Updated Guidance Goes Into Effect October 24, 2022
Just when our nursing homes and their residents were beginning to see light on the other side of the pandemic, they will now be more regulated and scrutinized with the June 29, 2022 release by CMS of sweeping surveyor guidance for Phase 3 of the Requirements for Participation (RoP) and updates/modifications to existing guidance. How will the labor crisis impact compliance? How will the nursing homes be funded and supported for these changes? How will rural areas be more impacted due to recruitment barriers?
My initial review of the guidance and updates leads me to wonder if nursing home Plaintiff attorneys/advocates were consultants for the changes to guidance on abuse and neglect, the Psychosocial Outcome Severity Guide, admission, transfer and discharge, investigations of complaints and Facility Reported Incidents (FRIs), Resident Rights and Infection as well as arbitration agreements. Many of revisions include clinical and legal theories and categories of damages we routinely see alleged in Complaints in nursing home lawsuits. Claims of understaffing/lack of staff track the added direction to surveyors in using data from the payroll-based journal (PBJ) to identify staffing issues and enforce compliance with PBJ reporting requirements.
Phase 3 went into effect in November 2019 and nursing homes have waited more than 3 years for the guidance for how surveyors will interpret the requirements.
NOTE: The effective date of the guidance for use by surveyors is October 24, 2022. CMS is also updating other survey documents, including the Critical Element (CE) Pathways, which are used for investigating potential care areas of concern. From a litigation perspective, these many updates and changes will also create more opportunities for Plaintiff’s attorneys to utilize surveys as a basis for claims for lack of staffing, abuse and neglect and multiple other theories of liability and damages. The CMS Memorandum can be found here. QSO-22-19-NH (cms.gov).
Key Points:
Phase 2 and 3 Requirements: CMS provided clarifications and technical corrections of Phase 2 guidance issued in 2017, and new guidance for Phase 3 requirements which went into effect on November 28, 2019.
Arbitration Requirements: CMS provided guidance on the new requirements which became effective September 16, 2019. See the Adelman Advantage article regarding the Arbitration Rule from 2019; ARBITRATION UPDATE: Final Rule - CMS Will Allow Binding Arbitration — Adelman Law Firm (adelmanfirm.com)
Complaint and Facility Reported Incidents (FRIs): CMS revised the guidance in Chapter 5 and related exhibits of the State Operations Manual (SOM) to strengthen the oversight of nursing home complaints and FRIs. CMS also revised its guidance for all Medicare-certified provider/supplier types to improve consistency across the State agencies in their communication to complainants.
Psychosocial Outcome Severity Guide: CMS revised guidance to clarify the reasonable person concept and examples across the different severity levels
Recommendations for Resident Rooms: While not included in the revised guidance, CMS is urging providers to consider making changes to their physical environment to allow for a maximum of double occupancy in each room. Additionally, CMS is encouraging facilities to explore ways in which they can allow for more single occupancy rooms for residents.
Infection Control: Revisions include the requirement that nursing homes have an Infection Preventionist (IP) who has specialized training onsite at least part-time to effectively oversee the facility’s infection prevention and control program (IPCP).
Key Updates:
Abuse and Neglect: CMS has made significant revisions to the guidance for Abuse/Neglect in Appendix PP. CMS is providing clarifications to surveyors about facility reported incidents, including examples of cases and what information should be reported.
Adelman Advantage (AA) Comments: The updates increase the risk of citation including findings of noncompliance and increased enforcement actions. CMS also included examples of citations for noncompliance of F600 intersecting with F686 (Pressure Ulcers) and F689 (Accidents).
