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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

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AcknowledgmentsEvan Anderson, J.D.

Research Associate, Johns Hopkins Bloomberg School of Public HealthSenior 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 UniversityInvestigator

Gabor Kelen, M.D.Professor and Chair, Department of Emergency Medicine

School of Medicine, Johns Hopkins UniversityCo-Principal Investigator, PACER

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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

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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]

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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.

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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.

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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.

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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

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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.

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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.

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Construction of the Model MOU

• Drafted for those who may primarily rely on the document

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Construction of the Model MOU

• Drafted for those who may primarily rely on the document

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Construction of the Model MOU

• Unlike some existing MOUs, the Model MOU is not constructed as a binding contract.

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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.]

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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]

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Major Topical Themes in the Model MOU

• Legal Environment in Declared Emergencies

• Transferring Patients

• Liability of Individuals and Institutions

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Legal Environment During Declared Emergencies - 1

Once an emergency has been

declared (as in response to

the H1N1 outbreak), the legal

landscape changes.

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U.S. Confirmed Cases of 2009 U.S. Confirmed Cases of 2009 H1N1 FluH1N1 Flu

Last Updated: May 27, 2009Last Updated: May 27, 2009Source: CDC Source: CDC http://www.cdc.gov/h1n1flu/http://www.cdc.gov/h1n1flu/

>10 confirmed cases

Legend

>1 confirmed case(s)

No confirmed cases

>50 confirmed cases

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Multiple Levels of Emergency Declarations

LocalLocal

StateState

FederalFederal

Emergency

or

Disaster

Public

Health

Emergency

Emergency

or

Disaster

Public

Health

Emergency

“FEMA”

Emergency

“HHS”

Public

Health

Emergency

InternationalInternational

WHO

Public Health Emerg-ency of

Intl Concern

Emergency

Declarations

By Intl Govs

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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)

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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

Localities Declaring Emergencies/Disasters/Public Health Emergencies

Emergency, Disaster, and Public Health Emergency, Disaster, and Public Health Declarations in Response to H1N1 Flu Declarations in Response to H1N1 Flu

Los Angeles County

Last Updated: May 27, 2009Last Updated: May 27, 2009

Disaster Declaration

Emergency Declaration

Public Health Emergency Declaration

Federal DHHS Public Health Emergency Declaration

LEGENDLEGEND

Emergency and Public Health Emergency Declarations

San Mateo County

San Bernardino County

Alameda County

Sonoma County

American Samoa(U.S. Territory)

Ventura County

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San Francisco

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Multiple Levels of Emergency Declarations

Local emergency or disaster

Local public health emergency

State emergency or disaster

State public health emergency

Federal “FEMA” emergency

Federal “DHHS” public health emergency

Authorities, powers, actors, liabilities, immunities, and other critical legal issues vary depending on the type of declared emergency

International W.H.O. Public Health Emergency of International Concern (PHEIC)

International Govts Emergency Declarations

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Maryland Emergency Declarations

May 1, 2009:• Declaration of an Emergency • Declaration of Public Health

Emergency [Catastrophic health

emergency]

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Maryland Emergency Declarations

Declaration of Public Health Emergency

What the Declaration Authorizes: Potential Impact on Hospitals:

Isolation and quarantine of individuals or groups

Healthcare services may be redirected

Immunizes health care providers from civil or criminal liability

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

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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 areas

HCWs/patients/staff may be 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

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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.

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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

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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

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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

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Liability Concerns - 2Mitigating 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

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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

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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., jhodge@jhsph.edu

• Stephen P. Teret, steret@jhsph.edu

• Evan Anderson, eanderso@jhsph.edu

• Thank you!