Centers for Medicare & Medicaid Services Issues Rule on Long-Term Care Facilities
A Proposed Rule by the
Publication Date:
Agencies:
Dates: To be assured consideration, comments must be received at one of
Entry Type: Proposed Rule
Action: Proposed rule.
Document Citation: 80 FR 42167
Page: 42167 -42269 (103 pages)
CFR: 42 CFR 405
42 CFR 431
42 CFR 447
42 CFR 482
42 CFR 483
42 CFR 485
42 CFR 488
Agency/Docket Number: CMS-3260-P
RIN: 0938-AR61
Document Number: 2015-17207
Shorter URL: https://federalregister.gov/a/2015-17207
Action
Proposed Rule.
Summary
This proposed rule would revise the requirements that
DATES:
To be assured consideration, comments must be received at one of the addresses provided below, no later than
ADDRESSES:
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SUPPLEMENTARY INFORMATION:
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Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the
I. Background
A. Executive Summary
1. Purpose
Consolidated
Since the current requirements were developed, significant innovations in resident care and quality assessment practices have emerged. In addition, the population of nursing homes has changed, and has become more diverse and more clinically complex. Over the last two to three decades, extensive, evidence-based research has been conducted and has enhanced our knowledge about resident safety, health outcomes, individual choice, and quality assurance and performance improvement. In light of these changes, we recognized the need to evaluate the regulations on a comprehensive basis, from both a structural and a content perspective. Therefore, we are reviewing regulations in an effort to improve the quality of life, care, and services in LTC facilities, optimize resident safety, reflect current professional standards, and improve the logical flow of the regulations. Specifically, we are proposing to add new requirements where necessary, eliminate duplicative or unnecessary provisions, and reorganize the regulations as appropriate. Many of the revisions are aimed at aligning requirements with current clinical practice standards to improve resident safety along with the quality and effectiveness of care and services delivered to residents. Additionally, we believe that these proposed revisions may eliminate or significantly reduce those instances where the requirements are duplicative, unnecessary, and/or burdensome.
2. Summary of the Major Provisions
Basis and Scope (section 483.1)
The Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively known as the Affordable Care Act) provisions: We propose to add the statutory authority citations for sections 1128I(b) and (c) and section 1150B of the Act to include the compliance and ethics program, quality assurance and performance improvement (QAPI), and reporting of suspicion of a crime requirements.
Definitions (section 483.5)
Expanded Definitions: We propose to add the definitions for "adverse event", "documentation", "posting/displaying", "resident representative", "abuse", "sexual abuse", "neglect", "exploitation", "misappropriation of resident property", and "person-centered care".
Resident Rights (section 483.10)
Comprehensive Restructuring: We propose to retain all existing residents' rights but update the language and organization of the resident rights provisions to improve logical order and readability, clarify aspects of the regulation where necessary, and to update provisions to include advances such as electronic communications. This includes--
Eliminating language, such as "interested family member" and replacing the term "legal representative" with "resident representative."
Addressing roommate choice.
Adding language regarding physician credentialing to specify that the physician chosen by the resident must be licensed to practice medicine in the state where the resident resides, and must meet professional credentialing requirements of the facility. Facility Responsibilities (section 483.11) *New Section*
New Section: We propose to add a new section to subpart B that focuses on the responsibilities of the facility (that is, protecting the rights of their residents, enhancing a resident's quality of life) and brings together many of the facility responsibilities currently dispersed throughout existing regulations. This section parallels many residents' rights provisions.
Visitation: We propose to revise visitation requirements to establish open visitation, similar to the hospital conditions of participation (CoPs).
Re-designation of Requirements: We propose to--
Relocate provisions from existing Resident's Rights (section 483.10) section that pertain to the responsibilities of the facility into this section.
Relocate the existing requirements in Quality of Life (section 483.15) into this section. Freedom From Abuse, Neglect, and Exploitation (section 483.12)
Revised Title: Formerly "Resident behavior and facility practices," we propose to revise the title to "Freedom from abuse, neglect, and exploitation."
Prohibiting abuse, neglect, and exploitation: We propose to--
Specify that facilities cannot employ individuals who have had a disciplinary action taken against their professional license by a state licensure body as a result of a finding of abuse, neglect, mistreatment of residents or misappropriation of their property.
Require facilities to develop and implement written policies and procedures that prohibit and prevent abuse, neglect, and mistreatment of residents or misappropriation of their property.
