By Andrew Yeung, Pharm.D.
LTC Industry News
July 20, 2015

Proposed Changes to Nursing Home Rules: Biggest Changes in 24 Years

Proposed Changes to Nursing Home Rules: Biggest Changes in 24 Years

Judi Kulus, RN, NHA, MAT, RAC-MT, C-NE

by Judi Kulus, RN, NHA, MAT, RAC-MT, C-NE | Jul 16, 2015

On Monday, July 13, 2015, the Centers for Medicare & Medicaid Services (CMS) released a preliminary copy of the proposed Reforms for Medicare/Medicaid LTC Requirements. These significantly amend the requirements for long-term care (LTC) facilities that participate in the Medicare and Medicaid programs. The 403-page document outlines the proposed changes, which, the rule states, are targeted 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.” These regulations represent the most comprehensive update to LTC facilities’ conditions of participation since 1991. The key drivers of these new rules, CMS states, are innovations in resident care and quality practices, more diverse and clinically complex residents, revised clinical standards of practice, and evidence-based research.

In response to the Patient Protection and Affordable Care Act of 2010 (ACA) legislation are two of the most significant requirements outlined in this proposed rule: the implementation of a comprehensive quality assurance and performance improvement (QAPI) program and a requirement for facility compliance and ethics programs. The rule also outlines myriad other changes, including resident rights, pharmacy services, behavioral health services, laboratory, radiology and other diagnosis services, dental services, food and nutrition services, specialized rehabilitative services, outpatient rehabilitation services, physical environment, and staff training requirements (look for these items described in next week’s AANAC’s LTC Leader).

Quality Assurance and Performance Improvement (QAPI)

The long-awaited QAPI regulations are spelled out in this proposed rule. Facility staff will be required to present a comprehensive QAPI plan to the state agency surveyors at the first annual recertification survey that occurs after the effective date of this regulation, annually at the recertification survey, and upon request (§483.75). The rules specify that “each LTC facility, including a facility that is part of a multi-unit chain, must develop, implement, and maintain an effective, comprehensive, data-driven QAPI program that focuses on indicators of the outcomes of care and quality of life” (§483.75; all quotations and paraphrases used in this article are from the proposed rule).

Elements of the QAPI program include the following:

          Program design and scope—Facilities must develop a QAPI program that is ongoing and that addresses the full range of care and services provided by the facility. The program should address all systems of care and management practices, including clinical care, quality of life, and resident choice. Facility staff should “utilize the best available evidence to define and measure indicators of quality and facility goals that reflect processes of care and facility operations that have been shown to be predictive of desired outcomes for residents of a SNF or NF.”

          Program feedback, data systems, and monitoring—Facility staff “must establish and implement written policies and procedures for feedback, data collections systems, and monitoring, including adverse event monitoring.” An adverse event is defined as an “untoward, undesirable, and usually unanticipated event that causes death or serious injury, or the risk thereof.”

          Program systematic analysis and systemic action—“The facility must take actions aimed at performance improvement and, after implementing those actions, measure its success, and track performance to ensure that improvements are realized and sustained.”

          Program activities

o    Selecting performance improvement activities:  “The facility must set priorities for its performance improvement activities that focus on high-risk, high-volume, or problem-prone areas; consider the incidence, prevalence, and severity of problems in those areas; and affect health outcomes, resident safety, resident autonomy, resident choice, and quality of care.”

o    Specific required performance improvement activities:  “Performance improvement activities must track medical errors and adverse resident events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the facility.”

o    Distinct performance improvement activities:  “The facility must conduct distinct performance improvement projects.”

o    Number and timing of performance improvement activities: “The number and frequency of improvement projects conducted by the facility must reflect the scope and complexity of the facility’s services and available resources, as reflected in the facility assessment . . . Improvement projects must include at least annually a project that focuses on high risk or problem-prone areas identified through the data collection and analysis” from the feedback, data systems, monitoring, systematic analysis, and systemic action processes.

