Exceptional Proff

Legal Perspectives

Federal Declaration of a Public Health Emergency

Jennifer Ray

During certain emergencies (naturally caused or deliberate) that can have a significant impact on the public’s health, the

Secretary of the U.S. Department of Health and Human Services (HHS) has broad discretion to declare a Public Health

Emergency (PHE). While many public health emergencies will not require a formal declaration, this type of declaration

can be an important and necessary step to authorize the secretary to take a variety of actions that enable the department to

respond optimally to an emergency. This article outlines the HHS Secretary’s PHE authority, discusses possible dis-

cretionary actions that the secretary may take after declaring a PHE, and provides examples of PHE declarations that have

been issued.

The Pandemic and All-Hazards Preparedness Actof 2006 (P.L. 109-417) designates the Secretary of the U.S. Department of Health and Human Services (HHS) as the lead for all federal public health and medical responses to public health emergencies and incidents covered by the National Response Plan (NRP) or any plan that succeeds it (eg, the National Response Framework, which succeeds the NRP).1 Under the National Response Framework, HHS is the lead for Emergency Support Function (ESF) 8, the Public Health and Medical Services Annex, as well as the Biological Incident Annex. HHS also plays a significant role as a supporting agency for ESF 6, the Mass Care, Housing, and Human Services Annex.2 The HHS Assistant Secretary for Preparedness and Response (ASPR) serves as the sec- retary’s principal advisor on matters related to federal

public health and medical preparedness and response for public health emergencies.3

During public health and other emergencies, the ability for a government official to declare an emergency or a public health emergency, or to make a similar declaration, can be an important tool from a legal perspective; it may allow officials to exercise special powers and may also permit them to suspend certain legal requirements in order to respond to the event.4 For example, all state governors have the authority to declare an emergency, and governors in some states may specifically declare a public health emergency.4 Government officials in certain ter- ritories and some local jurisdictions may also be autho- rized to declare an emergency or to make a similar declaration.

Legal Perspectives is a regular journal column aimed at informing healthcare providers, emergency planners, and other decision makers about important legal issues related to public health and healthcare preparedness and response. The articles will describe these potentially challenging topics and conclude with the authors’ suggestions for further action. The articles do not provide legal advice. Therefore, those affected by the issues discussed in this column should seek further guidance from legal counsel. Readers may submit topics of interest to the column’s editor, Brooke Courtney, through the Journal’s editorial office at [email protected]

Jennifer Ray is a Senior Attorney with the Office of the General Counsel, Public Health Division, U.S. Department of Health and Human Services, Washington, DC.

Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science Volume 7, Number 3, 2009 ª Mary Ann Liebert, Inc. DOI: 10.1089=bsp.2009.0039

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At the federal level, the HHS Secretary may declare a Public Health Emergency (PHE) when she determines under section 319 of the Public Health Service (PHS) Act ‘‘that 1) a disease or disorder presents a public health emergency or 2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists.’’5 The term public health emergency is not specifically defined in section 319, so the HHS Secretary has broad discretion to determine when an event meets one of the criteria listed in section 319.

While HHS has broad authority to assist states and other entities during an emergency—even without a PHE declaration—such a declaration can facilitate HHS’s prep- aration and mobilization for disasters and emergencies by authorizing the secretary to take certain actions to respond to the emergency. States, healthcare facilities and providers, legal counsel, and others may not be familiar with federal Public Health Emergency declarations, the actions that can flow from PHE declarations, and the limitations of these declarations. This article provides a brief overview of sec- tion 319 of the PHS Act and PHE declarations; describes actions that the secretary may take to respond to the PHE; and discusses implementation of PHE declarations in past events.

Overview of Section 319 of the PHS Act

History of Section 319 and Public Health Emergency Funding In 1983, Congress enacted Public Law No. 98-49 to add a new section—section 319—to the PHS Act, primarily to establish a Public Health Emergency Fund (PHEF) that would make appropriations available to the Secretary of HHS in a public health emergency. Legislative history in- dicates that Congress intended the PHEF funds to be used for severe, complex, or sizable emergencies or for emer- gencies that might occur during a fiscal year in which an agency’s reserves had been drained by prior events.6(p618)

