Public Health Law for Medical Reserve Corps Members

October 2010

Part 1:New Jersey Public Health Law

Emergency Management Act

State, County, and Municipal governments all must have emergency plans– Updated every 2 years

Governor can assume control of a local emergency if it is beyond capabilities of municipality or county

In an emergency, the Governor can temporarily employ citizens and use private property in emergency response efforts– Proper compensation provided after emergency

Local Emergency Plan

Hunterdon County has a local emergency plan

– The Department of Health is listed in an annex of the planStandard operating procedures of the MRC are

listed in an appendix

NJ Good Samaritan Act of 1963

Protects a person providing emergency first aid care at the scene of an accident or emergency from liability for civil damages

Does not cover MRC members acting under orders during an emergency

Emergency Health Powers Act of 2005

Governor may declare a public health emergency, identifying:– Nature of the emergency– Location of the emergency– History of the emergency – Countermeasures to protect

the public’s health– Duration of the emergency

Emergency Health Powers Act of 2005

Commissioner of Health and Senior Services is in charge of:– Assessment, prevention, preparedness,

response, and recovery activities– Coordinating state and local authorities– Collaborating with federal government,

elected officials, private organizations, etc– Controlling public information regarding

emergency situation

Emergency Health Powers Act of 2005

Provides protection from liability for volunteers and employees of the state, counties, and municipalities for:– Deaths, injuries, and property loss or damage

occurring during a public health emergency– Deaths, injuries, and property loss or damage

occurring during training and preparation exercises

Does not include cases of gross negligence, willful misconduct, or a crime or fraud

Part 2:Federal Public Health Law

Robert T. Stafford Disaster Relief and Emergency Assistance Act

When a disaster overwhelms a state’s emergency plans, the Governor can ask the President to declare a “major disaster” or “emergency”

Declaration of “major disaster” or “emergency” puts FEMA in charge of relief funds and other assistance to the area

National Emergencies Act

Allows President to formally declare a national emergency

President then selects which authorities are in charge and which emergency statues go into effect

Does not provide emergency funds for disaster areas

Used during the 2009 H1N1 outbreak

Emergency Management Assistance Compact

Establishes legal protocols and methods for sharing supplies and personnel between states during an emergency situation

During an emergency, State A (requesting state) can request assistance– State B (assisting state) estimates available resources

and cost of assistance– State A accepts aid on State B’s reimbursement terms– State A must repay State B after emergency unless

State B waives fees

Emergency Management Assistance Compact

States must adhere to protocols for sharing personnel and resources– Volunteers from one state who enter another to

assist during an emergency are not provided legal protections UNLESS the state with the emergency has formally requested volunteer assistance under the Emergency Management Assistance Compact

Public Health Service Act

Section 311: HHS can assist a state if the President declares an emergency with the Stafford Act– Can assist states with

personnel, equipment, medical supplies, and other resources

Public Health Service Act

Section 319: HHS Secretary can declare a public health emergency if a disease or disorder, an outbreak of infectious disease, or a bioterrorist attack presents a public health emergency– Declaration lasts for 90 days – Independent of Presidential declaration of emergency

Section 361: CDC can apprehend, examine, detain, or conditionally release persons with certain communicable diseases

Social Security Act: Section 1135 Waiver

Allows HHS Secretary to waive certain aspects of Medicare, Medicaid, Children’s Health Insurance Program (CHIP), Health Insurance Portability and Accountability Act (HIPAA), and Emergency Medical Treatment and Active Labor Act (EMTALA)

– HIPAA and EMTALA waivers last for 72 hours– All other waivers last for 60 days

Applicable only when and where:– The President declares an emergency or disaster

and– The HHS Secretary declares a public health emergency

SSA: Section 1135 Waiver

Possible waivers include:– Licensing requirements for providers– EMTALA requirements as indicated in the state’s

emergency or pandemic preparedness plans– Certain HIPAA requirements including:

Obtaining a patient’s agreement to speak with family or friends

Patient’s right to request confidential communications

Section 1135 Waiver for H1N1

4/26/09 - HHS declared public health emergency. 10/24/09 - President declared emergency. 10/27/09 - HHS used Section 1135.