NOTE: When a facility has identified abuse, the facility must take all appropriate steps to remediate the noncompliance and protect residents from additional abuse immediately. Facilities that take immediate action to correct any issues can reduce the risk of further harm continuing or occurring to other residents, thereby potentially preventing the scope and severity of the deficiency from increasing. Failure to take steps could result in findings of current noncompliance and increased enforcement action, including, but are not limited to, the following:
Taking steps to prevent further potential abuse [See F600, 483.12(a) and F610- §483.12(c)(3)];
Reporting the alleged violation and investigation within required timeframes [See F609- § 483.12(c)(1) and (c)(4)];
Conducting a thorough investigation of the alleged violation [See F610 – §483.12(c)(2)];
Taking appropriate corrective action [See F610 –§ 483.12(c)(4)]; and
The facility must revise the resident’s care plan if the resident’s medical, nursing, physical, mental, or psychosocial needs or preferences change as a result of an incident of abuse [See Tag F656- §483.21(b)].
AA Comments: The definition of “Neglect” (§ 483.5) is expanded and includes physical harm, pain, mental anguish, and emotional distress all of which are the types of damages alleged by Plaintiff’s attorneys in nursing home lawsuits. Thus, a citation for “neglect” will be evidence for a Plaintiff to use against the facility. The revised definition includes:
“the failure of the facility, its employees or service providers to provide goods and services to a resident that are necessary to avoid physical harm, pain, mental anguish or emotional distress.” Neglect occurs when the facility is aware of, or should have been aware of, goods or services that a resident(s) requires but the facility fails to provide them to the resident(s), that has resulted in or may result in physical harm, pain, mental anguish, or emotional distress. Neglect includes cases where the facility’s indifference or disregard for resident care, comfort or safety, resulted in or could have resulted in, physical harm, pain, mental anguish, or emotional distress. Neglect may be the result of a pattern of failures or may be the result of one or more failures involving one resident and one staff person.
Neglect occurs when the facility is aware of, or should have been aware of, goods or services that a resident(s) requires but the facility fails to provide them to the resident(s), resulting in, or may result in, physical harm, pain, mental anguish, or emotional distress
Another example of “Neglect” was added:
Failure to implement an effective communication system across all shifts for communicating necessary care and information between staff, practitioners, and resident representatives.
Staffing:
CMS added guidance that incorporates the use of PBJ staffing data to direct surveyors to investigate potential noncompliance with CMS’ nurse staffing requirements, such as insufficient staffing, lack of a registered nurse for eight hours each day, or lack of licensed nursing for 24 hours a day.
AA Comments: The deeper dive into staffing by surveyors creates an even greater burden on nursing homes and is a focus in litigation – insufficient staffing.
Arbitration:
The regulatory requirements for participation for long-term care facilities were updated in 2016 by the Obama administration, and the Trump administration made changes to regulations on binding arbitration agreements in 2019. The guidance clarified existing requirements for when arbitration agreements are used by nursing homes to settle disputes -- namely, that nursing homes cannot require pre-dispute arbitration agreements as a condition of admission to a facility, or a condition for continuing care. If an arbitration agreement is used, the resident or their representative must be able to understand it and the agreement can be rescinded within 30 days of being signed. The agreement also can’t prohibit anyone from communicating with surveyors, federal, state or local officials.
AA Comments: Enforcement of arbitration agreements continues to be difficult in nursing home litigation due to the lack of proper legal authorization and various state court opinions limiting enforceability. The CMS guidance includes specific information that must be conveyed to residents and representatives and must be included in the agreement. Additional challenges are expected to enforce arbitration agreements which have proven to be an advantage for facilities and residents (lower expenses, faster process and usually pre-arbitration mediation and possible early resolution). When a resident may have cognitive issues, the guidance and intent focus on the need for proper documentation of information conveyed to the resident/representative. We’ll provide an additional legal bulletin in advance of October 24 related to arbitration. Here are the key changes:
§483.70(n)(2) The facility must ensure that:
(i) The agreement is explained to the resident and his or her representative in a form and manner that he or she understands, including in a language the resident and his or her representative understands;
(ii) The resident or his or her representative acknowledges that he or she understands the agreement…
The intent includes an extremely long discussion of transparency in the arbitration process and includes the following:
Requirements for Arbitration Agreements - Transparency in the Arbitration Process: The requirements at §483.70(n)(2)(i) specify that the arbitration “agreement is explained to the resident and his or her representative in a form and manner that he or she understands, including in a language the resident and his or her representative understands.” It is important that the arbitration process is transparent. This means that facilities should take every step to meet the resident’s needs or special accommodations (e.g. literacy level, font size, format, language, etc.) when explaining the arbitration agreement.