Transitions of Care (section 483.15)
Revised Title: Formerly "Admission, transfer and discharge rights," we propose to revise the title to reflect current terminology that applies to all instances where care of a resident is transferred.
Transfers or Discharge: We propose to require not only that a transfer or discharge be documented in the clinical record, but also that specific information, such as history of present illness, reason for transfer and past medical/surgical history, be exchanged with the receiving provider or facility when a resident is transferred. We are not proposing to require a specific form, format, or methodology for this communication.
Resident Assessments (section 483.20)
Preadmission Screening and Resident Review (PASARR): We propose to clarify what constitutes appropriate coordination of a resident's assessment with the PASARR program under
Technical Corrections:
We propose to add references to statutory requirements that were inadvertently omitted from the regulation when we first implemented sections 1819 and 1919 of the Act.
Section 1919(e)(7)(A)(ii) and (iii) of the Act: We propose to add exceptions to the preadmission screening requirements for individuals with mental illness and individuals with intellectual disabilities for admittance into a nursing facility, with respect to transfer to or from a hospital.
Section 1919(e)(7)(B)(iii) of the Act: We propose to add a requirement that a nursing facility must notify the state mental health authority or intellectual disability authority for resident evaluation promptly after a significant change in the mental or physical condition of a resident with a mental illness or intellectual disability.
We propose to replace the term "mental retardation" with "intellectual disability" throughout the section, as appropriate. Comprehensive Person-Centered Care Planning (section 483.21) *New Section*
Baseline Care Plan: We propose to require facilities to develop a baseline care plan for each resident, within 48 hours of their admission, which includes the instructions needed to provide effective and person-centered care that meets professional standards of quality care.
PASARR: We propose to add a requirement to include as part of a resident's care plan any specialized services or specialized rehabilitation services the nursing facility will provide as a result of PASARR recommendations. If a facility disagrees with the findings of the PASARR, it must indicate its rationale in the resident's medical record.
Interdisciplinary Team (IDT):
We propose to add a nurse aide, a member of the food and nutrition services staff, and a social worker to the required members of the interdisciplinary team that develops the comprehensive care plan.
We propose to require facilities to provide a written explanation in a resident's medical record if the participation of the resident and their resident representative is determined to not be practicable for the development of the resident's care plan.
Discharge Planning:
The Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) (Pub. L. 113-185) amended Title XVIII of the Social Security Act by, among other things, adding Section 1899B to the Social Security Act. Section 1899B(i) requires that certain providers, including long term care facilities, take into account, quality, resource use, and other measures to inform and assist with the discharge planning process, while also accounting for the treatment preferences and goals of care of residents. We propose to implement the discharge planning requirements mandated by the IMPACT Act by revising, or adding where appropriate, discharge planning requirements for LTC facilities.
We propose to require facilities to document in a resident's care plan the resident's goals for admission, assess the resident's potential for future discharge, and include discharge planning in the comprehensive care plan, as appropriate.
We propose to require that the resident's discharge summary include a reconciliation of all discharge medications with the resident's pre-admission medications (both prescribed and over-the-counter).
We propose to add to the post discharge plan of care a summary of what arrangements have been made for the resident's follow up care and any post-discharge medical and non-medical services.
Quality of Care and Quality of Life (section 483.25)
Overarching Principles: We propose to clarify that quality of care and quality of life are overarching principles in the delivery of care to residents of nursing homes and should be applied to every service provided.
Activities of Daily Living (ADLs): We propose to clarify the requirements regarding a resident's ability to perform ADLs.
Director of Activities Qualifications: We propose to solicit comments on whether the requirements for the director of the activities program remain appropriate and what should serve as minimum requirements for this position. We are not proposing specific changes at this time.
Updating Current Practices: We propose to modify existing requirements for nasogastric tubes to reflect current clinical practice, and to include enteral fluids in the requirements for assisted nutrition and hydration.
Special Need Issues: We propose to add a new requirement that facilities must ensure that residents receive necessary and appropriate pain management.
Re-designation of Requirements: We propose to relocate the provisions regarding unnecessary drugs, antipsychotic drugs, medication errors, and influenza and pneumococcal immunizations to section 483.45 Pharmacy services.
Physician Services (section 483.30)
In-person Evaluation: We propose to require an in-person evaluation of a resident by a physician, a physician assistant, nurse practitioner, or clinical nurse specialist before an unscheduled transfer to a hospital.
