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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

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

[CMS-3260-P]

RIN 0938-AR61

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

AGENCY:

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

ACTION:

Proposed rule.

SUMMARY:

This proposed rule would revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These proposed changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These proposals are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.

DATES:

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 14, 2015.

ADDRESSES:

In commenting, please refer to file code CMS-3260-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

You may submit comments in one of four ways (please choose only one of the ways listed):

1.

Electronically.

You may submit electronic comments on this regulation to

http://www.regulations.gov

. Follow the “Submit a comment” instructions.

2.

By regular mail.

You may mail written comments to the following address only:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3260-P, P.O. Box 8010, Baltimore, MD 21244.

Please allow sufficient time for mailed comments to be received before the close of the comment period.

3.

By express or overnight mail.

You may send written comments to the following address only:

Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3260-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

4.

By hand or courier.

Alternatively, you may deliver (by hand or courier) your written comments only to the following addresses prior to the close of the comment period:

a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.

Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

For information on viewing public comments, see the beginning of the

SUPPLEMENTARY INFORMATION

section.

FOR FURTHER INFORMATION CONTACT:

Sheila Blackstock, (410) 786-6633, for issues related to Care transitions, QAPI.

Ronisha Blackstone, (410) 786-6633, for issues related to Comprehensive care planning, training.

Diane Corning, (410) 786-6633, for issues related to Behavioral health, infection control, facility assessment.

Lisa Parker, (410) 786-6633, for issues related to the Regulatory Impact Analysis.

Jeannie Miller, (410) 786-6633, for General information.

SUPPLEMENTARY INFORMATION:

Inspection of Public Comments:

All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received:

http://www.regulations.gov

. Follow the search instructions on that Web site to view public comments.

Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.

Acronyms

Because of the many terms to which we refer by acronym in this proposed rule, we are listing the acronyms used and their corresponding meanings in alphabetical order below:

AAA Area Agencies on Aging

ACL Administration for Community Living

ADL Activities of Daily Living

ADRCS Aging and Disability Resource Center

AHCA American Health Care Association

AHLA American Health Lawyers Association

ANSI American National Standards Institute

ASPE Assistant Secretary for Planning and Evaluation

BPSD Behavioral and Psychological Symptoms of Dementia

CARIE Center for Advocacy Rights and Interests

CASPER Certification and Survey Provider Enhanced Reports

CIL Centers for Independent Living

CLIA Clinical Laboratory Improvement Amendment

CMS Centers for Medicare & Medicaid Services

CNS Clinical Nurse Specialist

CPR Cardiopulmonary Resuscitation

DON Director of Nursing

EHR Electronic Health Records

FDA Food and Drug Administration

GAO Government Accountability Office

HACCP Hazard Analysis and Critical Control Point

HAI Healthcare-Associated Infection

HHS U.S. Department of Health and Human Services

HIPAA Health Insurance Portability and Accountability Act of 1996

ICN International Council of Nurses

IDT Interdisciplinary Team

IG Interpretive Guidance

IPCO Infection Prevention and Control Officer

IPCP Infection Prevention and Control Program

LSC Life Safety Code

LTC Long-Term Care

NATCEP Nurse Aide Training Competency Evaluation Program

NCEA National Center on Elder Abuse

MAR Medication Administration Record

MDS Minimum Data Set

NA Nurse Aide

NF Nursing Facility

NP Nurse Practitioner

OIG Office of the Inspector General

OMB Office of Management and Budget

ONC Office of the National Coordinator

PA Physician Assistant

PASARR Preadmission Screening and Resident Review

PIPs Performance Improvement Projects

PEU Protein-Energy under Nutrition

QA Quality Assurance

QAA Quality Assessment and Assurance

QAPI Quality Assurance and Performance Improvement

QIO Quality Improvement Organization

RFA Regulatory Flexibility Act

RN Registered Nurse

SMA State Medicaid Agency

SNF Skilled Nursing Facility

WHO World Health Organization

Table of Contents

This proposed rule is organized as follows:

I. Background

A. Executive Summary

1. Purpose

2. Summary of the Major Provisions

3. Summary of Costs and Benefits

a. Overall Impact

b. Section-by-Section Economic Impact Estimates

B. Statutory and Regulatory Authority of the Long-term care Requirements

C. Summary of Stakeholder Comments

D. Why revise the LTC requirements?

II. Provisions of the Proposed Regulation

A. Basis and scope. (§ 483.1)

B. Definitions (§ 483.5)

C. Resident rights (§ 483.10)

D. Facility responsibilities (§ 483.11)

E. Freedom from abuse, neglect, and exploitation (§ 483.12)

F. Transitions of care (§ 483.15)

G. Resident assessments (§ 483.20)

H. Comprehensive resident-centered care plans (§ 483.21)

I. Quality of care and quality of life (§ 483.25)

J. Physician services (§ 483.30)

K. Nursing services (§ 483.35)

L. Behavioral health services (§ 483.40)

M. Pharmacy services (§ 483.45)

N. Laboratory, radiology, and other diagnostic services (§ 483.50)

O. Dental services (§ 483.55)

P. Food and nutrition services (§ 483.60)

Q. Specialized rehabilitative services (§ 483.65)

R. Outpatient Rehabilitative Services (§ 483.67)

S. Administration (§ 483.70)

T. Quality assurance and performance improvement (§ 483.75)

U. Infection control (§ 483.80)

V. Compliance and ethics program (§ 483.85)

W. Physical environment (§ 483.90)

X. Training requirements (§ 483.95)

III. Long-Term Care Facilities Crosswalk

IV. Collection of Information Requirements

V. Response to Comments

VI. Regulatory Impacts

I. Background

A. Executive Summary

1. Purpose

Consolidated Medicare and Medicaid requirements for participation (requirements) for long term care (LTC) facilities (42 CFR part 483, subpart B) were first published in the

Federal Register

on February 2, 1989 (54 FR 5316). These regulations have been revised and added to since that time, principally as a result of legislation or a need to address a specific issue. However, they have not been comprehensively reviewed and updated since 1991 (56 FR 48826, September 26, 1991), despite substantial changes in service delivery in this setting.

Since the current requirements were developed, significant innovations in resident care and quality assessment practices have emerged. In addition, the population of nursing homes has changed, and has become more diverse and more clinically complex. Over the last two to three decades, extensive, evidence-based research has been conducted and has enhanced our knowledge about resident safety, health outcomes, individual choice, and quality assurance and performance improvement. In light of these changes, we recognized the need to evaluate the regulations on a comprehensive basis, from both a structural and a content perspective. Therefore, we are reviewing regulations in an effort to improve the quality of life, care, and services in LTC facilities, optimize resident safety, reflect current professional standards, and improve the logical flow of the regulations. Specifically, we are proposing to add new requirements where necessary, eliminate duplicative or unnecessary provisions, and reorganize the regulations as appropriate. Many of the revisions are aimed at aligning requirements with current clinical practice standards to improve resident safety along with the quality and effectiveness of care and services delivered to residents. Additionally, we believe that these proposed revisions may eliminate or significantly reduce those instances where the requirements are duplicative, unnecessary, and/or burdensome.

2. Summary of the Major Provisions

Basis and Scope (§ 483.1)

• The Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively known as the Affordable Care Act) provisions: We propose to add the statutory authority citations for sections 1128I(b) and (c) and section 1150B of the Act to include the compliance and ethics program, quality assurance and performance improvement (QAPI), and reporting of suspicion of a crime requirements.

Definitions (§ 483.5)

• Expanded Definitions: We propose to add the definitions for “adverse event”, “documentation”, “posting/displaying”, “resident representative”, “abuse”, “sexual abuse”, “neglect”, “exploitation”, “misappropriation of resident property”, and “person-centered care”.

Resident Rights (§ 483.10)

• Comprehensive Restructuring: We propose to retain all existing residents' rights but update the language and organization of the resident rights provisions to improve logical order and readability, clarify aspects of the regulation where necessary, and to update provisions to include advances such as electronic communications. This includes—

○ Eliminating language, such as “interested family member” and replacing the term “legal representative” with “resident representative.”

○ Addressing roommate choice.

○ Adding language regarding physician credentialing to specify that the physician chosen by the resident must be licensed to practice medicine in the state where the resident resides, and must meet professional credentialing requirements of the facility.

Facility Responsibilities (§ 483.11) *New Section*

• New Section: We propose to add a new section to subpart B that focuses on the responsibilities of the facility (that is, protecting the rights of their residents, enhancing a resident's quality of life) and brings together many of the facility responsibilities currently dispersed throughout existing regulations. This section parallels many residents' rights provisions.

• Visitation: We propose to revise visitation requirements to establish open visitation, similar to the hospital conditions of participation (CoPs).

• Re-designation of Requirements: We propose to—

○ Relocate provisions from existing Resident's Rights (§ 483.10) section that pertain to the responsibilities of the facility into this section.

○ Relocate the existing requirements in Quality of Life (§ 483.15) into this section.

Freedom From Abuse, Neglect, and Exploitation (§ 483.12)

• Revised Title: Formerly “Resident behavior and facility practices,” we propose to revise the title to “Freedom from abuse, neglect, and exploitation.”

• Prohibiting abuse, neglect, and exploitation: We propose to—

○ Specify that facilities cannot employ individuals who have had a disciplinary action taken against their professional license by a state licensure body as a result of a finding of abuse, neglect, mistreatment of residents or misappropriation of their property.

○ Require facilities to develop and implement written policies and procedures that prohibit and prevent abuse, neglect, and mistreatment of residents or misappropriation of their property.

Transitions of Care (§ 483.15)

• Revised Title: Formerly “Admission, transfer and discharge rights,” we propose to revise the title to reflect current terminology that applies to all instances where care of a resident is transferred.

• Transfers or Discharge: We propose to require not only that a transfer or discharge be documented in the clinical record, but also that specific information, such as history of present illness, reason for transfer and past medical/surgical history, be exchanged with the receiving provider or facility when a resident is transferred. We are not proposing to require a specific form, format, or methodology for this communication.

Resident Assessments (§ 483.20)

• Preadmission Screening and Resident Review (PASARR): We propose to clarify what constitutes appropriate coordination of a resident's assessment with the PASARR program under Medicaid.

• Technical Corrections:

○ We propose to add references to statutory requirements that were inadvertently omitted from the regulation when we first implemented sections 1819 and 1919 of the Act.

Section 1919(e)(7)(A)(ii) and (iii) of the Act: We propose to add exceptions to the preadmission screening requirements for individuals with mental illness and individuals with intellectual disabilities for admittance into a nursing facility, with respect to transfer to or from a hospital.

Section 1919(e)(7)(B)(iii) of the Act: We propose to add a requirement that a nursing facility must notify the state mental health authority or intellectual disability authority for resident evaluation promptly after a significant change in the mental or physical condition of a resident with a mental illness or intellectual disability.

○ We propose to replace the term “mental retardation” with “intellectual disability” throughout the section, as appropriate.

Comprehensive Person-Centered Care Planning (§ 483.21) *New Section*

• Baseline Care Plan: We propose to require facilities to develop a baseline care plan for each resident, within 48 hours of their admission, which includes the instructions needed to provide effective and person-centered care that meets professional standards of quality care.

• PASARR: We propose to add a requirement to include as part of a resident's care plan any specialized services or specialized rehabilitation services the nursing facility will provide as a result of PASARR recommendations. If a facility disagrees with the findings of the PASARR, it must indicate its rationale in the resident's medical record.

• Interdisciplinary Team (IDT):

○ We propose to add a nurse aide, a member of the food and nutrition services staff, and a social worker to the required members of the interdisciplinary team that develops the comprehensive care plan.

○ We propose to require facilities to provide a written explanation in a resident's medical record if the participation of the resident and their resident representative is determined to not be practicable for the development of the resident's care plan.

• Discharge Planning:

○ The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185) amended Title XVIII of the Social Security Act by, among other things, adding Section 1899B to the Social Security Act. Section 1899B(i) requires that certain providers, including long term care facilities, take into account, quality, resource use, and other measures to inform and assist with the discharge planning process, while also accounting for the treatment preferences and goals of care of residents. We propose to implement the discharge planning requirements mandated by the IMPACT Act by revising, or adding where appropriate, discharge planning requirements for LTC facilities.

○ We propose to require facilities to document in a resident's care plan the resident's goals for admission, assess the resident's potential for future discharge, and include discharge planning in the comprehensive care plan, as appropriate.

○ We propose to require that the resident's discharge summary include a reconciliation of all discharge medications with the resident's pre-admission medications (both prescribed and over-the-counter).

○ We propose to add to the post discharge plan of care a summary of what arrangements have been made for the resident's follow up care and any post-discharge medical and non-medical services.

Quality of Care and Quality of Life (§ 483.25)

• Overarching Principles: We propose to clarify that quality of care and quality of life are overarching principles in the delivery of care to residents of nursing homes and should be applied to every service provided.

• Activities of Daily Living (ADLs): We propose to clarify the requirements regarding a resident's ability to perform ADLs.

• Director of Activities Qualifications: We propose to solicit comments on whether the requirements for the director of the activities program remain appropriate and what should serve as minimum requirements for this position. We are not proposing specific changes at this time.

• Updating Current Practices: We propose to modify existing requirements for nasogastric tubes to reflect current clinical practice, and to include enteral fluids in the requirements for assisted nutrition and hydration.

• Special Need Issues: We propose to add a new requirement that facilities must ensure that residents receive necessary and appropriate pain management.

• Re-designation of Requirements: We propose to relocate the provisions regarding unnecessary drugs, antipsychotic drugs, medication errors, and influenza and pneumococcal immunizations to § 483.45 Pharmacy services.

Physician Services (§ 483.30)

• In-person Evaluation: We propose to require an in-person evaluation of a resident by a physician, a physician assistant, nurse practitioner, or clinical nurse specialist before an unscheduled transfer to a hospital.

• Delegation of Orders: We propose to allow physicians to delegate dietary orders to dietitians and therapy orders to therapists.

Nursing Services (§ 483.35)

• Sufficient Staffing: We propose to add a competency requirement for determining sufficient nursing staff based on a facility assessment, which includes but is not limited to the number of residents, resident acuity, range of diagnoses, and the content of care plans.

Behavioral Health Services (§ 483.40) *New Section*

• New Section: We propose to add a new section to subpart B that focuses on the requirement to provide the necessary behavioral health care and services to residents in accordance with their comprehensive assessment and plan of care.

• Staffing:

○

Facility Assessment:

We propose to require facilities to determine their direct care staff needs, based on the facility's assessment.

