Legal Authority for Pandemic Influenza Planning

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FEDERAL STATUTES

AUTHORITY GRANTED

1) 42 U.S.C. § 247(d)
(Federal Public Health Emergency Declaration)

When the HHS Secretary declares a public health emergency (as for novel H1N1 in April, 2009) under this section, HHS may waive certain Medicare, Medicaid, & CHIP requirements, may temporarily lift sanctions under HIPAA and EMTALA, & may allow Emergency Use Authorizations (see below).

2) 21 U.S.C. § 360bbb-3
(Emergency Use Authorizations)

During an emergency as determined by DHS, DOD or HHS, the HHS Secretary may issue an emergency use authorization (“EUA”) to utilize a drug, medical device, biological product, or diagnostic test outside label or prior licensing requirements.

3) 42 U.S.C. § 247d-6e—247d-6e
(Public Readiness and Emergency Preparedness Act—“PREP Act”)

Where the HHS Secretary declares a public health emergency and authorizes administration of “covered countermeasures” (drugs, biologics, medical devices), everyone in the chain of providing countermeasures (from manufacturer to clinic worker) receives protection from tort liability (except for willful misconduct). Persons injured by countermeasures are eligible for federal administrative compensation.

MINNESOTA STATUTES

AUTHORITY GRANTED

1) Minn. Stat. §§12.21 – 12.34

Governor’s authorities during declared emergencies.  These include power of the Governor or the Governor’s designees, during a declared national security or peacetime emergency, to direct and control the occupancy of facilities; exit from or entry to stricken or threatened public places, movement of persons on foot or by private and public transportation; public meetings or gatherings; and the evacuation, reception, and sheltering of persons.

2) Minn. Stat. §12.22, subds. 2a-2b

Individuals who volunteer with a local political subdivision or the state, and who are under the direction and control of the agency will be considered an employee of the governmental unit for workers’ compensation and for tort liability defense..

3) Minn. Stat. §12.331

In an emergency (no declaration required) and in the absence of a written mutual aid agreement, a political subdivision that requests the assistance of another political subdivision is responsible for salaries and expenses and tort claims liability, while the political subdivision sending the assistance is responsible for damage to its equipment and for its employees’ workers’ compensation.

4) Minn. Stat. §12.35, subds. 2-4

If emergency response personnel are activated by the state director of HSEM, they are considered state employees and have the same powers, duties, rights, privileges, and immunities provided by law for the employees of this state.  State reimbursement for help from other governments provided.

5) Minn. Stat. §12.381

Provides process for identification of bodies of persons believed to have died due to a declared emergency and authorizes governor to direct safe disposition of bodies in connection with such deaths.

6) Minn. Stat. §12.39

Confirms individual’s right to refuse treatment or examination during communicable disease outbreak or toxic substance exposure.

7) Minn. Stat. §12.42

The Governor may request out of state license, certificate, or permit holders to perform work within Minnesota during a declared emergency.  “Out of state” includes all states of the United States, the District of Columbia and Canada.  Similar provision also found in Minn. Stat. § 192.89 (“EMAC law”)

8) Minn. Stat. §12.61

Adjusted standard of liability protecting a region’s responders where Governor declares emergency and also finds region’s hospital or medical transport capacity is overwhelmed.

9) Minn. Stat. §§144.419-144.4196

The Commissioner of Health may request isolation and quarantine orders, and may also issue temporary holds pending court determination.  Individuals subject to an isolation or quarantine order have fair treatment rights, right to expedited court review, and certain employment protections. Peace officers are to enforce court orders and commissioner directives.

10) Minn. Stat. §§144.4197-144.4198

The Commissioner of Health may authorize individuals to administer vaccinations or dispense legend drugs if such action is necessary to protect the health and safety of the public.  Commissioner may also authorize alternative methods of mass dispensing.  Closed points of dispensing acting under approved plans receive adjusted standard of liability.

11) Minn. Stat. §145A.06, subds. 6-8

MRC volunteer deployment outside home jurisdiction at the call of the Commissioner of Health.  MRC volunteer assistance on Mobile Medical Unit authorized.  MRC volunteers will be considered state employees for workers’ compensation, tort claims liability, and expense reimbursement.  Licensure and liability protection for out-of-state volunteers assisting in a MN emergency also addressed.

12) Minn. Stat. §147A.23

A MN physician assistant may provide care under their license, registration, or credential once a temporary supervisory agreement is formed with a physician involved in the disaster response.

13) Minn. Stat. §148.171, subd. 15

A registered nurse may delegate medical functions to other nursing personnel. Medication administration is delegated to others and supervised by an RN or monitored by an LPN.

14) Minn. Stat. §148.235, subds. 8-9

Prescription by protocol - an RN may give a legend drug that has been predetermined and delegated when the condition falls within the protocol and the protocol specifies the circumstances under which the drug is administered
Vaccine by protocol - an RN or LPN may administer a vaccine from a protocol that does not reference a specific patient and results in an administration that has been pre-determined and delegated by a licensed practitioner.

15) Minn. Stat. §148.916, subd. 3

The American Red Cross and other disaster emergency relief organizations, or the state or federal government, may assign out of state psychologists to respond to a disaster or emergency relief effort for up to 30 days, without psychologists needing guest licensure from MN Board of Psychology.

16) Minn. Stat. §149A.91, subd. 3(4)

The Commissioner of Health may order bodies to be embalmed in order to control infectious disease and protect the public health.

17) Minn. Stat. §151.01, subd. 30

Pharmacy law defining “dispensing” of a drug. 

18) Minn. Stat. §151.37, subd. 2(a)

Pursuant to a licensed practitioner’s direction, a nurse, state-registered or nationally-certified PA, or medical student or resident may dispense legend drugs pursuant to protocol.

19) Minn. Stat. §151.37, subd. 2(b)

Clarifies authority of Commissioner of Health, or practitioner designated by Commissioner, to prescribe drugs for mass dispensing or communicable disease control. In time-critical emergency, Commissioner may modify state labeling, documentation, and screening requirements.

20) Minn. Stat. §151.37, subd. 10

Expanded list of drugs, pharmaceutical agents, and medical supplies which Commissioner of Health may purchase, store, and distribute to treat or prevent communicable diseases.

21) Minn. Stats. §§176.011, subds. 9(9) and 9(25); 176.021, subd. 1

Workers’ compensation protections for MRC and other government volunteers engaged in emergency management activities, including provision of health care.

22) Minn. Stat. §192.89

Interstate Emergency Management Assistance Compact in which all states and three territories participate.  Widely used to provide aid after 2005 and 2008 Gulf hurricanes.

MINNESOTA RULES

AUTHORITY GRANTED

1) Minn. R. parts 4605.7030-4605.7300

Requires sixty listed diseases to be reported to the Minnesota Department of Health.  The rules also require reporting of unusual case incidence, designated infectious diseases, and sentinel surveillance.

 

 

Updated Monday, 22-Nov-2010 09:07:15 CST