Delegation of Orders: We propose to allow physicians to delegate dietary orders to dietitians and therapy orders to therapists.
Nursing Services (section 483.35)
Sufficient Staffing: We propose to add a competency requirement for determining sufficient nursing staff based on a facility assessment, which includes but is not limited to the number of residents, resident acuity, range of diagnoses, and the content of care plans.
New Section: We propose to add a new section to subpart B that focuses on the requirement to provide the necessary behavioral health care and services to residents in accordance with their comprehensive assessment and plan of care.
Staffing:
Facility Assessment: We propose to require facilities to determine their direct care staff needs, based on the facility's assessment.
Competency Approach: We propose to require that staff must have the appropriate competencies and skills to provide behavioral health care and services, which include caring for residents with mental and psychosocial illnesses and implementing non-pharmacological interventions.
Social Worker: We propose to add "gerontology" to the list of possible human services fields from which a bachelor degree could provide the minimum educational requirement for a social worker. Pharmacy Services (section 483.45)
Drug Regimen Review:
We propose to add the requirement that a pharmacist review a resident's medical chart at least every 6 months and when the resident is new to the facility, a prior resident returns or is transferred from a hospital or other facility, and during each monthly drug regimen review when the resident has been prescribed or is taking a psychotropic drug, an antibiotic or any drug the QAA Committee has requested be included in the pharmacist's monthly drug review.
We propose to require the pharmacist to document in a written report any irregularities noted during the drug regimen review that lists at a minimum, the resident's name, the relevant drug, and the irregularity identified, to be sent to the attending physician and the facility's medical director and director of nursing.
We propose to require that the attending physician document in the resident's medical record that he or she has reviewed the identified irregularity and what, if any, action they have taken to address it. If there is to be no change in the medication, the attending physician should document his or her rationale in the resident's medical record.
Irregularities: We propose to add a definition of "irregularities" that would include, but not be limited to, the definition of "unnecessary drugs."
Psychotropic Drugs: We propose to revise existing requirements regarding "antipsychotic" drugs to refer to "psychotropic" drugs.
We propose to require that facilities ensure residents who have not used psychotropic drugs not be given these drugs unless medically necessary.
We propose that residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue use of these psychotropic drugs.
We propose to define "psychotropic drug" as any drug that affects brain activities associated with mental processes and behavior.
We propose that PRN (Pro re nata or as needed) orders for psychotropic drugs be limited to 48 hours. Orders could not be continued beyond that time unless the primary care provider (for example, the resident's physician) reviewed the need for the medications prior to renewal of the order, and documented the rationale for the order in the resident's clinical record.
Re-designation of Requirements: We propose to relocate provisions in section 483.25 "Quality of Care" regarding unnecessary drugs, antipsychotic drugs, medication errors, and influenza and pneumococcal immunizations into this section.
Laboratory, Radiology, and Other Diagnostic Services (section 483.50) *New Section*
Ordering Services: We propose to clarify that a physician assistant, nurse practitioner or clinical nurse specialist may order laboratory, radiology, and other diagnostic services for a resident in accordance with state law, including scope of practice laws.
Laboratory Services: We propose to clarify that the ordering physician; physician assistant; nurse practitioner or clinical nurse specialist, be notified of abnormal laboratory results when they fall outside of clinical reference ranges, in accordance with facility policies and procedures for notification of a practitioner or per the ordering physician's, physician assistant's; nurse practitioner's or clinical nurse specialist's orders.
Dental Services (section 483.55)
For Skilled Nursing Facilities (SNFs): We propose to prohibit SNFs from charging a
For Nursing Facilities (NFs): We propose to require NFs to assist residents who are eligible to apply for reimbursement of dental services as an incurred medical expense under the
For both SNFs and NFs: We propose to clarify that with regard to a referral for lost or damaged dentures "promptly" means within 3 business days unless there is documentation of extenuating circumstances.
Food and Nutrition Services (section 483.60)
Staffing: We propose to require facilities to employ sufficient staff with the appropriate competencies and skills sets to carry out the functions of the dietary service while taking into consideration resident assessments, and individual plans of care, including diagnoses and acuity, as well as the facility's resident census..
