CMS Finalizes New Regulations for Facilities: Part 2

Review of Changes to Sections on Quality of Life, Quality of Care, Physician Services, Nursing Services, Behavioral Health Services and Pharmacy Services

This is the second article in a series discussing the complete overhaul of Part 483 to Title 42 of the Code of Federal Regulations, the Requirements for States and Long-Term Care Facilities by the Centers for Medicare & Medicaid Services (“CMS”).

Because CMS’s Final Regulations (“Final Regulations”) impose numerous requirements on long-term care facilities, we will be issuing a series of articles on various components of the Final Regulations. This article focuses on provisions regarding Quality of Life, Quality of Care, Physician Services, Nursing Services, Behavioral Health Services and Pharmacy Services.

Recently, Hall Render published an overview of Final Regulations components as well as Part 1 in the series, which is located here.

Background

On September 28, 2016, CMS released a complete overhaul of Part 483 to Title 42 of the Code of Federal Regulations, the Requirements for States and Long-Term Care Facilities. CMS’s Final Regulations cover many regulatory requirements for long-term care facilities and create new compliance obligations for providers. The Final Regulations seek to target rehospitalizations, facility-acquired infections, overall quality and resident safety.

Quality of Life – Sec. 483.24

The Final Regulations create Section 483.24 to refer to quality of life. The Final Regulations provide that quality of life is a key principle in the delivery of care to residents and should be applied to every service provided by facilities. The Final Regulations require that each resident receive, and the facility provide, the necessary care and services to attain or maintain the highest practicable physical, mental and psychosocial well-being, consistent with the resident’s comprehensive assessment and plan of care.

Implementation Timeframe. Section 483.24 will be implemented in Phase 1, upon the effective date of the Final Regulations, November 28, 2016.

Detailed Summary. Current regulations at Sec. 483.25 address requirements for many aspects of care and special needs of nursing home residents. The Final Regulations add a new section Quality of Life. The new Section 483.24 updates some sections and adds others.

States quality of life is a key principle in the delivery of care to residents and should be applied to every service provided by facilities.
Clarifies the requirements regarding a resident’s ability to perform Activities of Daily Living.
Requires a qualified professional to direct the activities program and outlines the required licensing and experience of such professional.

Quality of Care – Sec. 483.25

Final Regulations make changes to Section 483.25, Quality of Care. The Final Regulations provide that quality of care and quality of life are key principles in the delivery of care to residents and should be applied to every service provided by facilities. The Final Regulations create a new provision to ensure that residents receive necessary and appropriate pain management. Based on the comprehensive assessment of a resident, the Final Regulations require that facilities ensure that residents receive treatment and care in accordance with professional standards of practice, the comprehensive person-centered care plan and the residents’ choices.

Implementation Timeframe. Except as noted below, Section 483.25 will be implemented in Phase 1, upon the effective date of the Final Regulations, November 28, 2016.

Detailed Summary. Current regulations at Sec. 483.25 address requirements for many aspects of care and special needs of nursing home residents. The Final Regulations update some sections of Sec. 483.25 and add others.

Restates that quality of care is a key principle in the delivery of care to residents and should be applied to every service provided by facilities.
Redesignates and revises the section on restraints. Prohibits the use of any physical or chemical restraints not required to treat the resident’s medical symptoms. Adds new requirement that if used, restraints must be the least restrictive alternative and for the least amount of time.
Establishes specific requirements when a facility uses bed rails on a resident’s bed.
Creates a new provision to ensure that residents receive necessary and appropriate pain management.
Modifies existing requirements for nasogastric tubes to reflect current clinical practice and to include enteral fluids or assisted nutrition and hydration.

Physician Services – Sec. 483.30

The Final Regulations moved the requirements for physician services from 483.40 to 483.30 and included additional requirements related to physician services including orders upon admission and the ability of physicians to delegate the responsibility for writing orders for dietary and therapy services.

Implementation Timeframe. Section 483.30 will be implemented in Phase 1, upon the effective date of the Final Regulations, November 28, 2016.

Detailed Summary. The Final Regulations added some flexibility with respect to the writing of orders for dietary and therapy services. Additionally, the Final Regulations require that a resident not only be admitted upon the recommendation of a physician, but also that a physician, physician assistant, nurse practitioner or clinical nurse specialist must provider orders for the resident’s immediate care needs.

Importantly, the Final Regulations did not include the proposed requirement that an in-person evaluation occur by a physician, nurse practitioner, physician assistant or clinical nurse specialist prior to the resident being transferred to the hospital unexpectedly unless the transfer was emergent and the in-person evaluation would endanger the health or safety of the resident. Many commenters expressed concern that the requirement would not only burden small or rural facilities but could also not be met based on current practitioner shortages.

Nursing Services – Sec. 483.35

The Final Regulations moved the requirements for nursing services from 483.30 to 483.35 and added requirements to not only train nursing staff members but also to consider the competency of the nursing staff members when determining the appropriate number staffing levels to meet the needs of the facility’s residents.

