Long-Term Care Facility Requirements Updated by CMS Proposed Rule

Members | July 14, 2015

Undertaking its most comprehensive review and revision since 1991, the Centers for Medicare and Medicaid Services (CMS) has issued a proposed rule updating the Requirements of Participation for nursing homes.

Undertaking its most comprehensive review and revision since 1991, the Centers for Medicare and Medicaid Services (CMS) has issued a proposed rule updating the Requirements of Participation for nursing homes. 

The rule, Medicare and Medicaid Programs: Reform of Requirements for Long-Term Care Facilities, adds new requirements and reorganizes various other existing regulations. 

Among the new requirements proposed are the Affordable Care Act (ACA) provisions on: 

  • Quality assurance and performance improvement (QAPI).
  • Compliance and ethics programs.
  • Reporting of suspicion of a crime.
  • Training requirements related to dementia and abuse prevention. 

Facility-Wide Assessment

CMS has also taken a competencies-based approach to facility staffing and plans to incorporate a mandate for facility-wide assessment for determining sufficient nursing and direct care staff as well as meeting requirements such as infection control and specialized rehabilitative services. 

The facility-based assessment requirements, identified by CMS in the preamble as a "central feature" to these proposed revisions, include, but are not limited to factors such as: 

  • Physical characteristics of the home.
  • Number and acuity levels of residents.
  • Range of diagnoses.
  • Care plan content. 

CMS views these assessments as multi-purpose actions, applicable to and impacting a broad range of functions such as the development of QAPI plans, resource use, and emergency preparedness planning. 

The agency estimates the total projected cost for implementation and compliance with this rule to be around $729 million for the 1st year, and $638 million for the 2nd and subsequent years. 

Comments

We are preparing detailed comments on this rule for submission to CMS. We share the agency’s goal of continuous improvement in nursing home care. We have long taken a leadership role in initiatives including Quality First and Advancing Excellence, which have been recognized by CMS for measurable improvements in outcomes for nursing home residents.

We are concerned, however, that this rule seriously underestimates the time, staff and financial resources necessary to comply with the proposed new requirements. For example, CMS estimates that meaningful participation in a facility’s QAPI plan would only require an hour of a medical director’s time, whereas a more realistic estimate would be 5 to 6 hours. 

The proposed rule would require changes to nursing home physical environment and construction that could force facilities with major reconstruction projects in the works to go back to the drawing board. The rule proposes a level of staff expertise in infection control that is unclear, open to subjective surveyor interpretation, and potentially unachievable if sufficient numbers of staff with the necessary credentials, whatever they may turn out to be, are not available.  

We will recommend to CMS that the new requirements be phased in over a five-year period to allow adequate opportunity for the significant new staff training and other changes nursing homes  will have to make. We want these improvements to succeed, which will not happen unless sufficient time is provided for nursing homes to properly comply.

We will also point out to CMS that the proposed changes in the requirements of participation are taking place in the context of other major changes in payment systems. Medicare sequestration is giving nursing homes a likely cut in reimbursement for 2016. 

Value-based purchasing will result in another 2% “withholding,” which will at best be only partially returned to those nursing homes achieving the lowest rates of rehospitalizations. And Medicaid, which provides the largest share of nursing home revenue, is still grossly underpaying in most states. 

We will urge the agency to take these financial challenges into account.

Comments are due to CMS by Sept. 14. If you have recommendations for change or amendment, please respond to emunley@leadingage.org no later than Wednesday, Sept. 9. And in addition to sending us your comments, please also forward them to CMS.

Hard copies of your comments may be sent to CMS at:

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

Overview of Proposed Rule by Section

Definitions (§483.5)   

Adds definitions for:

  • “Adverse event.”
  • “Documentation.”
  • “Posting/displaying.”
  • “Resident representative.”
  • “Abuse.”
  • “Sexual abuse.”
  • “Neglect.”
  • “Exploitation.”
  • “Misappropriation of resident property.”
  • “Person centered care.”

Resident Rights (§483.10)

CMS would retain all existing residents’ rights, but update language and organization to include, e.g., electronic communications.