○

Competency Approach:

We propose to require that staff must have the appropriate competencies and skills to provide behavioral health care and services, which include caring for residents with mental and psychosocial illnesses and implementing non-pharmacological interventions.

○

Social Worker:

We propose to add “gerontology” to the list of possible human services fields from which a bachelor degree could provide the minimum educational requirement for a social worker.

Pharmacy Services (§ 483.45)

• Drug Regimen Review:

○ We propose to add the requirement that a pharmacist review a resident's medical chart at least every 6 months and when the resident is new to the facility, a prior resident returns or is transferred from a hospital or other facility, and during each monthly drug regimen review when the resident has been prescribed or is taking a psychotropic drug, an antibiotic or any drug the QAA Committee has requested be included in the pharmacist's monthly drug review.

○ We propose to require the pharmacist to document in a written report any irregularities noted during the drug regimen review that lists at a minimum, the resident's name, the relevant drug, and the irregularity identified, to be sent to the attending physician and the facility's medical director and director of nursing.

○ We propose to require that the attending physician document in the resident's medical record that he or she has reviewed the identified irregularity and what, if any, action they have taken to address it. If there is to be no change in the medication, the attending physician should document his or her rationale in the resident's medical record.

• Irregularities: We propose to add a definition of “irregularities” that would include, but not be limited to, the definition of “unnecessary drugs.”

• Psychotropic Drugs: We propose to revise existing requirements regarding “antipsychotic” drugs to refer to “psychotropic” drugs.

○ We propose to require that facilities ensure residents who have not used psychotropic drugs not be given these drugs unless medically necessary.

○ We propose that residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue use of these psychotropic drugs.

○ We propose to define “psychotropic drug” as any drug that affects brain activities associated with mental processes and behavior.

○ We propose that PRN (Pro re nata or as needed) orders for psychotropic drugs be limited to 48 hours. Orders could not be continued beyond that time unless the primary care provider (for example, the resident's physician) reviewed the need for the medications prior to renewal of the order, and documented the rationale for the order in the resident's clinical record.

• Re-designation of Requirements: We propose to relocate provisions in § 483.25 “Quality of Care” regarding unnecessary drugs, antipsychotic drugs, medication errors, and influenza and pneumococcal immunizations into this section.

Laboratory, Radiology, and Other Diagnostic Services (§ 483.50) *New Section*

• Ordering Services: We propose to clarify that a physician assistant, nurse practitioner or clinical nurse specialist may order laboratory, radiology, and other diagnostic services for a resident in accordance with state law, including scope of practice laws.

• Laboratory Services: We propose to clarify that the ordering physician; physician assistant; nurse practitioner or clinical nurse specialist, be notified of abnormal laboratory results when they fall outside of clinical reference ranges, in accordance with facility policies and procedures for notification of a practitioner or per the ordering physician's, physician assistant's; nurse practitioner's or clinical nurse specialist's orders.

Dental Services (§ 483.55)

• For Skilled Nursing Facilities (SNFs): We propose to prohibit SNFs from charging a Medicare resident for the loss or damage of dentures determined in accordance with facility policy to be the facility's responsibility.

• For Nursing Facilities (NFs): We propose to require NFs to assist residents who are eligible to apply for reimbursement of dental services as an incurred medical expense under the Medicaid state plan.

• For both SNFs and NFs: We propose to clarify that with regard to a referral for lost or damaged dentures “promptly” means within 3 business days unless there is documentation of extenuating circumstances.

Food and Nutrition Services (§ 483.60)

• Staffing: We propose to require facilities to employ sufficient staff with the appropriate competencies and skills sets to carry out the functions of the dietary service while taking into consideration resident assessments, and individual plans of care, including diagnoses and acuity, as well as the facility's resident census..

• Dietitian Qualification: We propose to clarify that a “qualified dietitian” is one who is registered by the Commission on Dietetic Registration of the Academy of Nutrition and Dietetics or who meets state licensure or certification requirements. For dietitians hired or contracted with prior to the effective date of these regulations, we propose to allow up to 5 years to meet the new requirements.

• Director of Food Service: We propose to add to the requirement for the designation of a director of food and nutrition service that the person serving in this position be a certified dietary manager, certified food service manager, or have a certification for food service management and safety from a national certifying body or have an associate's or higher degree in food service management or hospitality from an accredited institution of higher learning. In states that have established standards for food service managers, this person must meet state requirements for food service managers.

• Menus and Nutritional Adequacy: We propose to add to the requirements that menus reflect the religious, cultural and ethnic needs and preferences of the residents, be updated periodically, and be reviewed by the facility's qualified dietitian or other clinically qualified nutrition professional for nutritional adequacy while not limiting the resident's right to make personal dietary choices.

• Providing Food and Drink: We propose to add to the requirements that facilities provide food and drink that take into consideration resident allergies, intolerances, and preferences and ensure adequate hydration.

• Ordering Therapeutic Diets: We propose to allow the attending physician to delegate to a registered or licensed dietitian the task of prescribing a resident's diet, including a therapeutic diet, to the extent allowed by state law.

• Frequency of Meals: We propose to require facilities to have available suitable and nourishing alternative meals and snacks for residents who want to eat at non-traditional times or outside of scheduled meal times in accordance with the resident's plan of care.

• Use of Feeding Assistants: We propose to require that facilities document the clinical need of a feeding assistant and the extent to which dining assistance is needed in the resident's comprehensive care plan.

• Food Safety: We propose to—

○ Clarify that facilities may procure food items obtained directly from local producers and are not prohibited from using produce grown in facility gardens, subject to compliance with applicable safe growing and food-handling practices.

○ Clarify that residents are not prohibited from consuming foods that are not procured by the facility.

○ Require facilities to have a policy regarding the use and storage of foods brought to residents by family and other visitors.

Specialized Rehabilitative Services (§ 483.65)

• Provision of Services. We propose to—

○ Add respiratory services to those services identified as specialized rehabilitative services.

○ Clarify what constitutes as rehabilitative services for mental illness and intellectual disability.

Outpatient Rehabilitative Services (§ 483.67)

• Providing Services: We propose to establish new health and safety standards for facilities that choose to provide outpatient rehabilitative therapy services.

Administration (§ 483.70)

• Organization: We propose to largely relocate various portions of this section into other sections of subpart B as deemed appropriate.

• Facility Assessment: We propose to require facilities to—

○ Conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies. The facility must review and update that assessment, as necessary, and at least annually.

○ Review and update this assessment whenever there is, or the facility plans for, any change that would require a substantial modification to any part of this assessment.

○ Address in the facility assessment the facility's resident population (that is, number of residents, overall types of care and staff competencies required by the residents, and cultural aspects), resources (for example, equipment, and overall personnel), and a facility-based and community-based risk assessment.

• Clinical Records: We propose to establish requirements that mirror some of those found in the HIPAA Privacy Rule (45 CFR part 160, and subparts A and E of part 164).

• Binding Arbitration Agreements: We propose specific requirements for the facility and the agreement itself to ensure that if a facility presents binding arbitration agreements to its residents that the agreements be explained to the residents and they acknowledge that they understand the agreement; the agreements be entered into voluntarily; and arbitration sessions be conducted by a neutral arbitrator in a location that is convenient to both parties. Admission to the facility could not be contingent upon the resident or the resident representative signing a binding arbitration agreement. Moreover, the agreement could not prohibit or discourage the resident or anyone else from communicating with federal, state, or local health care or health-related officials, including representatives of the Office of the State Long-Term Care Ombudsman.

Quality Assurance and Performance Improvement (QAPI) (§ 483.75) *New Section*

• QAPI Program: In accordance with the statute, we propose to require all LTC facilities to develop, implement, and maintain an effective comprehensive, data-driven QAPI program that focuses on systems of care, outcomes of care and quality of life.

Infection Control (§ 483.80)

• Infection Prevention and Control Program (IPCP): We propose to require facilities to have a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under an arrangement based upon its facility and resident assessments that is reviewed and updated annually.

• Infection Prevention and Control Officer (IPCO): We propose to require facilities to designate an IPCO for whom the IPCP is their major responsibility and who would serve as a member of the facility's quality assessment and assurance (QAA) committee.

Compliance and Ethics Program (§ 483.85) *New Section*

• Compliance and Ethics Program: We propose to require the operating organization for each facility to have in operation a compliance and ethics program that has established written compliance and ethics standards, policies and procedures that are capable of reducing the prospect of criminal, civil, and administrative violations in accordance with section 1128I(b) of the Act.

Physical Environment (§ 483.90)

• Resident Rooms: We propose to require facilities initially certified after the effective date of this regulation to accommodate no more than two residents in a bedroom.

• Toilet Facilities: We propose to require facilities initially certified after the effective date of this regulation to have a bathroom equipped with at least a toilet, sink and shower in each room.

• Smoking: We propose to require facilities to establish policies, in accordance with applicable federal, state and local laws and regulations, regarding smoking, including tobacco cessation, smoking areas and safety.

Training Requirements (§ 483.95) *New Section*

• We propose to add a new section to subpart B that sets forth all the requirements of an effective training program that facilities must develop, implement, and maintain for all new and existing staff, individuals providing services under a contractual arrangement, and volunteers, consistent with their expected roles. We propose that training topics must include—

○ Communication: We propose to require facilities to include effective communications as a mandatory training for direct care personnel.

○ Resident Rights and Facility Responsibilities: We propose to require facilities to ensure that staff members are educated on the rights of the resident and the responsibilities of a facility to properly care for its residents as set forth in the regulations.

○ Abuse, Neglect, and Exploitation: We propose to require facilities, at a minimum, to educate staff on activities that constitute abuse, neglect, exploitation, and misappropriation of resident property, and procedures for reporting these incidents.

○ QAPI & Infection Control: We propose to require facilities to include mandatory training as a part of their QAPI and infection prevention and control programs that educate staff on the written standards, policies, and procedures for each program.

○ Compliance and Ethics: In accordance with section 1128I of the Act, as added by the Affordable Care Act, we would require the operating organization for each facility to include training as a part of their compliance and ethics program. We propose to require annual training if the operating organization operates five or more facilities.

○ In-Service Training for Nurse Aides: In accordance with sections 1819(f)(2)(A)(i)(I) and 1919(f)(2)(A)(i)(I) of the Act, as amended by the Affordable Care Act, we propose to require dementia management and resident abuse prevention training to be a part of 12 hours per year in-service training for nurse aides.

○ Behavioral Health Training: We propose to require that facilities provide behavioral health training to its entire staff, based on the facility assessment at § 483.70(e).

3. Summary of Costs and Benefits

a. Overall Impact

We estimate the total projected cost of this rule would be $729,495,614 in the first year. This results in an estimated first-year cost of approximately $46,491 per facility and a subsequent-year cost of $40,685 per facility on 15,691 LTC facilities.

b. Section-by-Section Economic Impact Estimates

Estimated Cost To Comply With All the Requirements of the Proposed Rule

Regulatory area

Section

First year total cost

Total cost in year 2 and thereafter

Resident Rights

483.10

$10,436,051

$10,436,051

Facility Obligations

483.11

1,935,785

999,345

Transitions of Care

483.15

3,331,225

3,331,225

Comprehensive Resident Centered Care Planning

483.21

118,184,092

118,184,092

Physician Services

483.30

35,660,786

35,660,786

Nursing Services

483.35

3,640,312

3,640,312

Food and Nutrition Services

483.60

1,788,774

1,663,246

QAPI

483.75

118,419,977

47,402,511

Infection Control

483.80

283,944,336

283,944,336

Compliance and Ethics Program

483.85

139,356,716

120,327,296

Training

483.95

General Training Topics

483.95(a)

7,280,624

7,280,624

Compliance and Ethics Training

483.95(f)

1,876,624

1,876,624

Dementia Management and Abuse Training

483.95(g)

3,640,312

3,640,312

Total

729,495,614

638,386,760

B. Statutory and Regulatory Authority of the Requirements for Long-Term Care Facilities

In addition to specific statutory requirements set out in sections 1819 and 1919 and elsewhere in the Social Security Act, sections 1819(d)(4)(B) and 1919(d)(4)(B) of the Act permit the Secretary of the Department of Health and Human Services (the Secretary) to establish any additional requirements relating to the health, safety, and well-being of SNF and NF residents respectively as the Secretary finds necessary.

Under sections 1866 and 1902 of the Act, providers of services seeking to participate in the Medicare or Medicaid program, or both, must enter into an agreement with the Secretary or the state Medicaid agency, as appropriate. LTC facilities seeking to be Medicare and Medicaid providers of services must be certified as meeting federal participation requirements. LTC facilities include SNFs for Medicare and NFs for Medicaid. The federal participation requirements for SNFs, NFs, or dually certified facilities, are set forth in sections 1819 and 1919 of the Act and codified in the implementing regulations at 42 CFR part 483, subpart B. Sections 1819(b)(1)(A) and 1919(b)(1)(A) of the Act provide that a SNF or NF must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident. In addition, the IMPACT Act (Pub. L. 113-185) amended Title XVIII of the Act by, among other things, adding Section 1899B to the Act. Section 1899B(i) requires that certain providers, including long term care facilities, take into account, quality, resource use, and other measures to inform and assist with the discharge planning process, while also accounting for the treatment preferences and goals of care of residents.

The Affordable Care Act made a number of changes to the Medicare and Medicaid programs. For instance, in an effort to increase accountability for SNFs and NFs, section 6102 of the Affordable Care Act established a new section 1128I of the Act. In general, section 1128I(b) of the Act requires LTC facilities to have in operation an effective compliance and ethics program that is effective in preventing and detecting criminal, civil, and administrative violations and in promoting quality of care. Section 1128I(b)(2) of the Act specifies that the Secretary, working jointly with the Inspector General of the Department of Health and Human Services (HHS), shall promulgate regulations for an effective compliance and ethics program for operating organizations, which may include a model compliance program. Further, section 1128I(c) of the Act adds a requirement for a quality assurance and performance improvement program (QAPI). Lastly, in an effort to promote dementia management and prevent abuse, section 6121 of the Affordable Care Act amended section 1819(f)(2)(A)(i)(I) and section 1919(f)(2)(A)(i)(I) of the Act by requiring dementia and abuse prevention training to be included as part of training requirements for nurse aides.