The requirement at §483.70(n)(2)(ii) specifies that “the resident or his or her representative acknowledges that he or she understands the agreement.” After the arbitration agreement is explained in a manner and form the resident or their representative understands, the facility must ensure there is evidence that the resident or their representative has acknowledged understanding of the agreement. In some cases, the binding arbitration agreement may specify that the resident or his or her representative acknowledges understanding by signing the document. When a signature is used to acknowledge understanding, additional evidence may be needed to establish that in fact the resident or their representative understood what he or she was signing. It may not be sufficient that the resident or their representative signed the document. It is also important that facilities clarify when a signature is used to acknowledge understanding, when it indicates consent to enter into an agreement, or is used for both purposes.
Surveyors should determine how the facility ensures residents or their representatives understood the terms of the binding arbitration agreement, and how this understanding is acknowledged. Surveyors must verify through interview and record review, that the resident or their representative understood what they were signing. In situations where the resident may have cognitive impairment, surveyors should refer to the medical record to identify the resident’s health care decision-making capacity at the time the agreement was offered, explained, and entered into.
State Investigations of Complaint Allegations:
The revised guidance increases oversight of nursing home complaints and FRIs. The revised guidance includes the following:
• Ensures that facilities have policies and procedures that are consistent with Federal requirements;
• Revises timeframes for investigation, to ensure that serious threats to residents’ health and safety are investigated immediately;
• Requires that allegations of abuse, neglect, and exploitation are tracked in CMS’ system;
• Requires that the facility report all suspected crimes to law enforcement if it has not yet been reported; and
• Removes the term “substantiate” from the survey manual and instructs surveyors to specify whether non-compliance was identified during a complaint investigation.
AA Comments: CMS has made broad updates in Complaint and Facility Reported Incidents. CMS has included “Reporting Suspicious Injuries of Unknown Source” which would include unobserved/unexplained fractures, sprains or dislocations and other injuries. It is expected that lawsuits will include more allegations of “unobserved/unexplained injuries” which, by their very nature, will be nearly impossible to defend.
CMS includes the following examples:
• Unobserved/Unexplained injuries that could have resulted from a burn, including blisters or scalds
• Unobserved/Unexplained bite marks
• Unobserved/Unexplained scratches and bruises found in suspicious locations such as the head, neck, upper chest or back
• Unobserved/Unexplained swelling that is not linked to a medical condition
• Unobserved/Unexplained lacerations with or without bleeding
• Unobserved/Unexplained skin tears in sites found in suspicious locations (e.g., in sites other than the arms or legs)
• Unobserved/Unexplained skin tears in patterns (e.g., bilateral, symmetrical skin tears on both arms)
• Unobserved/Unexplained patterned bruises that suggest hand marks or finger marks, or bruising pattern caused by an object
•Unobserved/Unexplained bilateral bruising to arms, bilateral bruising of the inner thighs, “wrap around” bruises that encircle the legs, arms or torso, and multicolored bruises which would indicate that several injuries were acquired over time.
• Unobserved/Unexplained facial injuries, including facial fractures, black eye(s), bruising, or bleeding or swelling of the mouth or cheeks with or without broken or missing teeth
• Unobserved/Unexplained bruising or other injuries in the genital area, inner thighs, or breasts
• Injuries where the resident was able to explain or describe how he/she received the injury as long as there is no other indication of abuse or neglect
• Injuries that were witnessed by staff, where there is no indication of abuse or neglect
PER CMS: Even if the injury is not one that requires a report, the facility should adequately assess and monitor the resident, notify the physician/resident representative as appropriate, and document the injury and investigation as a part of the resident’s medical record.
