1. Long Term Care Facilities
Reform of Requirements for Participation –
Implementation Update
Nancy L Fisher, RN, MD, MPH
CMO Region VIII* and X
Centers for Medicare and Medicaid

2. Final LTC Requirements of Participation
These requirements have not been comprehensively updated since despite significant changes in the industry.
The proposed revisions reflect advances in the theory and practice of service delivery and safety, and implement sections of the Affordable Care Act (ACA).
The proposed rule received over 9,800 public comments, resulting in a number of revisions to the proposed requirements.
Final rule on display in Federal Register: September 28, 2016
Effective: November 28, 2016 (with phased implementation dates)
for-medicare-medicaid-services

3. Background
The requirements for Long-Term Care (LTC) Facilities are the health and safety standards that LTC facilities must meet in order to participate in the Medicare or Medicaid Programs.
The Requirements for Participation are found at 42 CFR 483 Subpart B.
Additional guidance can be found in the State Operations Manual, Appendix PP 4 3

4. Themes of the Final LTC Rule
Person-Centered Care
Quality
Facility Assessment, Competency-Based Approach
Alignment with HHS priorities
Comprehensive Review and Modernization
Implementation of Legislation 5 4

5. Phased In Implementation Schedule
Regulation will be implemented in 3 phases.
Phase 1: Existing requirements, those requirements relatively straightforward to implement, and require minor changes to survey process (November 28, 2016)
Phase 2: All Phase 1 requirements, and those that providers need more time to develop, foundational elements, new survey process can assess compliance (November 28, 2017)
Phase 3: All Phase 1 and 2, those requirements that need more time to implement (personnel hiring and training, implementation of systems approaches to quality) (November 28, 2019) 6 5

6. Phase 1
Phase 1 (* this section is partially implemented in Phase 2 and/or 3)
Resident Rights*
Freedom from Abuse Neglect and Exploitation*
Admission, Transfer and Discharge*
Resident Assessment
Comprehensive, Person-Centered Care Planning*
Quality of Life
Quality of Care*
Physician Services
Nursing Services*
Pharmacy Services*
Laboratory, radiology and other diagnostic services
Dental Services*
Food and Nutrition*
Specialized Rehabilitation
Administration (Facility Assessment – Phase 2)*
Quality Assurance and Performance Improvement* - QAA Committee
Infection Control – Program*
Physical Environment*

7. Phases 2 and 3 Phase 2 Behavioral Health Services*
Primary Implementation
Phase 2
Behavioral Health Services*
Quality Assurance and Performance Improvement* - QAPI Plan
Infection Control – Facility Assessment and Antibiotic Stewardship **
Physical Environment- smoking policies *
Phase 3
Quality Assurance and Performance Improvement* - Implementation of QAPI
Infection Control – Infection Control Preventionist *
Compliance and Ethics
Physical Environment- call lights at resident bedside *
Training *
* This section is partially implemented in other phases.

8. 483.5 Definitions & 483.10 Resident Rights
Added federal definitions: Abuse, neglect, exploitation, mistreatment, Adverse event (QAPI), Person-centered care
Resident Rights
Significant existing language
Participation in care plan
Smaller changes (e.g., interest bearing account for funds >$100, posting additional contact information)
Almost all Phase 1 9 8

9. Abuse, Neglect, Exploitation & Adm., Transfer, Discharge
Freedom from Abuse, Neglect, and Exploitation
Phase 1 – Strengthens existing protections, in addition to review of policies and procedures. Adds language related to resident “right to be free from neglect” and “exploitation”, and expands on freedom from restraints requirement.
Phase 2 – Regulatory inclusion of 1150B requirements (Reporting reasonable suspicion of a crime). This is an existing requirement under the Statute.
Phase 3 – QAPI must be involved in review of allegations/incidences of abuse, neglect and exploitation.
Admission, Transfer, and Discharge Rights
Strengthens requirements for discharge planning.
Phase 1: all sections implemented except: (c)(2) Transfer/Discharge Documentation—Implemented in Phase 2. 10 9