C. Summary of Stakeholder Comments

In order to evaluate the need to update the requirements for long term care facilities, CMS provided LTC stakeholders and members of the general public with opportunities to provide suggestions and recommendations for our revision of the requirements. Specifically, we reached out to industry groups, advocates and other stakeholders by announcing our intention to conduct a comprehensive review of the requirements during CMS open door forums and other regularly scheduled stakeholder calls. We established an email box to receive

comments and feedback. In response to our outreach, we received more than 20 comments from a variety of stakeholder organizations and individuals. Comments ranged from those who were concerned that burden-reducing changes would weaken important protections for vulnerable seniors to those who believe the existing regulations are working well and no changes were necessary. We also received a number of comments that included very detailed and comprehensive recommendations for changes to our regulations. One consistent theme of the comments was the need to address staffing levels. Most comments suggested that we increase the required number of registered nurse (RN) hours of onsite duty per resident day. They also suggested that we strengthen our training requirements for staff and require trainings for specific skills and procedures. Another common theme in the comments was the need to revise the regulations so that they reflect a person-centered care approach and improve the quality of care and life for the residents. For example, commenters requested that residents be included in the care planning process and given complete control over their meal choices. Commenters also requested that we ensure the regulations are current and consistent with federal privacy legislation and the associated implementing regulations, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the HIPAA Privacy Rule (45 CFR part 160 and subparts A and E of part 164).

We have reviewed all of the stakeholder's comments and have taken them into consideration while drafting this proposed rule. We note that some commenters requested changes that conflicted directly with statute. Moreover, some of the comments we received were outside the scope of our review (that is, comments related to the LTC facility survey process or the interpretive guidance (IG)). However, we have shared all of the stakeholder's comments with appropriate CMS staff for their review and consideration. We appreciate all of the stakeholders input and responses to our outreach efforts thus far and believe that this proposed rule reflects our desire to promote person-centered care and improve the quality of care and services, while further protecting resident's safety, choice and well-being.

D. Why revise the LTC requirements?

Although there have been many discrete changes to specific provisions, the requirements for LTC facilities have not been comprehensively reviewed and updated since 1991. The number of Medicare beneficiaries who accessed care in a SNF increased from 636,000 (or 19 per 1,000 enrollees) in 1989 to 1,839,000 (or 52 per 1,000 enrollees) in 2010, not including managed care enrollees (Data Compendium. 2002 edition. Centers for Medicare & Medicaid Services [on-line].

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

).

In addition to the increase in the number of individuals accessing SNF care, the health concerns of individuals residing in LTC facilities have become more clinically complex. The LTC population includes a mix of elderly individuals, younger residents with intellectual or developmental disabilities who are chronically ill, and residents in need of post-acute rehabilitation services. Since the 1980's, the nursing home resident population has had some significant changes. Some of these changes have resulted in nursing homes having to care for many residents that generally have a higher acuity. One change has been a dramatic increase in the number of residents who are recuperating from an acute episode of an illness or injury and who would have usually been discharged from a hospital to their homes. In 1983, Medicare implemented the prospective payment system for hospitals (Decker, FH. Nursing homes, 1977-99: What has changed, what has not? Hyattsville, Maryland Center for Health Statistics. 2005, p. 3). In the subsequent years, there have been shorter hospital stays for Medicare beneficiaries and increased Medicare-funding for post-acute stays in nursing homes. Decker noted that while the discharge rate for individuals who had nursing home stays of 3 months or more had not changed significantly, the discharge rate for individuals who were discharged after a nursing home stay of 90 days or less accounted for virtually all of the increase. Thus, Decker used this as a benchmark for short versus long stays. The number of discharges per 100 nursing home beds in 1977 and 1985 were 86 and 77, respectively. However, by 1999, the discharge rate per 100 nursing home beds had increased by about 56 percent to 134 (Decker, p. 2). In addition, the percentage of these stays in which Medicare was the primary payer had more than tripled from 11 percent in 1985 to 39 percent in 1999. Medicare generally only covers the first 100 days of a stay in a skilled nursing facility (

https://www.medicare.gov/Pubs/pdf/10153.pdf

).

Another factor that has resulted in a higher acuity in the nursing home resident population has been the increase in assisted-living facilities and other alternatives to nursing home care, such as home care (Decker, p. 5 and Harris-Kojetin, L., Sengupta, M., Park-Lee, E., and Valverde, R. Long-term care services in the United States: 2013 overview. National health care statistics reports; no 1. Hyattsville, MD: National Center for Health Statistics, 2013). This has resulted in nursing homes caring for residents that require more medical care and rehabilitation services. This is supported by the significant decrease in the percentage of residents that could perform their ADLs independently. In 1977, almost 67 percent of residents could eat independently (Decker, p. 5, Figure 6). However, by 1999, that percentage had decreased to almost 53 percent and by 2004 it was down to only about 41 percent (Decker and Jones, AL, Dwyer, LL, Bercovitz, AR, Strahan, GW. The National Nursing Home Survey: 2004 Overview. National Center for Health Statistics. Vital Health Stat 13(167). 2009, Figure 5.). In 1977, almost 30 percent of residents were independent in dressing; however, by 1999, that percent was down to almost 13 percent and by 2004 it was down to about 10 percent (Decker and Jones). By 2004, more than 50 percent of all nursing home residents either required extensive assistance with bathing, dressing, toileting, and transferring or were totally dependent for these ADLs (Jones, Figure 5 and Harris-Kojetin, Figure 24). Only 1.6 percent of all nursing home residents received no assistance for any ADL (Jones, Figure 4).

Nursing homes are also caring for a significant number of residents who require behavioral health services. In 2004, over 16 percent of nursing home residents received a primary diagnosis of a mental disorder upon admission (Jones, Figure 7). By the time residents were interviewed for the National Nursing Home Survey that percentage increased to almost 22 percent. The 1999 estimate was about 18 percent. In addition, nursing homes are caring for a significant number of patients with dementia and depression. By 2012, over 48 percent of nursing home residents had a diagnosis of Alzheimer's disease or another dementia and/or depression (Harris-Kojetin, p. 35, Figure 23). Similiarly, in looking at the prevalence of four mental health conditions (depression, anxiety disorders, bipolar disorder, and schizophrenia) in nursing home residents 65 and older, the Institute of Medicine (IOM) found almost 50 percent had depression and almost 57 percent had one or more of those conditions (IOM (Institute of

Medicine) 2012.

The mental health and substance use workforce for older adults: In whose hands?

Washington, DC: The National Academies Press). In addition, substance abuse disorders are also increasing in the nursing home population. Substance abuse disorders are described in the

Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

(

http://www.dsm5.org/Documents/Substance%20Use%20Disorder%20Fact%20Sheet.pdf

Accessed on June 17, 2015). Thus, in this rule, when we discuss behavioral health or mental illness, we are also discussing substance abuse disorders.

To accommodate a more diverse population, the current care and service delivery practices of LTC facilities have changed to meet these changing service needs. These factors not only demonstrated a need to comprehensively review the regulations, but also informed our approach for revising the regulations. The following discussion highlights our approach to proposing revisions as well as some of the most significant revisions set forth in this proposed rule.

Facility Assessment and Competency-Based Approach

One of our goals in revising our minimum health and safety requirements for LTC facilities is to ensure that our regulations align with current clinical practice and allow flexibility to accommodate multiple care delivery models to meet the needs of the diverse populations that are provided services in these facilities. We considered prescriptive approaches, such as requiring specific numbers and types of staff based on facility size and acuity of residents, but were concerned that such an approach would conflict with requirements already established in many states, and would limit flexibility and innovation in designing new models of person-centered care delivery for residents. Thus, we are instead taking a competency-based approach that focuses on achieving the statutorily mandated outcome of ensuring that each resident is provided care that allows the resident to maintain or attain their highest practicable physical, mental, and psychosocial well-being. Under this competency-based approach, we are proposing requirements that are compatible with existing state requirements and consistent with what we believe are already common practices by facilities. As discussed in further detail in this proposed rule in section II, “Provisions of the Proposed Rule,” we propose to require facilities to assess their facility capabilities and their resident population. Using the information from that assessment, facilities would be required to provide sufficient staff with the necessary competencies and skills to meet each resident's needs based on acuity, diagnosis, and the resident's person-centered comprehensive care plan. Based on our experience with LTC facilities, we believe most facilities already make these assessments, at least informally, in order to determine staffing needs; our revisions will ensure it is consistently performed and documented in all SNFs and NFs.

Application of facility assessments and competence-based staffing decisions would involve every service provided by a NF or SNF and apply to all members of the staff, including the interdisciplinary team. For example, a facility that provides dementia care would need to ensure it has sufficient numbers of staff and that the staff has the necessary training, education, and/or experience to care for individuals with dementia. These staff may be nursing service staff, behavioral health staff, or other appropriate care providers. Similarly, adding a competence-based requirement would ensure that a facility serving residents requiring post-acute rehabilitation care had sufficient staff with the required training, education and/or experience to care for individuals requiring those services. We propose that the focus be on the competencies and skill sets of the individuals delivering care and services rather than just on the overall number of care givers available. This competence-based approach is compatible with existing state requirements and business practices, and promotes both efficiency and effectiveness in care delivery. In addition to a competence-based approach, this proposed rule is intended to meet the spirit of current HHS quality initiatives that cut across various providers.

Current HHS Quality Initiatives

As an effective steward of public funds, CMS is committed to strengthening and modernizing the nation's health care system to provide access to high quality care and improved health at lower cost. This includes improving the patient experience of care, both quality and satisfaction, improving the health of populations, and reducing the per capita cost of health care. In drafting the proposed rule, we considered current initiatives underway to support these aims and improve care across providers as well as initiatives targeted specifically at nursing home residents. As discussed below, we are proposing several revisions consistent with these efforts.

• Reducing Avoidable Hospitalization

Nearly two-thirds of nursing home residents are enrolled in Medicaid, and most are also enrolled in Medicare. These Medicare-Medicaid enrollees are among the most fragile and chronically ill individuals served by both programs. Although estimates vary, CMS research found that approximately 45 percent of hospitalizations among Medicare-Medicaid enrollees receiving either Medicare skilled nursing facility services or Medicaid nursing facility services could have been avoided(

http://innovation.cms.gov/initiatives/rahnfr/

). One goal of the HHS Partnership for Patients Initiative is to reduce the number of individuals who experience a preventable complication requiring rehospitalization. This effort aims to improve the quality of care and services for individuals cared for in LTC facilities. In support of this initiative, CMS has launched the “Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents” (

http://innovation.cms.gov/initiatives/rahnfr/

). CMS is supporting organizations that partner with nursing facilities to implement evidence-based interventions that both improve care and lower costs. The initiative is focused on long-stay nursing facility residents who are enrolled in the Medicare and Medicaid programs. Additional information and resources are available at

http://innovation.cms.gov/initiatives/rahnfr/index.html

.

Consistent with the HHS focus on reducing unnecessary hospitalization, in drafting this proposed rule, we looked at what, if any, minimum health and safety standards could be developed or strengthened that would contribute to a reduction in unnecessary hospital admissions of nursing home residents. First, we considered many factors that contribute to a decision to transfer a nursing home resident to a hospital. This is primarily a clinical decision, but it may be impacted by environmental or financial factors that are not amenable to change based on regulatory requirements. These concerns include family and resident preferences and demands, concern regarding the LTC facility's liability, and payment incentives. We believe, however, that there are some regulatory changes that would help reduce avoidable hospitalization of nursing home residents. We discuss those changes in section II, “Provisions of the Proposed Rule”.

• Healthcare Associated Infections

HHS is also working to reduce the incidence of healthcare associated infections (HAIs) across providers. In recognition of HAIs as an important public health and patient safety issue, HHS is sponsoring the “National Action Plan to Prevent HAIs”. This initiative seeks to coordinate and maximize the efficiency of prevention efforts across the federal government (

http://www.hhs.gov/ash/initiatives/hai/actionplan/

). Given the growing number of individuals receiving care in LTC settings and the presence of more complex medical care, these individuals are at an increased risk for HAIs. Therefore, to advance these initiatives, we have proposed revisions that we believe will provide more opportunities to achieve broad based improvement and contribute to reduced healthcare costs. We also believe this approach would be flexible enough to be adapted to any business model and would allow for targeted interventions specific to the facility.

• Behavioral Health

On March 29, 2012, CMS launched an initiative aimed at improving behavioral healthcare and safeguarding nursing home residents from the use of unnecessary antipsychotic medications. As part of the initiative, CMS has developed a national action plan that uses a multidimensional approach including public reporting, raising public awareness, regulatory oversight, and technical assistance/training and research. This plan is targeted at enhancing person-centered care for nursing home residents, particularly those with dementia-related behaviors (

http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/Spotlight/html

).

Similarly, with regard to minimum health and safety standards, we looked at possible regulatory changes that could lead to a reduction in the unnecessary use of antipsychotic medication and improvements in the quality of behavioral healthcare. After conducting a review of literature, stakeholder comments, and available Office of Inspector General (OIG) reports we found that many residents are not receiving the individualized quality of care mandated by the current requirements. We address this issue further in section II, “Provisions of the Proposed Rule”.

• Health Information Technology

HHS also has a number of initiatives designed to encourage and support the adoption of health information technology and to promote nationwide health information exchange to improve health care. HHS believes all patients, their families, and their healthcare providers should have consistent and timely access to their health information in a standardized format that can be securely exchanged between the patient, providers, and others involved in the patient's care (HHS August 2013 Statement, “Principles and Strategies for Accelerating Health Information Exchange.”). The Department is committed to accelerating health information exchange (HIE) through initiatives including: (1) Establishing a coordinated governance framework and process for nationwide health IT interoperability; (2) improving technical standards and implementation guidance for sharing and using a common clinical data set; (3) enhancing incentives for sharing electronic health information according to common technical standards, starting with a common clinical data set; and (4) clarifying privacy and security requirements that enable interoperability. Ensuring that individuals and care providers can send, receive, find, and use a basic set of essential health information across the health care continuum will enhance care coordination and enable health system reform to improve care quality. This strategy is described in greater detail in “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap, available at

http://www.healthit.gov/sites/default/files/nationwide-interoperability-roadmap-draft-version-1.0.pdf

. Developed with significant stakeholder input, this 10-year Roadmap describes barriers to interoperability across the current health IT landscape, the desired future state that the industry believes will be necessary to enable a learning health system, and a suggested path for moving from the current state to the desired future state. In addition, ONC has released the 2015 Interoperability Standards Advisory (available at

http://www.healthit.gov/standards-advisory

), which provides a list of the best available standards and implementation specifications to enable priority health information exchange functions. ONC expects to annually update the Advisory through a transparent and structured process that includes advice from the Health IT Standards Committee (ONC's federal advisory committee) and the public at large.