Before the enactment of P.L. 98-49, the Public Health Service had been called on to respond quickly to large, unanticipated public health crises such as the Tylenol tampering incident and the AIDS epidemic and to perform large recalls of contaminated food.6(p618) For these and similar events, the PHS had had to divert funds from other ongoing activities, respond to the emergency, and then request supplemental appropriations—or respond unevenly or with minimal resources because of fiscal limitations— thereby allowing crises to continue longer and more broadly.6(p619) Congress further amended section 319 in 2000 and 2002.7

The Public Health Emergency Fund still exists under section 319, and the secretary is still authorized to access funds appropriated to the PHEF when she has declared a Public Health Emergency.8 However, in the years since the

enactment of P.L. 98-49, Congress generally has not ap- propriated any funds to this account. Instead, Congress usually provides any funds for emergency response and pre- paredness activities directly to relevant HHS components.

Since 2001, Congress has also provided funding for such activities to the Public Health and Social Services Emer- gency Fund.9 In addition, HHS receives reimbursement from the U.S. Department of Homeland Security’s Federal Emergency Management Agency (FEMA) when FEMA directs HHS to provide assistance to states in emergencies or major disasters under the Stafford Act.10 Thus, when the secretary declares a Public Health Emergency, there are currently no funds in the PHEF that are made available to HHS as a result of that declaration. And a PHE declaration does not provide HHS with funds to distribute to states or other entities outside of HHS.

Authority of the HHS Secretary to Declare a PHE Section 319 states that:

[i]f the Secretary determines, after consultation with such public health officials as may be necessary, that 1) a disease or disorder presents a public health emergency or 2) a public health emergency, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists, the Secretary may take such action as may be appropriate to respond to the public health emergency, including making grants, providing awards for expenses, and entering into contracts and conducting and supporting investigations into the cause, treatment, or prevention of [the] disease or disorder [causing the public health emergency].11

Also, the secretary may grant extensions or waive sanc- tions relating to the submission of data or reports required under HHS laws when she determines that, as a result of the Public Health Emergency, individuals or public or private entities are unable to comply with deadlines for such data or reports.12

Process The secretary has broad discretion to determine when an event meets 1 of the 2 criteria listed in section 319 and to determine with which particular public health officials in HHS or outside the department to consult about a specific declaration. Unlike presidential declarations of an emer- gency or major disaster under the Robert T. Stafford Dis- aster Relief and Emergency Assistance Act (Stafford Act), which ordinarily require a formal request by a state gov- ernor, there is no statutory requirement that a governor or other entity make a formal request for a Public Health Emergency declaration. The HHS Office of Intergovern- mental Affairs, the Office of the ASPR, the HHS Centers for Medicare & Medicaid Services (CMS), and other

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252 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science

relevant HHS components work closely with state officials during emergencies to evaluate whether a PHE declaration is necessary.

Duration A Public Health Emergency declaration lasts until the secretary declares that the PHE no longer exists or until the end of the 90-day period beginning on the date the secre- tary declared a PHE exists, whichever occurs first. The secretary may extend the Public Health Emergency decla- ration for subsequent 90-day periods for as long as the PHE continues to exist, and she may terminate the declaration whenever she determines that the PHE has ceased to exist.11

HHS publishes on its website PHE declarations, extensions of PHE declarations, and terminations of PHE declarations (for declarations that terminate prior to the 90-day expi- ration period).

Other Statutory Authorities

that May Require a PHE Declaration

HHS has broad authority under other sections of the PHS Act and other laws administered by HHS to assist states and other entities during an emergency even without a formal PHE declaration under section 319.13 For example, under section 311 of the PHS Act, the secretary may, at the re- quest of a state or local authority, extend temporary assis- tance to states or localities to meet health emergencies that warrant federal assistance.14 Other examples include: pro- moting research and studies into the causes, diagnosis, treatment, control, and prevention of diseases under section 301 of the PHS Act; establishing isolation and quarantine under section 361 of the PHS Act; maintaining and de- ploying the Strategic National Stockpile under section 319F-2 of the PHS Act; and deploying National Disaster Medical System teams under section 2812 of the PHS Act and select members of the Medical Reserve Corps under section 2813 of the PHS Act.15

However, a Public Health Emergency declaration can be a necessary step in enabling the secretary to take a variety of discretionary actions under other authorities to respond to the PHE. As a result of September 11, 2001, and the an- thrax attacks a month later, as well as other events such as Hurricane Katrina, certain authorities have been added to the PHS Act, the Social Security Act (SSA), the Federal Food, Drug, and Cosmetic Act (FFDCA), and other laws administered by the secretary that permit her to take certain actions when she has declared a Public Health Emergency under section 319 of the PHS Act. Most notably, when the secretary has declared a PHE and the president has made a declaration under the Stafford Act or National Emergencies Act, the secretary may issue an ‘‘1135 waiver’’ to waive or modify temporarily certain Medicare, Medicaid, and

