# Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2016-23503 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** October 4, 2016 - **Citation:** 81 FR 68688 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 405, 431, 447, 482, 483, 485, 488, and 489 [CMS-3260-F] RIN 0938-AR61 Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule will revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These revisions are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers. DATES: Effective date: These regulations are effective on November 28, 2016. Implementation date: The regulations included in Phase 1 must be implemented by November 28, 2016. The regulations included in Phase 2 must be implemented by November 28, 2017. The regulations included in Phase 3 must be implemented by November 28, 2019. A detailed discussion regarding the different phases of the implementation timeline can be found in Section B. II “Implementation Date.” FOR FURTHER INFORMATION CONTACT: LTC Regulations Team, (410) 786-6633: Sheila Blackstock, Ronisha Blackstone, Diane Corning, Lisa Parker. SUPPLEMENTARY INFORMATION: Acronyms Because of the many terms to which we refer by acronym in this final rule, we are listing the acronyms used and their corresponding meanings in alphabetical order below: AAA Area Agencies on Aging ACL Administration for Community Living ADL Activities of Daily Living AHCA American Health Care Association AHLA American Health Lawyers Association ANSI American National Standards Institute ASPE Assistant Secretary for Planning and Evaluation BPSD Behavioral and Psychological Symptoms of Dementia CASPER Certification and Survey Provider Enhanced Reports CIL Centers for Independent Living CLIA Clinical Laboratory Improvement Amendment CMS Centers for Medicare & Medicaid Services CNS Clinical Nurse Specialist CPR Cardiopulmonary Resuscitation DoN Director of Nursing EHR Electronic Health Records FDA Food and Drug Administration GAO Government Accountability Office HACCP Hazard Analysis and Critical Control Point HAI Healthcare-Associated Infection HHS U.S. Department of Health and Human Services HIPAA Health Insurance Portability and Accountability Act of 1996 ICN International Council of Nurses IDT Interdisciplinary Team IG Interpretive Guidance IP Infection Preventionist IPCP Infection Prevention and Control Program LSC Life Safety Code LTC Long-Term Care NATCEP Nurse Aide Training Competency Evaluation Program MAR Medication Administration Record MDS Minimum Data Set NA Nurse Aide NF Nursing Facility NP Nurse Practitioner OIG Office of the Inspector General OMB Office of Management and Budget ONC Office of the National Coordinator PA Physician Assistant PASARR Preadmission Screening and Resident Review PIPs Performance Improvement Projects PEU Protein-Energy under Nutrition QA Quality Assurance QAA Quality Assessment and Assurance QAPI Quality Assurance and Performance Improvement QIO Quality Improvement Organization RFA Regulatory Flexibility Act RN Registered Nurse SNF Skilled Nursing Facility WHO World Health Organization Table of Contents This final rule is organized as follows: I. Background A. Executive Summary 1. Purpose 2. Summary of the Major Provisions 3. Summary of Costs and Benefits B. Statutory and Regulatory Authority of the Requirements for Long-Term Care Facilities C. Why revise the LTC requirements? II. Provisions of the Proposed Regulation and Responses to Public Comments A. General Comments B. Implementation Date C. Basis and Scope (§ 483.1) D. Definitions (§ 483.5) E. Resident Rights (§ 483.10) F. Facility Responsibilities (§ 483.11) G. Freedom From Abuse, Neglect, and Exploitation (§ 483.12) H. Transitions of Care (§ 483.15) I. Resident Assessments (§ 483.20) J. Comprehensive Resident-Centered Care Planning (§ 483.21) K. Quality of Care and Quality of Life (§ 483.25) L. Physician Services (§ 483.30) M. Nursing Services (§ 483.35) N. Behavioral Health Services (§ 483.40) O. Pharmacy Services (§ 483.45) P. Laboratory, Radiology, and Other Diagnostic Services (§ 483.50) Q. Dental Services (§ 483.55) R. Food and Nutrition Services (§ 483.60) S. Specialized Rehabilitative Services (§ 483.65) T. Outpatient Rehabilitative Services (§ 483.67) U. Administration (§ 483.70) V. Quality Assurance and Performance Improvement (§ 483.75) W. Infection Control (§ 483.80) X. Compliance and Ethics Program (§ 483.85) Y. Physical Environment (§ 483.90) Z. Training Requirements (§ 483.95) III. Provisions of the Final Regulations IV. Long-Term Care Facilities Crosswalk V. Collection of Information Requirements VI. Regulatory Impacts I. Background A. Executive Summary 1. Purpose Consolidated Medicare and Medicaid requirements for participation (requirements) for long term care (LTC) facilities (42 CFR part 483, subpart B) were first published in the Federal Register on February 2, 1989 (54 FR 5316). These regulations have been revised and added to since that time, principally as a result of legislation or a need to address a specific issue. However, they have not been comprehensively reviewed and updated since 1991 (56 FR 48826, September 26, 1991), despite substantial changes in service delivery in this setting. Since the current requirements were developed, significant innovations in resident care and quality assessment practices have emerged. In addition, the population of LTC facilities has changed, and has become more diverse and more clinically complex. Over the last two to three decades, extensive, evidence-based research has been conducted and has enhanced our knowledge about resident safety, health outcomes, individual choice, and quality assurance and performance improvement. In light of these changes, we recognized the need to evaluate the regulations on a comprehensive basis, from both a structural and a content perspective. Therefore, we reviewed regulations in an effort to improve the quality of life, care, and services in LTC facilities, optimize resident safety, reflect current professional standards, and improve the logical flow of the regulations. Specifically, we are adding new requirements where necessary, eliminating duplicative or unnecessary provisions, and reorganizing the regulations as appropriate. Many of the revisions are aimed at aligning requirements with current clinical practice standards to improve resident safety along with the quality and effectiveness of care and services delivered to residents. Additionally, we believe that these revisions will eliminate or significantly reduce those instances where the requirements are duplicative, unnecessary, and/or burdensome. 2. Summary of Provisions Basis and Scope (§ 483.1) • We have added the statutory authority citations for sections 1128I(b) and (c) and section 1150B of the Social Security Act (the Act) to include the compliance and ethics program, quality assurance and performance improvement (QAPI), and reporting of suspicion of a crime requirements to this section. Definitions (§ 483.5) • We have added the definitions for “abuse”, “adverse event”, “exploitation”, “misappropriation of resident property”, “mistreatment”, “neglect”, “person-centered care”, “resident representative”, and “sexual abuse” to this section. Resident Rights (§ 483.10) • We are retaining all existing residents' rights and updating the language and organization of the resident rights provisions to improve logical order and readability, clarify aspects of the regulation where necessary, and updating provisions to include advances such as electronic communications. Freedom From Abuse, Neglect, and Exploitation (§ 483.12) • We are requiring facilities to investigate and report all allegations of abusive conduct. We also are specifying that facilities cannot employ individuals who have had a disciplinary action taken against their professional license by a state licensure body as a result of a finding of abuse, neglect, mistreatment of residents or misappropriation of their property. Admission, Transfer, and Discharge Rights (§ 483.15) • We are requiring that a transfer or discharge be documented in the medical record and that specific information be exchanged with the receiving provider or facility when a resident is transferred. Resident Assessments (§ 483.20) • We are clarifying what constitutes appropriate coordination of a resident's assessment with the Preadmission Screening and Resident Review (PASARR) program under Medicaid. We are also adding references to statutory requirements that were inadvertently omitted from the regulation when we first implemented sections 1819 and 1919 of the Act. Comprehensive Person-Centered Care Planning (§ 483.21) *New Section* • We are requiring facilities to develop and implement a baseline care plan for each resident, within 48 hours of their admission, which includes the instructions needed to provide effective and person-centered care that meets professional standards of quality care. • We are adding a nurse aide and a member of the food and nutrition services staff to the required members of the interdisciplinary team that develops the comprehensive care plan. • We are requiring that facilities develop and implement a discharge planning process that focuses on the resident's discharge goals and prepares residents to be active partners in post-discharge care, in effective transitions, and in the reduction of factors leading to preventable re-admissions. We are also implementing the discharge planning requirements mandated by The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) by revising, or adding where appropriate, discharge planning requirements for LTC facilities. Quality of Care (§ 483.24) • We are requiring that each resident receive and the facility provide the necessary care and services to attain or maintain the highest practicable physical, mental, and psychosocial well-being, consistent with the resident's comprehensive assessment and plan of care. Quality of Life (§ 483.25) • Based on the comprehensive assessment of a resident, we are requiring facilities to ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan, and the residents' choices. Physician Services (§ 483.30) • We are allowing attending physicians to delegate dietary orders to qualified dietitians or other clinically qualified nutrition professionals and therapy orders to therapists. Nursing Services (§ 483.35) • We are adding a competency requirement for determining the sufficiency of nursing staff, based on a facility assessment, which includes but is not limited to the number of residents, resident acuity, range of diagnoses, and the content of individual care plans. Behavioral Health Services (§ 483.40) • We are adding a new section to subpart B that focuses on the requirement to provide the necessary behavioral health care and services to residents, in accordance with their comprehensive assessment and plan of care. • We are adding “gerontology” to the list of possible human services fields from which a bachelor degree could provide the minimum educational requirement for a social worker. Pharmacy Services (§ 483.45) • We are requiring that a pharmacist review a resident's medical chart during each monthly drug regimen review. • We are revising existing requirements regarding “antipsychotic” drugs to refer to “psychotropic” drugs and define “psychotropic drug” as any drug that affects brain activities associated with mental processes and behavior. We are requiring several provisions intended to reduce or eliminate the need for psychotropic drugs, if not clinically contraindicated, to safeguard the resident's health. Laboratory, Radiology, and Other Diagnostic Services (§ 483.50) *New Section* • We are clarifying that a physician assistant, nurse practitioner or clinical nurse specialist may order laboratory, radiology, and other diagnostic services for a resident in accordance with state law, including scope-of-practice laws. Dental Services (§ 483.55) • We are prohibiting SNFs and NFs from charging a Medicare resident for the loss or damage of dentures determined in accordance with facility policy to be the facility's responsibility, and we are adding a requirement that the facility have a policy identifying those instances when the loss or damage of dentures is the facility's responsibility. We are requiring NFs to assist residents who are eligible to apply for reimbursement of dental services under the Medicaid state plan, where applicable. • We are clarifying that with regard to a referral for lost or damaged dentures “promptly” means that the referral must be made within 3 business days unless there is documentation of extenuating circumstances. Food and Nutrition Services (§ 483.60) • We are requiring facilities to provide each resident with a nourishing, palatable, well-balanced diet that meets his or her daily nutritional and special dietary needs, taking into consideration the preferences of each resident. We are also requiring facilities to employ sufficient staff, including the designation of a director of food and nutrition service, with the appropriate competencies and skills sets to carry out the functions of dietary services while taking into consideration resident assessments and individual plans of care, including diagnoses and acuity, as well as the facility's resident census. Specialized Rehabilitative Services (§ 483.65) • We have added respiratory services to those services identified as specialized rehabilitative services. Administration (§ 483.70) • We have largely relocated various portions of this section into other sections of subpart B as deemed appropriate. • We require facilities to conduct, document, and annually review a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies. Facilities are required to address in the facility assessment the facility's resident population (that is, number of residents, overall types of care and staff competencies required by the residents, and cultural aspects), resources (for example, equipment, and overall personnel), and a facility-based and community-based risk assessment. • Binding Arbitration Agreements: We are requiring that facilities must not enter into an agreement for binding arbitration with a resident or their representative until after a dispute arises between the parties. Thus, we are prohibiting the use of pre-dispute binding arbitration agreements. Quality Assurance and Performance Improvement (QAPI) (§ 483.75) • We are requiring all LTC facilities to develop, implement, and maintain an effective comprehensive, data-driven QAPI program that focuses on systems of care, outcomes of care and quality of life. Infection Control (§ 483.80) • We are requiring facilities to develop an Infection Prevention and Control Program (IPCP) that includes an Antibiotic Stewardship Program and designate at least one Infection Preventionist (IP). Compliance and Ethics Program (§ 483.85) *New Section* • We are requiring the operating organization for each facility to have in effect a compliance and ethics program that has established written compliance and ethics standards, policies and procedures that are capable of reducing the prospect of criminal, civil, and administrative violations in accordance with section 1128I(b) of the Act. Physical Environment (§ 483.90) • We are requiring facilities that are constructed, re-constructed, or newly certified after the effective date of this regulation to accommodate no more than two residents in a bedroom. We are also requiring facilities that are constructed, or newly certified after the effective date of this regulation to have a bathroom equipped with at least a commode and sink in each room. Training Requirements (§ 483.95) *New Section* • We are adding a new section to subpart B that sets forth all the requirements of an effective training program that facilities must develop, implement, and maintain for all new and existing staff, individuals providing services under a contractual arrangement, and volunteers, consistent with their expected roles. 