On July 16, 2015, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule to revise the requirements that skilled nursing facilities and nursing homes must satisfy to participate in the Medicare and Medicaid programs. Interested persons may file comments on the proposed rule on or before September 14.

The Medicare and Medicaid requirements for participation for long-term care facilities have not been comprehensively reviewed and updated since 1991. The proposed rule adds new requirements, eliminates duplicative or unnecessary provisions and reorganizes the regulations. CMS indicates that many of the revisions are aimed at aligning requirements with current clinical practice standards, and are intended to improve resident safety as well as the quality and effectiveness of care.

CMS estimates that the proposed rule would cost over $729 million in the first year, resulting in an estimated cost of $46,491 per facility. For subsequent years, CMS estimates that the proposed rule would cost approximately $638 million per year, or $40,685 per facility.

The following is a summary of key provisions of the proposed rule:

Resident Rights and Facility Responsibilities: CMS proposes to revise and update the regulations pertaining to resident rights and facility responsibilities. The proposed rule includes provisions regarding residents’ ability to exercise their rights; be informed of and participate in their treatment; select attending physicians; be treated with respect and dignity; self-determination, including requirements related to the deposit of residents’ personal funds; access to information; privacy and confidentiality; communication; safe environment; grievances and contact with external entities.

Comprehensive Person-Centered Care Planning: The proposed rule would require a physician, physician assistant, nurse practitioner, or clinical nurse specialist to provide orders for the resident’s immediate care and needs upon admission. Within 48 hours of admission, facilities would need to develop a baseline care plan for each resident. CMS specifies that the baseline care plan is to include the minimum healthcare information necessary to care for a resident, and must include: (1) initial goals based on admission orders; (2) physician orders; (3) dietary orders; (4) therapy services; (5) social services; and (6) a preadmission screening and resident review (PASARR) recommendation, if applicable.

CMS proposes to expand the membership of the interdisciplinary team that is responsible for developing a resident’s comprehensive care plan. Current regulations require the interdisciplinary team to include the attending physician, a registered nurse responsible for the resident, other appropriate staff in disciplines as determined by the resident’s needs, and to the extent possible, the resident or the resident’s family/legal representative. CMS proposes to expand the team to include a nurse aide with responsibility for the resident, a member of the food and nutrition services staff and a social worker. In addition, CMS proposes that “other appropriate staff” may be included on the team. For example, this could include a qualified mental health professional or a chaplain or other spiritual care provider. Facilities would be required to provide a written explanation in a resident’s medical record if the participation of the resident and their resident representative is determined not to be practicable for the development of the resident’s care plan.

In addition, CMS proposes to revise the regulations pertaining to resident assessments to specify that CMS (not the State) prescribes the resident assessment instrument and to indicate that the assessment is to be conducted so that the resident’s needs, strengths, goals, life history and preferences are understood by the medical staff.

Transitions of Care: CMS proposes several provisions to facilitate transitions of care, including admissions to and discharges or transfers to or from a skilled nursing facility or nursing facility. The proposed rule would require facilities to establish admissions policies wherein facilities would be prohibited from requesting or requiring residents (or potential residents) to waive their rights or any potential facility liability for losses of personal property. Additionally, facilities would be required to disclose to a resident or potential resident, at or prior to the time of admission, notice of special characteristics or service limitations of the facility.

Discharge assessment and planning would be a part of developing the comprehensive care plan. The proposed rule would require transfers or discharges to be documented in the resident’s clinical record. If a transfer or discharge is necessary for the resident’s safety and welfare, the facility would be required to document the resident needs that it cannot meet, the facility’s attempts to meet the resident’s needs and the services available at the receiving facility that will satisfy the resident’s needs. CMS proposes specific data elements or a set of information that would be required to be communicated during the transfer process, but does not propose to require a specific form, format or methodology for the communication.

The proposed rule also would require an in-person evaluation of a resident by a physician, a physician assistant, nurse practitioner or clinical nurse specialist before a non-emergent transfer of the resident to the hospital. A patient’s physician would need to be notified if the patient is moved to a different facility.

CMS also proposes to require facilities to develop and implement an effective discharge planning process. The proposed regulations would implement the discharge planning requirements mandated by the IMPACT Act, which requires long term care facilities to take into account quality, resource use and other measures to inform and assist with discharge planning, while also accounting for the treatment preferences and goals of care of residents.

Staffing: The proposed rule would require facilities to determine their staffing needs based on a competency model that accounts for the number of residents, resident acuity, range of diagnoses and the content of care plans. For instance, a facility that provides dementia care would need to ensure that it has a sufficient number of staff, and that the staff has the necessary training, education and experience to care for individuals with dementia. CMS proposes that staff be required to have competencies and skills to provide behavioral health care and services, which includes caring for residents with mental and psychosocial illness and implementing non-pharmacological interventions.

CMS declined to specify a federal nurse-to-resident ratio. Rather, the proposed rule would require nursing homes to report staffing levels, which CMS would review for adequacy. Nonetheless, CMS is soliciting comments on mandating that a registered nurse be on site 24-hours per day. CMS is also soliciting evidence for appropriate thresholds for minimum staffing requirements.

