4/3/2018. Nursing Facility Changes to Conditions of Participation (& Enforcement): What You Need to Know. Revisions to State Operations Manual

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1 DAVIS, BROWN, KOEHN, SHORS & ROBERTS, 1P.C. Nursing Facility Changes to Conditions of Participation (& Enforcement): What You Need to Know Lynn Böes and Ken Watkins 2 Revisions to State Operations Manual S&C Letter from CMS detailing revisions to the SOM, Appendix PP effective Nov. 28, 2017 Revised Interpretive Guidance Based on CMS revisions to Requirements for Participation under the Medicare and Medicaid Programs Reform of Requirements for Long-Term Care Facilities rule (RoPs) Updated Interpretive Guidelines to ensure clear standards and examples Added Key Elements of Noncompliance Revised F-tags Revisions resulted in many citations to be re-designated CMS crosswalk for F-tags 3 1

2 Temporary Enforcement Delays Certain Phase 2 F-Tags Temporary moratorium 18 mo. Civil money penalties Discretionary denials of payment for new admissions Discretionary termination Deficiency findings on one of these Phase 2 F-tags: F655 (Baseline Care Plan); (a)(1) (a)(3) F740 (Behavioral Health Services); F741 (Sufficient/Competent Direct Care/Access F838 (Facility Assessment); Staff Behavioral Health); (a)(1) (a)(2) (e) F758 (Psychotropic Medications) related to F881 (Antibiotic Stewardship PRN Limitations (e)(3) (e)(5) Program); (a)(3) F865 (QAPI Program and Plan) related to the development of the QAPI Plan; (a)(2) F926 (Smoking Policies); (i)(5) 4 Facility-Initiated Discharges Violating Federal Regulations CMS initiative to examine and mitigate facility-initiated discharges violating federal regulations Discharge/eviction was most frequent issue reported to LTC Ombudsman nationally in FY15 Direction from CMS for all SAs to transfer all facilityinitiated discharge violations to the CMS RO for review 5 Notice Requirements Transfer/Discharge CMS clarification of timing for providing notice to State LTC Ombudsman when resident is transferred or discharged Transfer in an emergency to acute care facility Discharge while resident is hospitalized Other facility-initiated discharge Resident-initiated transfer or discharge Notice of transfer to resident and resident rep as soon as possible Copies of notices sent to Ombudsman, when practicable, such as list of residents on a monthly basis Send notice of discharge to resident and resident rep Notice to Ombudsman must occur at the same time Send notice of discharge to resident and resident rep and copy to ombudsman at least 30 days prior Notice of transfer/discharge to Ombudsman is not required Medical record must contain documentation or evidence of resident s or resident rep s verbal or written notice of intent to leave 6 2

3 Quality Assurance and Performance Improvement (QAPI) Facilities must produce QAPI for surveyors to review Starting Nov 28, 2017 Guidance surveyors review QAPI/QAA docs at end of survey Draft Entrance Worksheet indicates surveyors will request QAPI Plan on entrance Guidance surveyors review QAPI plan and QA activities anytime there is a SQC or E or higher 7 QAPI Plan Monitoring Performance Improvement (PI) Program Activities Develop written policies for feedback, data collection and monitoring, including adverse event monitoring Develop policies addressing the systemic approach used, how corrective actions will be developed and method of monitoring PI activities Set priorities for PI activities (e.g. high-risk, high-volume, etc.) and track and analyze medical errors and adverse events 8 Governing Body Responsibility Ensuring QAPI Program exists and is operational Ensuring adequate resources to support the Program Ensuring Program sets priorities that reflect resident and staff input Ensuring that corrective action is taken to address gaps in systems Outlining clear expectations for resident safety, quality, rights, choice and respect 9 3

4 Duties of the Committee Reports to Governing Body Meets at least quarterly Develops and implements appropriate plans of action to correct quality deficiencies Regularly reviews and analyzes data, including data collected by QAPI Program and drug regime reviews, and acts on the data 10 Surveyor Access to QAPI Documentation Surveyor may not require disclosure of the records of such Committee except in so far as such disclosure is related to the compliance of such committee with the requirements of this section. Good faith attempts by the Committee to identify and correct quality deficiencies will not be used as a basis for sanctions. Guidance provides Information gleaned from disclosure of QAA Committee documents will not be used to cite new issues... Incident and accident reports, wound logs or other adverse event logs are not protected from disclosure If a facility refuses to provide requested information, it could lead to federal remedies and other enforcement Facts considered are not privileged; analysis of the facts is privileged QA materials should be: Clearly marked/labeled & kept separate Only circulated and accessed by QA Committee members 11 What Will Surveyors Look For? Initially, evidence that Committee meets quarterly, that it is properly constituted and that staff (at all levels) are aware of its existence and how to identify and refer QA concerns to the Committee If quality issues are identified, surveyors will want to see whether same issue was identified and whether an action plan was developed and facility was making good faith efforts to address the issue. If so, the QA tag should not be cited Can t ask to see QA minutes in general in absence of specific quality issue surveyors have identified Can t cite new deficiencies or expand the survey based on the specific information they review Can seek penalties if facility does not cooperate with their request as to a particular quality issue 12 4