3. Summary of Costs and Benefits We estimate the total projected cost of this final rule will be about $831 million in the first year and $736 million per year for subsequent years. While this is a large amount in total, the average costs per facility are estimated to be about $62,900 in the first year and $55,000 per year for subsequent years. Although the overall magnitude of cost related to this regulation is economically significant, we note that these costs are significantly less than the amount of Medicare and Medicaid spending for LTC services. According to the 2015 Annual Report of the Medicare Trustees, payments for SNF services from Medicare Part A were $29.92 billion for fiscal year 2015 and payments for NF services were $50.6 billion for fiscal year 2013 (see https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Statistics-Reference-Booklet/2015.html ). We are unable to quantify the benefits of the final rule; however, this final rule creates new efficiencies and flexibilities for facilities that are likely to reduce avoidable hospital readmissions, increase the rate of improvement in quality throughout facilities, and create positive business benefits for facilities. B. Statutory and Regulatory Authority of the Requirements for Long-Term Care Facilities In addition to specific statutory requirements set out in sections 1819 and 1919 and elsewhere in the Act, sections 1819(d)(4)(B) and 1919(d)(4)(B) of the Act permit the Secretary of the Department of Health and Human Services (the Secretary) to establish any additional requirements relating to the health, safety, and well-being of SNF and NF residents, respectively, as the Secretary finds necessary. Under sections 1866 and 1902 of the Act, providers of services seeking to participate in the Medicare or Medicaid program, or both, must enter into an agreement with the Secretary or the state Medicaid agency, as appropriate. LTC facilities seeking to be Medicare and Medicaid providers of services must be certified as meeting federal participation requirements. LTC facilities include SNFs for Medicare and NFs for Medicaid. The federal participation requirements for SNFs, NFs, or dually certified facilities, are codified in the implementing regulations at 42 CFR part 483, subpart B. Sections 1819(b)(1)(A) and 1919(b)(1)(A) of the Act provide that a SNF or NF must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident. In addition, the IMPACT Act (Pub. L. 113-185) amended Title XVIII of the Act by, among other things, adding Section 1899B to the Act. Section 1899B(i) of the Act requires that certain providers, including long term care facilities, take into account, quality, resource use, and other measures to inform and assist with the discharge planning process, while also accounting for the treatment preferences and goals of care of residents. The Affordable Care Act made a number of changes to the Medicare and Medicaid programs. For instance, in an effort to increase accountability for SNFs and NFs, section 6102 of the Affordable Care Act established a new section 1128I of the Act. In general, section 1128I(b) of the Act requires LTC facilities to have in operation an effective compliance and ethics program that is effective in preventing and detecting criminal, civil, and administrative violations and in promoting quality of care. Section 1128I(b)(2) of the Act specifies that the Secretary, working jointly with the Inspector General of the Department of Health and Human Services (HHS), shall promulgate regulations for an effective compliance and ethics program for operating organizations, which may include a model compliance program. Further, section 1128I(c) of the Act adds a requirement for a quality assurance and performance improvement program (QAPI). Lastly, in an effort to promote dementia management and prevent abuse, section 6121 of the Affordable Care Act amended sections 1819(f)(2)(A)(i)(I) and 1919(f)(2)(A)(i)(I) of the Act by requiring dementia and abuse prevention training to be included as part of training requirements for nurse aides (NAs). C. Why revise the long-term care requirements On July 16, 2015, we published a proposed rule entitled, “Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities” (80 FR 42168). In the proposed rule we included a robust discussion about the history the LTC requirements and how the current care and service delivery practices of LTC facilities have changed over time. We encourage readers to refer to the proposed rule for this discussion. As discussed in the proposed rule, the requirements for LTC facilities have not been comprehensively reviewed and updated since 1991. In addition, the number of individuals accessing SNF care has increased and the health concerns of individuals residing in LTC facilities have become more clinically complex. These factors demonstrated a need to comprehensively review the regulation and informed our approach for revising the regulations. The following discussion highlights our approach for revising the LTC regulations as well as some of the most significant revisions set forth in this final rule. Facility Assessment and Competency-Based Approach One of our goals in revising our minimum health and safety requirements for LTC facilities is to ensure that our regulations align with current clinical practice and allow flexibility to accommodate multiple care delivery models to meet the needs of the diverse populations that are provided services in these facilities. We have taken a competency-based approach that focuses on achieving the statutorily mandated outcome of ensuring that each resident is provided care that allows the resident to maintain or attain their highest practicable physical, mental, and psychosocial well-being. As discussed in further detail, we are requiring facilities to assess their facility capabilities and their resident population. This competency-based approach is compatible with existing state requirements and business practices, and promotes both efficiency and effectiveness in care delivery. Current HHS Quality Initiatives This final rule is intended to meet the spirit of current HHS quality initiatives that cut across various providers. As an effective steward of public funds, CMS is committed to strengthening and modernizing the nation's health care system to provide access to high quality care and improved health at lower cost. This includes improving the patient experience of care, both quality and satisfaction, improving the health of populations, and reducing the per capita cost of health care. As discussed below, we are implementing several revisions consistent with these efforts. • Reducing Avoidable Hospitalizations One goal of the HHS Partnership for Patients Initiative is to reduce the number of individuals who experience a preventable complication requiring rehospitalization. This effort aims to improve the quality of care and services for individuals cared for in LTC facilities. In support of this initiative, CMS launched the “Initiative to Reduce Avoidable Hospitalizations among Nursing Facility Residents” ( http://innovation.cms.gov/initiatives/rahnfr/ ) in 2012. This Initiative focuses on long-stay nursing facility residents who are enrolled in the Medicare and Medicaid programs. Additional information and resources are available at http://innovation.cms.gov/initiatives/rahnfr/index.html. Consistent with the HHS focus on reducing unnecessary hospitalization, this final rule strengthens the minimum health and safety standards for LTC facilities in hopes of contributing to a reduction in unnecessary hospital admissions of LTC facility residents. We discuss those changes in more detail in the discussion that follows. • Healthcare Associated Infections HHS is also working to reduce the incidence of healthcare associated infections (HAIs) across providers. In recognition of HAIs as an important public health and patient safety issue, HHS is sponsoring the “National Action Plan to Prevent HAIs.” This initiative seeks to coordinate and maximize the efficiency of prevention efforts across the federal government ( http://www.hhs.gov/ash/initiatives/hai/actionplan/ ). Given the growing number of individuals receiving care in LTC settings and the presence of more complex medical care, these individuals are at an increased risk for HAIs. To advance these initiatives, this final rule implements revisions that we believe will provide more opportunities to achieve broad based improvement and contribute to reduced healthcare costs, while allowing for targeted interventions specific to each LTC facility. • Behavioral Health On March 29, 2012, CMS launched an initiative aimed at improving behavioral healthcare and safeguarding LTC facility residents from the use of unnecessary antipsychotic medications, the National Partnership to Improve Dementia Care in Nursing Homes. As part of the initiative, CMS has developed a national action plan that uses a multidimensional approach including public reporting, raising public awareness, regulatory oversight, and technical assistance/training and research. This plan is targeted at enhancing person-centered care for LTC facility residents, particularly those with dementia-related behaviors ( https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/National-Partnership-to-Improve-Dementia-Care-in-Nursing-Homes.html ). Similarly, with regard to minimum health and safety standards, this final rule implements regulatory changes that may lead to a reduction in the unnecessary use of antipsychotic medication and improvements in the quality of behavioral healthcare. • Health Information Technology HHS also has a number of initiatives designed to encourage and support the adoption of health information technology and to promote nationwide health information exchange to improve health care. The Department is committed to accelerating health information exchange (HIE) through initiatives including: (1) Establishing a coordinated governance framework and process for nationwide health IT interoperability; (2) improving technical standards and implementation guidance for sharing and using a common clinical data set; (3) enhancing incentives for sharing electronic health information according to common technical standards, starting with a common clinical data set; and (4) clarifying privacy and security requirements that enable interoperability. This strategy is described in greater detail in “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap”, available at https://www.healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf . The use of such technology can effectively and efficiently help facilities and other providers improve internal care delivery practices, support the exchange of important information across care team members (including patients and caregivers) during transitions of care, and enable reporting of electronically specified clinical quality measures (eCQMs). • Trauma-Informed Care HHS has also undertaken broad-based activities to support Americans that have specific needs to be considered in delivering health care and other services. Activities include raising awareness about the special care needs of trauma survivors, including a targeted effort to support the needs of Holocaust survivors living in the United States. Trauma survivors, including veterans, survivors of large-scale natural and human-caused disasters, Holocaust survivors and survivors of abuse, are among those who may be residents of long-term care facilities. For these individuals, the utilization of trauma-informed approaches is an essential part of person-centered care. Person-centered care that reflects the principles set forth in SAMSHA's “Concept of Trauma and Guidance for a Trauma-Informed Approach,” HHS Publication No. (SMA) 14-4884, available at http://store.samhsa.gov/shin/content/SMA14-4884/SMA14-4884.pdf, will help advance the quality of care that a resident receives and, in turn, can substantially improve a resident's quality of life. II. Provisions of the Proposed Regulation and Response to Public Comments In response to our July 16, 2015 proposed rule (80 FR 42168), we received over 9,800 public comments. Commenters included long-term care consumers, advocacy groups for long-term care consumers, organizations representing providers of long-term care and senior service, long-term care ombudsman, state survey agencies, various health care associations, legal organizations, and many individual