Dietitian Qualification: We propose to clarify that a "qualified dietitian" is one who is registered by the
Director of Food Service: We propose to add to the requirement for the designation of a director of food and nutrition service that the person serving in this position be a certified dietary manager, certified food service manager, or have a certification for food service management and safety from a national certifying body or have an associate's or higher degree in food service management or hospitality from an accredited institution of higher learning. In states that have established standards for food service managers, this person must meet state requirements for food service managers.
Menus and Nutritional Adequacy: We propose to add to the requirements that menus reflect the religious, cultural and ethnic needs and preferences of the residents, be updated periodically, and be reviewed by the facility's qualified dietitian or other clinically qualified nutrition professional for nutritional adequacy while not limiting the resident's right to make personal dietary choices.
Providing Food and Drink: We propose to add to the requirements that facilities provide food and drink that take into consideration resident allergies, intolerances, and preferences and ensure adequate hydration.
Ordering Therapeutic Diets: We propose to allow the attending physician to delegate to a registered or licensed dietitian the task of prescribing a resident's diet, including a therapeutic diet, to the extent allowed by state law.
Frequency of Meals: We propose to require facilities to have available suitable and nourishing alternative meals and snacks for residents who want to eat at non-traditional times or outside of scheduled meal times in accordance with the resident's plan of care.
Use of Feeding Assistants: We propose to require that facilities document the clinical need of a feeding assistant and the extent to which dining assistance is needed in the resident's comprehensive care plan.
Food Safety: We propose to--
Clarify that facilities may procure food items obtained directly from local producers and are not prohibited from using produce grown in facility gardens, subject to compliance with applicable safe growing and food-handling practices.
Clarify that residents are not prohibited from consuming foods that are not procured by the facility.
Require facilities to have a policy regarding the use and storage of foods brought to residents by family and other visitors.
Specialized Rehabilitative Services (section 483.65)
Provision of Services. We propose to--
Add respiratory services to those services identified as specialized rehabilitative services.
Clarify what constitutes as rehabilitative services for mental illness and intellectual disability.
Outpatient Rehabilitative Services (section 483.67)
Providing Services: We propose to establish new health and safety standards for facilities that choose to provide outpatient rehabilitative therapy services.
Administration (section 483.70)
Organization: We propose to largely relocate various portions of this section into other sections of subpart B as deemed appropriate.
Facility Assessment: We propose to require facilities to--
Conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies. The facility must review and update that assessment, as necessary, and at least annually.
Review and update this assessment whenever there is, or the facility plans for, any change that would require a substantial modification to any part of this assessment.
Address in the facility assessment the facility's resident population (that is, number of residents, overall types of care and staff competencies required by the residents, and cultural aspects), resources (for example, equipment, and overall personnel), and a facility-based and community-based risk assessment.
Clinical Records: We propose to establish requirements that mirror some of those found in the HIPAA Privacy Rule (45 CFR part 160, and subparts A and E of part 164).
Binding Arbitration Agreements: We propose specific requirements for the facility and the agreement itself to ensure that if a facility presents binding arbitration agreements to its residents that the agreements be explained to the residents and they acknowledge that they understand the agreement; the agreements be entered into voluntarily; and arbitration sessions be conducted by a neutral arbitrator in a location that is convenient to both parties. Admission to the facility could not be contingent upon the resident or the resident representative signing a binding arbitration agreement. Moreover, the agreement could not prohibit or discourage the resident or anyone else from communicating with federal, state, or local health care or health-related officials, including representatives of the
Quality Assurance and Performance Improvement (QAPI) (section 483.75) *New Section*
QAPI Program: In accordance with the statute, we propose to require all LTC facilities to develop, implement, and maintain an effective comprehensive, data-driven QAPI program that focuses on systems of care, outcomes of care and quality of life.
Infection Control (section 483.80)
Infection Prevention and Control Program (IPCP): We propose to require facilities to have a system for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and other individuals providing services under an arrangement based upon its facility and resident assessments that is reviewed and updated annually.
Infection Prevention and Control Officer (IPCO): We propose to require facilities to designate an
Compliance and Ethics Program (section 483.85) *New Section*
Compliance and Ethics Program: We propose to require the operating organization for each facility to have in operation a compliance and ethics program that has established written compliance and ethics standards, policies and procedures that are capable of reducing the prospect of criminal, civil, and administrative violations in accordance with section 1128I(b) of the Act.
Physical Environment (section 483.90)
Resident Rooms: We propose to require facilities initially certified after the effective date of this regulation to accommodate no more than two residents in a bedroom.