• Unobserved/unexplained injury requiring transfer to a hospital for examination and/or treatment
NOTE: Any injury that is explained and appears to be a result of abuse must be reported.
Other key changes are noted below in the table, and we’ll unpack them here over the next months. Phase 3 requirements such as Trauma Informed Care, Compliance and Ethics, and Quality Assurance Performance Improvement (QAPI) as well as the clarifications of Quality of Life and Quality of Care, Food and Nutrition Services, and Physical Environment are also included in this guidance.
Start Now!
We’ll be identifying immediate ways to make needed changes for survey-readiness and compliance. Your Governing Body, Administration, Management, Compliance and QAPI teams should begin to review in detail the changes identified in the advanced copy of the guidance found here https://www.cms.gov/files/document/appendix-pp-guidance-surveyor-long-term-care-facilities.pdf. Appendix PP, Guidance to Surveyor for Long Term Care Facilities.
The other referenced forms and manual citation are linked below.
- - SOM Chapter 5- Complaint Procedures Medicare State Operations Manual (cms.gov)
- - SOM Exhibit 23- ACTS Required Fields SOM - Exhibit 23 (cms.gov)
- - SOM Exhibit 358- Sample Form for Facility Reported Incidents Exhibit 358 - Sample Form for Facility Reported Incidents (cms.gov)
- - SOM Exhibit 359- Follow-up Investigation Report Exhibit 359 - Follow-up Investigation Report (cms.gov)
- - Psychosocial Outcome Severity Guide Psychosocial Severity Guide (cms.gov)
Summary of Significant Changes
Abuse and Neglect
Clarifies compliance, abuse reporting, including sample reporting templates, and provides examples of abuse that, because of the action itself, would be assigned to certain severity levels.
Admission, Transfer, and Discharge:
Clarifies requirements related to facility-initiated discharges.
Mental Health/Substance Use Disorder (SUD):
Addresses rights and behavioral health services for individuals with mental health needs and SUDs.
Nurse Staffing (Payroll-Based Journal):
Uses payroll-based staffing data to trigger deeper investigations of sufficient staffing and added examples of noncompliance.
Resident Rights:
Imports guidance related to visitation from memos issued related to COVID-19, and makes changes for additional clarity and technical corrections.
Potential Inaccurate Diagnosis and/or Assessment
Addresses situations where practitioners or facilities may have inaccurately diagnosed/coded a resident with schizophrenia in the resident assessment instrument.
Pharmacy:
Addresses unnecessary use of non-psychotropic drugs in addition to antipsychotics, and gradual dose reduction.
Infection Control:
Requires facilities have a part-time Infection Preventionist.
While the requirement is to have at least a part-time IP, the IP must meet the needs of the facility.
The IP must physically work onsite and cannot be an off-site consultant or work at a separate location.
IP role is critical to mitigating infectious diseases through an effective infection prevention and control program.
IP specialized Training is required and available.
Arbitration:
Clarifies existing requirements for compliance when arbitration agreements are used by nursing homes to settle disputes.
Psychosocial Outcome Severity Guide
Clarifies the application of the “reasonable person concept” and severity levels for deficiencies.
State Operations Manual Chapter 5
Clarifies timeliness of state investigations, and communication to complainants to improve consistency across states.
The survey process has become even more complicated and challenging and our goals are to identify key risk areas and provide risk and litigation mitigation recommendations. The many obstacles facing the industry seemed to have been improving and now CMS adds another lawyer of compliance pressure. There are actions that the administration can take to support quality of care, process improvement and care force needs including funding. More regulations is not the answer.