          Governance and leadership—“The governing body and/or executive leadership (or organized group or individual who assumes full legal authority and responsibility for operation of the facility) is responsible and accountable for ensuring that an ongoing QAPI program is defined, implemented, and maintained and addresses identified priorities. The QAPI program [must be] sustained during transitions in leadership and staffing. The QAPI [must be] adequately resourced, including ensuring staff time, equipment, and technical training as needed. The QAPI program [must identify and prioritize] problems and opportunities based on performance indicator data, and resident and staff input that reflects organizational processes, functions, and services provided to residents.”

          Quality assessment and assurance (QAA) committee—The facility must maintain a QAA committee that meets quarterly and consists of, at a minimum, the director of nursing services, the medical director or designee, at least three other members of the facility staff (of which one must be the administrator, owner, a board member, or an individual in a leadership role), and the infection control and prevention officer. The QAA committee must report its activities to the facility’s governing body.

          Disclosure of information—“A State or the Secretary may not require disclosure of the records of [the QAA] committee except [when] the disclosure is related to the compliance of such committee with the requirements of [the QAPI regulations]. Demonstration of compliance with the requirements of this section may require State or Federal surveyor access to [QAPI] systems and reports demonstrating systematic identification, reporting, investigation, analysis, and prevention of adverse events; documentation demonstrating the development, implementation, and evaluation of corrective actions or performance improvement activities; and other documentation considered necessary by a State or Federal surveyor in assessing compliance.”

          Sanctions—“Good faith attempts by the committee to identify and correct quality deficiencies will not be used as a basis for sanctions.”

Compliance and Ethics Programs

The term compliance and ethics is woven throughout the posted 403-page document; it appears 101 times. Facility staff must develop a compliance and ethics program that prevents criminal, civil, and administrative violations and promotes quality care.

          Timing for compliance—This requirement is mandated one year from the effective date of the final rule.

          Program components

o    Written and enforced standards, policies, and procedures to reduce the prospect of criminal, civil, and administrative violations.

o    The designation of an appropriate compliance and ethics program contact to which individuals may report suspected violations.

o    A method of reporting suspected violations anonymously without fear of retribution.

o    Policies must include disciplinary standards that set out the consequences for committing violations for the operating organization's entire staff, contractors, and volunteers.

o    Designated program leaders, selected from among the organization’s high-level personnel, such as the chief executive officer, members of the board of directors, or directors. These leaders will oversee compliance with the operating organization’s compliance and ethics program’s standards, policies, and procedures.

o    Sufficient resources and delegated authority to carry out the program.

o    Steps must be in place to prevent the delegation of authority to individuals who the organization leaders know (or should have known) have a propensity to engage in criminal, civil, and administrative violations.

o    Effectively communicate to staff, contractors, and volunteers—through mandatory training, orientation, and other means—the standards, policies, and procedures of the compliance and ethics program.

o    Monitor and audit the program to ensure detection of criminal, civil, and administrative violations by staff, contractors, and volunteers. This includes publicizing the facility’s system for anonymous reporting without fear of retribution.

o    Reported violations are responded to and steps are taken to implement processes to prevent future violations.

Facility Assessment and Sufficient Staffing

The proposed rule addresses the newly introduced “facility assessment” requirement. Facility staff must develop a formal, documented, facility-wide assessment to determine what resources a facility would need to care for its residents competently during both day-to-day operations and in emergencies. The rule indicates that the facility staff must review and update this assessment as necessary and at least annually. They must also review and update this assessment whenever there is an actual or proposed change that would require a substantial modification to any part of the assessment. As a result of the facility assessment, facility management would be required to ensure that “licensed nurses have the specific competencies and skill sets necessary to care for residents’ needs, as identified through resident assessments, and described in the plan of care.”