Proposed revisions would:

  • Eliminate  language, such as “interested family member”;  replace “legal representative” with “resident representative.”

  • Address roommate choice.

  • Add 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.

New Section: Facility Responsibilities (§483.11)

This section focuses on facility responsibilities (protecting the residents’ rights, enhancing quality of life), and parallels many residents’ rights provisions:

  • Visitation: Would establish open visitation, similar to the hospital conditions of participation (CoPs).
  • Abuse/Neglect/Exploitation (§483.12): Would revise “Resident behavior and facility practices,” to “Freedom from abuse, neglect, and exploitation”.
  • Prohibit employment of individuals with disciplinary actions against their professional license by a state licensure body following a finding of abuse, neglect, mistreatment, or misappropriation of property.
  • Require implementation of written policies and procedures that prohibit and prevent abuse, neglect, mistreatment and/or misappropriation of  property.

Transitions of Care (§483.15)

This section revises “admission, transfer and discharge rights," to apply to all transfers of resident care.

  • Transfers/Discharge: Would require specific information/data elements, e.g., demographic; history of present illness including, e.g., active diagnoses, functional status, medications; reason for transfer and past medical/surgical history, be exchanged with the receiving provider. CMS is not proposing a specific form, format, or methodology.

Resident Assessments (§483.20); Preadmission Screening and Resident Review (PASRR)

This section would:

  • Clarify appropriate coordination of resident assessment with PASRR.
  • Add exceptions to PASRR requirements for mental illness and intellectual disabilities for admission with respect to transfers to or from a hospital.

  • Require notification of state mental health or intellectual disability authorities promptly after a significant change in the mental or physical condition of a resident with a mental illness or intellectual disability.

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

Section 483.21 would require development of a baseline care plan for each resident within 48 hours of admission, including instructions needed to provide effective and person-centered care meeting professional standards.

Preadmission Screening and Resident Review (PASRR)

CMS would require the care plan to include any specialized services or specialized rehabilitation services the facility will provide as a result of PASRR;  a rationale for disagreement with PASRR findings must be documented in the medical record.

Interdisciplinary Team (IDT)

CMS would add a nurse aide, food and nutrition services, and a social worker to the IDT that develops the comprehensive care plan.

Discharge Planning [as part of Comprehensive Person-Centered Care Planning]

This section would:

  • Implement IMPACT Act requirements for long term care facilities to take into account quality, resource use, and other measures to inform and assist the discharge planning process, while accounting for resident treatment preferences and goals. 

  • Require facilities to document the resident’s goals for admission in the care plan; assess potential for future discharge; include discharge planning in the comprehensive care plan, as appropriate.

  • Require the discharge summary to include reconciliation of all discharge medications with pre-admission medications (prescribed and OTC).

  • Require addition to the post discharge care plan a summary of arrangements made for follow up and any post discharge services.

Quality of care and Quality of Life (§483.25) [retitled]

This section would:

  • Clarify that quality of care and quality of life are overarching principles in all care and services.

  • Clarify the requirements regarding a resident’s ability to perform ADLs.

  • Modify requirements for nasogastric tubes to reflect current clinical practice, and include enteral fluids in requirements for assisted nutrition and hydration.

  • Add a new requirement that facilities ensure pain management needs are met.

  • Move current provisions for unnecessary drugs, antipsychotics, medication errors, and influenza and pneumococcal immunizations to pharmacy services.

As of now, there is no proposal, but CMS is seeking comments on whether current requirements for activities’ director are appropriate; what minimum requirements should be.

Physician Services

CMS would require an in-person evaluation by a physician, a physician assistant  (PA), nurse practitioner (NP, or clinical nurse specialist (CNS) before an unscheduled transfer to a hospital, and allow physicians to delegate dietary orders to dietitians and therapy orders to therapists.

Nurse Staffing

CMS would add a competencies/skill set requirement for determining sufficient nursing and direct care staff based on a facility assessment, including but not limited to: # of residents, acuity, range of diagnoses, and care plan content.