health care professionals. Below, we have organized our response to comments as follows: A. General Comments; B. Implementation, and C. Public Comments by Regulatory Section. A. General Comments Comment: Most commenters expressed overall support for the proposed revisions to the requirements. Commenters agreed that reforms to the existing requirements are necessary to ensure high quality care and quality of life in LTC facilities across the nation. Specifically, many commenters support the change in focus towards person-centered care. One commenter stated that “[t]he rule would require that facilities learn more about who the resident is as a person, provide greater support for resident preferences and give residents increased control and choice. This focus on person-centered care and culture change would improve both the resident's quality of life and quality of care.” Commenters also expressed support for improved protections of resident's rights, protections against abuse and neglect, and a greater emphasis on resident and representative participation in care planning. Commenters also stated that change is necessary to reflect current standards of practice, and support our use of geriatrics-focused medical literature in developing the proposed requirements. Response: We thank commenters for their support. Our intent in issuing the proposed requirements was to improve the quality of care and quality of life for residents of long term care facilities. Comment: Some commenters commended CMS for the proposed revisions to the requirements, while stating that CMS should have proposed additional changes and reforms. For example, a few commenters stated that we should have explicitly required facilities to accommodate supported decision making, which is when an individual assists a resident in making his or her own decisions, rather than making decisions on their behalf. Commenters also expressed disappointment that the proposed requirements did not directly address dementia care. Response: We thank the commenters for their responses, and believe that the flexible, person-centered nature of these requirements will support facilities in addressing each resident's goals and needs. For example, residents and their designated representatives can certainly engage in supported decision making with their care team—nothing in these requirements prohibits it. Further, we do address dementia care in the Behavioral Health sections of this final rule. Comment: Many commenters expressed general worries that the proposed changes were too broad in scope, and that incremental changes would be easier to implement and better for LTC residents. We directly requested comments on the implementation of the revised requirements and commenters overwhelmingly indicated their preference for a phased implementation. Commenters also requested more time in which to submit comments, due to the depth and volume of the proposed revisions. Response: We acknowledge that these requirements may be difficult to effectively implement within the standard delayed implementation period (typically 60 days for more comprehensive rulemakings). We are therefore implementing these requirements over a “phase-in” period. Please see section II.B. of this rule, “Implementation,” for a detailed discussion of the implementation timeframe. Also, in order to allow sufficient time for public review of the proposed rule, we did extend the public comment period by 30 days, instead of closing submissions after the typical 60-day public comment period. We thank the thousands of commenters who provided comments during the extended period. Comment: Some commenters expressed disappointment that we continue to approach LTC facilities as health care institutions rather than “homes.” One commenter suggested we use the word “nursing home” instead of “facility.” Conversely, many commenters believe we should acknowledge that LTC facilities are no longer necessarily de facto homes, but skilled health care facilities providing more intensive care for shorter periods of time, and that the requirements should address the specific needs of shorter-stay residents, such as those who are rehabilitating after medical events before returning to their private residence. For example, these shorter stay residents (who usually stay for fewer than 30 days) are not likely interested in resident or family councils, or concerned about selecting a roommate. Commenters also expressed that short-stay individuals may not benefit from the same type of care planning as would be appropriate for longer term residents. Response: We recognize that for many residents, a LTC facility is their home. That said, LTC facilities are specialized health care settings for individuals not capable of living independently and are not directly comparable to private residences. We do support LTC facilities in developing a home-like environment, and note that residents are indeed recognized as residents, even if their stay is short. We believe that the person-centered approach to care required in this rulemaking allows for flexibility in care planning and resident accommodations. A resident at the LTC facility for a short period of time may have a shorter or more focused plan of care than a long-term resident. Similarly, a short-term resident may elect not to participate in resident councils. Comment: One commenter, who stated that their facility provides short-term rehab services following hospitalizations in addition to long-term care, expressed the belief that our proposed requirements would inhibit their ability to accept patients during evenings and weekends. They stated that this may cause “backups” in hospital discharges, and lead to patients being inappropriately discharged to their private home. Response: We do not agree that our revised requirements limit admissions to long-term care facilities outside of weekday business hours. We encourage LTC facilities to work with local hospitals to ensure safe care transitions, and to exercise the flexibility allowed by the requirements to establish admissions and care planning policies appropriate for their community. Comment: Commenters appreciated that CMS acknowledged and proposed to incorporate the full scopes of practice for non-physician practitioners related to actions that were formerly restricted to physicians. They supported these changes for being both cost effective and responsive to current standards of care. Response: We agree and thank commenters for their support. Please note that statute restricts some positions and tasks to physicians, such as the requirement at section 1819(b)(6)(A) of the Act, which requires that the care of every resident be provided under the supervision of a physician. Where appropriate and permissible by statute, we have allowed for flexibility in who may perform certain tasks or services within their respective scopes of practice. Comment: Some commenters stated that they saw no need for CMS to revise requirements for LTC facilities. They expressed concerns that the proposed requirements would be both excessively burdensome and confusing. A few commenters expressly identified the regulatory language of the proposed requirements as confusing. Commenters also stated their belief that the current requirements are adequate, and that changes would be detrimental to care. Response: We thank the commenters for their input, but disagree that changes to the LTC requirements are unnecessary. Current requirements do not, in some respects, reflect advances in technology and the science of care delivery. In addition, while it is true that many facilities provide excellent care under the current requirements, data and incidents continue to show that there are LTC facilities that have room for improvement. These updated and revised requirements establish a framework for those facilities to raise their quality of care. We have reviewed and considered all comments, and in response to concerns over burden, we have revised some proposed requirements and burden estimates in this final rule. Where commenters brought up specific concerns, we address those in the relevant parts of this rule. Also, we have made clarifying revisions to several parts of the rule, in order to improve understanding. Comment: Commenters disagreed on whether the proposed requirements align with current standards of practice. Some believe that current standards of practice may be inadequate or stated that they already met many of the newly proposed requirements. Others expressed concerns that a number of the proposed requirements are unrealistic or contrary to sound standards of practice. Response: We recognize that standards of care are constantly evolving and have therefore tried to create meaningful, yet appropriately flexible, requirements. We thank the commenters for their input, and point out that this regulation establishes revised baseline requirements. These requirements are meant to ensure safe, professional, patient-centered care in all Medicare-and Medicaid-participating LTC facilities, while leaving room for facilities to improve and excel. We commend those facilities who strive to improve upon them and look forward to stakeholder feedback as the requirements are implemented. Comment: A few commenters stated that they do not support the proposed reorganization of the Requirements of Participation and disagreed with the assertion that the reorganization improves the logical flow of the regulations. Commenters stated that working within the existing structure of the requirements would make it easier to implement new requirements and reduce burden on stakeholders. Response: We thank the commenters for their input. In response to comments, we have made some changes to the order and arrangement of the requirements from the proposed rule, specifically with respect to proposed §§ 483.10, 483.11, and 483.25. In response to the concerns related to implementation, we again note that we are implementing the requirements over a phase-in period to allow for appropriate clarification and education for facilities, surveyors, and other stakeholders. Comment: A few commenters were not supportive of the designation of these requirements of participation as “requirements,” rather than “conditions of participation” that apply to other Medicare-participating providers. Specifically, the commenters are concerned that this terminology effectively makes any violation or unmet requirement a reason for surveyors to close a facility. Response: The term “requirements” reflects the statutory language at sections 1819 and 1919 of the Act. Although this rule establishes requirements for LTC facilities, and not conditions, we note that CMS and state agencies have always taken into consideration the scope and severity of violations. Except in very rare cases of serious, immediate health and safety risks to residents, facilities are always given an opportunity to address and correct deficiencies. The goal of the requirements and their enforcement is to ensure the health and safety of residents, which includes giving facilities the opportunity to improve and come into compliance with the requirements. Comment: Some commenters expressed concerns that hands-on care would take a backseat to paperwork and documentation under the proposed requirements. Other commenters suggested that we could have gone further and established a detailed data collection program, which could be used to better identify achievement and best practices in LTC settings. Response: It is not our intention to reduce staff time spent performing direct patient care; however, facilities must be able to demonstrate that care and services meet the requirements for participation. Unfortunately, instances of significant lapses in care continue to occur in facilities. Our requirements, including QAPI, Compliance and Ethics, and Infection Control, as well as requirements for policies and procedures, are intended to protect the health and safety of residents, prevent harm and support quality of life for residents. Establishing a detailed data collection program is outside the scope of this rule. Comment: Some commenters stated that revisions to the requirements are meaningless without appropriate enforcement. Commenters asked that, prior to implementation of new requirements, CMS ensure all federal and state surveyors are thoroughly trained about the substance of these new requirements as well as current professional standards of care for all professionals working in nursing centers. One commenter further suggested that surveyors be required to demonstrate competence in all relevant areas, as shown through testing and monitoring. Alternately, one commenter offered their support for “movement from a punitive survey process to more towards a process which survey agencies and care givers work hand in hand for positive outcomes. Surveyors have a wealth of knowledge and exposure to numerous facilities. Passing on best practices to improve care giving and focusing on training the care givers would be a[n] improvement.” Other commenters offered concerns about variability and perceived inconsistencies between surveys and surveyors. A few commenters urged CMS to provide defined consequences for noncompliance with the regulations, particularly those related to residents' rights, grievances, and abuse and neglect, including finding of Immediate Jeopardy (as appropriate) and, ultimately, sanctions, including large civil monetary penalties, temporary management, directed corrective actions, and exclusion from participation in Federal health care programs, as appropriate. Response: We agree that surveyors must be educated and trained on the new requirements and note that such training happens on a regular basis, especially when new requirements are issued. We will consider these comments for future rulemaking. We note that surveyors are not permitted by law to act simultaneously as consultants. Specifying precise consequences for facilities out of compliance with specific requirements is outside the scope of this rulemaking. Comment: Commenters expressed strong support for stakeholder involvement in the development of sub-regulatory materials. One commenter