1. Nursing Home Culture Change: Legal Apprehensions and Opportunities Marshall B. Kapp, JD,MPH Florida State University Center for Innovative Collaboration in Medicine and Law Marshall.kapp@med.fsu.edu Marshall B. Kapp, JD,MPH Florida State University Center for Innovative Collaboration in Medicine and Law Marshall.kapp@med.fsu.edu

2. FSU C OLLEGE OF M EDICINE Acknowledgment  Melissa Villalta, Undergraduate Research Opportunity Program (UROP) student

3. FSU C OLLEGE OF M EDICINE The Culture Change Movement in Nursing Homes  Persisting problems in NH quality of care and quality of life, despite extensive regulation and litigation – http://www.nursinghome411.org/articles/?cat egory=lawgovernment http://www.nursinghome411.org/articles/?cat egory=lawgovernment

4. FSU C OLLEGE OF M EDICINE  Culture Change Movement is an attempt to improve quality of life by making facilities less institutional, more homelike – Originated 1997 – Pioneer Network – E.g., Eden Alternative, Wellspring Program, Green House Project, Advancing Excellence in America’s NHs Campaign

5. FSU C OLLEGE OF M EDICINE  Premises – Person-centered care – “deinstitutionalizing services and individualizing care” – Resident dignity and freedom – Collaborative decision making – Resident and staff empowerment

6. FSU C OLLEGE OF M EDICINE Example 1: New Dietary Standards  NH must “provide each resident with a nourishing, palatable, well- balanced diet that meets the daily nutritional and special dietary needs of each resident”—42 CFR §483.35, surveyed via “Dining Area and Eating Assistance Observation” worksheet (Form CMS-523), 42 CFR §488.110

7. FSU C OLLEGE OF M EDICINE  2010-11 initiative of the Pioneer Network and Food and Dining Clinical Standards Task Force published “New Dining Practice Standards” (Aug. 2011), http://pioneernetwork.net/Data/Documents/NewDiningPracticeStandards.pdf – Emphasis: Individualized diets – Marshall B. Kapp, “Nursing Home Culture Change: Legal Apprehensions and Opportunities,” Vol. 53, No. 5, pp. 718-726, T HE G ERONTOLOGIST (2013); doi: 10.1093/geront/gns131, reprinted in Chapter 10 of Judah L. Ronch & Audrey S. Weiner, C ULTURE C HANGE IN E LDER C ARE, Health Professions Press, Baltimore, MD (2013).

8. FSU C OLLEGE OF M EDICINE Example 2  Rothschild Person-Centered Care Planning Task Force, A Process for Care Planning for Resident Choice (Feb. 2015) (prepared by M. Calkins, K. Schoeneman, J. Brush, & R. Mayer) – Hulda B. and Maurice L. Rothschild Foundation funded – http://ideasinstitute.org/PDFs/Process_for_Care_Planni ng_for_Residnet_Choice.pdf – Disclosure: MBK was Task Force member

9. FSU C OLLEGE OF M EDICINE Rothschild Person-Centered Care Planning Process  Identifying and clarifying the resident’s choice  Discussing the choice and options with the resident  Determining how to honor the choice (and which choices are not possible to honor)  Communicating the choice through the care plan  Monitoring and making revisions to the care plan

10. FSU C OLLEGE OF M EDICINE Legal Apprehensions as Impediment  Resident choices may be inconsistent with professional custom and/or recommendations  Health care providers have low/no tolerance for risk  Perceived RM drives out everything else

11. FSU C OLLEGE OF M EDICINE  Regulatory climate – Nursing Home Quality Reform Act (OBRA 1987), 42 U.S.C. § 1396r, implementing regs at 42 CFR chap. IV, subchap. C, Part 483, set Medicare/Medicaid Conditions of Participation.

12. FSU C OLLEGE OF M EDICINE  Orientation toward medical outcomes, not quality of life: NHs “must provide services and activities to attain or maintain the highest practicable physical, mental, and social well-being of each resident…”  “Best interests” may be defined differently by the person and the professional.

13. FSU C OLLEGE OF M EDICINE  Other regulatory components: – HIPAA – OSHA – State licensure requirements – Private accreditation (e.g., Joint Commission) – False Claims Act – State abuse and neglect prosecutions

14. FSU C OLLEGE OF M EDICINE  Malpractice litigation and liability – Negligence actions brought by or on behalf (families) of residents with bad outcomes (e.g., stroke/high blood pressure/deviation from low sodium diet; choking on steak that resident requested) – Breach of contract and fraud actions re marketing claims

15. FSU C OLLEGE OF M EDICINE Responding to Regulatory and Liability Apprehensions  Education of NH providers, attys, and courts about Autonomy and RM – Informed consent – Documentation of processes and rationales – Assumption of risk – Negotiating alternatives/Mitigating risks  Education about evidence-based Clinical Practice Guidelines, illustrated by “New Dining Practice Standards”

16. FSU C OLLEGE OF M EDICINE  Ameliorating Anxiety About Regulatory Sanctions – Emphasizing consistency between person- centered care and resident rights regulations – Amending applicable regulations and sub- regulations, e.g., incorporating by reference New Dining Practices Standards in CMS LTC interpretive guidelines for surveyors

17. FSU C OLLEGE OF M EDICINE – Need to closely examine proposed new federal rules, https://www.federalregister.gov/article s/2015/07/16/2015-17207/medicare- and-medicaid-programs-reform-of- requirements-for-long-term-care- facilities https://www.federalregister.gov/article s/2015/07/16/2015-17207/medicare- and-medicaid-programs-reform-of- requirements-for-long-term-care- facilities

18. FSU C OLLEGE OF M EDICINE – Interpretation and Enforcement of Regs  Current survey & certification process is often inconsistent and not transparent.  CMS Quality Indicator Survey (QIS) (2011), 42 CFR § 488.110, process  Education of state surveyors to be less punitive (“gotcha”), more collaborative (e.g., R.I. Individualized Care Pilot Project, CMS video training module on New Dining Practice Standards, advocates working with Medicare Quality Improvement Organizations)

19. FSU C OLLEGE OF M EDICINE  Proactive communication and collaboration with resident advocacy groups and ombudsmen

20. FSU C OLLEGE OF M EDICINE When the Resident’s Choice Should Not Be Honored  Process for determining and documenting: – Incapacity to decide/Necessity for surrogate decision making – When the safety of others justifies not honoring the resident’s choice

21. FSU C OLLEGE OF M EDICINE Opportunities for Interdisciplinary Research (Law and Health Services)  What resident choices and alternatives present what actual risks? – To the resident – To others  Best practices for informing and negotiating with residents and families about choices and risks? – Effectiveness – Costs  Actual legal risks associated with specific scenarios?

22. FSU C OLLEGE OF M EDICINE Opportunities for Teaching Law and Health Professions Students  Identifying specific, not free-floating, risks  Putting risks into realistic and relative perspective  Connection between regulatory and c.l. requirements and enforcement  Looking at the legal environment as a whole  Role as creative enabler among multiple parties, not roadblock  Reconciling good clinical and ethical care with effective risk management