Toilet Facilities: We propose to require facilities initially certified after the effective date of this regulation to have a bathroom equipped with at least a toilet, sink and shower in each room.
Smoking: We propose to require facilities to establish policies, in accordance with applicable federal, state and local laws and regulations, regarding smoking, including tobacco cessation, smoking areas and safety.
Training Requirements (section 483.95) *New Section*
We propose to add a new section to subpart B that sets forth all the requirements of an effective training program that facilities must develop, implement, and maintain for all new and existing staff, individuals providing services under a contractual arrangement, and volunteers, consistent with their expected roles. We propose that training topics must include--
Communication: We propose to require facilities to include effective communications as a mandatory training for direct care personnel.
Resident Rights and Facility Responsibilities: We propose to require facilities to ensure that staff members are educated on the rights of the resident and the responsibilities of a facility to properly care for its residents as set forth in the regulations.
Abuse, Neglect, and Exploitation: We propose to require facilities, at a minimum, to educate staff on activities that constitute abuse, neglect, exploitation, and misappropriation of resident property, and procedures for reporting these incidents.
QAPI & Infection Control: We propose to require facilities to include mandatory training as a part of their QAPI and infection prevention and control programs that educate staff on the written standards, policies, and procedures for each program.
Compliance and Ethics: In accordance with section 1128I of the Act, as added by the Affordable Care Act, we would require the operating organization for each facility to include training as a part of their compliance and ethics program. We propose to require annual training if the operating organization operates five or more facilities.
In-Service Training for Nurse Aides: In accordance with sections 1819(f)(2)(A)(i)(I) and 1919(f)(2)(A)(i)(I) of the Act, as amended by the Affordable Care Act, we propose to require dementia management and resident abuse prevention training to be a part of 12 hours per year in-service training for nurse aides.
Behavioral Health Training: We propose to require that facilities provide behavioral health training to its entire staff, based on the facility assessment at section 483.70(e).
3. Summary of Costs and Benefits
a. Overall Impact
We estimate the total projected cost of this rule would be
b. Section-by-Section Economic Impact Estimates
Estimated Cost To Comply With All the Requirements of the Proposed Rule
Regulatory area ..... Section ..... First year total cost ..... Total cost in year 2 and thereafter
Resident Rights ..... 483.10 .....
Facility Obligations ..... 483.11 ..... 1,935,785 ..... 999,345
Transitions of Care ..... 483.15 ..... 3,331,225 ..... 3,331,225
Comprehensive Resident Centered Care Planning ..... 483.21 ..... 118,184,092 ..... 118,184,092
Physician Services ..... 483.30 ..... 35,660,786 ..... 35,660,786
Nursing Services ..... 483.35 ..... 3,640,312 ..... 3,640,312
Food and Nutrition Services ..... 483.60 ..... 1,788,774 ..... 1,663,246
QAPI ..... 483.75 ..... 118,419,977 ..... 47,402,511
Infection Control ..... 483.80 ..... 283,944,336 ..... 283,944,336
Compliance and Ethics Program ..... 483.85 ..... 139,356,716 ..... 120,327,296
Training ..... 483.95 ..... .....
General Training Topics ..... 483.95(a) ..... 7,280,624 ..... 7,280,624
Compliance and Ethics Training ..... 483.95(f) ..... 1,876,624 ..... 1,876,624
Dementia Management and Abuse Training ..... 483.95(g) ..... 3,640,312 ..... 3,640,312
Total ..... ..... 729,495,614 ..... 638,386,760
B.