expressed concerns about the approach CMS has been recently taking utilizing relatively brief conference calls with numerous callers (too numerous to allow effective discussion) allegedly to engage stakeholders in development of critical implementation issues. The commenters felt that this did not constitute sufficient stakeholder engagement. One commenter observed that upon issuance of a final rule, CMS will need to develop sub-regulatory requirements, including interpretive guidelines, to provide much greater detail and guidance on the regulatory revisions. The commenter recommended that provider organizations and association representatives be involved in the development of these specific requirements and guidelines to ensure they are consistent with sound practice, pragmatic in approach, sufficiently flexible, cost-effective and representative of the current realities of providing LTC facility care to an increasingly complex and diverse resident population. Response: We thank commenters for their input and will consider their views for possible later action. Comment: Several commenters associated with rural LTC facilities expressed concerns that meeting the proposed requirements would be difficult in rural areas. They identified staffing as a particular hardship in rural areas, especially the proposed requirement for physician evaluation prior to non-emergency hospital transfer. Rural facilities also stated that it was already difficult to hire and retain qualified staff in all skilled positions, simply due to rural population levels. Other commenters pointed to the general labor shortage in health care across much of the country. Response: We appreciate the commenters' input and note that we have revised the proposed requirements to allow for greater flexibility and in consideration of staffing concerns. Specifically, we are not finalizing the proposed requirement for pre-transfer evaluation by a practitioner. That said, these regulations establish what we have identified as basic staffing needs to ensure appropriate expertise and quality of care. We sympathize with those facilities that are unable to access a large labor pool, but we cannot condone substandard care. We discuss physician services and staffing requirements in greater detail in the relevant sections of this rule. Comment: Commenters expressed concern about the overall burden of the proposed requirements, and many believe that we may have underestimated the burden on stakeholders. One commenter expressed concern about the cumulative compliance costs associated with the many changes proposed in the regulations. They believe that the additional staffing, credentialing, training, systems and contractual relationships that will be required for compliance will add to the financial stresses that LTC facilities are experiencing from ongoing Medicare and Medicaid cuts. Another commenter protested our issuance of new, burdensome requirements while at the same time “cutting fee-for-service reimbursements” and implementing value-based purchasing. Response: We have revised some provisions, such as the requirement for credentialing, in response to concerns about burden. In addition, we have our burden estimates in response to comments. Please see sections V, “Collection of Information Requirements,” and VI, “Regulatory Impact Analysis (RIA),” of this rule for more details about regulatory burden estimates. We acknowledge that the SNF value-based purchasing (VBP) program, which will take effect in FY 2019, is intended to tie SNF payments more closely to rewarding positive patient care outcomes. Under section 1888(h)(6) of the Act, the VBP incentive payments to the higher-performing SNFs are to be funded through a 2 percent reduction in the overall SNF PPS payment rates (again, effective in FY 2019); accordingly, under the terms of the VBP legislation, a SNF's successful performance in meeting the applicable quality measures can help mitigate the actual impact of the overall payment reduction. These payment changes were specifically mandated by Congress when it enacted the SNF VBP legislation in section 215 of the Protecting Access to Medicare Act of 2014 (PAMA, Pub. L. 113-93). The requirements in this rulemaking share the VBP program's objective of improving the quality of care in the LTC setting. We note in addition that SNF PPS payment rates have increased steadily over recent years, due to market basket updates. Comment: Many commenters stated concerns about inadequate Medicaid reimbursement, while others pointed out that private payer rates are continually rising to compensate for low Medicare reimbursement. Commenters worry that the current reimbursement rates are barely sufficient, in some cases already insufficient, to meet the current requirements, and that the issue will compound as facilities attempt to comply with the new requirements. Several commenters stated that falling Medicare and Medicaid reimbursement rates, relative to costs, will cause their facilities to close. Many of these commenters identified themselves as the sole LTC facilities within a geographic area, which would severely limit the options of their residents if faced with closure. One commenter suggested that, due to low Medicaid reimbursement rates, this rulemaking would disproportionately affect poor individuals who rely on Medicaid and the facilities that serve them. Another commenter stated concerns about reduced amounts of Public Aid funding. Response: Reimbursement rules are outside the scope of this rulemaking, and Medicaid reimbursement rates are determined by the states, with limited involvement by CMS. We do not participate in disbursement of public aid funding. We encourage commenters to address Medicaid reimbursement and public aid concerns to relevant state agencies and departments. Many commenters noted that phased implementation would be helpful in absorbing new costs. Please see Section B. “Implementation” for our discussion of phased-in implementation deadlines. Comment: A number of commenters responded to our request for comments in ways that suggest misunderstandings of either current requirements or the proposed requirements. Notable misconceptions include the: • Belief that allowing residents to choose their attending physician would be a new requirement. • Impression that having a RN on the interdisciplinary care team would be a new requirement. • Concerns that these requirements are entirely new, such that all existing health and safety activities at LTC facilities would need to be recreated or developed from scratch. • Concerns that new staff would need to be hired to perform tasks already being handled by existing staff. • Belief that a chaplain would be a mandatory member of the interdisciplinary care team. • Belief that a complete care plan would have to be developed within a new resident's first 48 hours at the LTC facility. • Belief that existing facilities would have to limit occupancy to two residents per room, even if that would reduce bed count. • Impression that the new requirements are simply a duplicate of the old requirements. • Uncertainty as to whether the LTC requirements are applicable to other healthcare settings, such as hospital “swing-beds” or assisted living facilities. Some commenters also expressed concern that CMS may be unreasonably focused on regulating LTC facilities, to the point of not updating regulations and requirements for other provider types. Commenters also claimed that LTC facilities are “the most regulated industry in America,” and that “the nuclear industry is less regulated” than the LTC facility industry. Response: We recognize that the proposed rule and this final rule are large, detailed documents, and that many individuals relied on summaries to learn about the proposed requirements. We understand that working professionals and family caregivers can be very busy, but we are concerned by some of these misinterpretations. Most of the misconceptions fell into three categories: Unfamiliarity with the old requirements, misunderstanding of the proposed requirements, or confusion about which facilities must meet the LTC requirements. The comments displaying unfamiliarity with the existing requirements are troubling to us. The right of a LTC resident to choose his or her own attending physician is a long-standing patient right, which was established at section 1819(c)(1)(A)(i) of the Act by section 4201 of the Omnibus Budget Reconciliation Act of 1987 and at section 1919(c)(1)(A)(i) by section 4211 of the Omnibus Budget Reconciliation Act of 1987. We included the right to choose a physician in this rulemaking in order to support the statutory requirement, and remind stakeholders that it is not a new requirement and therefore should add no new regulatory burden. Similarly, the requirement that a RN serve as a member of an interdisciplinary team is not new to this rulemaking, but “carried over” from the old requirements to the revised requirements as an important foundational aspect of care planning. Also, we do not expect facilities to completely recreate health and safety activities. Existing effective programs may already meet the substance of the revised requirements completely, in which case no additional implementation work is necessary. We address these comments, and others, in greater detail in the relevant sections of this preamble. For those misunderstood provisions of the proposed rule, we have attempted to clarify the relevant sections of the rule, and note that we did not propose that chaplains must be members of all interdisciplinary teams, only that their inclusion is permitted as deemed appropriate by facilities or residents. Similarly, we did not propose that a full plan of care be developed within a resident's first 48 hours, only that a baseline plan be established. The “two persons per room” requirement applies only to those facilities that receive approval to be constructed or reconstructed, or are newly certified after this rulemaking. Existing facilities with larger rooms are effectively grandfathered into compliance. For those health care providers who are not sure whether these requirements apply to them, we encourage them to work with their facility's administration and governing body to determine applicability. This rulemaking applies to Medicare- and Medicaid-certified long term care facilities as defined at sections 1819 and 1919 of the Act and all facilities receiving payment under such programs. Swing-bed hospital units, for example, would need to meet specific conditions of participation for such units, as set out at 42 CFR 482.58, and which include a subset of the requirements contained 42 CFR 483. We note that CMS does not issue regulations or guidance for assisted living facilities, nor are they eligible for Medicare reimbursement. While some assisted living facilities do provide health services (such as medication supervision, nurse support, and emergency medical assistance for residents), they are not classified as health care providers or suppliers under the Act. Some states do regulate them, often as social service providers rather than health care providers. The requirements in this rulemaking may be helpful to other health care and social service settings, but only LTC facilities are required to meet them. Comment: One commenter expressed concern about our use of the term “state plan” throughout the rule. The commenter felt that this is not meant to exclude those states where all Medicaid services in long term care are covered by a Section 1115 waiver and recommended we add the phrase “or waiver” where appropriate. Response: We thank the commenter for their suggestion, but do not believe it is necessary to add “or waiver.” The commenter is correct that the use of the term “state plan” does not exclude those states where Medicaid-covered services in long term care facilities are provided pursuant to a CMS-approved demonstration project (often referred to as “waivers”). Our use of the term “state plan” encompasses the plan and any such demonstrations. B. Implementation Date Comment: We received a substantial number of comments requesting that we consider delaying the implementation of the proposed requirements. Several commenters noted that the proposed rule was complex and that the comprehensive update of the regulations will be overwhelming for facilities to comply with. However, a few commenters noted that many of the proposed requirements will simply require adjustments in the current process. One commenter specifically noted that facilities should be well on their way with establishing a QAPI program and complying with the proposed QAPI requirements. Many commenters also indicated concern regarding the financial burden associated with this regulation and suggested that a delayed implementation would allow facilities the time needed to establish compliance with the new requirements. Commenters provided varying suggestions for a implementation timeframe. Some commenters provided suggestions specific to certain requirements. For example, one commenter recommended a 12- to 18-month implementation timeframe for pharmacy services-related requirements. Other commenters recommended that the entire regulation be implemented by phasing in requirements over a certain time period. In addition, commenters provided varying suggestions for an implementation date of the entire regulation that ranged from 1 to 10 years in the future. Response: We appreciate the feedback from commenters. Given the comprehensive nature of the regulatory revisions, we agree that a longer period of time is necessary to implement the changes outlined in this final rule. We acknowledge that LTC facilities may find the comprehensive revision to the LTC requirements overwhelming and want to avoid any unintended consequences or unanticipated risks to both facilities and residents. We believe that allowing for a longer implementation period will allow LTC facilities the time necessary to come into compliance with the new requirements. In addition, we anticipate that additional time will be needed to develop revised interpretive guidance and survey processes, conduct surveyor training on the changes, and implement