Children’s Health Insurance Program (CHIP) require- ments under section 1135 of the Social Security Act.16 This authority is discussed in more detail below. Also, a PHE declaration may be the basis for a declaration under section 564 of the FFDCA, which allows the FDA Commissioner to issue emergency use authorization (EUA) of drugs, de- vices, or medical tests under certain circumstances.17 This EUA authority is described in more detail elsewhere in this issue (see p. 245).

Possible HHS Actions that Could Follow a PHE Declaration Discretionary actions that the secretary may take after a Public Health Emergency declaration include:

� Exempting for 30 days a person from requirements re- garding the possession, transfer, or use of select agents as necessary to provide for the timely participation of that person in a response to a domestic or foreign public health emergency that involves the select agent or toxin18 (Note that a formal declaration of a PHE under section 319 may be the basis for this exemption but is not necessary for the secretary to exempt a person from select agent require- ments under section 351A(g)(3) of the PHS Act.);

� Waiving certain prescription and dispensing require- ments relating to Risk Evaluation and Mitigation Stra- tegies under section 505-1(f ) of the FFDCA;19

� Adjusting Medicare reimbursement for certain Part B drugs;20

� Waiving certain Ryan White HIV=AIDS grant program requirements under section 2683 of the PHS Act21 (Note that a formal PHE declaration under section 319 of the PHS Act is one basis for the secretary to waive these requirements. The secretary may also waive such require- ments in an emergency area and during an emergency period in which there exists a presidential declaration of an emergency or disaster under the National Emergencies Act or the Stafford Act.);

� Making temporary appointments of personnel to posi- tions that directly respond to the Public Health Emer- gency when the urgency of filling positions prohibits examining applicants through the competitive process; the secretary also may waive dual compensation (salary offset) for temporarily re-employed annuitants during the time period when the secretary declares a PHE or the president declares a national emergency involving a direct threat to life or property or other unusual circum- stances;22

� Declaring an emergency justifying emergency use of an investigational product under section 564 of the FFDCA;

� Waiving certain Health Insurance Portability and Ac- countability Act (HIPAA) sanctions for 72 hours under section 1135 of the SSA;

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� Waiving certain Medicare, Medicaid, and CHIP re- quirements (including a temporary waiver of Emergency Medical Treatment and Labor Act [EMTALA] sanc- tions) under section 1135 of the SSA.

Not all of these actions have been implemented by HHS in past public health emergencies. Also, it is important to note that, following the declaration of a Public Health Emer- gency, the exercise of any of these authorities is discre- tionary, these authorities do not automatically flow from a PHE, and they do not create entitlements for those who may benefit from any of these actions.

1135 Waiver Authority After the terrorist attacks in 2001, Congress passed the Public Health Security and Bioterrorism Preparedness and Re- sponse Act of 2002 (P.L. 107-188) to improve the ability of the U.S. to prevent, prepare for, and respond to bioterrorism and other public health emergencies. Section 143 of the act amended section 1135 of the SSA to authorize the HHS Secretary to temporarily waive or modify certain Medicare, Medicaid, and CHIP requirements when the president has declared an emergency or major disaster pursuant to the Stafford Act or the National Emergencies Act and the Se- cretary of HHS has declared a PHE.16 When the secretary has invoked this authority under section 1135, she may also waive certain specific sanctions and penalties arising from noncompliance with HIPAA privacy regulations for a 72- hour period after a hospital implements its disaster protocol.

Under section 1135 of the SSA, the secretary may waive or modify certain requirements as necessary to ensure to the maximum extent feasible that, in an emergency area during an emergency period, sufficient healthcare items and ser- vices are available to meet the needs of individuals enrolled in Medicare, Medicaid, and CHIP and that providers of such services in good faith who are unable to comply with certain statutory requirements are reimbursed and ex- empted from sanctions for noncompliance, absent fraud or abuse.23 An emergency area and an emergency period are defined as the geographic area in which and time period during which there exists an emergency or a disaster de- clared by the president pursuant to the National Emer- gencies Act or the Stafford Act and a Public Health Emergency declared by the secretary.24

Program Requirements that May Be Waived Under section 1135 of the SSA, the following Medicare, Medicaid, CHIP, and HIPAA requirements may be waived or modified:25

� Conditions of participation or other certification re- quirements, or program participation and similar re- quirements for individual providers or types of providers.