In addition to specific statutory requirements set out in sections 1819 and 1919 and elsewhere in the Social Security Act, sections 1819(d)(4)(B) and 1919(d)(4)(B) of the Act permit the Secretary of the
Under sections 1866 and 1902 of the Act, providers of services seeking to participate in the
The Affordable Care Act made a number of changes to the
C. Summary of Stakeholder Comments
In order to evaluate the need to update the requirements for long term care facilities, CMS provided LTC stakeholders and members of the general public with opportunities to provide suggestions and recommendations for our revision of the requirements. Specifically, we reached out to industry groups, advocates and other stakeholders by announcing our intention to conduct a comprehensive review of the requirements during CMS open door forums and other regularly scheduled stakeholder calls. We established an email box to receive comments and feedback. In response to our outreach, we received more than 20 comments from a variety of stakeholder organizations and individuals. Comments ranged from those who were concerned that burden-reducing changes would weaken important protections for vulnerable seniors to those who believe the existing regulations are working well and no changes were necessary. We also received a number of comments that included very detailed and comprehensive recommendations for changes to our regulations. One consistent theme of the comments was the need to address staffing levels. Most comments suggested that we increase the required number of registered nurse (RN) hours of onsite duty per resident day. They also suggested that we strengthen our training requirements for staff and require trainings for specific skills and procedures. Another common theme in the comments was the need to revise the regulations so that they reflect a person-centered care approach and improve the quality of care and life for the residents. For example, commenters requested that residents be included in the care planning process and given complete control over their meal choices. Commenters also requested that we ensure the regulations are current and consistent with federal privacy legislation and the associated implementing regulations, such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the HIPAA Privacy Rule (45 CFR part 160 and subparts A and E of part 164).
We have reviewed all of the stakeholder's comments and have taken them into consideration while drafting this proposed rule. We note that some commenters requested changes that conflicted directly with statute. Moreover, some of the comments we received were outside the scope of our review (that is, comments related to the LTC facility survey process or the interpretive guidance (IG)). However, we have shared all of the stakeholder's comments with appropriate CMS staff for their review and consideration. We appreciate all of the stakeholders input and responses to our outreach efforts thus far and believe that this proposed rule reflects our desire to promote person-centered care and improve the quality of care and services, while further protecting resident's safety, choice and well-being.
D. Why revise the LTC requirements?
Although there have been many discrete changes to specific provisions, the requirements for LTC facilities have not been comprehensively reviewed and updated since 1991. The number of
In addition to the increase in the number of individuals accessing SNF care, the health concerns of individuals residing in LTC facilities have become more clinically complex. The LTC population includes a mix of elderly individuals, younger residents with intellectual or developmental disabilities who are chronically ill, and residents in need of post-acute rehabilitation services. Since the 1980's, the nursing home resident population has had some significant changes. Some of these changes have resulted in nursing homes having to care for many residents that generally have a higher acuity. One change has been a dramatic increase in the number of residents who are recuperating from an acute episode of an illness or injury and who would have usually been discharged from a hospital to their homes. In 1983,
Another factor that has resulted in a higher acuity in the nursing home resident population has been the increase in assisted-living facilities and other alternatives to nursing home care, such as home care (Decker, p. 5 and Harris-Kojetin, L., Sengupta, M., Park-Lee, E., and Valverde,
Nursing homes are also caring for a significant number of residents who require behavioral health services. In 2004, over 16 percent of nursing home residents received a primary diagnosis of a mental disorder upon admission (
To accommodate a more diverse population, the current care and service delivery practices of LTC facilities have changed to meet these changing service needs. These factors not only demonstrated a need to comprehensively review the regulations, but also informed our approach for revising the regulations. The following discussion highlights our approach to proposing revisions as well as some of the most significant revisions set forth in this proposed rule.
Facility Assessment and Competency-Based Approach
One of our goals in revising our minimum health and safety requirements for LTC facilities is to ensure that our regulations align with current clinical practice and allow flexibility to accommodate multiple care delivery models to meet the needs of the diverse populations that are provided services in these facilities. We considered prescriptive approaches, such as requiring specific numbers and types of staff based on facility size and acuity of residents, but were concerned that such an approach would conflict with requirements already established in many states, and would limit flexibility and innovation in designing new models of person-centered care delivery for residents. Thus, we are instead taking a competency-based approach that focuses on achieving the statutorily mandated outcome of ensuring that each resident is provided care that allows the resident to maintain or attain their highest practicable physical, mental, and psychosocial well-being. Under this competency-based approach, we are proposing requirements that are compatible with existing state requirements and consistent with what we believe are already common practices by facilities. As discussed in further detail in this proposed rule in section II, "Provisions of the Proposed Rule," we propose to require facilities to assess their facility capabilities and their resident population. Using the information from that assessment, facilities would be required to provide sufficient staff with the necessary competencies and skills to meet each resident's needs based on acuity, diagnosis, and the resident's person-centered comprehensive care plan. Based on our experience with LTC facilities, we believe most facilities already make these assessments, at least informally, in order to determine staffing needs; our revisions will ensure it is consistently performed and documented in all SNFs and NFs.