Implementation Timeframe. Except as noted below, Section 483.35 will be implemented in Phase 1, upon the effective date of the Final Regulations, November 28, 2016.

Detailed Summary. The Final Regulations add a requirement that the Facility Assessment established at 483.70, including the number and acuity of residents, the range of diagnoses and resident needs as well as the training, experience and skill sets of nursing staff must be taken into consideration in making staffing plans and assignments. (Implemented in Phase 2 – November 28, 2017)

The Final Regulations also re-designated the training requirements for nursing aides and clarified that non-permanent employees are also required to meet the competency training expectations in order to provide care in a facility.

Behavioral Health Services – Sec. 483.40

In an attempt to ensure that all residents of facilities receive the necessary behavioral health care and services they need, the Final Regulations add a new Section 483.40 that includes requirements for behavioral health services and facility staffing qualifications.

Implementation Timeframe. Except as noted below, Section 483.40 will be implemented in Phase 2, upon the effective date of the Final Regulations, November 28, 2017.

Detailed Summary. The new section related to behavioral health services adds the following requirements:

Each facility must have sufficient direct care staff with the appropriate competencies and skills to provide nursing and related services to ensure resident safety and attain or maintain the highest practicable well-being of each resident in accordance with the resident’s plan of care. These appropriate competencies and skills include knowledge and training for caring for residents with mental illness, psychosocial issues or a history of trauma. Staff must also be trained in implementing non-pharmacological interventions. The requirement that staff have the skill set to care for residents with mental health and psychosocial disorders, as well as residents with a history of trauma, will be implemented in Phase 3 by November 28, 2019.
The facility must ensure that a resident who displays or is diagnosed with mental or psychological adjustment difficulty receives appropriate treatment and services to correct the issue or attain the highest practicable well-being. Further, the Final Regulations require a facility to ensure that residents without a mental or behavioral health disorder identified in their assessment do not display patterns of decreased social interaction and/or increased withdrawn, angry or depressive behaviors, unless the behavior is unavoidable given the resident’s clinical condition. This requirement will be implemented in Phase 1 by November 28, 2016.
The facility must provide appropriate treatment to residents identified by the comprehensive assessment to have a mental disorder, psychosocial adjustment difficulty or a history of trauma and/or post-traumatic stress disorder.

Pharmacy Services – Sec. 483.45

The Final Regulations relocated and revised the Pharmacy Services requirements. These new requirements include pharmacist review of the medical records with each drug regimen review, revision of existing requirements related to “antipsychotic” drugs to include “psychotropic” drugs and provisions designed to reduce or eliminate the use of psychotropic drugs.

Implementation Timeframe. Except as noted below, Section 483.45 will be implemented in Phase 1, upon the effective date of the Final Regulations, November 28, 2016.

Detailed Summary. The Pharmacy Services regulations previously located at 483.60 were moved to 483.45 and revised to include the following provisions.

A pharmacist is required to review the resident’s medical record when completing each monthly drug regimen review. This requirement will be implemented in Phase 2 by November 28, 2017.
Defined psychotropic drugs as “a drug that affects brain activities associated with mental processes and behavior” and grouped them in the following six categories: 1) anti-psychotic; 2) anti-depressant; 3) anti-anxiety; 4) hypnotic; 5) opioid analgesic; and 6) any other drug with effects similar to the drugs identified above.
Irregularities include, but are not limited to, any drug when used:

1. In excessive dose;
2. For excessive duration;
3. Without adequate monitoring;
4. Without adequate indications for its use; or
5. In the presence of adverse consequences that indicate the dose should be reduced or discontinued.

The pharmacist is required to provide a separate, written report to the attending physician, the facility’s medical director and the director of nursing when an irregularity is identified.
The attending physician is required to document in the patient’s medical record that the irregularity has been reviewed and addressed.
PRN (Pro re nata or as needed) orders for psychotropic drugs are limited to 14 days. The attending physician or prescribing practitioner may extend the order if he/she documents the rationale in the medical record and indicates the duration of the PRN order. This requirement will be implemented in Phase 2 by November 28, 2017.
PRN orders for anti-psychotic drugs must be limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of the medication.

Practical Takeaways

The Final Regulations did not include the proposed requirement that an in-person evaluation occur by a physician, nurse practitioner, physician assistant or clinical nurse specialist prior to the resident being transferred to the hospital unexpectedly unless the transfer was emergent and the in-person evaluation would endanger the health or safety of the resident.
While many of the Final Regulations are revisions to current regulations, facilities should keep in mind that many of the Final Regulations have changes that could impact facility operations.

If you have questions or would like additional information about this topic, please contact:

Todd Selby at 317.977.1440 or tselby@wp.hallrender.com;
Brian Jent at 317.977.1402 or bjent@wp.hallrender.com;
David Bufford at 502.568.9368 or dbufford@wp.hallrender.com;
Sean Fahey at 317.977.1472 or sfahey@wp.hallrender.com; or
Your regular Hall Render attorney.

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