New Section: Behavioral Health Services (§483.40)

This section focuses on provision of necessary behavioral health care and services to residents in accordance with their comprehensive assessment and plan of care. It would require staff to have appropriate competencies to provide behavioral health care and services, including care of residents with mental and psychosocial  illnesses and implementing non-pharmacological interventions.

CMS notes in the Preamble that reference to mental health/illness includes substance abuse disorders.

The section also would add "gerontology" bachelor’s degree to the minimum social worker educational requirements.

Pharmacy Services (§483.45); Drug Regimen Review

This section would require pharmacist review of a resident’s medical chart at least every 6 months and when the resident is new to the facility, a resident returns or is transferred from a hospital or other facility, and during each monthly drug regimen review (DRR) when a resident has been prescribed or is taking a psychotropic drug, an antibiotic or any drug the QAA Committee has requested be included in the monthly drug review.

It also would require the pharmacist to document any irregularities noted during the DRR, including at minimum:

  • The resident’s name.
  • The relevant drug and irregularity identified, to be sent to the attending physician, medical director, and director of nursing.

Attending physicians would be required to document that he/she has reviewed the identified irregularity and what, if any, action they have taken. “Irregularities” would include “unnecessary drugs.”

This section would require facilities to ensure residents who have not used psychotropic drugs not be given these drugs unless medically necessary; receive gradual dose reductions and behavioral interventions unless clinically contraindicated.

    • “Psychotropic drug” would include any drug that affects brain activities associated with mental processes and behavior.

PRN orders for psychotropic drugs would be limited to 48 hours unless the primary care provider reviews and documents the rationale.

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

This section would clarify that a physician assistant (PA), a nurse practioner (NP), or a clinical nurse specialists (CNS) may order laboratory, radiology, and other diagnostic services in accordance with state and scope of practice laws.

It also would clarify that the ordering practitioner be notified of abnormal laboratory results when they fall outside of clinical reference ranges, in accordance with facility notification policies and procedures.

Dental services (§483.55)

This section would

  • Prohibit skilled nursing facilities (SNF) from charging a Medicare resident for the loss or damage of dentures determined to be the facility’s responsibility.

  • Require NFs to assist eligible residents to apply for reimbursement of dental services under the Medicaid state plan.

  • Clarify that a referral for lost or damaged dentures “promptly” means within 3 business days absent documentation of any extenuating circumstances.

Dietary Services

This section would require facilities to employ sufficient staff with appropriate competencies to carry out dietary services in accordance with resident assessments, individual care plans, and facility census.

A “qualified dietitian” is registered by the Commission on Dietetic Registration of the Academy of Nutrition and Dietetics or meets state licensure or certification requirements. Dietitians hired/contracted with prior to these regulations, would have 5 years to meet the new requirements.

The director of food and nutrition service must be a certified dietary manager, certified food service manager, or be certified for food service management and safety by a national certifying body or have an associate’s or higher degree in food service management or hospitality; would have to meet any state requirements for food service managers.

This section also would:

  • Require menus to reflect religious, cultural and ethnic needs and preferences, be updated periodically, and reviewed by the qualified dietitian or other clinically qualified nutrition professional for nutritional adequacy while not limiting residents’ right to personal dietary choices.

  • Require facilities to consider resident allergies, intolerances, and preferences and ensure adequate hydration.

  • Allow attending physicians to delegate prescribing resident diets to registered or licensed dietitians, including therapeutic diets, in accordance with state law.

  • Require availability of suitable, 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 plan of care.

  • Require documentation in the care plan the clinical need for a feeding assistant and the extent of dining assistance needed.

  • Clarify facilities may procure food items directly from local producers and may use produce grown in facility gardens.
  • Clarify residents are not prohibited from consuming foods not procured by the facility.

  • Require a policy regarding use and storage of foods brought to residents by family and other visitors.