HHS is committed to encouraging HIE among all health care providers, including those who are not eligible for the EHR Incentive Programs, to improve care delivery and coordination across the entire care continuum. Our revisions to this rule are intended to recognize the advent of electronic health information technology and to accommodate and support adoption of ONC certified health IT and interoperable standards. We believe that the use of such technology can effectively and efficiently help facilities and other providers improve internal care delivery practices, support the exchange of important information across care team members (including patients and caregivers) during transitions of care, and enable reporting of electronically specified clinical quality measures (eCQMs). For more information, we direct stakeholders to the ONC guidance for EHR technology developers serving providers ineligible for the Medicare and Medicaid EHR Incentive Programs titled, “Certification Guidance for EHR Technology Developers Serving Health Care Providers Ineligible for Medicare and Medicaid EHR Incentive Payments,” which addresses use of the 2014 Edition of ONC certification criteria (available at

http://www.healthit.gov/sites/default/files/generalcertexchangeguidance_final_9-9-13.pdf

). ONC anticipates updating the 2014 Edition Certification Guidance once the ONC 2015 Edition Certification becomes final. Information on the development of standards applicable to the long-term care setting can be found at:

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

and

http://wiki.siframework.org/Longitudinal+Coordination+of+Care

.

• Trauma-Informed Care

HHS has also undertaken broad-based activities to support Americans that have specific needs to be considered in delivering health care and other services. Activities include raising awareness about the special care needs of trauma survivors, including a targeted effort to support the needs of Holocaust survivors living in the United States. Trauma survivors, including veterans, survivors of large-scale natural and human-caused disasters, Holocaust survivors and survivors of abuse, are among those who may be residents of long-term care facilities. For these individuals, the utilization of trauma-informed approaches is an essential part of person-centered care. For many trauma survivors, the transition to living in an institutional setting (and the associated loss of independence) can trigger profound re-traumatization. In addition, aspects of institutional settings can be significant triggers. While these triggers are highly individualized, some common triggers include: Experiencing

a lack of privacy or confinement in a crowded or small space; or being exposed to certain loud noises, or bright/flashing lights. It is also important to note that cognitive impairment, such as dementia, may worsen or further complicate a trauma survivor's response to triggers and may also introduce additional language barriers as individuals return to their first (non-English) languages. Culturally-competent, trauma-informed approaches that help to minimize triggers and re-traumatization, including those that address the unique care needs of Holocaust survivors and survivors of war, disasters, and other profound trauma are an important aspect of person-centered care for these individuals. Person-centered care that reflects the principles set forth in SAMSHA's Concept of Trauma and Guidance for a Trauma-Informed Approach, HHS Publication No. (SMA) 14-4884, available at

http://store.samhsa.gov/shin/content/SMA14=4884/SMA14-4884.pdf

, would help advance the quality of care that a resident receives and, in turn, can substantially improve a resident's quality of life.

• Requirements for Long Stay Residents

Ninety five percent of nursing homes in the United States are dually certified as SNF/NFs. That is, they provide both the Medicare SNF benefit, and the Medicaid NF benefit. Both benefits cover skilled nursing care and rehabilitation services, with a few minor differences, as noted in these proposed regulations. In addition, Medicaid NFs provide long term care for residents who require support for activities of daily living. Some residents covered by long term care insurance or paying privately may also be receiving long-term care in the nursing home indefinitely. For these residents, the facility is their home. For both residents and facilities, making the nursing facility a home is a different experience and undertaking than is a course of rehabilitation followed by discharge to the individual's residence in the community. The requirements have not reflected this distinction.

We received some comments that would apply primarily to serving long term residents. Some of the ideas and practices, known collectively as “Culture Change,” are of benefit to all nursing home residents by making services and supports more person-centered, but are particularly crucial to the quality of life of long stay facility residents. Person-centered care is an aspect of culture change that focuses on the resident as the locus of control, supported in making their own choices and having control over their daily lives. According to the authors of the “Long-Term Care Improvement Guide,” “culture change” refers to the progression from institutional or traditional models of care to more individualized, consumer-directed practices that embrace choice and autonomy for care providers and recipients (Frampton, Susan, et al. “Making the Case for Change” Long-Term Care Improvement Guide 2010, retrieved from

http://www.residentcenteredcare.org/Pages/About%20the%20guide.html

). The authors go on to explain that this kind of care not only enhances quality for consumers and staff but also creates opportunities for the organization to improve operational benchmarks in areas such as quality of care, efficiency of operation, revenue generation and stabilized staffing. CMS has participated in the culture change movement and we are familiar with both the goals and challenges of this effort. We note that the many present efforts to serve individuals in the community rather than in an institution, for example, in compliance with the Supreme Court

Olmstead

decision (

Olmstead

v.

L.C ex rel. Zimring,

527 U.S. 581, 119 S. Ct. 2176 (1999)), are primarily directed at long-stay nursing home residents rather than those receiving rehabilitation or skilled nursing care, and this characteristic may be relevant to facility requirements.

While CMS is engaged in the issues around long stay nursing home residents, we do not have enough verifiable information to propose specific changes to the regulations specifically applicable to long-stay situations at this time. We solicit comments on how the requirements could acknowledge the special needs of the long stay resident. In addition, because we also received comments regarding the need to specifically address the needs of short stay residents, we solicit comments on how the requirements could acknowledge the special needs of short stay residents. Nursing facility providers describe the challenges of serving these two rather different populations in a single model of care. We are particularly interested in any suggestions to improve existing requirements, within the authority of existing statute, where they make serving one or the other population difficult or less effective. The most useful comments will be those that offer suggestions to amend specific sections of the existing requirements or offer particular additions. For example, should new construction or capitalized renovations be based on models of effective long term residence?

In addition to the requirements for participation, CMS is seeking comment on a number of issues related to the finalization and implementation of the proposed rule: Unintended consequences and unanticipated risks to SNF and NF residents, the involvement of stakeholders in developing sub-regulatory requirements and in implementing changes, and the timeline for proposed implementation following finalization of the rule.

The requirements for participation have not been substantially updated since the regulations implementing the Omnibus Budget Reconciliation Act of 1987 were finalized. As such, the intent of the proposed rule is modernization of the regulation, harmonization with other federal laws, and implementation of certain provisions of the Affordable Care Act. CMS is seeking comments on the scope and type of changes proposed here. Given the comprehensive nature of our proposed revisions, we are soliciting comments regarding potential unintended consequences or unanticipated risks to SNF and NF residents, either related to a specific proposal or in general, and what those concerns might be. In addition, we are interested in stakeholder comments related to an appropriate timeframe for nursing homes to implement these regulations. CMS generally implements changes to regulatory requirements for the survey and certification process within 12 months of a final rule. Following finalization of this proposed rule, CMS anticipates that it may require a longer period of time to implement the changes outlined in the final rule. The additional time may be needed to develop revised interpretive guidance and survey processes, conduct surveyor training on the changes, and implement the software changes in the Quality Indicator Survey (QIS) system, which would include changing the underlying framework of the QIS system as many of the existing requirements have been re-organized. We also expect that it may take a longer period for nursing facilities to implement these changes and seek stakeholder suggestions regarding an appropriate implementation timeframes. Lastly, we seek comment on additional streamlining and reduction of outdated policies as a means of balancing the new policies being proposed.

Implementation of the Affordable Care Act Provisions

We are proposing to implement several provisions required by the Affordable Care Act. First, section 6102 of the Affordable Care Act, which added

new section 1128I to the Act requires the operating organizations for facilities (both SNFs and NFs as defined in sections 1819(a) and 1919(a) of the Act) to have in operation a compliance and ethics program. The compliance and ethics programs must be effective in preventing and detecting criminal, civil, and administrative violations under the Act and in promoting quality of care consistent with regulations that are promulgated under this new section.

Second, section 1128I of the Act requires the Secretary to establish and implement Quality Assurance and Performance Improvement (QAPI) program requirements for facilities, including multi-unit chains of facilities. Under this requirement, the Secretary must establish and implement standards relating to QAPI and provide technical assistance to facilities on the development of best practices in order to meet these standards. A facility must submit to the Secretary a plan for the facility to meet such standards and implement the best practices, including how to coordinate the implementation of a plan with quality assessment and assurance (QAA) activities already required under sections 1819(b)(1)(B) and 1919(b)(1)(B) of the Act as implemented at 42 CFR 483.75(o). This proposed rule would establish standards relating to QAPI for SNFs and NFs, as required by the Affordable Care Act.

Finally, section 6121 of the Affordable Care Act, amending sections 1819(f)(2)(A)(i)(I) and 1919(f)(2)(A)(i)(I) of the Act, requires dementia management and abuse prevention to be included as part of training requirements for nurse aides. We are proposing to amend the requirements that an institution must meet in order to participate as a SNF/NF in the Medicare and Medicaid programs, by requiring that the current mandatory on-going training requirements for nurse aides (NAs) include dementia management and resident abuse prevention training. This proposed rule would also clarify that the definition of NA includes an individual who provides NA services through an agency or under contract with a LTC facility, as provided in sections 6121(a)(2) and (b)(2) of the Affordable Care Act.

Executive Order 13563

In January 2011 the President issued Executive Order 13563 “Improving Regulation and Regulatory Review,” which directs agencies to select the least burdensome approaches, to minimize cumulative costs, to simplify and harmonize overlapping regulations, and to identify and consider flexible approaches that maintain freedom of choice for the American public. Executive Order 13563 also requires agencies to engage in a process of reviewing existing regulations to see if those rules make sense and continue to be justified. The provisions of this proposed rule are intended to meet the letter and spirit of Executive Order 13563, for reviewing existing regulations to see if those rules make sense and continue to be justified. The provisions of this proposed rule also meet the objectives of section 610 of the Regulatory Flexibility Act (RFA), which also requires agencies to review the impact of existing rules on small businesses or other small entities for possible reforms to reduce burden and costs. We conducted a general review of the regulations for outdated, confusing, and unnecessarily burdensome requirements and considered areas for improvement.

II. Provisions of the Proposed Regulation

Reorganization of Part 483 Subpart B

In our comprehensive review of part 483 subpart B, we felt that improvements could be made to the overall readability and logical order of the regulatory provisions. Therefore, we propose to revise the order of the regulatory provisions. As in the existing subpart B, required sections including basis and scope and definitions, would come first. Similar to the existing regulations, we propose to follow these sections with provisions assuring resident-centered care, including resident rights, facility responsibilities, freedom from abuse, neglect and exploitation, transitions of care, and individualized resident assessment and care planning. We propose to then include service-specific provisions, including quality of care, starting with physician services and concluding with administration. We propose to conclude subpart B with requirements for facility-wide programs such as infection control, compliance and ethics, training, and facility physical environment. We believe our proposed revised order significantly improves the readability and logical order of the regulations and would allow individuals less familiar with the regulations to find information they are seeking more easily. A crosswalk of the current provisions to the proposed provisions is included as Table A in section III of this proposed rule.

Cross Cutting Proposals

While some proposed changes require revisions that are contained in one specific section of the requirements, other issues apply across multiple sections and thus would require changes in several sections of the regulations. These cross-cutting topics include proposals regarding unnecessary hospitalization, HAIs, antipsychotic medications, care planning, and QAPI. Below is a general discussion of our approach to revising the regulations to address these issues. Specific changes to the regulatory text are discussed in detail in the relevant requirements.

• Unnecessary Hospitalization

The transfer to an acute care hospital is a stressful event for a resident of a SNF or NF. As noted by The Office of the Assistant Secretary for Planning and Evaluation (ASPE) in its June 2011 report on Hospitalizations of Nursing Home Residents, such hospitalizations impose a high personal cost on nursing home residents, causing disruption, risk of complications and infections, and likelihood of reduced functioning on return to the nursing home (Ouslander, J.G., Lamb, G., Perloe, M., Givens, J.H., Kluge, L., Rutland, T., et al. (2010).

Potentially avoidable hospitalizations of nursing home residents: Frequency, causes, and costs.

Journal of the American Geriatrics Society, 58, 627-635.). Nursing home residents are especially vulnerable to the risks that accompany hospitalizations and transitions of care, including medication errors and hospital-acquired infections. Hospital episodes are even more difficult for residents with dementia, who become disoriented in new, unfamiliar settings. Preventing potentially avoidable hospitalizations of nursing home residents is an important quality-improvement initiative from the standpoint of the residents and their families, and also may yield cost reductions (Polniaszek, Susan, Walsh, Edith G. and Wiener, Joshua M. (2011)

Hospitalizations of Nursing Home Residents: Background and Options.

U.S. Department of Health and Human Services, Assistant Secretary for Planning and Evaluation, Office of Disability, Aging and Long-Term Care Policy).

In order to decrease unnecessary hospitalizations, the June 2011 report from ASPE gives options such as reporting potentially avoidable hospitalization rates on the CMS Nursing Home Compare Web site, increasing registered nurse (RN) staffing and the use of nurse practitioners (NPs), modifying the Medicare 3-day qualifying stay requirement, providing education and care tools, and changing Medicaid coverage policy to direct incentives to reduce avoidable

hospitalization of nursing home residents (“Hospitalizations of Nursing Home Residents: Background and Options” U.S. DHHS, Assistant Secretary for Planning and Evaluation, Office of Disability, Aging and Long-Term Care Policy. June 2011). Of these options, we believe education is one of the areas that is most amenable to addressing through revising the requirements. Young

et al.

conclude, based on a cross-sectional survey of randomly selected nursing homes in New York State, that contributing factors to unnecessary hospitalizations amenable to change include communication effectiveness training, ensuring adequate access to prior medical history, laboratory results and ECGs, and encouraging physicians who practice at nursing homes to treat residents within the nursing home whenever possible (Journal of the American Geriatric Society, 58:901-907, May 2010). The availability of patient information, including resident medical history, assessment of current condition including recent laboratory and radiology results, availability of physicians or other practitioners to evaluate the patient if needed, and effective interdisciplinary team communication are areas we can impact through the requirements.

In this proposed rule, we propose to take a multifaceted approach to reducing unnecessary hospitalization which includes:

• Requiring that a facility notify the resident's physician when there is a change in a resident's status, including any pertinent information specified in § 483.15(b)(2)-(§ 483.11(e)(7)(ii))

• Addressing communication through a robust interdisciplinary team, comprehensive person-centered care planning process and through training requirements (§ 483.21).

• Proposing a requirement for practitioner assessment prior to transfer to a hospital, except in an emergency situation (§ 483.30(e)).

• Enhancing nursing care through a competency-based approach (§ 483.35).

• Strengthening the clinical record requirements to ensure adequate and appropriate information is available to evaluating practitioners (§ 483.70(i)).

• Ensuring ongoing evaluation of care process through implementation of a robust QAPI plan (§ 483.75)

This multifaceted approach would build on existing requirements and standard business practices through incremental change. We also believe that this approach would not only have a positive impact on reducing unnecessary readmissions, but may also improve other quality areas as well and is intended to be flexible enough to encompass any care model and all facility populations.