Application of facility assessments and competence-based staffing decisions would involve every service provided by a NF or SNF and apply to all members of the staff, including the interdisciplinary team. For example, a facility that provides dementia care would need to ensure it has sufficient numbers of staff and that the staff has the necessary training, education, and/or experience to care for individuals with dementia. These staff may be nursing service staff, behavioral health staff, or other appropriate care providers. Similarly, adding a competence-based requirement would ensure that a facility serving residents requiring post-acute rehabilitation care had sufficient staff with the required training, education and/or experience to care for individuals requiring those services. We propose that the focus be on the competencies and skill sets of the individuals delivering care and services rather than just on the overall number of care givers available. This competence-based approach is compatible with existing state requirements and business practices, and promotes both efficiency and effectiveness in care delivery. In addition to a competence-based approach, this proposed rule is intended to meet the spirit of current HHS quality initiatives that cut across various providers.
Current HHS Quality Initiatives
As an effective steward of public funds, CMS is committed to strengthening and modernizing the nation's health care system to provide access to high quality care and improved health at lower cost. This includes improving the patient experience of care, both quality and satisfaction, improving the health of populations, and reducing the per capita cost of health care. In drafting the proposed rule, we considered current initiatives underway to support these aims and improve care across providers as well as initiatives targeted specifically at nursing home residents. As discussed below, we are proposing several revisions consistent with these efforts.
Reducing Avoidable Hospitalization
Nearly two-thirds of nursing home residents are enrolled in
Consistent with the HHS focus on reducing unnecessary hospitalization, in drafting this proposed rule, we looked at what, if any, minimum health and safety standards could be developed or strengthened that would contribute to a reduction in unnecessary hospital admissions of nursing home residents. First, we considered many factors that contribute to a decision to transfer a nursing home resident to a hospital. This is primarily a clinical decision, but it may be impacted by environmental or financial factors that are not amenable to change based on regulatory requirements. These concerns include family and resident preferences and demands, concern regarding the LTC facility's liability, and payment incentives. We believe, however, that there are some regulatory changes that would help reduce avoidable hospitalization of nursing home residents. We discuss those changes in section II, "Provisions of the Proposed Rule".
Healthcare Associated Infections
HHS is also working to reduce the incidence of healthcare associated infections (HAIs) across providers. In recognition of HAIs as an important public health and patient safety issue, HHS is sponsoring the "National Action Plan to Prevent HAIs". This initiative seeks to coordinate and maximize the efficiency of prevention efforts across the federal government (http://www.hhs.gov/ash/initiatives/hai/actionplan/). Given the growing number of individuals receiving care in LTC settings and the presence of more complex medical care, these individuals are at an increased risk for HAIs. Therefore, to advance these initiatives, we have proposed revisions that we believe will provide more opportunities to achieve broad based improvement and contribute to reduced healthcare costs. We also believe this approach would be flexible enough to be adapted to any business model and would allow for targeted interventions specific to the facility.
On
Similarly, with regard to minimum health and safety standards, we looked at possible regulatory changes that could lead to a reduction in the unnecessary use of antipsychotic medication and improvements in the quality of behavioral healthcare. After conducting a review of literature, stakeholder comments, and available
Health Information Technology
HHS also has a number of initiatives designed to encourage and support the adoption of health information technology and to promote nationwide health information exchange to improve health care. HHS believes all patients, their families, and their healthcare providers should have consistent and timely access to their health information in a standardized format that can be securely exchanged between the patient, providers, and others involved in the patient's care (HHS
HHS is committed to encouraging HIE among all health care providers, including those who are not eligible for the EHR Incentive Programs, to improve care delivery and coordination across the entire care continuum. Our revisions to this rule are intended to recognize the advent of electronic health information technology and to accommodate and support adoption of ONC certified health IT and interoperable standards. We believe that the use of such technology can effectively and efficiently help facilities and other providers improve internal care delivery practices, support the exchange of important information across care team members (including patients and caregivers) during transitions of care, and enable reporting of electronically specified clinical quality measures (eCQMs). For more information, we direct stakeholders to the ONC guidance for EHR technology developers serving providers ineligible for the
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
Dated:
Acting Administrator,
Approved:
Secretary,
Editor's note: For the full-text of this document, click this link or copy it into your browser: https://www.federalregister.gov/articles/2015/07/16/2015-17207/medicare-and-medicaid-programs-reform-of-requirements-for-long-term-care-facilities.
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