the software changes in the Quality Indicator Survey (QIS) system. While commenters provided varying suggestions for the appropriate implementation timeframe (ranging between 1 and 10 years), overall all commenters agreed that implementation will require more than a year and the majority of commenters suggested between 3 and 5 years. After considering these proposals, we are finalizing a phased-in implementation of the requirements over a 3 year time period. We believe that a phased-in approach over 3 years will sufficiently allow for LTC facilities to achieve compliance with the revised regulations without jeopardizing resident care. We note that these final regulations will be effective 60 days following the display of this final rule in the Federal Register , as discussed under the “Effective Date” section. Over the 3 year time period following the effective date of the final rule the requirements will be implemented in three phases. We have categorized the three phases based on the complexity of the revisions and the work necessary to revise the interpretive guidance and survey process based on the revisions. The first phase of implementation will occur upon the effective date of the final rule and include those requirements that were unchanged or received minor modification. We will provide updated training to surveyors on the new regulatory language. The second phase of implementation will have a deadline of 1 year following the effective date of the final rule and in addition to those requirements implemented in phase one, this phase will also include those brand new requirements and those provisions that required more complex revisions. The additional time for implementation will allow for complete changes in our survey processes as well as updates to the survey guidance. We will provide updated guidance to facilities, update the traditional and QIS survey process, update the survey tags in accordance with the reorganization of the regulations, and provide training to surveyors on the new tags. The third and final phase of implementation will have a deadline of 3 years from the effective date of the final rule and include all the remaining requirements that were not implemented in phases 1 and 2. We expect that this final phase will allow for the complete set of revised requirements to be incorporated into the practices of LTC facilities and sufficiently enforced through the updated survey process. Below we provide a detailed chart specifying the specific requirements that will be implemented in phases 1, 2, and 3 of the implementation time period for this final rule. We note that some regulatory sections may have certain requirements that are implemented in varying phases. In those instances we highlight the specific requirements in a regulatory section that will be implemented in a different phase. Implementation Timeframes **Note: These final regulations will be effective 60 days following the date of public inspection of this final rule in the Federal Register . ** Phase 1: Upon the effective date of the final rule. Phase 2: 1 year following the effective date of the final rule. Phase 3: 3 years following the effective date of the final rule. Regulatory section Implementation deadline § 483.1 Basis and scope This entire section will be implemented in Phase 1. § 483.5 Definitions This entire section will be implemented in Phase 1. § 483.10 Resident rights The section will be implemented in Phase 1 with the following exception: • (g)(4)(ii)-(v) Providing contact information for State and local advocacy organizations, Medicare and Medicaid eligibility information, Aging and Disability Resources Center and Medicaid Fraud Control Unit —Implemented in Phase 2. § 483.12 Freedom from abuse, neglect, and exploitation This section will be implemented in Phase 1 with the following exceptions: • (b)(4) Coordination with QAPI Plan —Implemented in Phase 3. • (b)(5) Reporting crimes/1150B —Implemented in Phase 2. § 483.15 Admission, transfer, and discharge rights This section will be implemented in Phase 1 with the following exceptions: • (c)(2) Transfer/Discharge Documentation —Implemented in Phase 2. § 483.20 Resident assessment This entire section will be implemented in Phase 1. § 483.21 Comprehensive person-centered care planning This section will be implemented in Phase 1 with the following exceptions: • (a) Baseline care plan —Implemented in Phase 2. • (b)(3)(iii) Trauma informed care —Implemented in Phase 3. § 483.24 Quality of life This entire section will be implemented in Phase 1. § 483.25 Quality of care This section will be implemented in Phase 1 with the following exception: • (m) Trauma-informed care —Implemented in Phase 3. § 483.30 Physician services This entire section will be implemented in Phase 1. § 483.35 Nursing services This section will be implemented in Phase 1 with the following exception: • Specific usage of the Facility Assessment at § 483.70(e) in the determination of sufficient number and competencies for staff —Implemented in Phase 2. § 483.40 Behavioral health services This section will be implemented in Phase 2 with the following exceptions: • (a)(1) As related to residents with a history of trauma and/or post-traumatic stress disorder —Implemented in Phase 3. • (b)(1), (b)(2), and (d) Comprehensive assessment and medically related social services —Implemented in Phase 1. § 483.45 Pharmacy services This section will be implemented in Phase 1 with the following exceptions: • (c)(2) Medical chart review —Implemented in Phase 2. • (e) Psychotropic drugs —Implemented in Phase 2. § 483.50 Laboratory, radiology, and other diagnostic services This entire section will be implemented in Phase 1. § 483.55 Dental services This section will be implemented in Phase 1 with the following exceptions: • (a)(3) and (a)(5) Loss or damage of dentures and policy for referral —Implemented in Phase 2. • (b)(3) and (b)(4) Referral for dental services regarding loss or damaged dentures —Implemented in Phase 2. § 483.60 Food and nutrition services This section will be implemented in Phase 1 with the following exceptions: • (a) As linked to Facility Assessment at § 483.70(e) —Implemented in Phase 2. • (a)(1)(iv) Dietitians hired or contracted with prior to effective date —Built in implementation date of 5 years following effective date of the final rule. • (a)(2)(i) Director of food & nutrition services designated to serve prior to effective —Built in implementation date of 5 years following the effective date of the final rule. • (a)(2)(i) Dietitians designated to after the effective date—Built in implementation date of 1 year following the effective date of the final rule. § 483.65 Specialized rehabilitative services This entire section will be implemented in Phase 1. § 483.70 Administration This section will be implemented in Phase 1 with the following exceptions: • (d)(3) Governing body responsibility of QAPI program —Implemented in Phase 3. • (e) Facility assessment —Implemented in Phase 2. § 483.75 Quality assurance and performance improvement This section will be implemented in Phase 3 with the following exceptions: • (a)(2) Initial QAPI Plan must be provided to State Agency Surveyor at annual survey —Implemented in Phase 2. • (g)(1) QAA committee —All requirements of this section will be implemented in Phase 1 with the exception of subparagraph (iv), the addition of the ICPO, which will be implemented in Phase 3. • (h) Disclosure of information —Implemented in Phase 1. • (i) Sanctions —Implemented in Phase 1. § 483.80 Infection control This section will be implemented in Phase 1 with the following exceptions: • (a) As linked to Facility Assessment at § 483.70(e) —Implemented in Phase 2. • (a)(3) Antibiotic stewardship —Implemented in Phase 2. • (b) Infection preventionist (IP) —Implemented in Phase 3. • (c) IP participation on QAA committee —Implemented in Phase 3. § 483.85 Compliance and ethics program This entire section will be implemented in Phase 3. § 483.90 Physical environment This section will be implemented in Phase 1 with the following exceptions: • (f)(1) Call system from each resident's bedside —Implemented in Phase 3. • (h)(5) Policies regarding smoking —Implemented in Phase 2. § 483.95 Training requirements This entire section will be implemented in Phase 3 with the following exceptions: • (c) Abuse, neglect, and exploitation training —Implemented in Phase 1. • (g)(1) Regarding in-service training, (g)(2) dementia management & abuse prevention training, (g)(4) care of the cognitively impaired —Implemented in Phase 1. • (h) Training of feeding assistants —Implemented in Phase 1. C. Basis and Scope (§ 483.1) We proposed 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 proposed to spell out the term “skilled nursing facility”. We did not receive any comments in response to our proposals in this section. Therefore, we are finalizing our proposal without modification. D. Definitions (§ 483.5) Current regulations at § 483.5 provide definitions for terms commonly used in the LTC requirements. We proposed to revise some of the existing terms for clarity and define new terms that we believe are widely used within the LTC setting, and that we believe will add value to the LTC requirements while promoting resident choice and safety. We retained the existing definitions for “facility” and “distinct part”. In addition, we retained the definition of “major modification”, which was added to the LTC regulations in the May 12, 2014 final rule, “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Part II” (79 FR 27106). We also proposed minor revisions to the definition of “common area” to recognize that some facilities have living rooms or other areas where residents gather. We proposed to expand this section to include the following definitions: “abuse,” “adverse event,” “exploitation,” “misappropriation of resident property,” “neglect,” “person-centered care,” “resident representative,” and “sexual abuse”. In addition, we proposed to relocate the definitions for “licensed health professional” and “nurse aide” to this section from the “Administration” section at § 483.75(e)(1). In addition, we proposed to revise the definition of “nurse aide” in accordance with amendments to sections 1819(b)(5)(F) and 1919(b)(5)(F) of the Act made by sections 6121(a)(2) and (b)(2) of the Affordable Care Act. “Nurse aide” is currently defined as any individual providing nursing or nursing-related services to residents in a facility who is not a licensed health professional, a registered dietitian, or someone who volunteers to provide these services without pay. “Nurse aides” do not include those individuals who furnish services to residents only as paid feeding assistants, as defined in § 488.301. Section 6121 of the Affordable Care Act added the following clarification to the definition of “nurse aide”: “Such term includes an individual who provides such services through an agency or under a contract with the facility.” We proposed to amend the regulatory definition accordingly. We proposed to add the term “adverse event” to ensure clarity in our requirements relating to proposed requirements for QAPI. For purposes of this regulation, we also proposed to define the term “resident representative” broadly to include both an individual of the resident's choice who has access to information and participates in healthcare discussions as well as personal representative with legal standing, such as a power of attorney for healthcare, legal guardian, or health care surrogate or proxy appointed in accordance with state law to act in whole or in part on the resident's behalf. We also noted that the same-sex spouse of a resident would be afforded treatment equal to that afforded to an opposite-sex spouse if the marriage was valid in the jurisdiction in which it was celebrated. In addition, we proposed to add a definition of “person-centered care” to be defined as focusing on the resident as the locus of control and supporting the resident in making their own choices and having control over their daily lives. For purposes of these regulations, we proposed that “abuse” would include actions such as the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish. As used in this definition of “abuse”, “willful” means the individual must have acted deliberately, not that the individual must have intended to inflict injury or harm. We proposed that “abuse” would also include the deprivation by an individual of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being. The term “sexual abuse” would extend the meaning of “abuse” to include non-consensual sexual contact of any type with a resident. We proposed to define the term “neglect” as “the failure of the facility, its employees or service providers to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish or mental illness.” We proposed to define “exploitation” as “the unfair treatment or use of a resident or the taking of a selfish or unfair advantage of a resident for personal gain, through manipulation, intimidation, threats, or coercion.” We also proposed to add the term “misappropriation of resident property” and define the term as “the deliberate misplacement, exploitation, or wrongful, temporary, or permanent use of a resident's belongings or money without the resident's consent.” Finally, we proposed to move the existing definition of “transfer and discharge” from § 483.12(a)(1) to § 483.5. Comment: Several commenters supported the addition of terms to the definitions section and indicated that making the link between terms that are defined in regulation and guidance will support an increased response to elder abuse. Multiple commenters provided suggestions for additional terms to be included in the definitions sections. One commenter indicated that there is a need to define “behavioral health” given the addition of the regulatory section focused on behavioral health. Other commenters also suggested that the definition of “mistreatment” be added to the regulations for clarity. Lastly, one commenter suggested that definitions of “portable order for scope of treatment” and “staffing practices” be added to the regulations. Response: We agree with commenters and believe that