• Reduction in Inappropriate Use of Antipsychotic Medications

Antipsychotic medications are frequently prescribed off-label, which means that the drug is being prescribed for a use that is not approved by the U.S. Food and Drug Administration (FDA), to residents with behavioral and psychological symptoms of dementia (BPSD). This has led to increased attention to the behavioral health management of nursing home residents with dementia and the potentially inappropriate use of antipsychotics in this population. Evidence suggests that antipsychotics have limited benefits in this population, and the potential to lead to adverse consequences such as the risk of movement disorders, falls, hip fractures, cerebrovascular accidents, and death. Additionally, the health profiles of this population are often medically complex and residents may take multiple medications that increase their risk of adverse effects and drug interactions. A previous OIG study found that when this population received these drugs, about half of the drugs were not given for medically accepted indications as required for Medicare coverage or recorded as being administered to the resident and one-fifth of the drugs were not given in accordance with federal safeguards to protect nursing facility residents from unnecessary antipsychotic drug use (OEI-07-08-00150). The potential overuse of antipsychotic agents is a symptom of a much larger problem—namely, that many nursing facilities may not have a systematic plan to provide comprehensive behavioral health care to residents with diagnoses such as dementia and BPSD.

In this proposed rule, we would take a multifaceted approach to reducing the unnecessary use of antipsychotic medications which would include:

• Requiring that each nursing home conduct a comprehensive assessment, including its physical characteristics (that is, size, location, and number of residents), its resident population (including both a psychosocial and mental health assessment), the competencies and knowledge of its staff, and the identification of any resources or support, including training and additional staff, that the facility would need to ensure the appropriate care and treatment for all residents (§ 483.70)

• Revising the current requirements that apply to antipsychotic drugs to also apply to any psychotropic drug; that is, any drug that affects brain activities associated with mental processes and behavior (§ 483.45)

• Including a requirement that once the facility's consultant pharmacist has identified an irregularity (such as, a drug given for an excessive duration of time or prescribed without adequate indications documented in the resident's medical record), or has recommended a gradual dose reduction for one or more medication, the attending physician would be required to document in the resident's medical record that he or she has reviewed the identified irregularity and what, if any, action they took to address it. If there is to be no change in the medication, the attending physician should document his or her rationale in the resident's medical record (§ 483.45)

Similar to our proposals for reducing unnecessary hospitalizations, this multifaceted approach would build on existing requirements and standard health care practices through incremental change. We believe that this approach would provide the best opportunity for a broad-based improvement in the areas of mental, behavioral, and psychosocial-related health care concerns, while also providing facilities with flexibility regarding how to address the type of staff and training or other resources and support they need to provide care and services in these areas.

• Healthcare Associated Infections (HAIs)

Although estimates vary widely, there are between 1.6 and 3.8 million HAIs in nursing homes every year. Annually, these infections result in an estimated 150,000 hospitalizations, 388,000 deaths, and between $673 million and $2 billion dollars in additional healthcare costs (Castle, et al. Nursing home deficiency citations for infection control, American Journal of Infection Control, May 2011; 39, 4). In some ways, the resident population in nursing homes presents unique regulatory challenges, particularly with respect to infection control. Residents in nursing homes not only receive skilled nursing care in these facilities, but for many individuals, these facilities are also their homes. In addition, nursing homes are required to provide social activities for residents which may include group activities or functions. These activities or functions, such as dining, social events, and religious services, may increase the risk of transmission and exposure to communicable diseases and infections. The diversity of the nursing home community presents each facility with unique challenges to meet the needs and choices of all of the

individuals they serve, creating a much harder task of regulating and managing infection control and prevention activities. Nursing home residents are often frail, elderly individuals and individuals with disabilities who have increased susceptibility to infections from malnutrition, dehydration, comorbidities, or functional impairments (for example, urinary and fecal incontinence), and medications that diminish immunity or immobility. In addition, as patients are discharged from hospitals to nursing homes sooner, the nursing home population increasingly has more residents with greater medical needs, which not only increases the acuity level but also likely results in higher invasive device use (for example, mechanical ventilators, central venous catheters, and enteral feeding tubes). Therefore, when developing our approach to promote prevention and control of HAIs, we took into consideration this diverse resident population, as well as the interaction residents will have with staff, visitors, and each other.

Similar to our approach to address unnecessary hospitalizations, we identified the following areas to consider addressing HAIs when revising the nursing home infection control requirements:

• Requirements for the facility to perform a facility-specific assessment of their resident population and facility (§ 483.70)

• Integration of the infection prevention and control program (IPCP) with the facility's QAPI processes (§ 483.75)

• Revising the description of the infection control program and adding a requirement to periodically review and update the program (§ 483.80)

• Requiring an antibiotic stewardship program that includes antibiotic use protocols and a system for monitoring antibiotic use (§ 483.80)

• Designation of specific infection prevention and control officers (IPCOs) (§ 483.80)

• Written policies and procedures for the IPCP (§ 483.80)

• Education or training related to the infection control program (§ 483.80)

Likewise, with the other cross-cutting provisions, we believe that taking a multifaceted approach when revising the infection control requirements would provide the best opportunity to achieve broad-based improvement while also being flexible enough to be adapted to any health care delivery model. These revisions may also result in positive impacts in the care and services to residents, reducing unnecessary hospitalizations and overall lowered healthcare costs.

In the following sections we detail our proposed revisions to the requirements. The discussion follows our proposed reorganization of subpart B.

A. Basis and Scope (§ 483.1)

We propose to revise § 483.1 “Basis and Scope” to include references to sections 1819(f), 1919(f), 1128I (b) and (c), and 1150B of the Act. Sections 1819(f) and 1919(f) of the Act require that the current mandatory on-going training for NAs include dementia management and resident abuse prevention training. New section 1128I (b) of the Act requires the operating organizations for SNFs and NFs to have a compliance and ethics program and new section 1128I(c) of the Act requires the Secretary to establish and implement a QAPI program for facilities. New section 1150B of the Act establishes requirements for reporting to law enforcement suspicion of crimes occurring in federally funded LTC facilities. In addition, we propose to spell out the term “skilled nursing facility”.

B. Definitions (§ 483.5)

Current regulations at § 483.5 provide definitions for terms commonly used in the LTC requirements. We propose to revise some of the existing terms for clarity and define new terms that we believe are widely used within the LTC setting, and that we believe would add value to the LTC requirements while promoting resident choice and safety.

We have retained the existing definitions for “facility” and “distinct part”. We are aware of stakeholder concerns that defining “distinct part” and “composite distinct part” possibly allow facilities to segregate residents by payment source. On August 4, 2003, we published a final rule entitled, “Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities-Update” (68 FR 46036). Through this final rule, the definitions of “distinct part” and “composite distinct part” were added to this section and we believe the rationale for the addition at that time remains valid. While some SNFs function as separate, independent entities, we have recognized since the inception of the Medicare program that it is also possible for a SNF to operate as a component, or “distinct part” or “composite distinct part” of a larger organization. While we do not agree that “distinct part” and “composite distinct part” should be removed from the current regulations, based on concerns raised by some stakeholders, we have modified the definition of “composite distinct part” to make it clear that a composite distinct part designation cannot be used as a means to segregate residents by payment status or on any basis other than care needs. Such segregation may violate a patient's privacy by implicitly revealing their payment source and lends itself to creating inequitable care situations. In addition, we have retained the definition of “major modification”, which was added to the LTC regulations in the May 12, 2014 final rule, “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Part II” (79 FR 27106). We also propose to make minor revisions to the definition of “common area” to recognize that some facilities have living rooms or other areas where residents gather.

As discussed in detail below, based on our internal review and feedback from stakeholders, we propose to expand this section to include the following definitions: “abuse,” “adverse event,” “exploitation,” “misappropriation of resident property,” “neglect,” “person-centered care,” “resident representative,” and “sexual abuse”. In addition, we propose to relocate the definitions for “licensed health professional” and “nurse aide” to this section from the “Administration” section at § 483.75(e)(1). We believe that these definitions apply broadly to the regulations and would more appropriately be defined in this section of definitions. In addition, we propose to revise the definition of “nurse aide” in accordance with amendments to sections 1819(b)(5)(F) and 1919(b)(5)(F) of the Act made by sections 6121(a)(2) and (b)(2) of the Affordable Care Act. “Nurse aide” is currently defined as any individual providing nursing or nursing-related services to residents in a facility who is not a licensed health professional, a registered dietitian, or someone who volunteers to provide these services without pay. “Nurse aides” do not include those individuals who furnish services to residents only as paid feeding assistants as defined in § 488.301. Section 6121 of the Affordable Care Act added the following clarification to the definition of “nurse aide”: “Such term includes an individual who provides such services through an agency or under a contract with the facility.” We propose to amend the regulatory definition accordingly.

We propose to add the term “adverse event” to ensure clarity in our requirements relating to proposed requirements for QAPI. We discuss this definition further in section II.T. of the preamble and welcome comment on our

proposed definition. We also propose the addition of the term “resident representative” because the use of a representative is often common practice within the nursing home setting. We believe a resident can designate an individual to have certain rights and/or responsibilities, such as the ability to make decisions about a resident's care, the ability to manage a resident's finances, or the ability to participate in discussions about the residents care and the ability to access a resident's medical information. For purposes of this regulation, we would define the term “resident representative” broadly to include both an individual of the resident's choice who has access to information and participates in healthcare discussions as well as personal representative with legal standing, such as a power of attorney for healthcare, legal guardian, or health care surrogate or proxy appointed in accordance with state law to act in whole or in part on the resident's behalf. One individual may or may not fulfill both of these roles. We also note that the same-sex spouse of a resident would be afforded treatment equal to that afforded to an opposite-sex spouse if the marriage was valid in the jurisdiction in which it was celebrated. Throughout this proposed regulation, where we use the term resident, it includes, as applicable, the resident representative. In addition, we propose to add a definition of “person-centered care”. For purposes of this subpart, we would define person-centered care as focusing on the resident as the locus of control and supporting the resident in making their own choices and having control over their daily lives.

The addition of the definitions of “abuse”, “sexual abuse”, “neglect”, “exploitation”, and “misappropriation of resident's property” are being proposed to achieve clarity within the current regulations and eliminate confusion regarding what actions or circumstances rise to the level of these terms. For purposes of these regulations, “abuse” would include actions such as the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish. As used in this definition of “abuse”, “willful” means the individual must have acted deliberately, not that the individual must have intended to inflict injury or harm. “Abuse” would also include the deprivation by an individual of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being. The term “sexual abuse” would extend the meaning of “abuse” to include non-consensual sexual contact of any type with a resident. We propose to define the term “neglect” as “the failure of the facility, its employees or service providers to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish or mental illness.” We would define “exploitation” as “the unfair treatment or use of a resident or the taking of a selfish or unfair advantage of a resident for personal gain, through manipulation, intimidation, threats, or coercion.” Based on internal discussions and stakeholder input, we are aware of industry concerns regarding certain incidents that can take place within a nursing home that are not easily classified as abuse or neglect, but nonetheless are inappropriate and harmful. For example, there has been a substantial increase in the use of technology to exploit the elderly since these regulations were first implemented. When these regulations were originally implemented, social media and the wide use of cellular and personal electronic devices were not a major concern or topic of consideration in the protection of residents. These advances in technology have made it easier to invade someone's privacy and therefore increase the risk of exploitation. We feel that there is a need to account for these technological changes to ensure that all nursing home residents are protected. We believe the addition of the terms “abuse”, “sexual abuse”, “neglect”, and “exploitation” would help to eliminate confusion as to what behaviors rise to the level of these terms and promote resident safety and would clarify that abuse includes abuse facilitated or enabled through the use of technology.

We also propose to add the term “misappropriation of resident property” to provide clarity. The term “misappropriation of resident property” is widely used throughout the regulations and in our interpretive guidance for surveyors of nursing homes; therefore, we felt that there was a need to ensure that the term was clearly defined as “the deliberate misplacement, exploitation, or wrongful, temporary, or permanent use of a resident's belongings or money without the resident's consent.”

Finally, we move the existing definition of “transfer and discharge” from § 483.12(a)(1) to § 483.5(p).

C. Resident Rights (§ 483.10)

Current regulations at § 483.10 address a number of resident rights and facility requirements, including those establishing a resident's right to exercise his or her rights, including rights associated with a dignified existence, self-determination, planning and implementing care, access to information, privacy and confidentiality. Resident rights are also addressed in existing § 483.15. Based on a review of these regulations, we propose to retain all existing residents' rights but update the language and organization of the resident rights provisions to improve logical order and readability, to clarify aspects of the regulation that warrant it, and to update provisions to include technological advances such as electronic communications. In order to achieve these objectives, we propose to revise existing § 483.10 to include only those provisions specifying resident rights, including a number of provisions that are currently included in § 483.15. We further propose to add a new § 483.11, which would focus on the responsibilities of the facility, including relevant provisions currently included in § 483.10 and § 483.15. We propose multiple re-designations and revisions to improve logical order and readability, clarify aspects of the regulation that warrant it, and reflect technological advances such as electronic communications. Under our proposal, some existing provisions will have components in both § 483.10 and § 483.11. A detailed crosswalk of all of the proposed re-designations is provided in Table A in section III of this proposed rule. Re-designations without substantive changes are not discussed in detail below. We discuss below our proposed revisions to those provisions retained in or moved to § 483.10. Regulatory citations have been updated throughout to reflect the proposed new structure.

We propose to revise § 483.10 to focus specifically on resident rights. In proposed § 483.10(a)(2), we would clarify the resident's right to be supported in his or her exercise of rights under this subpart. In proposed § 483.10(a)(3), we would clarify the resident's right to designate a representative, the resident representative's limitation to those rights delegated by the resident, and the resident's retention of those rights not delegated, including the right to revoke a delegation. We have heard concerns that resident representatives may be accorded more decision making authority than their appointment or delegation permits. Our proposed clarification is intended to ensure that facilities do not afford more decision making authority to a resident representative than is intended by the

resident or permitted under applicable law. We note that resident representatives fall into three categories: court-ordered or otherwise designated under applicable law (

e.g.,

state law), supported by documentation (that is, an advance directive), and informal/oral. The scope of resident representative authority may vary based on how they are designated.