Components for the facility assessment must include the following:

          The facility’s assessment of their resident population, including but not limited to:

o    Both the number of residents and the facility’s resident capacity

o    The care required by the resident population, considering the types of diseases, conditions, physical and cognitive disabilities, overall acuity, and other pertinent facts that are present within that population

o    The staff competencies that are necessary to provide the level and types of care needed for the resident population

          The physical environment, equipment, services, and other physical plant considerations that are necessary to care for this population

          Any ethnic, cultural, or religious factors that may potentially affect the care provided by the facility, including but not limited to activities and food and nutrition services

          The facility’s resources, including but not limited to:

o    All buildings and/or other physical structures and vehicles

o    Equipment (medical and non-medical)

o    Services provided, such as physical therapy, pharmacy, and specific rehabilitation therapies

o    All personnel, including managers, staff (both employees and those who provide services under contract), and volunteers, as well as their education and/or training and any competencies related to resident care

o    Contracts, memorandums of understanding, or other agreements with third parties to provide services or equipment to the facility during both normal operations and emergencies

o    Health information technology resources, such as systems for electronically managing patient records and electronically sharing information with other organizations

          Facility-based and community-based risk assessment, utilizing an all-hazards approach

Suspicion of a Crime: Reporting Requirements

Details of resident rights are a significant section of the proposed rule. One notable statement is the requirement that covered individuals report the suspicion of bodily harm within 2 hours and report within 24 hours events that did not cause bodily harm. Suspicion of a crime against residents must be reported to both the state agency and law enforcement agencies. Facility management must post notices of employees’ right to report without fear of retribution the suspicion that a resident is being abused, neglected, or exploited. All alleged incidents must be reported to the administrator and fully investigated.

Transitions of Care

Replacing the concepts of admission, transfer, and discharge is the term transitions of care. The new requirements will significantly shape the process of communication between providers who care for a resident transitioning to different settings. When a resident transfers from the facility, the following standard information about the resident must be included in the transition:

          A physician order for transfer

          Demographic information, including name, sex, date of birth, race, ethnicity, and preferred language

          Resident representative information, including contact information

          Advance directive information

          History of present illness and the reason for the transfer, including primary care team contact information

          Past medical and surgical history, including procedures

          Active diagnoses and a current problem list and status

          Laboratory tests and the results of pertinent laboratory and other diagnostic testing

          Functional status

          Psychosocial assessment, including cognitive status

          Social supports

          Behavioral health issues


          Allergies, including medication allergies


          Smoking status

          Vital signs

          Unique device identifier(s) for a patient’s implantable device(s), if any

          Comprehensive care plan goals, including health concerns, assessment and plan, resident preferences, interventions, including efforts to meet resident needs, and resident status

While facility staff might find it optimal and efficient to use an electronic health record program to send and receive the resident information, CMS indicates that the transition documentation listed above does not have to be electronic, as financial incentives for use of electronic health record systems are not included in this mandate. Compliance with the above details can be satisfied with the use of a discharge summary.

Discharging Residents to Another Provider

For residents who are transferring to another skilled nursing facility (SNF) or who are discharging to the community with home health agency (HHA) services, to an inpatient rehabilitation facility (IRF), or to a long-term care hospital (LTCH), the facility staff must assist residents and their resident representatives in selecting a post-acute care provider. Facility staff must do this by using data that includes but is not limited to SNF, HHA, IRF, or LTCH standardized patient assessment data, data on Quality Measures, and data on resource use to the extent the data is available. The facility staff must ensure that all this data is relevant and applicable to the resident’s care goals and treatment preferences.

Additionally, the discharge summary must be prepared and sent with the resident when he or she transitions to another setting. In addition to the transition documentation listed above, the discharge summary must include but is not limited to the following:

          “A recapitulation of the resident’s stay that includes, but is not limited to, diagnoses, course of illness/treatment or therapy, and pertinent lab, radiology, and consultation results.”

          “A final summary of the resident’s status” at the time of the discharge that is available for release to authorized persons and agencies, with the consent of the resident or resident’s representative.