improving the definitions section will promote resident safety and choice. For further clarity we have added discussion to the behavioral health section explaining what behavioral health is. Since behavioral health is largely discussed in the “Behavioral Health” section we believe it is more appropriate to add the discussion at § 483.40 rather than in the “Definitions” section at § 483.5. We agree with commenters who suggested that the term “mistreatment” be defined in the regulation. Regulations at proposed § 483.12(a)(2)(iii) specify that facilities cannot employ or otherwise engage individuals who have had a disciplinary action taken against their professional license as a result of mistreatment. Therefore, based on public comments and the use of the term “mistreatment” in § 483.12, we are revising the definitions section to add the term; “mistreatment” which means “to inappropriately treat or exploit a resident.” Lastly, we do not agree that the terms “staffing practices” and “portable order for scope of treatment” should be defined because these terms are not used in the regulations. Comment: One commenter supported moving the definition of “transfer and discharge” to the “Definitions” section, but recommended that the definition also be discussed in the “Transitions of Care” section (finalized as “Admission, Transfer, and Discharge Rights”) so that readers are aware of it. The commenter also recommended that the definition of “transfer and discharge” be revised to include language from interpretive guidance in order to help address the failure of LTC facilities to recognize adequately a resident's transfer and discharge rights. Response: We agree with commenters and have added a cross-reference to the definition of “transfer and discharge” at § 483.15(b)(1), which discusses the requirements regarding a resident's transfer and discharge rights. We note that the definition of “transfer and discharge” aligns with the definition that is in the state operations manual. We are unclear what information the commenter requests to have added into the definition. Comment: Overall, commenters agreed that abuse should be defined in the regulations. Commenters provided varying suggestions aimed to improve the proposed definition. Some commenters communicated support for including the word “willful” in the definition of abuse. However, commenters articulated that as proposed, the definition of “willful” (as used in abuse) could potentially create major and unreasonable legal complications for facilities and practitioners who are forced to make difficult decisions in unclear circumstances. For example, commenters indicated that unintentional errors, such as deliberately providing medications to a resident that are later discovered to be harmful or differences of clinical opinions, such as withdrawing life-sustaining treatment, will be inappropriately categorized as abuse. In addition, commenters suggested deleting the clause regarding the deprivation of goods and services from the definition of “abuse”. Commenters indicated that the use of this clause is problematic and is more appropriately covered by the definition of “neglect.” One commenter further suggested that the sentence, “This presumes that instances of abuse of all residents, irrespective of any mental or physical condition, cause physical harm, pain or mental anguish”, also be removed from the definition of abuse. The commenter communicated that definitions should not include presumptions and the phrase “instances of abuse of all residents” is unclear. Another commenter recommended that the definition clarify further that abuse facilitated or enabled through the use of technology refers to platforms such as social media. Response: We appreciate the feedback from commenters regarding the definition of “abuse”. We disagree with commenters and do not believe that the definition of “abuse” repeats the definition of “neglect”. With regard to a deprivation of goods or services, we believe that “abuse” requires a willful act, while “neglect” does not. We agree with commenters that definitions should not contain presumptions and therefore have revised the language “this presumes” to make an explicit statement that instances of abuse of all residents, irrespective of any mental or physical condition, cause physical harm, pain or mental anguish.” We do not believe that the use of the term “willful” should be removed from the definition of “abuse.” We encourage readers to refer to Merrimack County Nursing Home, DAB CR2352 (December 5, 2011) (ALJ Decision) and Honey Grove Nursing Center, DAB CR3039 (May 8, 2014) (ALJ Decision), which discusses actions that were deliberate, not inadvertent or accidental or with the intent to inflict injury or harm. We agree that abuse enabled through the use of technology would include the use of social media, as well as the use of cameras or the Internet. Following the publication of the final rule, we will release updated interpretive guidance that will aid facilities in implementing these regulations and provide further clarification for this regulation. The interpretive guidance is the most appropriate place to further clarify and provide examples regarding abuse that is facilitated through the use of technology. Comment: One commenter indicated that an “adverse event” is adverse whether or not it is anticipated and suggested that the concept of anticipation be removed from the proposed definition, as it may be misleading. Another commenter recommended that the definition of “adverse event” be expanded to include events noted in the February 2014 OIG report entitled, “Adverse Events in Skilled Nursing Facilities: National Incidence Among Medicare Beneficiaries” (OEI-06-11-00370), such as preventable harm due to substandard treatment, inadequate resident monitoring, and failure or delay of necessary care. The commenter indicates that the focus of the definition should be placed on a facility's systematic analysis and action rather than only on one-time events. Response: We appreciate the commenters' feedback. When considering the proposed definition of “adverse events” we reviewed the February 2014 Office of the Inspector General (OIG) report referenced by commenters. We believe that increasing the level of specificity in the definition could potentially preclude recognition of additional adverse events. As proposed, the definition encompasses events that harm the patient, that are a result of substandard treatment, inadequate resident monitoring, and failure or delay of necessary care. In addition, we proposed the definition of “adverse event” that is currently defined in regulations for transplant centers. As written, the definition does not exclude anticipated events, but rather states “adverse events” are “usually unanticipated.” Comment: Several commenters supported the clarification added to the definition of “composite distinct part” which prohibits the use of a composite distinct part designation as a means to segregate residents by payment status or on any other basis other than care needs. Response: We appreciate the support from commenters and believe that the clarification will help to avoid creating inequitable care situations. Comment: Many commenters supported our proposal to add a definition of “exploitation” to the regulations. A few commenters provided suggestions to improve the proposed definition. One commenter indicated that the use of the term “selfish” in the definition of “exploitation” is misplaced and unnecessary. Another commenter disagreed with the use of the term “manipulation” in the definition because manipulation is difficult to identify and pinpoint. The commenter indicated that the definition of “exploitation” should not create unanticipated consequences and recommended substituting the use of the term “manipulation” with “deception”. Response: We appreciate the commenters' feedback and believe that further revisions are needed to improve clarity. We agree that the term “selfish” may possibly be hard to identify and evaluate. However, we prefer to use the term “manipulation” rather than “deception,” as recommended by commenters. We believe that the term “manipulation” is generally understood and appropriately indicates when power is being used in an unacceptable manner. Overall, in response to comments we have revised the definition of “exploitation” to “taking advantage of a resident for personal gain by using manipulation, intimidation, threats, or coercion.” Comment: A few commenters suggested that the definition of “licensed health professional” be expanded to include pharmacists, respiratory therapists, dietitians, and psychologists. Response: The statute at section 1819(b)(5)(G) of the Act defines “licensed health professional” as “a physician; physician assistant; nurse practitioner; physical, speech, or occupational therapist; physical or occupational therapy assistant; registered professional nurse; licensed practical nurse; or licensed or certified social worker; registered respiratory therapist or certified respiratory therapy technician.” Therefore, in an effort to conform our definition to the statute, we have added respiratory therapists to the regulatory definition of “licensed health professional.” We have not added “pharmacists, dietitians, and psychologists,” since they are not included in the statutory definition. Comment: Several commenters supported including the definition of “misappropriation of property” in the “Definitions” section. One commenter recommended replacing the term “deliberate” with “willful” for consistency throughout the definitions, since “willful” is used in the definition of “abuse”. Another commenter requested that the definition of “misappropriation of property” be revised to add language to ensure that the facility remains responsible for replacing or reimbursing for items that are lost or stolen. Response: We appreciate the commenters' feedback, but disagree with the suggestions. The term “willful” is defined specifically, since it is an element of the definition of “abuse.” We believe that the term “deliberate” is correctly used in the definition of “misappropriation of property”. In addition, it is not appropriate to add language regarding facility responsibilities to the definition of “misappropriation of property”. The definition was added to clarify what constitutes as the misappropriation of a resident's property. Regulations at § 483.12(c) discuss the requirements that must be met in response to allegations of the misappropriation of resident property. While our regulations do not require replacement or reimbursement, facilities have the flexibility to establish their own policies related to internal remedies for replacement or reimbursement of resident property. Comment: Multiple commenters supported the addition of the definition of “neglect”. One commenter indicated that mental disorder is not a condition that can be attributed to neglect. The commenter recommended modifying the definition of “neglect” to explicitly state that neglect could lead to increased psychiatric or behavioral symptoms. Another commenter recommended the definition of “neglect” be revised to remove the statement that an individual suspected of neglect must have acted willfully. Response: We agree that the wording in the definition of “neglect” can be improved and have revised the definition to clarify that the facility and its employees are neglectful when a reasonable person would conclude that a deprivation of the omitted goods and services would cause, among other things, emotional distress (rather than mental disorder). As proposed, the definition of “neglect” does not include the term “willful”. We have revised the definition of “neglect” to read, “the failure of the facility, its employees or service providers to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish or emotional distress.” Comment: One commenter indicated that “nursing aide” is an obsolete term and the correct terminology is “nursing assistant”. Response: We appreciate the commenter's feedback, however we are maintaining the use of the term “nursing aide” since that is the term used in the statute. Comment: Several commenters supported promoting individual choices and individualized care and agreed that adding a definition of “person-centered care” is necessary. Commenters suggested additional terms to replace “person-centered care”. A few commenters provided suggestions to improve the definition. One commenter indicated that the proposed definition only addresses resident choice and is too narrow. The commenter notes that the concept of “focusing on the resident as the locus of control” is vague and unsurveyable. Furthermore the commenter suggests that the definition should specify the actions that facilitate individualized care and not just focus on the resident as the locus of control. Another commenter recommended that the definition of “person-centered care” be modified to include that the relationship between residents and providers is a collaborative partnership. Response: The term “person-centered care” is recognized in the long-term care community. However, we understand that some facilities and health care professionals may use alternative terms and wording to describe a similar care model. We have used the term “person-centered care”, but facilities have the flexibility to use any term they choose internally as long as the principles described in the regulation are met. Facilities should implement the principle of “person-centered care” by developing internal guidelines that promote resident choice and control over their individual care. The definition of “person-centered care” has been added to the regulation to assist in meeting these requirements and to provide some guidance regarding our intent and expectations. We note that the interpretive guidance for this regulation will also provide more detailed information and best practices for implementing person-centered care. Comment: Many commenters believe that as proposed the definition of “resident representative” may create potential problems and supersede state law, regulations, or case law regarding a resident's surrogate decision