In § 483.10(a)(4) we would address those residents who have been adjudged incompetent under the laws of a state. We would clarify the resident representative's limitation to exercising only the rights delegated, and the resident's retention of rights not delegated. Specifically, we would clarify that the resident who has been adjudged incompetent under the laws of a state retains the right to exercise those rights not addressed by a court order, that the resident representative can only exercise the rights that devolve to them as a result of the court order, that the resident's wishes and preferences should continue to be considered, and that the resident should continue to be involved in the care planning process to the extent practicable, as the resident is at the center of the care team. We believe that it is important for a resident who has been adjudicated incompetent to be treated with respect and dignity and to continue to make those decisions that are appropriate for him or her to make. Continuing to honor these residents' preferences and involving them in care planning will improve both quality of life and quality of care, resulting in better outcomes. Lastly, in our proposed rule “Medicare and Medicaid Programs; Revisions to Certain Patient's Rights Conditions of Participation and Conditions for Coverage” (CMS-3302-P) (79 FR 73873), published on December 12, 2014, at § 483.10(a)(4), we proposed to require that the same-sex spouse of a resident must be afforded treatment equal to that afforded to an opposite-sex spouse if the marriage was valid in the jurisdiction in which it was celebrated. In this regulation, we are proposing to redesignate this requirement from § 483.10(a)(4) (as set out in the December 2014 proposed rule at 79 FR 73811) to § 483.10(a)(5). We believe that this revision is necessary to implement the Supreme Court decision in

United States

v.

Windsor,

570 U.S.12, 133 S.Ct. 2675 (2013).

In proposed § 483.10(b), we have included resident rights related to planning and implementing care. It is important for each resident to understand his or her health conditions and the care and services he or she will receive and to be able to participate in the care planning process. These rights are already included for the most part in the regulations, but we would update the language and co-locate related provisions. Thus, we propose to re-designate and revise in this provision current § 483.10(b)(3), § 483.10(b)(4) and § 483.10(b)(8), relating to the resident's right to be informed of his or her total health status, including medical conditions; the right to be informed in advance of the risks and benefits of proposed care, including treatment and treatment alternatives or treatment options so that the resident can choose the alternative or option he or she prefers; the right to request, refuse and/or discontinue treatment, including participating in or refusing to participate in experimental research; and the right to formulate advance directives. We propose to add new requirements in § 483.10(b)(5) to specify that the resident has the right to participate in the care planning process, including the right to identify individuals or roles to be included in the planning process, the right to request meetings and the right to request revisions to the person-centered plan of care. These requirements support the standards set forth by the Secretary in the “Guidance for Implementing Standards for Person-Centered Planning and Self-Direction in Home and Community-Based Services Programs” on June 6, 2014 (see

http://www.acl.gov/Programs/CDAP/OIP/docs/2402-a-Guidance.pdf

). We further specify in § 483.10(b)(5)(iv) that the resident has the right to receive the services and items included in the plan of care. We also propose to re-designate and revise existing § 483.10(d)(2) to specify that the resident has the right, in advance, to be informed of and to participate in, his or her care and treatment, including the right to be informed, in advance, of the care to be furnished and the disciplines that will furnish care. In addition, we propose to specify the resident's right to participate in the development of his or her comprehensive care plan. We also propose at § 483.10(b)(6) to include the resident's right to self-administer medication if the interdisciplinary team has determined that doing so would be clinically appropriate. Finally, we propose to add a new section at § 483.10(b)(7) to specify that these rights cannot be construed as a right to receive medical care that is not medically necessary or appropriate.

The ability of the resident to select his or her attending physician remains an important right. However, it is also important that the selected physician meet licensure requirements and be willing and able to comply with the requirements of this subpart. Therefore, we propose to require that the facility ensure that the attending physician is appropriately licensed and credentialed to provide care and meet the requirements of applicable regulations. In proposed § 483.10(c), we would add new § 483.10(c)(1), (2) and (3) to specify that the physician chosen by the resident must be licensed to practice medicine, and must meet professional credentialing requirements of the facility. If the physician chosen by the resident refuses or is unable to meet requirements specified in this part, we specify that the facility has the right, after informing and discussing with the resident, to seek alternate physician participation to assure the provision of appropriate and adequate care and treatment. If the resident chooses a new physician that meets the necessary requirements, the facility must respect that choice.

As indicated earlier, NFs not only provide medical care, but may also serve as a resident's home. This makes issues of respect and dignity particularly important. In § 483.10(d), we propose to re-designate a number of provisions relating to resident respect and dignity, based on existing § 483.13(a) and § 483.15. We further propose to add a new § 483.10(d)(5) to specify that a resident has the right to share a room with his or her roommate of choice, when both residents live in the same facility, both residents consent to the arrangement, and the facility can reasonably accommodate the arrangement. We note that married couples, whether opposite or same sex, are addressed by § 483.10(d)(5). Our proposed provision would provide for a rooming arrangement that could include a same-sex couple, siblings, other relatives, long term friends or any other combination as long as the requirements above are met. We recognize that in some instances, specific roommates requests cannot be accommodated by a facility for clinical, safety, or logistical reasons. However, we believe it is an important aspect of respect and dignity, as well as self-determination, for individuals to be able to choose who they live with, especially for long-term residents.

Self-determination is a critical element in the care and treatment of nursing home residents. In proposed § 483.10(e), we propose to revise a number of provisions relating to resident self-determination. We propose to revise § 483.10(e)(3) to ensure not only that specified individuals and/or organizations have access to the resident, but also to ensure that the

resident can receive his or her visitors of choice at the time of his or her choosing. We discuss our rationale further in our discussion of proposed § 483.11(d)(2). We propose to revise § 483.10(e)(4) and (5), clarifying that it is the resident's right to participate in family groups and have his or her family members or resident representatives participate in family groups in the facility.

The ability to have access to information such as personal medical records and facility-specific information has changed significantly since the promulgation of the original requirements for long-term care facilities. We propose to co-locate provisions related to the resident's right to access facility specific information, medical records, information about advocacy and fraud control organizations, Medicare and Medicaid coverage, and notices that the facility is required to provide to the resident. These notices include, but are not limited to a written description of legal rights, a written description of the facility's policies to implement advance directives and applicable state law pertaining to advance directives, and information on how to apply for and use Medicare and Medicaid benefits. In addition, we will update the provisions as appropriate to take into account electronic medical records and other electronic communications. Specifically, in proposed § 483.10(f), we propose to re-designate and revise a number of provisions relating to resident access to information. First, we propose to specify in § 483.10(f)(2) that the resident has the right to receive notices verbally (meaning spoken) and in writing (including Braille) in a format and a language he or she understands. We note that effective communication for some residents requires the use of auxiliary aids and services and have revised this provision to reflect that. Next, we propose to add a new § 483.10(f)(2)(i) to reference required notices and a new § 483.10(f)(2)(iv) to ensure residents are aware of and can contact an Aging and Disability Resource Center or other No Wrong Door program. The Aging and Disability Resource Center Program (ADRC), established under Section 202(20)(B)(iii) of the Older Americans Act; is a collaborative effort of the U.S. Administration on Community Living and the Centers for Medicare & Medicaid Services (CMS). ADRCs serve as single points of entry into the long-term supports and services system for older adults and people with disabilities. Sometimes referred to as a “one-stop shops” or “no wrong door” systems, ADRCs address many of the frustrations consumers and their families experience when trying to find needed information, services, and supports. Through integration or coordination of existing aging and disability service systems, ADRC programs raise visibility about the full range of options that are available, provide objective information, advice, counseling and assistance, empower people to make informed decisions about their long term supports, and help people more easily access public and private long term supports and services programs. Additional information on ADRC programs is available at

http://www.adrc-tae.acl.gov/tiki-index.php?page_ref_id=1325

.

Federal requirements and expectations related to the privacy and confidentiality of patient records, especially with regard to protected health information, changed substantially with the enactment of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and subsequent promulgation of the HIPAA Privacy and Security Rules (see 45 CFR part 160 and subparts A, C, and E of part 164) as well as the subsequent enactment of the Health Information Technology for Economic and Clinical (HITECH) Act as title XIII of division A and title IV of division B of the American Recovery and Reinvestment Act of 2009 (ARRA) and the promulgation of the Omnibus HIPAA Final Rule (78 FR 5566). For simplicity, we will hereinafter collectively refer to these laws and their implementing regulations as “HIPAA.” We note that administration and enforcement of the privacy and security-related portions of the HIPAA regulatory scheme are delegated to the HHS Office for Civil Rights (OCR) and more detailed information related to these provisions can be accessed through the OCR Web site at

http://www.hhs.gov/ocr/privacy

.

We propose to retain the requirements of current § 483.10(b)(2)(i) and (ii), subject to the clarifying revisions described below, at new § 483.10(f)(3). In doing so, we recognize that the HIPAA Rules establish a federal floor of privacy and security protections and individual rights with respect to protected health information held by covered entities (and their business associates), and the rights granted in this proposed regulation are not intended to conflict in any way with those HIPAA regulations. In addition, to the extent that HIPAA provides additional rights to individuals (that is, residents, in the long-term care context) beyond what is provided in this proposal, this proposed regulation would not diminish those rights. Therefore, we propose revisions that would clarify the relationship between the requirements of 45 CFR 164.524 and the revised version of § 483.10(f)(3)(i) and (ii). We propose to specify in paragraph (f)(3) that the resident has the right to access medical records pertaining to him or herself and to further specify in proposed (f)(3)(i) that the resident, upon oral or written request, has the right to receive requested medical records in the form and format requested by the resident, if it is readily producible in such form and format (including in an electronic form or format when such records are maintained electronically); or, if not, in a readable hard copy form or such other form and format as agreed to by the facility and the individual. This is consistent with the requirements of 45 CFR 164.524(c)(2). Finally, we propose to specify in paragraph (f)(3)(ii) that the facility may impose a reasonable, cost-based fee for providing copies of the medical records, provided that the fee includes only the cost of labor for copying the health information requested by the individual, whether in paper or electronic form; the supplies for creating the paper copy or electronic media if the individual requests that the electronic copy be provided on portable media; and postage, when the individual has requested the copy be mailed. This is consistent with 45 CFR 164.524(c)(4).This proposal does not address the creation or provision of summary reports, which may be provided in accordance with applicable law.

In § 483.10(g)(1) we propose to revise a number of provisions related to resident privacy and confidentiality to update the language to accommodate electronic communications. We propose to retain existing § 483.10(c)(1) at proposed § 483.10(g)(2), reiterate the residents' right to a secure and confidential medical record at proposed § 483.10(g)(3) and, in proposed § 483.10(g)(4), we would retain the provisions of existing § 483.10(e)(2) and (3).

Today, individuals have a number of electronic options for communicating with others that are not addressed in the existing regulations for LTC facilities. Thus, we propose to update these regulations to take into consideration widespread advances in electronic communications technologies. In proposed § 483.10(h), we propose to re-designate and revise a number of provisions relating to resident communications. Specifically, we propose a new § 483.10(h)

Communications, with § 483.10(h)(1) revised to include TTY and TDD services and cellular telephones; and a new § 483.10(h)(2) to provide reasonable access and privacy for electronic communications such as email or internet-based interpersonal video communications. We also include internet access, which can serve as a communications medium as well as a means for residents to interact with entities and persons outside of the facility or to use various programs and tools for entertainment, shopping, conducting research and obtaining information.

In proposed § 483.10(i), we propose to revise the language to state that the resident has a right to a safe, clean, comfortable, homelike environment, and a right to receive treatment safely. In proposed § 483.10(j), we propose to revise language relating to resident grievances to add that a resident cannot be deterred from voicing a grievance for fear of reprisal or discrimination. This clarifies that even when no actual reprisal or discrimination occurs, intimidation and threats of reprisal or discrimination are not permissible.

D. Facility Responsibilities (§ 483.11)

We propose a new § 483.11 “Facility Responsibilities,” in which we combine many of the regulations addressing facility responsibilities which are currently dispersed throughout the existing provisions regarding resident rights and quality of life. This proposed revision is consistent with our overall objectives of updating the language and organization of the resident rights provisions to improve the logical order and readability, clarifying aspects of the regulation, and updating provisions to include advances such as electronic communications.

Consistent with § 483.10, the introductory language for proposed § 483.11 would establish, based on existing requirements, that the facility must treat its residents with respect and dignity and provide care and services for its residents in a manner and in an environment that promotes maintenance or enhancement of the resident's quality of life and must protect and promote the resident's rights as specified in § 483.10. Further, the facility must recognize each resident's individuality and provide services in a person-centered manner. We propose to establish sections similar to those proposed in § 483.10. The proposed sections are “Exercise of Rights,” “Planning and Implementing Care,” “Attending Physician,” “Self-Determination,” “Information and Communication,” “Privacy and Confidentiality,” “Safe Environment,” and Grievances.”

In a new section proposed at § 483.11(a), “Exercise of Rights,” we establish our expectation that the facility promote and protect the rights of the resident. These expectations are not new requirements, and are already set out in our regulations as resident's rights. In order to ensure clarity, we have restated them clearly in this provision as the responsibility of the facility to recognize and effectuate those rights. Proposed § 483.11(a)(1) would provide that the facility ensure that the resident can exercise his or her rights without interference, coercion, discrimination, or reprisal from the facility. We propose to re-designate current § 483.12(c)(1) as new § 483.11(a)(2) and move to this section the requirement that the facility provide equal access to quality care regardless of diagnosis, severity of condition, or payment source and establish and maintain identical policies and practices regarding transfer, discharge, and the provision of services for all residents regardless of source of payment. In proposed § 483.11(a)(3) and (4), we would specify that the facility must treat the decisions of a resident representative as the decisions of the resident to the extent required by the court or as delegated by the resident, with the condition that the facility could not extend greater authority to the resident representative than is permitted under applicable law. We reiterate this point in the proposed regulation as we respect the need to establish alternative decision makers under certain circumstances. However, we received and are concerned by external input suggesting that some facilities or staff members defer to resident representatives for decisions that exceed the scope of a court order, resident delegation, or other applicable law. Proposed § 483.11(a)(3) and (4) would clarify our expectations. In addition, we propose to add a new § 483.11(a)(5) that would clarify for facilities that if facility staff believed that a resident representative was making decisions or taking actions that are not in the best interest of the resident, we would expect the facility to comply with any state reporting requirements that might apply. We understand that there is the potential for abuse and neglect in this relationship and want to ensure that facilities recognize their role in appropriately identifying and reporting concerns that rise to the level of abuse, neglect or exploitation. The United States Government Accountability Office (GAO) has published two reports related to abuses that occur specifically in the context of guardianships. In September 2010, the GAO published “Guardianships: Cases of Financial Exploitation, Neglect and Abuse of Seniors” (GAO-10-1046). In July 2011, the GAO published “Incapacitated Adults: Oversight of Federal Fiduciaries and Court-Appointed Guardians Needs Improvement” (GAO-11-678). While these reports focus on the need for improved screening and monitoring of guardians, they also highlight the potential for abuse and neglect in this relationship. According to the National Center on Elder Abuse in the Administration on Aging, “the laws in most states require helping professions in the front lines—such as doctors and home health providers—to report suspected abuse or neglect. . . . Under the laws of eight states, `any person' is required to report a suspicion of mistreatment” (

http://www.ncea.aoa.gov/Stop_Abuse/Get_Help/Report/index.aspx

). These reporting requirements may apply to abuse, neglect or exploitation by resident representatives.