Training Requirements: CMS proposes to require facilities to develop, implement and maintain effective training programs for all new and existing staff, as well as for individuals providing services under a contractual arrangement and for volunteers. CMS proposes that staff receive training on several topics, such as: behavioral health; effective communications; rights of residents and responsibilities of a facility to properly care for its residents; abuse, neglect and exploitation; the facility’s quality assurance and performance improvement program; the facility’s infection prevention and control program; and compliance and ethics. Nurse aides would be required to be trained in caring for residents with dementia and in preventing elder abuse.

Pharmacy Services: The proposed rule would require a pharmacist to review a resident’s medical chart at least every six months. In addition, a pharmacist would be required to review a resident’s medical chart (1) if the resident is new to the facility, (2) if a prior resident returns or is transferred from a hospital or other facility, and (3) during each monthly drug regimen review when the resident has been prescribed or is taking a psychotropic drug, an antibiotic or any drug the quality assessment and assurance committee has requested to be included in the pharmacist’s monthly drug review. The proposed rule would extend the current requirements applicable to antipsychotic drugs to psychotropic drugs.

In addition, a pharmacist would be required to document and report irregularities, such as drugs given for an excessive period of time, in excessive dose, without adequate monitoring, without adequate indications for its use, or the presence of adverse consequences that indicate that the dose should be reduced or discontinued. Once a pharmacist identifies an irregularity or recommends a gradual dose reduction for one or more medications, the attending physician would be required to document in the resident’s medical record that he or she has reviewed the irregularity and what, if any, action was taken to address the irregularity.

Quality Assurance and Performance Improvement: CMS proposes requirements for each facility’s quality assurance and performance improvement (QAPI) program, which was required by the Affordable Care Act. CMS would require facilities to develop, implement and maintain an effective, comprehensive data-driven QAPI program, reflected in a QAPI plan, which focuses on systems of care, outcomes and services for residents and staff.

Infection Prevention and Control Program: CMS proposes to require facilities to update their infection prevention and control programs. Facilities would be required to designate an infection prevention and control officer. They would also be required to create an antibiotic stewardship program that includes protocols for antibiotic use and a system to monitor use. Facilities would be required to review their infection prevention and control program annually and update the program as necessary.

Compliance and Ethics Program: CMS proposes to require SNFs, NFs and dually-participating SNF/NFs to have in place effective compliance and ethics programs with internal controls to monitor adherence to applicable statutes, regulations and program requirements.

Physical Environment: CMS proposes several changes to the regulations pertaining to the physical environment. Bedrooms must accommodate no more than two residents unless the facility is currently certified to participate in Medicare/Medicaid or has received approval of construction or reconstruction plans by state and local authorities before the effective date of the regulation. Facilities that receive approval of construction or reconstruction plans or are newly certified after the effective date of the final rule would be required to have each resident room equipped with its own bathroom with at least a toilet, sink and shower. Facilities would be required to have a resident call system. They would need to establish policies regarding smoking, including tobacco cessation, smoking areas and safety, including but not limited to non-smoking residents.

Health Information Technology and Interoperability: CMS indicates that the proposed rule is intended to reflect the existence of electronic health information technology (IT) and to accommodate and support the adoption of ONC-certified health IT and interoperable standards. Although CMS does not propose requiring skilled nursing facilities or nursing homes to use certified health IT, it encourages facilities that are electronically capturing the proposed data elements that are required to be communicated during the transfer process to “do so using certified health IT that will enable the real time electronic exchange with the receiving provider.” Similarly, CMS highlights the benefits of using certified health IT to develop comprehensive care plans that can be shared with other providers, and encourages facilities to explore how certified health IT can be used to develop and share standardized discharge summaries. Throughout the preamble, CMS recommends specific resources related to certified health IT and interoperability.

Miscellaneous: Other key modifications to the regulations governing skilled nursing facilities and nursing homes include:

• Permitting the attending physician to delegate to dietitians and therapists the task of writing orders in their areas of expertise to the extent allowed by state law.
• Adding respiratory therapy to the list of specialized rehabilitative services (which currently are physical therapy, speech-language pathology, occupational therapy, and rehabilitative services for mental illness and intellectual disability).
• Clarifying that physicians, physician assistants, nurse practitioners, and clinical nurse specialists may order laboratory, radiology and other diagnostic services for a resident in accordance with state law, including scope of practice laws.
• Implementing an annual facility assessment to be used for activities such as determining staffing requirements, establishing a QAPI program and conducting emergency preparedness planning.
• Requiring facilities that provide outpatient rehabilitative therapy services to non-residents to meet similar requirements to those already established for hospitals.
• Revising the requirements for food and nutrition services.
• Modifying the regulations on nasogastric tubes to include gastrostomy tubes (both percutaneous endoscopic gastrostomy and percutaneous endoscopic jejunostomy) and to include enteral fluids.

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