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Modeling Mutual Assistance Among Hospitals: Innovations in Response to the 2009 H1N1 Influenza (and future) Outbreaks James G. Hodge, Jr., J.D., LL.M. Professor, Johns Hopkins Bloomberg School of Public Health; Executive Director, Centers for Law and the Public’s Health: A Collaborative 1 Acknowledgments Evan Anderson, J.D. Research Associate, Johns Hopkins Bloomberg School of Public Health Senior Fellow, Centers for Law and the Public’s Health: A Collaborative Stephen P. Teret, J.D., M.P.H. Professor, Johns Hopkins Bloomberg School of Public Health Co-Principal Investigator Jon S. Vernick, J.D., M.P.H. Associate Professor, Johns Hopkins Bloomberg School of Public Health Investigator Thomas D. Kirsch, M.D., M.P.H., F.A.C.E.P. Associate Professor and Director of Operations Department of Emergency Medicine, Johns Hopkins University Investigator Gabor Kelen, M.D. Professor and Chair, Department of Emergency Medicine School of Medicine, Johns Hopkins University Co-Principal Investigator, PACER 2 Principal Objectives • Briefly discuss the need to align health care services and resources among hospitals during emergencies • Examine the use of MOUs between hospitals during emergencies to help coordinate services and allocate resources • Explain our research and methodology to develop a Model MOU • Summarize the central features of the Model MOU • Examine how the Model MOU helps to address key legal and policy issues during actual emergencies, including the H1N1 influenza outbreak 3 Project Steps to Create a Model MOU • Comprehensive examination of existing MOUs and various legal issues [September 2007] • Creation of a Blueprint Outline identifying critical provisions of a Model MOU [April 2008] • Vetting of the Blueprint Outline with Experts in Hospital Emergency Preparedness [May – October, 2008] • Drafting and Vetting the Model MOU [November – May 2009] • Completion of the Model MOU [May 13, 2009] 4 Public health emergency preparedness - 1 • During government-declared emergencies, medical and health resources can become scarce… leaving hospitals and other health care providers overwhelmed and challenged in their abilities to render patient care. 5 Public health emergency preparedness - 2 • Hospitals and other health care providers may need to share resources (e.g., personnel, equipment, supplies) to meet patient surge capacity during declared emergencies. 6 Public health emergency preparedness - 3 • Collaboration among hospitals and health care entities in specific regions can be vital to securing the health of individuals and populations. 7 Key Challenges to Collaboration • Creating consistency among hospital response efforts • Facilitating policy decisions in times of medical triage • Defusing obstacles to sharing resources and personnel, including concerns about: – Liability – Reimbursement – Coordination • Providing clear directions for responses that convey and meet expectations 8 Hospitals’ Use of MOUs in Emergencies - 1 • Memoranda of Understanding (MOUs) offer hospitals and administrators an important tool to coordinate personnel and resources in specific regions • Nationally, hundreds of emergency care hospitals and other health care entities have executed MOUs over the last decade to facilitate collaborative efforts. • However, these MOUs differ extensively in breadth, scope, quality, and utility. • Many of these agreements do not reflect critical legal issues that may be implicated during declared states of emergency. 9 Hospitals’ Use of MOUs in Emergencies - 2 The goal of Project B2 is to develop a national model MOU for acute care hospitals (and potentially other healthcare entities within a regional health care system) that reflects legal principles and best practices during declared emergencies. 10 Construction of the Model MOU • Drafted for those who may primarily rely on the document 11 Construction of the Model MOU • Drafted for those who may primarily rely on the document 12 Construction of the Model MOU • Unlike some existing MOUs, the Model MOU is not constructed as a binding contract. 13 Model MOU - 1 • Definitions [Section 1.1] • Activation of the Hospital Mutual Aid Network [Section 1.3] • Effect of Emergency Laws [Section 1.4] • Effect of National Incident Management System (NIMS) Requirements [Section 1.8] • Requesting and Sharing Resources [Section 2.0 et seq.] 14 Model MOU - 2 • Transfer of Resources [Section 2.2 – 2.4] • Transfer of Personnel (employees, contractors, volunteers) [Section 2.5] • Scope of Practice [Section 2.6] • Transfer of Patients [Section 2.9] • Liability of Hospitals and Healthcare Personnel [Section 3.1] • Financial Obligations [Section 3.2] • Mediation and Dispute Resolution [Section 4.2] 15 Major Topical Themes in the Model MOU • Legal Environment in Declared Emergencies • Transferring Patients • Liability of Individuals and Institutions 16 Legal Environment During Declared Emergencies - 1 Once an emergency has been declared (as in response to the H1N1 outbreak), the legal landscape changes. 