In proposed § 483.11(b), facility responsibilities include ensuring that the resident is informed of, and participates in, his or her treatment to the extent practicable, consistent with § 483.10(b), and that the resident participates in care planning, making informed decisions, and self-administering drugs when appropriate. In addition to the self-administration of drugs, residents may also self-administer or take part in other health care practices, such as dialysis. We also expect that the facility, through the IDT and the care planning process, would determine if, and under what circumstances, this is appropriate. We also propose new requirements in § 483.11(b)(1) to require that the facility ensures that the care planning process facilitates the inclusion of the resident or resident representative, includes an assessment of the resident's strengths and needs, and incorporates the resident's personal and cultural preferences in developing goals of care. We note that person-centered planning involves providing those services and supports that assist individuals to live with dignity and to support their goals (including, but not limited to, goals to potentially return to a community setting). The Department of Health and Human Services has issued guidance for implementing person-centered planning and self-direction in home and community-based services programs, as set forth in section 2402(a) of the Affordable Care Act. The principles in

that guidance regarding dignity and self-direction apply equally to individuals who reside in a nursing facility.

http://www.acl.gov/Programs/CDAP/OIP/docs/2402-a-Guidance.pdf

. Our proposed requirements support those principles.

We propose to re-designate § 483.10(b)(9) as § 483.11(c)(1) and revise it to add other primary care providers to ensure that the resident knows the name, specialty and means of contacting the professionals officially responsible for his or her care, whether that provider is a physician, nurse practitioner, physician assistant, or clinical nurse specialist. We further propose to add a new § 483.11(c)(2), consistent with our proposed § 483.10(c)(1), (2) and (3), to clarify that the facility has a responsibility to ensure that the resident's attending physician has appropriate professional credentials and meets the requirements of this subpart. If the physician was not appropriately credentialed or was unwilling or unable to meet the requirements of this subpart, the facility could seek an alternate physician after informing and discussing this matter with the resident. In order to ensure that the resident could seek out a suitable alternative, we propose to add a new § 483.11(c)(3) to specify that if the resident subsequently finds a new physician who meets the necessary requirements, the facility would be required to honor that selection.

We propose a new § 483.11(d) to address the facility's responsibilities related to resident self-determination. We propose to re-designate § 483.10(j), regarding access to the resident, as § 483.11(d)(1), and revise it to include visitors as specified in our “Resident Rights” provision, including immediate access to the resident by the resident representative, and to update the languages and references for the Office of the State long term care ombudsman and the protection and advocacy system. This would be an addition to the current requirement which provides a right of access to any entity or individual that provides health, social, legal, or other services to the resident, subject to the resident's right to deny or withdraw consent at any time. This is consistent with our approach in other settings such as acute care hospitals, and in keeping with the person-centered focus of this proposed rule. In addition, we propose to add a new § 483.11(d)(2) to require that the facility have written policies and procedures regarding visitation rights of residents. This requirement would support resident self-determination, consistent with the person-centered focus of this proposed rule, and would follow the requirements established for inpatient hospitals. As noted in the November 19, 2010 final rule (75 FR 70831 at 70832), regarding hospital visitation rights, physicians, nurses, and other staff caring for the resident might miss an opportunity to gain valuable information from those who may know the resident best with respect to the resident's medical history, conditions, medications, and allergies, particularly if the resident had difficulties recalling or articulating, or is totally unable to recall or articulate, this vital personal information. Many times, these individuals who may know the resident best can act as an intermediary for the resident, helping to communicate the resident's needs to facility staff. As stated in that November 19, 2010 final rule, we believe that restrictive visitation policies can effectively eliminate these advocates for many residents, potentially to the detriment of the resident's health and safety. Further, given that the facility is often the resident's home, we suggest that, as in hospitals, the hazards and challenges regarding open visitation are manageable. In fact, we believe an open visitation policy helps residents by providing a better support system and a more homelike environment. Moreover, this policy may create more trust and a better working relationship between facility staff, the resident, and the resident's support system. Thus, we believe it is vital to establish open visitation in SNFs and NFs.

We propose to re-designate § 483.15(c)(5) as § 483.11(d)(3)(ii) and revise it to clarify that the facility-designated staff person who participates in a resident or family group must be approved by the resident or family group and the facility. It is important that the facility representative be an individual who the group can work with and who does not have a chilling effect on the function of the group. We further clarify that this provision does not require a facility to implement every recommendation of a resident or family group, but that the facility should be able to provide the rationale for their response. We propose a new § 483.11(d)(4), which would incorporate requirements currently specified in § 483.10(h) and would specify that the facility is responsible for ensuring that a resident is not required to perform services for the facility.

We propose a new § 483.11(d)(5), which would incorporate requirements from § 483.10(c) that focus on the facility's responsibility related to the protection of resident funds. Specifically, we propose in § 483.11(d)(5)(ii) to reflect the different dollar threshold requirements of sections 1819(c)(6)(B)(i) and 1919(c)(6)(B)(i) of the Act and establish the statutory requirement for deposit of resident funds in excess of $100 in an interest-bearing account for Medicare and other non-Medicaid SNF residents, consistent with section 1819(c)(6)(B)(i) of the Act, and funds in excess of $50 for Medicaid beneficiaries, consistent with section 1919(c)(6)(B)(i) of the Act. We propose in § 483.11(d)(5)(v) to include the return of funds to residents upon discharge or eviction, in accordance with state law in addition to the already existing regulatory requirement for conveyance to the estate upon death. We received suggestions to reduce the time frame for these conveyances. We researched common time frames for the return of security deposits and found that most states (at least 33) allow 30-days, and sometimes longer for the return of security deposits. Therefore, we determined the current time frame is reasonable and we do not propose to make any changes to this section.

We propose to add a new § 483.11(d)(6)(i)(G) to indicate that the facility may not charge the resident for hospice services elected by the resident and paid for under the Medicare Hospice Benefit or paid for by Medicaid under a state plan, whether provided directly by the SNF/NF or by a hospice provider under agreement with the SNF/NF.

We propose in § 483.11(d)(6)(ii), re-designated from § 483.10(c)(8)(ii), to add to the limitations on charges to residents' funds. This provision currently provides general categories and examples of items and services that the facility may charge to residents' funds if the items are requested by a resident, and are not required to achieve the goals stated in the resident's care plan. In these instances, the resident is informed that there will be a charge and that the items are not paid for by Medicare or under a state plan. We propose to add new § 483.11(d)(6)(ii)(L)(

1

) and (

2

) to clarify that the facility may not charge for special food and meals ordered for a resident by a physician, physician assistant, nurse practitioner, clinical nurse specialist, dietitian or other clinically qualified nutrition professional and to cross-reference to provisions regarding the expectation that the foods and meals a facility generally prepares should be developed taking into consideration residents' needs and individual preferences in addition to the overall cultural and religious make-up of the facility's population. Refer to our discussion in

Section II. P. “Food and Nutrition Services for additional information. We propose a clarification in proposed § 483.11(d)(6)(iii) by adding the term “non-covered” before “item or service,” as this provision would only apply to non-covered items or services.

We propose to establish a new § 483.11(e) to incorporate multiple provisions related to information and communication. With the exception of medical records, we propose in § 483.11(e)(1) to specify that the facility is responsible for ensuring that information provided to the resident is provided in a form and manner that the resident can access and understand, including in a language that the resident can understand. Medical records are addressed in proposed § 483.11(e)(2), As noted earlier, this proposal does not address the creation or provision of summary reports of medical records. Summary reports of medical records may be provided in accordance with applicable law. The language requirement is already a requirement for specific types of notices and information (see § 483.10(b)(1), § 483.10(b)(3), and § 483.12(a)(4)(i)). However, language is not the only barrier to effective communication and it is important for the resident to have the opportunity to understand all information that is provided. We also hope to provide facilities with some flexibility to implement this requirement. For example, in some cases, a resident representative may prefer to access information on the internet rather than receive a paper copy, or it may be more effective and efficient for a resident who is blind or visually impaired to listen to an audio file explaining resident rights. Some residents may require assistive technology or alternative formats. The key to this provision is ensuring that when there is a requirement to provide information, it is provided in a way to ensure both resident access and understanding.

We propose in § 483.11(e)(2) to revise facility requirements currently in § 483.10(b)(2)(i) through (ii), consistent with our proposal at § 483.10(f)(3). Proposed (e)(2)(i) would require that facilities provide residents with access to his or her medical records in the form and format requested by the individual, if it is readily producible in such form and format (including in an electronic form or format when such medical records are maintained electronically); or, if it is not readily producible in such form and format, in a readable hard copy form or other form and format as may be agreed to by the facility and the individual. This provision would include the existing requirement that access be provided upon oral or written request, redesignated from § 483.10(b)(2)(i), and that this access be provided within 24 hours, excluding weekends and holidays, as required by sections 1819(c)(1)(A)(iv) and 1919(c)(1)(A)(iv) of the Act. We believe in some circumstances an electronic copy may be a preferable and more efficient option for both the facility and the resident or resident's representative, particularly where the record already exists in an electronic format. We propose at (e)(2)(i) to require that the facility allow the resident, after receipt of his or her medical records for inspection, to purchase a copy of the medical records or any portion thereof upon request and with 2 working days advance notice to the facility. We further propose at § 483.11(e)(2)(iii) to revise the standard for the fee a facility may charge for the requested information from a community standard to a cost-based standard under which the fee includes only the cost of labor for copying the requested health information, whether in paper or electronic form; the supplies for creating the paper copy or electronic media if the individual requests that the electronic copy be provided on portable media, postage when the individual requested the copy be mailed. This is consistent with the requirements of 45 CFR 164.524(c)(4).

We propose to add a new § 483.11(e)(3), incorporating and re-designating part of existing § 483.10(g)(1), with revisions required by section 6103(c) of the Affordable Care Act, which added new sections 1819(d)(1)(C) and 1919(d)(1)(V). Those provisions require that individuals have access to surveys of the facility conducted by federal or state surveyors and any plan of correction in effect with respect to the facility for the preceding 3 years. We note that this provision does not require a specific format, but consistent with our proposed § 483.11(e)(1), it must be in a form and manner accessible to and understandable by the resident.

We propose to add a new § 483.11(e)(4)(i) and (ii) to require the facility to post, in a form and manner easily accessible and understandable to residents, resident representatives and support persons, information that would allow individuals to contact pertinent client advocacy groups, including the state survey and certification agency, the state licensure office, the State Long-Term Care Ombudsman Program, the Protection and Advocacy Network, and the Medicaid Fraud Control Unit. We also propose to require that the facility post a statement that a resident may file a complaint with the state survey and certification agency. The facility is already required at existing § 483.10(b)(7), which would be re-designated at proposed § 483.11(e)(12), to provide this information in the written description of legal rights provided to the resident. However, we believe that posting this information will ensure that resident representatives as well as other support persons and residents continue to have access to updated and readily understandable information.

We propose to add a new paragraph § 483.11(e)(7)(i) to specify that when a facility notifies a physician of a change in a resident's status, the facility must ensure that certain pertinent information is available and is provided to the physician upon request. The required information would be the same information we propose to require under new § 483.15(b)(2) (information in transfer or discharge). This requirement, in concert with proposals to improve transitions of care, communications among and between practitioners, appropriate exchange of information, and quality assessment activities, will help ensure that the physician's decisions relating to treatment or transfer of a resident to an acute care facility are made on the basis of the best information available. Widely available methodologies and tools may assist facilities in ensuring that effective information exchanges occur. For example, Situation, Background, Assessment, Recommendation (SBAR) is a common methodology for structured communication. Information and tools relating to SBAR are widely available, including but not limited to from sources such as the Agency for Healthcare Research and Quality (

www.innovations.ahrq.gov

), The Joint Commission (

www.jointcommission.org

), the Institute for Healthcare Improvement (

www.ihi.org

), the INTERACT (Interventions to Reduce Acute Care Transfers) project (

http://interact2.net

), and others.

We propose to revise the language of § 483.10(b)(11)(i) and re-designate it as new § 483.11(e)(7)(i) to provide that the facility would be required to notify the resident representatives, rather than the current requirement that the facility notify “. . . the resident's legal representative or an interested family member . . .”. The proposed language allows a guardian or other legal representative as well as any other individuals the resident identifies, including family members, other

relatives, close personal friends, or any other persons identified by the resident, to receive the required notifications and thus remain informed of important information about the resident.

We propose to re-designate § 483.10(b)(1), which addresses the facility requirement to provide a notice of rights and services, as § 483.11(e)(9)(i) through (iii). We propose one minor revision for clarity in § 483.11(e)(9)(ii) to state “the State-developed notice of Medicaid rights, if any” instead of the current language “notice (if any) of the State developed under 1919(e) of the Act”.

We propose to revise § 483.10(b)(5)(i) and (ii) and re-designate them as § 483.11(e)(10). The revised provision would specify that the facility must inform each resident, in writing, at the time of admission to a Medicaid-participating nursing facility and when the resident becomes eligible for Medicaid—(1) Of the items and services that are included in nursing facility services under the state plan and for which the resident may not be charged; (2) of those items for which the resident may be charged, and the amount of charges for those services; and (3) inform Medicaid-eligible residents when changes are made to the items and services in proposed paragraph (e)(11)(i) of this section.

We propose to revise and re-designate § 483.10(b)(6) as new § 483.11(e)(11). In addition, we propose to add new paragraphs (i) through (v) to require the facility to provide notice to residents when changes are made to the items and services covered by Medicare and/or Medicaid or to the amount that the facility charges for items and services. It is important that residents remain informed of these issues in order to ensure their ability to make informed decisions, both financial and health-care related.

To improve clarity, we propose to re-designate § 483.10(b)(7) as new § 483.11(e)(12) and revise current paragraph (b)(7)(iii) to require that the facility provide the resident with “a list of names, addresses (mailing and email), and telephone numbers of all pertinent state regulatory and informational agencies, resident advocacy groups such as the state survey and certification agency, the state licensure office, the state long-term care ombudsman program, the protection and advocacy agency, adult protective services, the state or local contact agencies for information about returning to the community and the Medicaid fraud control unit.” Additionally, we propose to revise current paragraph (b)(7)(iv) to require that the facility include in the written description of legal rights “a statement that the resident may file a complaint with the state survey and certification agency concerning any suspected violation of LTC requirements, including but not limited to resident abuse, neglect, misappropriation of resident property in the facility, non-compliance with the advance directives requirements, and requests for information regarding returning to the community.”

