Sec.  483.10, we have revised Sec.  483.10(b)(7)(i) to 
clarify that, in the case of a limited guardianship, a facility does 
not defer all decision making to a guardian, when a court's 
determination does not require it.
     In Sec.  483.10, we have consolidated proposed Sec.  
483.10(b) and proposed Sec.  483.11(b) into Sec.  483.10(c), ``Planning 
and implementing care.''
     In Sec.  483.10, we have changed the term '' disciplines'' 
to ``the type of care giver or professional'' at Sec.  483.10(c)(4).
     In Sec.  483.10, we have clarified in Sec.  483.10(c)(5) 
that the physician or other practitioner or professional informs the 
resident of the risks and benefits of proposed care, of treatment and 
treatment alternatives or treatment options.
     In Sec.  483.10, we have consolidated Sec.  483.10(b)(6) 
and Sec.  483.11(b)(2) into Sec.  483.10(c)(7) which now states ``The 
right to self-administer medications if the interdisciplinary team, as 
defined by Sec.  483.21(b)(2)(ii), has determined that this practice is 
clinically appropriate.''
     In Sec.  483.10, we have withdrawn proposed Sec.  
483.10(c)(2) to require that physician's meet facility credentialing 
requirements and consolidated Sec.  483.10(c)(1) and (3), and Sec.  
483.11(c)(1) through (3) at Sec.  483.10(d).
     In Sec.  483.10, we have redesignated Sec.  483.10(d) as 
Sec.  483.10(e), revised paragraph (6) to specify that the resident has 
a right to receive written notice, including the reason for the change 
before the resident's room or roommate in the facility is changed and 
added a new paragraph (7)(iii) to clarify that a room change cannot be 
solely for the convenience of staff.
     In Sec.  483.10, we have consolidated proposed Sec.  
483.10(e) and proposed Sec.  483.11(d) at Sec.  483.10(f), Self-
determination.
     In Sec.  483.10, we have added ``and other applicable 
provisions of this Part'' to Sec.  483.10(f)(1).
     In Sec.  483.10, we have consolidated Sec.  483.10(e)(3) 
and Sec.  483.11(d)(1) at Sec.  483.10(f)(4), clarified that the 
resident's right to deny visitation is ``when applicable,'' clarified 
that a facility must have written policies and procedures for 
visitation that includes restrictions, when such limitation may apply 
consistent with the requirements of this subpart, that the facility may 
need to place on such rights and the reasons for the clinical or safety 
restriction or limitation, and clarified that the facility must inform 
each resident not only of any limitation, but also to whom the 
restrictions apply.
     In Sec.  483.10, we have added at Sec.  483.10(f)(5)(i) 
that a facility must take reasonable steps, with the approval of the 
group, to make residents and family members aware of upcoming meetings 
in a timely manner.
     In Sec.  483.10, we have added at paragraph (f)(5)(ii) 
``or other guests'' to the list of individuals who may only attend a 
resident or family group meeting at the group's invitation.
     In Sec.  483.10, we have consolidated proposed Sec.  
483.10(e)(8) and Sec.  483.11(d)(4) into Sec.  483.10(f)(9).
     In Sec.  483.10, we have consolidated proposed Sec.  
483.10(e)(9) and Sec.  483.11(d)(5) into Sec.  483.10(f)(10).
     In Sec.  483.10, we have changed ``may'' to ``must'' in 
Sec.  483.10(f)(11)(i).
     In Sec.  483.10, we have changed ``health care provider'' 
to ``physician, physician assistant, nurse practitioner, or clinical 
nurse specialist'' in Sec.  483.10(f)(11)(ii)(L)(1).
     In Sec.  483.10, we have consolidated proposed Sec.  
483.10(f) and (h) and Sec.  483.11(e) into Sec.  483.10(g).
     In Sec.  483.10, we revised proposed Sec.  483.10(g)(2) to 
include both personal and medical records.
     In Sec.  483.10, we revised Sec.  483.10(g)(2)(ii) to 
remove the requirement that a resident must inspect a medical record 
prior to requesting to purchase a copy.

[[Page 68823]]

     In Sec.  483.10, we updated Sec.  483.10(g)(3) to exclude 
from its requirements documents specified in (g)(2) and (g)(11). This 
reflects that we do not require facilities to translate or summarize 
personal and medical records and survey reports.
     In Sec.  483.10, we added ``State Survey Agency'' to Sec.  
483.10(g)(4)(ii) and added ``any suspected violation of state or 
federal nursing facility regulations'' to paragraph (g)(4)(vi).
     In Sec.  483.10, we added ``requests for information 
regarding returning to the community'' to paragraph (g)(5)(ii).
     In Sec.  483.10, we require at paragraph (g)(9)(iii) that 
electronic communications under this section must comply with state and 
federal law.
     In Sec.  483.10, we have revised Sec.  483.10(g)(11) to 
reflect the stricter standard imposed by the statutory language in 
section 1919(c)(8) of the Act and to better reflect both sections 
1819(d) and 1919(d) of the Act, retaining the addition of availability 
of any plan of correction in effect with respect to facility, as 
proposed, and including the requirements that the notice of 
availability of such reports are prominent and accessible to the public 
and shall not make available identifying information about complainants 
or residents.
     In Sec.  483.10, we have revised paragraph (g)(18)(v) to 
specify that any admission contract, whether the facility requires it 
or not, must not conflict with the requirements of these regulations.
     In Sec.  483.10, we have consolidated proposed Sec.  
483.10(g) and Sec.  483.11(f) into Sec.  483.10(h), consolidating 
duplicative language in Sec.  483.10(g)(2) and Sec.  483.11(f)(1)(ii), 
consolidating proposed Sec.  483.11(f)(1) and (f)(1)(i) into Sec.  
483.10(h)(2), and deleting Sec.  483.11(f)(2) as an unnecessary cross-
reference.
     In Sec.  483.10, we have consolidated proposed Sec.  
483.10(i) and Sec.  483.11(g) into Sec.  483.10(i) ``Safe 
environment''.
     In Sec.  483.10, we have added a new Sec.  
483.10(i)(1)(ii) to require that the facili