HHS waived:– EMTALA– Provider licensing requirements– Certain HIPAA requirements

Pandemic and All-Hazards Preparedness Act

Establishes Secretary of HHS as lead federal official for public health emergencies

Establishes the HHS Assistant Secretary for Preparedness and Response (ASPR)– Controls Strategic Nat’l Stockpile– Directs MRC deployment and

assignment during a national emergency

Pandemic and All-Hazards Preparedness Act

HHS may federally deploy MRC members

Federal deployment by HHS means that MRC members are considered Intermittent Disaster Response Personnel, and receive:– Liability protection– Workers’ Compensation– Employment Protection

Public Readiness and Emergency Preparedness (PREP) Act

Provides covered persons with immunity from tort liability for claims:– Of death– Of physical, mental, or emotional injury, illness,

disability, or fear thereof– Related to administration of “covered

countermeasures”

PREP Act

“Covered Countermeasures”:– Countermeasures against biological, chemical, radiological, or

nuclear threats– Products to control pandemics and epidemics, including drugs,

biological products, and devices that are licensed, approved, or cleared for emergency or investigational use by the FDA

“Covered Persons”:– Manufacturers, distributors, and program planners– All levels of government (federal, state, local, territorial)– Licensed health professionals and others who prescribe,

administer, or dispense countermeasures– Officials, agents, and employees of all those mentioned

PREP Act

When MRC members are called to action by a branch of the government, they are covered under the PREP Act (if HHS chooses to enact it)

• HHS Secretary amended the PREP Act on June 15, 2009 to include pandemic H1N1 influenza measures

Public Health Security and Bioterrorism Preparedness and Response Act

HHS must develop and implement a coordinated strategy for public health emergencies

HHS Secretary must create and maintain Emergency System for Advance Registration of Health Professions Volunteers (ESAR-VHP) [NJ’s ESAR-VHP program is integrated with its Medical Reserve Corps Program (NJMRC) - both under NJDHSS]

Project BioShield Act

FDA can issue Emergency Use Authorization (EUA)

EUA allows for the use of:– Unapproved new drugs, medical devices or biological products

– Off-label use of drugs approved for other purposes

Can only occur if: – HHS declares public health emergency; – or Dept. of Homeland Security declares domestic

emergency– or Dept. of Defense declares heightened risk to the military

EUAs During H1N1 Pandemic

First EUA issued April 27, 2009

By end of public health emergency on June 23, 2010, EUAs had been issued for:– Diagnostic tools – Oseltamivir (Tamiflu)– Zananivir (Relenza)– Peramivir IV– N95 respirator

Uniformed Services Employment and Re-Employment Rights Act

An employer cannot discriminate in employment, reemployment, retention, promotion, or any benefit of employment on the basis of an individual’s ties to the uniformed services

MRC members who are federally deployed by HHS are considered intermittent unpaid federal employees, and are considered a “uniformed service” for the purposes of this act

Resources

Centers for Disease Control and Prevention. (2010, June 16). The 2009 H1N1 Pandemic: Summary Highlights, April 2009-April 2010. Retrieved July 22, 2010, from http://www.cdc.gov/h1n1flu/cdcresponse.htm.

Centers for Disease Control and Prevention, Public Health Law Program. 2009 H1N1 Flu Legal Preparedness. Retrieved July 22, 2010, from http://www2a.cdc.gov/phlp/H1N1flu.asp.

Donley, D., FEMA Disaster Relief., Ray, J. E., HHS Office of the General Counsel., Sherman, S. E., HHS Office of the General Counsel., & Dammers, K., Assistant US Attorney on Detail to CDC. (2009). Federal Public Health Emergency Law: Implications for State and Local Preparedness and Response [PowerPoint Presentation].

Emergency Health Powers Act, NJ Chapter Laws, P.L. 2005 ch. 222, http://www.njleg.state.nj.us/2004/Bills/PL05/222_.PDF.

Emergency Management Act, NJ Chapter Laws, P.L. 1989 ch. 22, http://www.njstatelib.org/Research_Guides/Law/Historical_New_Jersey_Laws.php#historicalcompilation.

Good Samaritan Act, NJ Chapter Laws P.L. 1963 ch. 140, http://www.njstatelib.org/Research_Guides/Law/Historical_New_Jersey_Laws.php#historicalcompilation.

National Archives and Records Administration. (n.d.). Part 1002—Regulations Under the Uniformed Services Employment and Reemployment Rights Act of 1994. Retrieved on July 22, 2010 from http://ecfr.gpoaccess.gov/cgi/t/text/ text-idx?c=ecfr&sid=c4f2781e3fdf017b31cd56cf2f950c3b&rgn=div5&view=text&node=20:3.0.6.3.2&idno=20.

Office of the Civilian Volunteer Medical Reserve Corps. (n.d.). Frequently Asked Questions (FAQ) About MRC Federal Deployment. Retrieved from http://www.medicalreservecorps.gov/File/MRC_Deployment/MRC_Deployment_FAQ(1).pdf.

Public Health Law Program, Centers for Disease Control and Prevention. (2009). Frequently Asked Questions about Federal Public Health Emergency Law (E. McCormick, M. M. Ransom, & S. Kershner, Eds.).

Public Health Law Program, Centers for Disease Control and Prevention. (2009). Selected Federal Legal Authorities Pertinent to Public Health Emergencies.

U.S. Department of Health and Human Services. (n.d.). News, PSAs, & Outreach. Retrieved July 22, 2010, from http://www.flu.gov/news/newsarchive.html.