5 Revision of Civil Money Penalty Policies and CMP Analytic Tool Past noncompliance A Per Instance CMP will be imposed for past noncompliance if the violation occurred before the current survey, has been fully addressed and the facility is back in compliance with the requirement. Per Instance CMP is default for noncompliance that existed before the Survey A Per Instance CMP generally will be imposed retroactively for noncompliance that still exists at the time of the survey, but began earlier. Per Day CMP will be used to address noncompliance that occurred where: A resident suffers actual serious harm at the IJ level; A resident was abused; OR The facility had persistent deficient practices violating federal regulations (Note: persistent deficient practices is undefined.) Per Day CMP is default for noncompliance existing during Survey and beyond Exceptions allowing a Per Instance CMP will be made for those facilities with a good compliance history, and for situations in which a single isolated incident causes harm to a resident (unless abuse is cited). Revisit timing ROs should consider the timing of the revisit survey to certify compliance when imposing the final CMP amount. Review of high CMPs CMS Central Office will review CMPs of $250,000 or more. 13 Revised Policies Federal Remedies For Action Draft memo that would replace S&C NH ROs should, consider the extent to which the noncompliance is a one time mistake or accident, the result of larger systemic concerns, or a more intentional action or disregard for resident health and safety, when contemplating whether to impose immediate Federal remedies. 14 Revisions include: Revised Policies Federal Remedies For Action Determination to impose Federal remedies for past noncompliance is at discretion of CMS RO Immediate Federal remedies if any one (or more) of: IJ identified on current survey Deficiency on current survey at G, H, or I level not IJ, but resulted in injury, harm, or impairment Deficiency at G or above on current survey where there were any such deficiencies on previous standard health or LSC survey, or on any type of survey between current and last standard health or LSC. Special Focus Facility has deficiency at level F, (exclusions F812, F813, F814) or higher for current health survey, or G or higher for current LSC survey 15 5

6 State Remedy Recommendation States are not required to recommend the types of remedies to be imposed, but are encouraged to do so More familiar with facility history and case specifics CMS RO may or may not adopt the recommendations 16 Federal Remedies in IJ Situations CMP must be imposed for serious injury, harm, impairment, or death Remedy or remedies that will best achieve the purpose of attaining and sustaining compliance where IJ citations without serious injury, harm, impairment or death, but the likelihood CMPs may be imposed, but not required 17 Forms of Remedies CMPs Directed Plan of Correction Temporary Management Only imposed by RO using Analytic Tool If per instance CMP, facility shall not be given opportunity to correct Directed In-Service Training State or CMS RO directs action the facility must take to address noncompliance Directed process to address root cause(s) of noncompliance CMS or State appoints substitute facility manager or administrator Must be imposed when deficiencies constitute IJ or widespread actual harm Denial of Payment for all New Medicare and Medicaid Admissions Must be imposed when: not in substantial compliance three months after last day of survey finding deficiencies Facility has been found to have substandard quality of care on last three consecutive surveys Denial of Payment for all New Medicare and Medicaid Residents Only imposed by CMS after consideration of: Seriousness of current survey findings Noncompliance history of facility Unsuccessful use of other remedies State Monitoring Oversee the correction of cited deficiencies as a safeguard against further harm to residents when harm or potential for harm has occurred. Must be used when facility has been cited with SQC deficiencies on last three standard health surveys. Termination of Provider Agreement Must be imposed when facility is not in substantial compliance six months after last day of survey finding deficiencies or within no more than 23 days if IJ is identified and not removed. May be imposed any time the circumstances warrant, regardless of IJ 18 6

7 Appendix Z, Emergency Preparedness Emergency Plan Facilities must develop and maintain an emergency preparedness plan, all hazards approach, including missing resident/elopement policy Must include facility-based and community-based assessments Must be specific to the location of the facility and consider most likely hazards in the area 19 Hazards to Consider for Inclusion Examples include, but are not limited to: Natural disasters Man made disasters Facility based disasters, that include, but are not limited to: Care related emergencies Equipment and utility failures, including but not limited to power, water gas, etc. Interruptions in communication, including cyber attacks Loss of all or portion of a facility Interruptions to the normal supply of essential resources, such as water, food, fuel (heating, cooking and generators), and in some cases, medications and medical supplies (including medical gases, if applicable) 20 Plan Requirements Include strategies for addressing emergency events identified by the risk assessment Address resident population, including, but not limited to, persons at risk Identify the type of services the facility has the ability to provide in an emergency Develop continuity of operations, including delegations of authority and succession plans Include a process for cooperation and collaboration with local, tribal, regional, State or Federal emergency preparedness officials efforts to maintain an integrated response during a disaster or emergency situation The plan must be reviewed and updated annually Written documentation and interviews with facility leadership will be basis of survey procedures 21 7