� Pre-approval requirements for providers or for healthcare items or services.

� Requirements that physicians and other healthcare pro- fessionals hold licenses in the state in which they provide services if they have an equivalent license from another state and are not barred from practice in that state or any state in the emergency area.26

� Sanctions under EMTALA for redirection of an indi- vidual to another location to receive a medical screening examination pursuant to a state emergency preparedness plan or, in the case of a PHE involving a pandemic in- fectious disease, a state pandemic preparedness plan, or for transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the declared emergency. A waiver of EMTALA sanctions is effective only if actions under the waiver do not dis- criminate on the basis of a patient’s source of payment or ability to pay. EMTALA waivers are subject to special time limits.27

� Sanctions related to Stark self-referral prohibitions, which could apply when a physician refers a patient for services to a provider in which the physician has a financial interest.

� Deadlines and timetables for performance of required activities to allow timing of such deadlines to be modified.

� Limitations on payments to permit Medicare Advantage enrollees to use out-of-network providers in an emer- gency situation. To the extent possible, the secretary must reconcile payments so that enrollees do not pay addi- tional charges and so that the plan pays for services in- cluded in the capitation payment.

� Sanctions and penalties arising from noncompliance with HIPAA privacy regulations related to: (1) obtaining a patient’s agreement to speak with family members or friends or honoring a patient’s request to opt out of the facility directory, (2) distributing a notice of privacy practices, or (3) the patient’s right to request privacy restrictions or confidential communications. The waiver of HIPAA requirements is effective only if actions under the waiver do not discriminate on the basis of a patient’s source of payment or ability to pay. These HIPAA waivers are subject to special time limits.

In past situations when the secretary issued an 1135 waiver, the Medicare, Medicaid, and CHIP requirements listed above generally were not automatically waived or modified. Rather, the HHS Centers for Medicare & Medicaid Ser- vices (CMS) received requests from affected hospitals, healthcare facilities, and healthcare providers for waivers or modifications of specific requirements and issued instruc- tions or guidance as needed. CMS reviewed such requests and generally considered, and approved, the requested waivers or modifications on a case-by-case basis. Regardless of whether the secretary has made a formal Public Health Emergency declaration under section 319 of the PHS Act, and even in the absence of an 1135 waiver, other SSA provisions and CMS regulations may provide certain flex- ibilities that may be implemented as appropriate to address an emergency or disaster. CMS works closely with affected

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254 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science

states, hospitals, healthcare facilities, and healthcare pro- viders during such situations to address their concerns. During a PHE, when the secretary issues an 1135 waiver, CMS generally publishes fact sheets about 1135 waivers, among other information for providers and healthcare fa- cilities on its website and communicates this information through other channels as well.

Duration and Termination of Waivers With regard to the HIPAA sanctions and penalties that may be temporarily waived under section 1135 of the SSA, when the secretary issues an 1135 waiver, HHS’s current practice is to automatically waive such sanctions and penalties de- scribed in the 1135 waiver in the emergency area for 72 hours beginning on implementation of a hospital disaster protocol. An 1135 waiver does not waive HIPAA in its entirety: the HIPAA sanctions and penalties that may be waived when an 1135 waiver is issued are specified in the 1135 waiver document. Even without an 1135 waiver, there are various flexibilities and exceptions that may apply to permit covered entities to share protected health infor- mation during a PHE.28

Waivers or modifications under section 1135 of the PHS Act may be retroactive to the beginning of the emergency period (or to any subsequent date).29 When the president declares an emergency or major disaster under the Stafford Act and the HHS Secretary declares a Public Health Emer- gency and issues an 1135 waiver, HHS often makes its PHE declaration and 1135 waiver retroactive so the dates in these documents coincide with the date the emergency or major disaster period began as listed in the president’s declaration.