makers. The commenters indicated that allowing for both a representative of the resident's choice as well as a representative with legal standing might create issues in instances where these two individuals disagree. They note that the regulation is not clear as to who supersedes and these types of decisions should not be made by the facility. Other commenters recommended that the definition of “resident representative” be revised to appropriately capture the many relationships that individuals may have with the resident. Commenters indicated that the definition should clearly identify the rights that such individuals have acting on behalf of or advocating with the resident. Commenters also noted that it is important to clarify that residents are not obligated to choose or designate anyone as a representative. Commenters recommended the use of terms, such as “resident enabler” and “resident supporter” to more appropriately incorporate the concept of supported decision-making. One commenter recommended that our definition be revised to align with the definition in the State Long-Term Care Ombudsman Program regulations found at 45 CFR 1327.1 (recently relocated to 45 CFR 1324.1; see the final rule, “Administration for Community Living Regulatory Consolidation” (81 FR 35644, June 3, 2016). One commenter affirmed the need to highlight the equal treatment of same-sex spouses, while another commenter suggested that the discussion regarding the selection of a same-sex spouse as a representative be removed from the definition. The commenter notes that same-sex spouses are now covered under state law and it is unnecessary to specify one particular group in this definition while omitting others. Response: We appreciate the feedback from commenters and agree that the definition of “resident representative” can be improved. Our intent behind proposing the definition of “resident representative” was to recognize that a resident has the right to designate an individual or individuals who can support them in their decision-making. We did not intend to expand the scope of authority of any representative or to supersede state law, regulations, or case law regarding a resident's surrogate decision makers. As one commenter noted, a definition of “resident representative” can be found in existing HHS regulations. The regulations at 45 CFR 1324.1 define a “resident representative” as “(1) An individual chosen by the resident to act on behalf of the resident in order to support the resident in decision-making; access medical, social or other personal information of the resident; manage financial matters; or receive notifications; (2) A person authorized by state or federal law (including but not limited to agents under power of attorney, representative payees, and other fiduciaries) to act on behalf of the resident in order to support the resident in decision-making; access medical, social or other personal information of the resident; manage financial matters; or receive notifications ; (3) Legal Representative, as used in 712 of the Older Americans Act; or (4) The court-appointed guardian or conservator of a resident. (5) Nothing in this rule is intended to expand the scope of authority of any resident representative beyond that authority specifically authorized by the resident, State or Federal law, or a court of competent jurisdiction.” We believe that this definition matches our intent behind defining “resident representative” in the LTC regulations and to align with existing HHS regulation, we are revising the definition of “resident representative” to match the definition found at 45 CFR 1324.1. Generally speaking, the authority of an individual vested with decision-making power under state law would exceed that of an individual without formal legal recognition. Comment: One commenter recommended that the definition of “sexual abuse” be modified in an effort to avoid categorizing accidental touching, which may occur while moving or cleaning a resident, as abuse. Another commenter recommended that the definition of “sexual abuse” be modified to include the use of technology to sexually abuse a resident. Response: We understand that accidental touching is possible; however the term “sexual abuse” has been added to the regulations in an effort to prevent harmful acts. It was not added to prevent or complicate care, but to ensure that residents are protected especially in vulnerable situations. For acts such as bathing a resident or assisting a resident with using the restroom, it is the facility's responsibility to have procedures and guidelines in place for what is acceptable and appropriate for providing assistance. We believe that the use of technology to harm a resident is covered by the definition of “abuse” which speaks specifically to abusive situations facilitated through technology. After consideration of the comments we received on the proposed rule, we are finalizing our proposal with the following modifications. We have— • Revised the definition of “abuse” to read, “the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish. Abuse also includes the deprivation by an individual, including a caretaker, of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being. Instances of abuse of all residents, irrespective of any mental or physical condition, cause physical harm, pain or mental anguish. It includes verbal abuse, sexual abuse, physical abuse, and mental abuse including abuse facilitated or enabled through the use of technology. Willful, as used in this definition of abuse, means that the individual must have acted deliberately, not that the individual must have intended to inflict injury or harm.” • Revised the definition of “exploitation” to read, “taking advantage of a resident for personal gain through the use of manipulation, intimidation, threats, or coercion.” • Revised the definition of “licensed health professional” by adding “registered respiratory therapist or certified respiratory therapy technician.” • Added a definition of “mistreatment” and defined it as “inappropriate treatment or exploitation of a resident.” • Revised the definition of “neglect” to read, “the failure of the facility, its employees or service providers to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish or emotional distress.” • Revised the definition of “resident representative” to read (in accordance with 45 CFR 1324.1), “(1) An individual chosen by the resident to act on behalf of the resident in order to support the resident in decision-making; access medical, social or other personal information of the resident; manage financial matters; or receive notifications; (2) A person authorized by State or Federal law (including but not limited to agents under power of attorney, representative payees, and other fiduciaries) to act on behalf of the resident in order to support the resident in decision-making; access medical, social or other personal information of the resident; manage financial matters; or receive notifications; (3) Legal representative, as used in section 712 of the Older Americans Act; or (4) The court-appointed guardian or conservator of a resident. (5) Nothing in this rule is intended to expand the scope of authority of any resident representative beyond that authority specifically authorized by the resident, State or Federal law, or a court of competent jurisdiction.” E. 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 proposed to retain all existing residents' rights, but update the language and organization of the resident rights provisions to improve logical order and readability, to clarify aspects of the regulation that warranted it, and to update provisions to include technological advances such as electronic communications. In order to achieve these objectives, we proposed to revise existing § 483.10 to include only those provisions specifying resident rights, including a number of provisions that are currently included in § 483.15. We further proposed to add a new § 483.11, to focus on the responsibilities of the facility, including relevant provisions currently included in § 483.10 and § 483.15. As with § 483.10, we proposed multiple re-designations and revisions to improve logical order and readability, clarify aspects of the regulation that warranted it, and reflect technological advances such as electronic communications. Under our proposal, some existing provisions would have components in both § 483.10 and § 483.11. We discuss below our proposed revisions to those provisions retained in or moved to § 483.10 and note that regulatory citations have been updated throughout to reflect the proposed new structure. We proposed to revise § 483.10 to focus specifically on resident rights. In proposed § 483.10(a)(2), we clarified the resident's right to be supported in his or her exercise of rights under this subpart. In proposed § 483.10(a)(3), we clarified the resident's right to designate a representative to exercise only those rights delegated by the resident, and the resident's retention of rights not delegated, including the right to revoke a delegation. In § 483.10(a)(4) we proposed to clarify that a resident who was adjudged incompetent under the laws of a state would retain the right to exercise those rights not addressed by a court order, that the resident representative can only exercise the rights that devolve to them as a result of the court order, that the resident's wishes and preferences should continue to be considered, and that the resident should continue to be involved in the care planning process to the extent practicable, as the resident is at the center of the care team. Lastly, in our December 12, 2014 proposed rule “Medicare and Medicaid Programs; Revisions to Certain Patient's Rights Conditions of Participation and Conditions for Coverage” (79 FR 73873), we proposed at § 483.10(a)(4) to require that the same-sex spouse of a resident be afforded treatment equal to that afforded to an opposite-sex spouse if the marriage was valid in the jurisdiction in which it was celebrated. We proposed to re-designate this requirement from § 483.10(a)(4) (as set out in the December 2014 proposed rule at 79 FR 73811) to § 483.10(a)(5). In proposed § 483.10(b), we included resident rights related to planning and implementing care. We proposed to re-designate and revise 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 proposed 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. We further specified 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 proposed 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 proposed to specify the resident's right to participate in the development of his or her comprehensive care plan. We also proposed 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 proposed 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. We proposed to require that the facility ensure that the attending physician is appropriately licensed and credentialed to provide care and meet the requirements of applicable regulations. In proposed § 483.10(c), we added new paragraphs § 483.10(c)(1), (2) and (3) to specify that the physician chosen by the resident must be licensed to practice medicine, and must meet professional credentialing requirements of the facility. In § 483.10(d), we proposed to re-designate a number of provisions relating to resident respect and dignity, based on existing § 483.13(a) and § 483.15. We further proposed 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 noted that married couples, whether opposite or same sex, are addressed by § 483.10(d)(5). Our proposed provision provided for a rooming arrangement that could include a same-sex couple, siblings, other relatives, long-term friends or any other combination as long as the requirements above are met. In proposed § 483.10(e), we proposed to revise a number of provisions relating to resident self-determination. We proposed 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 proposed 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. In § 483.10(f), we proposed to re-designate and revise a number of provisions relating to resident access to information. We proposed to specify in § 483.10(f)(2) that the resident has the right to receive notices verbally (meaning spoken) and in writing (including Braille) in a format and a language he or she understands. We also proposed to add a new § 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. Federal requirements and expectations related to the privacy and confidentiality of patient records, in particular regulations governing protected health information, changed substantially with the enactment of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and subsequent issuance of the HIPAA Privacy and Security Rules (see 45 CFR part 160 and subparts A, C, and E of part 164), the Health Information Technology for Economic and Clinical Health (HITECH) Act and the issuance of the HIPAA Breach Notification Rule and HIPAA Final Rule (45 CFR part 160 and subpart D of part 164; 78 FR 5566, January 25,2013). For simplicity, we hereinafter collectively refer to these laws and their implementing regulations as “HIPAA.” We note that administration and enforcement of the privacy, security, and breach-related portions of the HIPAA regulatory scheme are delegated to the HHS Office for Civil Rights (OCR) and more detailed information related to these regulations can be accessed through the OCR Web site at http://www.hhs.gov/ocr/privacy . We proposed to retain the requirements of current § 483.10(b)(2)(i) and (ii), subject to the clarifying revisions described below, at new § 483.10(f)(3). In doing so, we recognized that the HIPAA rules establish a federal floor of privacy and security protections and individual rights with respect to protected health information held by covered entities (and their business associates), and the rights granted in the proposed regulation do not conflict in any way with the HIPAA regulations. In addition, to the extent that HIPAA provides additional rights to individuals (that is, residents, in the long-term care context) beyond what is provided in this proposal, covered entities and business associates must comply with the requirements