17 U.S. Confirmed Cases of 2009 H1N1 Flu Legend No confirmed cases >1 confirmed case(s) >10 confirmed cases >50 confirmed cases Last Updated: May 27, 2009 Source: CDC http://www.cdc.gov/h1n1flu/ 18 Multiple Levels of Emergency Declarations International Federal WHO State Local Emergency Public or Health Disaster Emergency Emergency Public or Health “HHS” “FEMA” Public Emergency Health Emergency Disaster Emergency 19 Public Health Emergency of Intl Concern Emergency Declarations By Intl Govs 2009 H1N1 Flu - WHO • April 25, 2009: WHO Director General, Dr. Margaret Chan, declares first-ever public health emergency of international concern pursuant to the International Health Regulation (2005) 20 2009 H1N1 Flu - DHHS • April 26, 2009: U.S. DHHS Acting Secretary, Charles Johnson, declares a public health emergency Via the Public Health Service Act, 42 U.S.C. § 247d Allows federal, state, and local agencies to utilize federal resources to prevent and mitigate H1N1 flu 21 Emergency, Disaster, and Public Health Declarations in Response to H1N1 Flu Sonoma County Alameda County San Francisco San Mateo County San Bernardino County Ventura County Los Angeles County LEGEND Federal DHHS Public Health Emergency Declaration Emergency Declaration American Samoa (U.S. Territory) Disaster Declaration Public Health Emergency Declaration Emergency and Public Health Emergency Declarations Last Updated: May 27, 2009 Localities Declaring Emergencies/Disasters/Public Health Emergencies 22 Multiple Levels of Emergency Declarations International Govts Emergency Declarations International W.H.O. Public Health Emergency of International Concern (PHEIC) Federal “DHHS” public health emergency Federal “FEMA” emergency State public health emergency State emergency or disaster Local public health emergency Local emergency or disaster Authorities, powers, actors, liabilities, immunities, and other critical legal issues vary depending on the type of declared emergency 23 Maryland Emergency Declarations May 1, 2009: • Declaration of an Emergency • Declaration of Public Health Emergency [Catastrophic health emergency] 24 Maryland Emergency Declarations Declaration of Public Health Emergency What the Declaration Authorizes: Potential Impact on Hospitals: Isolation and quarantine of individuals or groups Immunizes health care providers from civil or criminal liability Healthcare services may be redirected HCWs have limited liability protections Penalizes any person who knowingly and willfully fails to comply with government orders Nonconforming HC services may lead to sanctions 25 Maryland Emergency Declarations Declaration of State of Emergency What the Declaration Authorizes Potential Impact on Hospitals: Governmental use/distribution of supplies, equipment, facilities Distribution meds may be dictated by state policy Suspension of laws that impede emergency responses Normal rules for HC delivery change Evacuation of the population from threatened HCWs/patients/staff may be areas diverted Control movement of populations; closure of facilities Availability of HCWs may be curtailed Use of private property subject to compensation for governmental purposes Taking of meds/ supplies may diminish available supplies 26 Legal Environment During Declared Emergencies - 2 Unlike many existing MOUs, our Model MOU recognizes and embraces these changes in the legal environment. Specifically, the provisions of the MOU shall be applied consistent with changing legal norms. 27 Transferring Patients in Emergencies - 1 • Transferring existing and prospective patients between hospitals may be essential during emergencies, but is subject to legal challenges: • • • • • EMTALA Resource availability Appropriate processes Benefits and burdens Health information privacy 28 Transferring Patients in Emergencies - 1 • The Model MOU addresses these issues: • Anticipates and recognizes the effect of EMTALA waivers • Requires hospitals to pre-determine “resourced beds” • Acute trauma care • Pediatric care • ICU • Implements a process for hospitals seeking to transfer existing patients: • Determination of a lack of adequate care • Seek patient consent • Notification of transfer • Safe transportation • Assurances of health information privacy 29 Liability Concerns - 1 Who may potentially face civil liability? Hospital employees, contractors, and volunteers Health care entities that transfer patients, resources, & personnel Health care entities that receive patients, resources, & personnel 30 Liability Concerns - 2 Mitigating liability risks via the Model MOU Recognition of changing standards of care Use of volunteer health practitioners Transferred employees/contractors Lending hospitals Failure to respond Workers’ compensation 31 Next Steps • Circulate the Model MOU nationally for potential consideration and use by hospitals • Scholarship to introduce and explain the Model MOU • Present the Model MOU at various national or regional conferences • Study its actual use in real-time emergencies to assess its utility 32 Conclusion • Questions, comments, thoughts? • For more information about legal preparedness issues, including real-time information related to legal responses to the 2009 H1N1 outbreak, please contact us or visit our website at: www.publichealthlaw.net • James G. Hodge, Jr., [email protected] • Stephen P. Teret, [email protected] • Evan Anderson, [email protected] • Thank you! 33