10. Resident Assessment & Comp Person-Centered Care Plan
Few changes to resident assessment, but strengthened PASARR section.
Implemented in Phase 1.
Comprehensive Person-Centered Care Planning
Most of requirements maintained- implemented in Phase 1
Baseline care plan—Implemented in Phase 2.
(b)(3)(iii) Trauma informed care—Implemented in Phase 3. 11 10

11. 483.24 Quality of Life & 483.25 Quality of Care
“Highest Practicable Well-Being” language added to this section.
No new requirements. More specifics related to CPR. ADLs moved from QoC.
Implemented Phase 1.
Quality of Care
Adds special care issues many of which were previously cited under F309 if there were care issues.
Special Needs expanded: Foot Care, pain management, incontinence (including bowel), dialysis services, trauma-informed care, bed rails.
Nutrition moved to new section of rule
Medication-related provisions moved to pharmacy section
All of this section implemented in Phase 1 except trauma-informed care (Phase 3). 12 11

12. 483.30 Physician Services & 483.35 Nursing Services
Final rule removed language in proposed rule regarding physician visit prior to transfer.
Ability to delegate dietary and therapy orders (per State law).
All of this section implemented in Phase 1.
Nursing Services
Need both sufficient and competent staffing based on resident population.
Embedded nurse aide minimum training and competency requirements.
Links staffing to Facility’s Assessment (Phase 2).
Otherwise, mostly existing requirements and will be implemented in Phase 1. 13 12

13. 483.40 Behavioral Health Services
New requirement (incorporates highest practicable well-being, specialized rehabilitation, and medical social services)
Prevention and treatment of mental and substance use disorders
Sufficient, competent staff
Resident with dementia has treatment and services needed to meet his/her needs
Implementation on non-pharmacological interventions
Mostly implemented in Phase 2, except:
Phase 1: Comprehensive assessment and medically-related social services.
Phase 3: Residents with history of trauma/PTSD 14 13

14. Pharmacy Services
Existing requirements (freedom from unnecessary medications and medication errors, medication storage, drug regimen review)
Definition of psychotropic medication
All in phase 1, except the following in phase 2:
Review of medical chart as part of drug regimen review
PRN usage of psychotropic medication – 14 days – difference between psychotropic and antipsychotic medications 15 14

15. Other Regulations Minor Changes
§ Laboratory, radiology, and other diagnostic services (phase 1):
Prompt notification of findings outside clinical reference ranges
Non-physician practitioners orders.
§ Dental services (new requirements for replacing lost dentures – Phase 2). 16 15

16. 483.60 Food and Nutrition Services
Primarily Phase 1.
Continues food and nutrition protections
Qualified Dietary Staff – sufficient and competent as linked to facility assessment (phase 2)
Updated education requirements for dietitian and Director of Food and Nutrition – must meet within 5 years for current employees (Diet., and Dir. F/N), or 1 year for new hires (Dir. F/N)
Reasonable efforts to address religious, cultural and ethnic needs
Snacks
Policy regarding use and storage of foods from outside 17 16

17. 483.70 Administration Primarily Phase 1
Maintains Existing Requirements
Facility Assessment (Phase 2): Holistic approach – resident population (e.g., conditions, acuity), physical environment, cultural environment, resources, equipment, services, personnel, contracts, technology
Full time social worker for 120 beds + /qualifications
Emergency preparedness: Moved to new (separate rule)
Incorporates recent regulations (facility closure, hospice, payroll based journal) 18 17

18. 483.75 Quality Assurance and Performance Improvement
Phase 1 - Participation in QAA Committee and maintain existing QAA requirements
Phase 2 – QAPI Plan – as required by Affordable Care Act
Phase 3 – Full Implementation of QAPI and integration of Infection Preventionist 19 18

19. 483.80 Infection Control Current Requirements – (Phase 1)
Infection Control Program
Linens
Infection Control Preventionist with Specialized Training (Phase 3)
Antibiotic Stewardship (Phase 2)
Flu and Pneumonia Vaccines 20 19

20. 483.85 Compliance and Ethics Program
Phase 3 Implementation
Program must be reasonably capable of reducing the prospect of criminal, civil and administrative violations under the Act and promoting quality of care and include:
Appointing a C&E representative for facility and organization
Enforcing operating standards
Responding to violations
Reviewing annually 21 20