          “Reconciliation of all pre-discharge medications with the resident’s post-discharge medications (both prescribed and over-the-counter).”

          “A post-discharge plan of care that is developed with the participation of the resident and, with the resident’s consent, his or her family, which will assist the resident to adjust to his or her new living environment. The post-discharge plan of care must indicate where the individual plans to reside, any arrangements that have been made for the resident’s follow up care and any post-discharge medical and non-medical services.”

Comprehensive Resident-Centered Care Plans

The proposed rule details the requirement for a “baseline care plan” within 48 hours of a resident’s admission to the facility. This care plan must be structured to provide instructions for the effective, person-centered care of the resident that meets professional standards of care. The following elements must be included in the baseline care plan:

          Initial goals based on admission orders

          Physician orders

          Dietary orders

          Therapy services

          Social services

          PASARR recommendation, if applicable

Once the baseline care plan is implemented, the facility staff should develop a comprehensive care plan to replace the baseline care plan. The comprehensive care plan must be completed within seven days of the comprehensive assessment (the MDS Admission assessment due by day 14 of the resident’s stay). The comprehensive care plan must include the following items:

          “Measurable objectives and timetables to meet a resident’s medical, nursing, and mental and psychosocial needs that are identified in the comprehensive assessment.”

          Care that would be required but was not provided due to the resident’s right to refuse treatment

          Specialized rehabilitative services indicated by PASARR recommendations.

          “The resident’s preference and potential for future discharge. Facilities must document whether the resident’s desire to return to the community was assessed and any referrals to local contact agencies and/or other appropriate entities for discharge purposes.”

The proposed rule enhances the definition of the interdisciplinary team required during development of the comprehensive care plan. The comprehensive care plan should be developed by the following team members:

          Attending physician

          Registered nurse with responsibility for the resident

          Nursing assistant with responsibility for the resident

          A member of the food and nutrition staff

          Social worker

          Other appropriate staff or professionals as needed

          When possible, the resident and the resident’s representative

If the resident or the resident’s representative cannot attend, an explanation must be placed in the resident’s record for why their attendance was not practicable.

Infection Control Officer

The proposed rule indicates that every facility should designate an Infection Prevention and Control Officer (IPCO). The IPCO should be employed by the facility at least part-time, have specialized training in infection prevention and control programming (IPCP), and be designated to serve on the QAA committee to help support the QAPI program in the facility. The IPCO will have the responsibility of supporting the facility’s systems for preventing, identifying, reporting, investigating, and controlling infections and communicable diseases for all residents, staff, volunteers, visitors, and contractors.

Physician Services

Under Physician Services, three key provisions are proposed to be added to the rules of participation. First, there should be a physician, physician assistant, nurse practitioner, or clinical nurse specialist available to evaluate residents for non-emergency transfer to a hospital. “The facility must provide or arrange for an in-person evaluation of a resident by a physician, a physician assistant, nurse practitioner, or clinical nurse specialist prior to transferring the resident to a hospital” (§483.30). Second, a physician may delegate the task of writing dietary orders to a qualified dietitian or other clinically qualified nutrition professional who is acting within the scope of practice defined by the state in which he or she practices and is under supervision of the physician (§483.60). Third, a physician may delegate the task of writing therapy orders to a qualified therapist who is acting within the scope of practice defined by state law and is under the supervision of the physician (483.65).

The proposed rule is open for public comment until September 14 at 5:00 p.m. Electronic comments can be submitted at If you would like to participate in providing comments to this rule, please contact

Author Description

Andrew Yeung, Pharm.D.

Andrew is a Lead Consultant Pharmacist at SCRx. He has experience at Sharp as a Systems Consultant Pharmacist and was Director of Pharmacy at Palomar Pomerado, Pomerado, Charter and Vista Hill Hospital. Andrew has Doctor of Pharmacy and a Fellowship in Geriatric Pharmacy from USC. He also has a Fellowship in Consultant Pharmacist from ASCP.

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