Specialized Rehabilitative Services (§483.65)

This section would: 

  • Add respiratory services to specialized rehabilitative services.
  • Clarify what constitutes rehabilitative services for mental illness and intellectual disability.
  • Establish new health and safety standards for provision of outpatient rehabilitative therapy services.
  • Require facilities to conduct, document, and update annually and when needed an assessment to determine resources necessary to care for its residents competently during both day-to-day operations and emergencies.
      • This would include resident population (#, overall care needs and staff competencies required, cultural aspects); resources (e.g., equipment, and overall personnel); and a facility- and community-based risk assessment.

Clinical Records

CMS would establish requirements that mirror some found in the HIPAA Privacy Rule (45 CFR part 160, and subparts A and E of part 164).

Binding Arbitration Agreements

This section proposes 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 and acknowledged regarding understanding;  that they 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 signing of a binding arbitration agreement. 

The agreement could not prohibit or discourage communication with federal, state, or local health care or health-related officials, including representatives of the Office of the State Long-Term Care Ombudsman.

New Section: Quality assurance and performance improvement (QAPI) (§483.75)

This section would require all long-term care facilities to develop, implement, and maintain an effective comprehensive, ongoing, data-driven QAPI programs that focus on systems of care, outcomes of care and quality of life.

Facilities would need to:

  • Submit the QAPI plan at the 1st standard survey after 1 year from the final rule effective date; and at each subsequent standard survey upon request; documentation and evidence of ongoing implementation also required upon request.

  • Maintain effective feedback systems from staff, residents/resident representatives; establish priorities; have a process for identifying, reporting, analyzing, and preventing adverse/potential adverse events; systematic determination of underlying causes; measure/monitor the success of actions taken and track performance for sustainability; and include Performance Improvement Projects (PIPS).

QAA Committee requirements would be maintained with amendment.

Infection control (§483.80)

This section would require:

  • A system (Infection and Control Program – IPCP) for preventing, identifying, surveillance, investigating, and controlling infections and communicable diseases for residents, staff, volunteers, visitors, and other individuals providing services based upon facility and resident assessments as reviewed and updated annually; would also require incorporation of an antibiotic stewardship program.
  • Designation of an Infection and Prevention Control Officer (IPCO) for whom the IPCP is their major responsibility and who would serve as a member of the facility’s quality assessment and assurance (QAA) committee.

New Section: Compliance and ethics program (§483.85)  

The rule would require the operating organization for each facility to have in operation a compliance and ethics program with established written compliance and ethics standards, policies and procedures capable of reducing the prospect of criminal, civil, and administrative violations in accordance with section 1128I(b) of the Act.

  • Required components: established written standards, policies, procedures; assignment of high-level personnel; sufficient resources and authority for these individuals; due diligence to prevent delegation to individuals with propensity for criminal, civil, administrative violations; effective communication and mandatory training; reasonable steps, e.g., monitoring/auditing systems, to achieve compliance; consistent enforcement; appropriate response to correct and prevent future occurrences.

Physical environment (§483.90)

Facilities initially certified after the effective date of this rule would be limited to 2 residents per bedroom, which would be required to have a bathroom equipped with at least a toilet, a sink, and a shower.

The rule would require policies, in accordance with applicable federal, state, and local laws and regulations, regarding smoking, including tobacco cessation, smoking areas and safety.

New Section: Training Requirements (§483.95)

The rule would add a new section setting forth all requirements of an effective training program for new and existing staff, contract staff, and volunteers.

Proposed topics include:

  • Effective communication.
  • Resident rights and facility responsibilities.
  • Abuse, neglect, and exploitation.
  • QAPI and infection control.
  • Compliance and ethics.  

Annual training would be required for organizations operating 5 or more facilities. 

The rule would require dementia management and resident abuse prevention training as part of the 12 hours per year in-service training for nurse aides, and facilities would also be required to provide behavioral health training to all staff, based on the facility assessment.

Cost of Implementation/Compliance

CMS estimates the total projected cost for implementation and compliance with this rule to be $729,495,614 for the 1st year; $638,386,760 for the 2nd and subsequent years.

LTC Facilities Crosswalk

Table A [end of the Preamble] provides a crosswalk between current requirements and the proposed rule.