21. 483.90 Physical Environment Primarily Phase 1
Maintains many existing protections:
Two residents to a room for new construction/reconstruction
Resident call next to the bed – Phase 3
Smoking policies – Phase 2 22 21

22. 483.95 Training Requirements
Training requirements for all staff, contractors, volunteers – in Phase 3 except...
Incorporates training requirements previously found elsewhere – (required training for nurse aides, prohibition of abuse and neglect) – Phase 1
Adds in requirements from Affordable Care Act – dementia care training – Phase 1 23 22

23. How are we going to implement?24

24. Implementation Timeline
Implementation Date
Type of Change
Details of Change
Phase 1: November 2016
Effective date of new LTC Requirements for Participation
New Regulatory Language under current F Tags
Phase 2: November 2017
Appendix PP of State Operations Manual
Implement new survey process
New F Tag numbers
Interpretive Guidance (IG) Changes
Begin surveying with the new survey process

25. What Exactly Does This Mean?
For example:
42 CFR § The facility must provide purple attire for all residents to wear on Sundays.
(Disclaimer: This is not a real requirement.) 26 25

26. Expected Impact Phase 1
F156 (Closest fit in terms of regulatory intent.)
§483.10(b)(1) -- The facility must inform the resident both orally and in writing in a language that the resident understands of his or her rights and all rules and regulations governing resident conduct and responsibilities during the stay in the facility…
§ The facility must provide purple attire for all residents to wear on Sundays.
*************************************
Interpretive Guidance/Survey Process doesn’t change… 27 26

27. Expected Impact Phase 2 F980 (Formerly F156)
§483.10(g)(16)(i) -- The facility must inform the resident both orally and in writing in a language that the resident understands of his or her rights and all rules and regulations governing resident conduct and responsibilities during the stay in the facility.
*************************************
F981 (NEW)
§ The facility must provide purple attire for all residents to wear on Sundays.
Interpretive Guidance/Survey Process may change… 28 27

28. New Survey Process Background
Regulatory
Changes
Quality Indicator Survey (QIS) and Traditional Survey operating simultaneously for ~10 years (S & C memorandum NH)
Maintaining two survey processes:
Positives/negatives to each process
Consistency issues
Efficiency issues
New Survey Process
Data/ Study/ Test
Quality Indicator Survey
Traditional

29. New Survey Protocol
New Survey Process starting in Phase 2 - November 28, 2017
Incorporates New Requirements and interpretive guidance (SOM App. PP)
New F-tags Coding System- F540 +
Computer-based
Two parts:
Sample Selection
Off-site
Onsite
Investigation
Interviews, observations, record reviews

30. Roll Out
Phase 1:
Recorded Webinar – highlighting Phase 1 changes (S&C NH)
Tools (S&C NH)
Revised F-Tags, Advance Copy Appendix PP, Job Aide
Phase 2:
Webinars and National Provider Calls
New Tags, Interpretive Guidance, Survey Process
Summer 2017 31 30

31. Survey and Certification Resources
Policy Memos to Regions and States:
Memos-to-States-and-Regions.html
16-13-NH: Electronic Staffing Data Submission – PBJ
16-15-NH: State Operations Manual (SOM) revisions to guidance for surveyors to help identify psychosocial harm
16-27-NH: Release of Nursing Home Enforcement Data
16-28-NH: Update Report on National Partnership to Improve Dementia Care in Nursing Homes
16-31-NH: Mandatory Immediate Imposition of Federal Remedies and Assessment Factors Used to Determine the Seriousness of Deficiencies for Nursing Homes
16-33-NH: Protecting Resident Privacy and Prohibiting Mental Abuse Related to Photographs and Audio/Video Recordings by Nursing Home Staff
17-03-NH: Save the Date: Training for Phase 1 Implementation of New Nursing Home Regulations
17-07-NH: Advance Copy - Revisions to State Operations Manual (SOM), Appendix PP-Revised Regulations and Tags
Questions:

32. Thank You
Thank you 32