in HIPAA to ensure individuals are afforded these additional rights. Therefore, we proposed revisions to clarify the relationship between the requirements of 45 CFR 164.524 and the revised version of § 483.10(f)(3)(i) and (ii). We proposed to specify in paragraph (f)(3) that the resident has the right to access medical records pertaining to him or herself and to further specify in proposed (f)(3)(i) that the resident, upon oral or written request, has the right to receive requested medical records in the form and format requested by the resident, if it is readily producible in such form and format (including in an electronic form or format when such records are maintained electronically); or, if not, in a readable hard copy form or such other form and format as agreed to by the facility and the individual. This is consistent with the requirements of 45 CFR 164.524(c)(2). Finally, we proposed to specify in paragraph (f)(3)(ii) that the facility could impose a reasonable, cost-based fee for providing copies of the medical records, provided that the fee included only the cost of labor for copying the health information requested by the individual, whether in paper or electronic form; the supplies for creating the paper copy or electronic media if the individual requested that the electronic copy be provided on portable media; and postage, when the individual requested that the copy be mailed. This is consistent with 45 CFR 164.524(c)(4). We noted in the proposed rule that this proposal does not address the creation or provision of summary reports, which could be provided in accordance with applicable law. More detailed information about the HIPAA right to access at 45 CFR 164.524 can be found at http://www.hhs.gov/hipaa/for-professionals/privacy/guidance/access/ . In § 483.10(g)(1) we proposed to revise a number of provisions related to resident privacy and confidentiality to update the language to accommodate electronic communications. We proposed to retain existing § 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 retained the provisions of existing § 483.10(e)(2) and (3). In § 483.10(h), we proposed to re-designate and revise a number of provisions relating to resident communications. Specifically, we proposed a new § 483.10(h) Communications, with § 483.10(h)(1) revised to include Teletypewriter (TTY) and Telecommunications Device for the Deaf (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. In § 483.10(i), we proposed to revise the language to state that the resident has a right to a safe, clean, comfortable, home-like environment, and a right to receive treatment safely. In § 483.10(j), we proposed to revise language relating to resident grievances to add that a resident could not be deterred from voicing a grievance for fear of reprisal or discrimination. Comment: A number of commenters expressed concern about the way in which CMS proposed to restructure the section on Resident Rights, and particularly the fact that there was not complete parity between residents' rights and facility responsibilities. One commenter stated that, since residents, their families and advocates look at the residents' rights language to know what residents' rights are (and they may be given copies of the federal rights), it is important that the statement of residents' rights be thorough, comprehensive, and accurate. The commenter recommended that CMS add rights currently found under Facility Responsibilities but not under Resident Rights to the Resident Rights section. Another commenter stated that the list of residents' rights should be complete and comprehensive and should not require review of other requirements of participation (RoPs) in order to identify all residents' rights. One commenter stated that they were concerned with the likely disruption of administrative and judicial decisions over the past 25 years interpreting the current regulations. Administrative Law Judges and state and federal court judges could view changes in regulatory language as signaling changes in administrative interpretation of the Nursing Home Reform Law. They will view prior long-standing interpretations of similar current regulations as no longer legally binding as they interpret new regulatory language, following the legal principle that an agency intends a new interpretation when it changes the language of a regulation. They believed that an agency does not change regulatory language unless it wants to make a change in the prior interpretation of that language. The commenter further objected to the reorganization of existing RoPs because the commenter felt it would inevitably involve unnecessarily long (but avoidable) delay. The commenter stated that CMS would need to draft the final standards in response to public comments, give facilities time to understand and implement the new Requirements, create a new survey protocol, and train state and federal surveyors in the new protocol, at the very least. As these multiple changes are made, effective enforcement of RoPs, already weak, will be further postponed. The commenter noted that, to maintain the same regulatory standards within the definition of substandard quality of care requires CMS to combine subsections of multiple RoPs. The commenter recommended that, instead of reorganizing the regulations, as CMS proposes, CMS should retain the current regulatory structure as much as possible and to make all revisions within that existing, familiar structure. Keeping the current structure will save time and effort on the part of CMS, surveyors, advocates, and providers alike, time and effort that would be better spent on addressing RoPs that actually reflect substantive change and improvement. Response: We considered commenters' concerns regarding proposed § 483.10 and § 483.11. Rather than increase duplication by adding language to both sections, we have combined these two sections for a comprehensive section that includes in a single location both statements of resident rights and, co-located, the attendant facility responsibilities to support those rights. We believe this addresses commenters' concerns and meets the commenter's suggestion that the statement of resident rights be thorough, comprehensive and accurate. This reorganization, to the extent that the regulatory language is unchanged, does not reflect any intent by CMS to change prior interpretations of regulatory language. Rather, our intent, as stated in the preamble to the proposed rule, is to improve the logical order, readability, and clarity of the regulations. We continue to believe that it is helpful to ensure that regulatory section titles reflect the content of the section. Thus, we have included provisions that state “the resident has a right to . . .”, in general, in a regulatory section titled “Residents Rights,” we have included provisions about prohibiting and preventing abuse, neglect and exploitation in a section titled “Freedom from Abuse, Neglect, and Exploitation,” and we have withdrawn our proposal to rename “Admission, Discharge, and Transfer Rights” to retain the title that most clearly relays the content of the section to the non-expert reader. We further clearly expressed in the preamble to the proposed rule that we do not intend in this update to diminish resident rights or protections. Rather, we want to ensure that those rights and protections encompass advancements, such as in the area of telecommunications, that were not envisioned when the original regulations were written. With regard to concerns that this revision will delay enforcement of the requirements and that keeping the current structure would save time and effort in updating facilities, surveyors, advocates, providers, and, we would add, current and future residents, we disagree that this effort is unnecessary or poorly focused. The commenter contends that enforcement of the current requirements is already weak. The efforts that we will undertake as a result of this rule to update and improve interpretive guidance, to train surveyors, and to outreach to the affected community of providers, residents, and caregivers will lead to stakeholders' improved understanding of our higher expectations, could result in improved efficiencies, and improve the effectiveness of our survey process. This final rule will be effective 60 days after its publication, maintaining existing protections for residents, with delayed implementation deadlines for certain sections, where there are new expectations and requirements that require additional time for providers to implement. Please see our discussion of implementation in section II.B. of this preamble for additional detail. We received a significant number of specific comments on both proposed sections § 483.10 and § 483.11. As we will finalize these sections as a single section, we respond to all specific comments on both proposed sections, following our description of our proposals regarding facility responsibilities, below. After consideration of the comments we received on the proposed rule, we are finalizing our proposal with the following modifications: • We finalize a consolidated section § 483.10, which contains provisions proposed in § 483.10 and § 483.11. Specific revisions are addressed in the following section. F. Facility Responsibilities (§ 483.11) We proposed a new § 483.11 “Facility Responsibilities,” in which we combined many of the regulations addressing facility responsibilities which are currently dispersed throughout the existing provisions regarding resident rights and quality of life. Consistent with § 483.10 and based on existing requirements, the introductory language for proposed § 483.11 would have established that the facility would have to treat its residents with respect and dignity and provide care and services for its residents in a manner and in an environment that promotes maintenance or enhancement of the resident's quality of life, and would be required to protect and promote the resident's rights, as specified in § 483.10. Further, the facility would be required to recognize each resident's individuality and provide services in a person-centered manner. We proposed to establish sections similar to those proposed in § 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 proposed a requirement that the facility would have to promote and protect the rights of the resident. These are not new requirements, and are already set out in our regulations as residents' rights. In order to ensure clarity, we restated clearly in this provision that it would be the responsibility of the facility to recognize and effectuate those rights. Proposed § 483.11(a)(1) provided that the facility ensure that the resident could exercise his or her rights without interference, coercion, discrimination, or reprisal from the facility. We proposed to re-designate current § 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 specified that the facility would have to treat the decisions of a resident representative as the decisions of the resident to the extent required by a court, or as delegated by the resident, with the condition that the facility could not extend greater authority to the resident representative than would be permitted under applicable law. In addition, we proposed to add a new § 483.11(a)(5) to clarify for facilities that if facility staff believed that a resident representative was making decisions or taking actions that are not in the best interest of the resident, the facility would have to comply with any state reporting requirements that might apply. In proposed § 483.11(b), “Facility responsibilities” would include ensuring that the resident was informed of, and participated in, his or her treatment to the extent practicable, consistent with § 483.10(b). The resident could participate in care planning, making informed decisions, and self-administering drugs when appropriate. We also proposed new requirements in § 483.11(b)(1) to require that the facility ensured that the care planning process facilitated the inclusion of the resident or resident representative, included an assessment of the resident's strengths and needs, and incorporated the resident's personal and cultural preferences in developing goals of care. We proposed to re-designate § 483.10(b)(9) as § 483.11(c)(1) and revise it to add other primary care providers to ensure that the resident would know the name, specialty and means of contacting the professionals officially responsible for his or her care, whether that provider was a physician, nurse practitioner, physician assistant, or clinical nurse specialist. We further proposed to add a new § 483.11(c)(2), consistent with our proposed § 483.10(c)(1), (2) and (3), to clarify that the facility would have a responsibility to ensure that the resident's attending physician had appropriate professional credentials and met the requirements of this subpart. If the physician was not appropriately credentialed or was unwilling or unable to meet the requirements of this subpart, the facility could seek an alternate physician after informing and discussing this matter with the resident. In order to ensure that the resident could seek out a suitable alternative, we proposed to add a new § 483.11(c)(3) to specify that if the resident subsequently found a new physician who met the necessary requirements, the facility would be required to honor that selection. We proposed a new § 483.11(d) to address the facility's responsibilities related to resident self-determination. We proposed to re-designate § 483.10(j), regarding access to the resident, as § 483.11(d)(1), and revised it to include visitors as specified in our “Resident Rights” provision, including immediate access to the resident by the resident representative, and to update the languages and references for the Office of the State long term care ombudsman and the protection and advocacy system. In addition, we proposed to add a new § 483.11(d)(2) to require that the facility have written policies and procedures regarding visitation rights of residents. We proposed to re-designate § 483.15(c)(5) as § 483.11(d [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2016-23503. Public record. Not legal advice.