We propose a new § 483.11(e)(13) that would establish that the facility must protect and facilitate a resident's right to communicate with individuals and entities both inside and external to the facility, including at § 483.11(e)(13)(ii) reasonable access to the internet, to the extent it is available to the facility. Section 483.11(e)(13)((i) would revise and replace § 483.10(k) and § 483.11(e)(13)((iii) would revise and replace § 483.10(i)(2) with regard to reasonable access to a telephone, including TTY and TDD services, and to stationery, postage, writing implements and the ability to send mail, respectively.

We propose a new § 483.11(f) to include provisions related to privacy and confidentiality. Proposed § 483.11(f)(1) would require that the facility respect the resident's right to personal privacy. Proposed (f)(1)(ii) would incorporate the definition of personal privacy currently set out at § 483.10(e)(1). We propose to replace the requirements of existing § 483.10(e)(2) with new § 483.11(f)(2) which requires the facility to comply with the requirements of proposed § 483.10(g)(3). We propose to redesignate existing § 483.10(j)(3) as § 483.11(f)(3) and revise it to require that the facility allow representatives of the Office of the State Long-Term Care Ombudsman to examine a resident's medical, social, and administrative records in accordance with state law. This is consistent with the requirements of section 712(b)(1) of the Older Americans Act.

We propose a new § 483.11(g) that would include provisions related to a safe environment. Specifically, we propose to re-designate § 483.15(h)(1) through (7) as § 483.11(g)(1) through (7) and revise paragraph (g)(1) to include paragraphs (g)(1)(i) specifying that the facility must ensure an environment where care and services can be delivered safely, and (g)(1)(ii) specifying that the facility must ensure that the physical layout of the facility maximizes independence and does not pose a safety risk.

We are proposing a new § 483.11(h) Grievances, which would incorporate the facility responsibilities expressed in existing § 483.10(f) and would also require that facilities ensure that residents know how to file grievances. The proposed provision would also require that the facility establish a grievance policy to ensure the prompt resolution of grievances, and identify a Grievance Officer. Additionally, the facility would be required to provide a copy of this policy upon request, as well as make information about filing grievances available to residents. Furthermore, the facility would be required to take a number of actions in response to a grievance, including:

1. Preventing further violations of resident rights during an investigation,

2. Immediately reporting allegations of neglect, abuse (including injuries of unknown source), and/or misappropriation of resident property, by anyone furnishing services on behalf of the facility, to the administrator of the facility and as required by state law,

3. Ensuring that all written grievance decisions include the date the grievance was received, a summary statement of the resident's grievance, the steps taken to investigate the grievance, a summary of the pertinent findings or conclusions regarding the resident's concerns, a statement as to whether the grievance was confirmed or not confirmed, any corrective action taken or to be taken by the facility as a result of the grievance, and the date the written decision was issued,

4. Taking appropriate corrective action in accordance with state law if the alleged violation of the residents' rights is confirmed by the facility or if an outside entity having jurisdiction confirms a violation of any of these residents' rights within its area of responsibility; and

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

The right to file a grievance is an important protection for residents and an important right of residents. The proposed revisions are intended to ensure that grievances are taken seriously and processed appropriately.

Finally, we propose a new § 483.11(i) which would require that a facility not prevent or discourage a resident from communicating with Federal, State, or local officials, including but not limited to Federal and State surveyors, other Federal or State health department employees, including representatives of the Office of the State Long-Term Care Ombudsman and of the protection and advocacy system. Residents must have the ability to communicate freely with representatives of these entities when

they have concerns about quality or care and quality of life.

E. Freedom From Abuse, Neglect, and Exploitation (§ 483.12)

Currently, § 483.13 is titled “Resident Behavior and Facility Practices.” The focus of this section is to ensure that residents of SNFs and NFs are not subjected to abuse, neglect, misappropriate of resident property, and exploitation when they reside in a facility, to specify the facility responsibilities to prevent abuse, neglect and exploitation, and to establish requirements for the facility response to allegations that any of these has occurred. Thus, we propose to re-designate and revise this section as § 483.12, “Freedom from Abuse, Neglect and Exploitation,” to more accurately reflect the contents and intent. The term “exploitation” was not previously included in this regulatory provision. However, in reviewing available materials related to abuse such as The Joint Commission standards for accreditation of long term care facilities and language relating to “misappropriation of resident property,” currently defined at § 488.301, we believe it is appropriate and necessary to add this term here as well to address circumstances that may not rise to the level of abuse or neglect but nonetheless would be prohibited. Therefore, we propose in our discussion of the definitions section of this regulation to provide a definition of “exploitation”. Although there have been significant improvements in many areas of nursing home care, abuse remains a serious issue. According to CMS Certification and Survey Provider Enhanced Reports (CASPER) data, there were 474 noncompliance deficiency citations related to freedom from abuse in Fiscal Year (FY) 2011, and 475 citations in FY 2012, affecting 2.5 percent of nursing home providers. Our proposed updates and revisions to this section are intended to both recognize that abuse continues to occur, and to provide language that will build on progress to improve conditions in nursing homes begun by the nursing home reforms of the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203 (OBRA '87).

Currently, paragraph § 483.13(a) addresses the use of restraints. We propose to address restraints in both the introductory paragraph to proposed § 483.12 and in proposed § 483.25(d)(1). In the introductory paragraph to proposed § 483.12, we would continue to prohibit the inappropriate use of restraints. Restraints can be used abusively. There may be very limited circumstances where restraints would be appropriate in a nursing facility. We propose to further address restraints in proposed section § 483.25(d)(1) on Quality of Care and Quality of Life. The use of restraints has fallen significantly in the last decade and CMS continues to promote reduction in the use of physical restraints. (See CMS 2012 Nursing Home Action Plan;

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Downloads/2012-Nursing-Home-Action-Plan.pdf

). We note that many facilities have achieved a rate of zero percent restraint use (see

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/Downloads/QAPINewsBrief.pdf

).

Existing paragraph § 483.13(b) would also be included in the new introductory paragraph to revised § 483.12. The revised introductory paragraph would set out the intent of this section. We propose to re-designate existing § 483.13(c)(1) as § 483.12(a)(2) and modify the language to clarify that a facility must not employ or otherwise engage individuals who have been found guilty of abuse, neglect, or mistreatment of residents by a court of law; had a finding of abuse, neglect, mistreatment of resident or misappropriation of property reported into a state nurse aide registry, or had a disciplinary action taken against a professional license by a state licensure body as a result of a finding of abuse, neglect, or mistreatment of residents or a finding of misappropriation of property. The proposed revision makes clear that the facility is responsible for protecting residents from abuse, neglect and exploitation by a person providing services, whether the individual has an employee relationship with the facility or is “otherwise engaged” by the facility—that is, providing services under a different arrangement, such as a volunteer or a contractor. Currently, the regulations require that a facility must not employ an individual who has had a finding entered against them into a state nurse aide registry concerning abuse, neglect, mistreatment of residents or misappropriation of property. We propose to add a new § 483.12(a)(2)(iii) to expand this employment prohibition to include licensed professionals who have had a disciplinary action taken against them by a state licensure body as a result of a finding of abuse, neglect, mistreatment of residents or misappropriation of resident property. Although a licensure disciplinary action would normally prevent a licensed professional from further practice in the state of licensure for some specified period of time, we believe inclusion in the federal standards is necessary to ensure the safety of long term care facility residents. We believe that disciplinary action information is available through state licensing boards and that it is appropriate to explicitly hold licensed personnel to the same standard as nurse aides.

We propose to re-designate existing § 483.13(c) as § 483.12(b) and to revise it to also require that the facility develop and implement written policies and procedures that prohibit and prevent abuse, neglect, exploitation of residents and misappropriation of resident property. We propose to add a new § 483.12 (b)(2) to require that the facility establish policies and procedures to investigate any allegations of abuse, neglect, exploitation, or misappropriation of property, We also propose to add a new § 483.12(b)(3) to require training, including training on resident's rights, facility responsibilities, and recognition and reporting of abuse neglect and exploitation, which we would require in proposed § 483.95. Our proposals related to training are discussed in section X, “Training requirements” (§ 483.95) of this preamble. We believe both the requirements in proposed new § 483.12(b)(2) and (b)(3) are necessary to ensure effective and consistent investigative processes and to ensure that direct care/direct access workers are trained to recognize when treatment is abusive or constitutes neglect or exploitation. We are hopeful that training may reduce the frequency of these incidents. Finally, we propose a new § 483.12(b)(5) to require that facilities establish policies and procedures to ensure reporting of crimes in accordance with section 1150B of the Act. The policies and procedures would have to include, at a minimum, annual notification of covered individuals, posting a conspicuous notice of employee rights, and prohibiting and preventing retaliation.

Annual notification of covered individuals, as defined at sec. 1150B(a)(3), includes notification of that individual's obligation, as specified at 1150B(b)(1), to report to the State Agency and one or more law enforcement entities for the political subdivision in which the facility is located any reasonable suspicion of a crime against any individual who is a resident of, or is receiving care from, the facility. Reporting to the State Agency fulfills the statutory directive to report to the Secretary. In accordance with 1150B(b)(2), the reporting required by 1150B(b)(1) must occur not later than 2 hours after forming the suspicion, if the

events that cause the suspicion result in serious bodily injury, or not later than 24 hours if the events that cause the suspicion do not result in serious bodily injury. A fuller discussion of these requirements was provided in a June 17, 2011 Survey and Certification Letter to State Survey Agency Directors and further addressed through a question and answers document in January, 2012. These documents are available at

http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SCLetter11_30.pdf

. We propose that enforcement of these requirements would be based on the terms of that guidance. We are specifically requesting comment on these proposed provisions and our proposed implementation of Section 1150B of the Act.

We propose to re-designate existing § 483.13(c)(1)(iii) as proposed § 483.12(a)(3) and revise existing § 483.13(c)(2), (3) and (4) as proposed § 483.12(c)(1), (2), (3) and (4). Specifically, we propose to add the term “exploitation” in proposed paragraph (c)(1) and add adult protective services where state law provides for jurisdiction in long-term care facilities to the list of officials who must be notified in accordance with state law; otherwise the language would be unchanged from § 483.12(c)(2). We propose to divide existing § 483.13(c)(3) into two paragraphs, § 483.12(c)(2) and (3), making the investigation of alleged violations distinct from the facility's obligation to prevent further abuse of the allegedly abused resident or other residents while the investigation is in progress.

F. Transitions of Care (§ 483.15)

We propose to re-designate current § 483.12 “Admission, transfer, and discharge rights” as new § 483.15, and revise the general title to “Transitions of care” in order to reflect current terminology that applies to all instances where care of a resident is transitioned between care settings. Extensive literature speaks to quality of care concerns related to the transitions.

In proposed new paragraph (a) we would begin with requirements for admissions policies, which would be moved to the beginning of the section to reflect chronological order. We propose a new paragraph (a)(1) to require that the facility establish an admissions policy.

Additionally, we would re-designate current § 483.12(d)(1) as § 483.15(a)(2) to state that facilities cannot request or require residents or potential residents to waive their rights to Medicare or Medicaid benefits or to any rights conferred by applicable state, federal and local licensing or certification laws. We propose to add a new paragraph (a)(2)(iii) to prohibit facilities from requesting or requiring residents or potential residents to waive any potential facility liability for losses of personal property. We understand that residents are sometimes asked to waive facility responsibility for the loss of their personal property or are unable to use personal property because it is only permitted in the facility if safeguarded by the facility in a manner that makes the property usually inaccessible to the resident. These policies effectively take away the residents' right to use personal possessions and relieve facilities from their responsibility to exercise due care with respect to residents' personal property. We expect this requirement will encourage facilities to develop policies and procedures to safeguard residents' personal possessions without effectively prohibiting a resident's use of personal possessions. We further propose to add a new paragraph (a)(6) to specify that a nursing facility must disclose and provide to a resident or potential resident, prior to time of admission, notice of any special characteristics or service limitations of the facility. For example, if a facility has a religious affiliation that guides its practices, any resulting special characteristics, requirements, or limitations would have to be communicated to potential residents at admission. Similarly, if a facility did not have the capability to care for residents requiring psychiatric care, potential residents would have to be advised of this prior to admission. The potential resident or resident representative could then make an informed initial decision about admission, should the need for specific types of care or services later become necessary, the need for an appropriate transfer will be more predictable and understandable to the resident. We believe this type of disclosure is current standard business practice, however, in keeping with proposed provisions related to specifying reasons for transfer or discharge as well as to ensure informed choices on the part of the resident at the time of admission, we would add this requirement explicitly.

We also propose to relocate existing § 483.10(b)(12) to new § 483.15(a)(7). This section addresses admission disclosure requirements for composite distinct part nursing facility, and is more appropriately located in the section on admissions.

We propose to re-designate § 483.12(a) as proposed § 483.15(b) and address transfers and discharges. § 483.15(b)(1)(ii)(C) would revise existing § 483.12(a)(2)(iii) and we would clarify that a resident could be discharged when the safety of other individuals is endangered due to the clinical or behavioral status of that resident. In proposed § 483.15(b)(1)(ii)(E), we would revise existing § 483.12(a)(2)(v) and clarify that provisions for discharge as a result of non-payment of facility charges would not apply unless the resident did not submit the necessary paperwork for third party payment or until the third party, including Medicare or Medicaid, denied the claim and the resident refused to pay for his or her stay. This is consistent with existing guidance and would help to clarify the meaning of failure to pay. Finally, we propose a new § 483.15(b)(1)(iii) to specify that the facility may not transfer or discharge the resident while the appeal is pending, pursuant to 42 CFR 431.230 when a resident exercises his or her right to appeal a transfer or discharge notice from the facility pursuant to 42 CFR 431.220(a)(3). “Discharge/Eviction” was the most frequent nursing facility complaint category processed by the Long-Term Care Ombudsman Programs nationally in FY 2013 (8,478 complaints) and has been the first or second most frequent complaint category consistently since 2006. Involuntary discharges are often traumatic for residents. Transfer or discharge from a facility prior to an appeal determination can result in an unnecessary transfer out of and back to a facility.

In the proposed revision to paragraph § 483.15(b)(2), we would make a number of revisions based on the importance of effective communication between providers during transitions of care. First, we propose to clarify that the transfer or discharge wo

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