8 Emergency Preparedness Policies and Procedures LTC facilities must develop and implement emergency preparedness policies and procedures (P&P) based on the emergency plan, risk assessment, and communication plan Must be reviewed and updated annually Facilities must be able to provide for adequate subsistence for all residents and staff for the duration of an emergency, evacuated or sheltered in place 22 P&P Requirements Food, water, medical and pharmaceutical supplies Alternative source of energy to maintain: Temperatures Emergency lighting Fire detection, fire extinguishing, and alarm systems A means to shelter in place for residents, staff and volunteers A system of medical documentation that preserves resident information The use of volunteers in an emergency or other emergency staffing strategies Sewage and waste disposal A system to track to location of on duty staff and sheltered residents in the facility s care during and after an emergency Safe evacuation of the facility The development of arrangements with other LTC facilities and other providers to receive residents The role of the LTC under a Section 1135 waiver declared by the Secretary 23 Emergency Preparedness Communication Plan Must have written emergency communication plan specifying how the facility coordinates resident care within the facility across healthcare providers with state and local public health departments. Must be reviewed and updated at least annually 24 8

9 Communication Plan Requirements Names and contact information of: Staff Entities providing services under arrangement Residents physicians Other facilities Volunteers Contact information for: Federal, State, tribal, regional, or local emergency preparedness staff The State Licensing and Certification Agency The Office of the State Long Term Care Ombudsman Other sources of assistance 25 Communication Plan Requirements Primary and alternate means for A means of providing information communicating with the following: about the general condition and location of residents Staff of the facility Federal, state, tribal, regional or local emergency management Method for sharing information and medical documentation A means, in the event of an evacuation, to release resident information A means of providing information about the facility s occupancy needs and its ability to provide assistance to others A method for sharing information from the emergency plan with residents, their families and representatives 26 Emergency Preparedness Testing and Training Must develop and maintain testing and training program that is document, reviewed, and updated at least annually Must maintain documentation of the annual training for all staff including specific training and methods used for demonstrating knowledge of the training programs. Facilities have flexibility regarding demonstration of staff knowledge 27 9

10 Testing and Training Requirements Program must reflect the risks identified and accomplish: Initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers Conduct exercises to test the emergency plan at least annually, including unannounced staff drills using the emergency procedures Participate in a full scale exercise that is community based Conduct an additional exercise that may include: A second full scale exercise that is community based or individual facility based, or A tabletop exercise 28 Emergency Preparedness Power and Standby Power Systems Facility must implement emergency and standby power systems based on the emergency plan in accordance with the location requirement of the Health Care Facilities Code 29 Arbitration Agreements 2016 CMS banned use of all pre-dispute binding arbitration agreements AHCA initiated litigation to block the rule Court issued preliminary injunction and later a permanent injunction prohibiting implementation and enforcement New proposed arbitration rule would help strengthen transparency in the arbitration process, reduce unnecessary provider burden and support residents rights to make informed decisions about important aspects of their health care

11 Arbitration Agreements Proposed Rule Provisions Elimination of the earlier prohibition on pre dispute Agreement must not contain any language that binding arbitration agreements prohibits or discourages the resident or anyone else from communicating with federal, state, or local All agreements for binding arbitration must be in officials, including federal and state surveyors, other plain language federal or state health department employees, or If a facility requires the execution of an agreement for representatives of the State Long Term Care binding arbitration as a condition of admission, the Ombudsman language of the agreement must be in plain writing If a facility resolves a dispute with a resident through and be contained in the admissions contract arbitration, it must retain a copy of the signed Agreement must be explained to the resident and his agreement for binding arbitration and the arbitrator s or her rep in a form and manner they understand, final decision so it can be inspected by CMS or its including in a language they understand designee Resident must acknowledge that he or she Facility must post a notice regarding its use of understands the agreement binding arbitration in an area that is visible to both residents and visitors 31 Arbitration Agreements Iowa Consortium Claims Roth et al., v. The Evangelical Lutheran Good Samaritan Society et al. (IA, 2016) Resident signed Agreement to Arbitrate during admission process Resident s estate brought lawsuit asserting negligence resulting in death of resident Adult children brought claims for loss of their consortium Facility sought to move the lawsuit into arbitration Court ruled Agreement to Arbitrate was binding on the resident s estate, but asked Supreme Court to rule on whether children s consortium claims were subject to arbitration. Supreme Court decided that the children are not bound by the terms of the arbitration provision 32 Arbitration Agreements Iowa Consortium Claims Effect of Roth et al., v. The Evangelical Lutheran Good Samaritan Society et al. Where a valid arbitration agreement is in place, a part of the claims (consortium) will remain in court and subject to jury trial Complicates matters and results in the claims being resolved in two separate forums, at increased costs and time to both parties 33 11

12 QUESTIONS? DAVIS, BROWN, KOEHN, SHORS & ROBERTS, P.C