The 1135 waiver or modification terminates either upon termination of the PHE emergency period or 60 days after the waiver or modification is first published (subject to 60-day renewal periods until termination of the emergen- cy).30 However, waivers of EMTALA (except in the case of pandemic infectious disease) or HIPAA requirements are effective only for 72 hours beginning on implementation of a hospital disaster protocol.25 A waiver of EMTALA sanctions in connection with an emergency involving a pandemic in- fectious disease (eg, pandemic influenza) is effective until the termination of the pandemic-related public health emer- gency. However, a particular waiver or modification will terminate prior to the ultimate termination dates described in this paragraph if the secretary determines that, as of an earlier date, the waiver or modification is no longer necessary to accomplish the purposes set forth in section 1135(a).

Examples of PHE Declarations

and Implementation of Section 319

In recent years, the Secretary of HHS declared a Public Health Emergency under section 319 in response to the attacks on September 11, 2001.31 The PHE declaration was

issued before authorities such as the 1135 waiver and the EUA authorities were added to the SSA and the FFDCA, respectively, so the actions HHS took in response to Sep- tember 11 generally were authorized by other sections of the PHS or other HHS laws.

Since that time, the secretary has declared Public Health Emergencies in response to some hurricanes, severe flood- ing conditions, the 2009 Presidential Inauguration, and the 2009 H1N1 influenza outbreak (Table 1).32 The Acting Secretary of HHS declared a PHE at the outset of the H1N1 influenza outbreak primarily so that he could issue several declarations under section 564 of the FFDCA that enabled the FDA Commissioner to issue multiple EUAs to make available to public health and medical personnel and the public important diagnostic, therapeutic, and respira- tory protection tools to identify and respond to the 2009 H1N1 flu virus under certain circumstances.33 As the H1N1 response evolves in future months, the PHE decla- ration may support other discretionary actions by the sec- retary as needed.

Other Public Health Emergency declarations, including those issued in response to hurricanes, severe flooding conditions, and the 2009 Inauguration, were issued pri- marily so that the secretary could issue an 1135 waiver.34

The 1135 waivers facilitated healthcare systems’ ability to deal with surges in patient volume that arose as a result of the public health emergency. Surges of patients may include individuals who are injured as a result of the emergency and also hospital patients and other individuals who are evac- uated out of the immediate emergency area to a nearby town within the same state or to a nearby state. The surge of patients affects healthcare facilities that are close to or at capacity when the emergency occurs and when evacuees arrive in their locality.

When the secretary declared a Public Health Emergency and issued an 1135 waiver, CMS was able to issue waivers to affected facilities on a case-by-case basis to expand the availability of inpatient beds and ensure that patients could have access to needed inpatient care. Among other things, CMS was able to waive certain Medicare classification re- quirements to allow specialized facilities and hospital units to treat patients needing inpatient care. This included, for example, waiving requirements to permit affected Critical Access Hospitals to exceed the 25-bed or 96-hour average length of stay limits, to allow hospitals to convert exempt beds to acute care beds to accommodate the needs of emergency victims, to not count patients admitted to a long-term care hospital located in an affected state toward the calculation of the facility’s average length of stay if such admissions were related to the emergency, and to allow beds in a distinct psychiatric unit in an acute care hospital lo- cated in affected states to be available for patients needing inpatient acute care services if such use was related to the emergency.36,37

In addition to waiving Medicare classification require- ments to expand the availability of inpatient beds, the

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Table 1. Public Health Emergencies Declared by the HHS Secretary

Emergency Rationale Datea

2009 (H1N1) influenza � Confirmed cases of swine influenza A in California, Texas, Kansas, and New York

� April 26, 2009 (nationwide), renewed July 24, 2009, because the 2009 H1N1 flu outbreak remains a worldwide public health threat

Severe flooding � Severe storms and flooding in North Dakota � March 25, 2009 (for North Dakota, retroactive to March 13, 2009)

� Severe storms and flooding in Minnesota � March 27, 2009 (for Minnesota, retroactive to March 16, 2009)

56th Presidential Inauguration � The 56th Presidential Inauguration and the emergency actions being undertaken by the District of Columbia in support of that event

� January 16, 2009 (effective from January 17-21, 2009)

Hurricane Ike � Hurricane Ike and its impact on Texas � September 11, 2008 (for Texas, retroactive to September 7, 2008)

� Hurricane Ike and its impact on Louisiana � September 13, 2008 (for Louisiana, retroactive to September 7, 2008)

Hurricane Gustav � Hurricane Gustav and its impact on Louisiana, Texas, Mississippi, and Alabama

� August 31, 2008 (for Louisiana and Texas, retroactive to August 27, 2008)

� August 31, 2008 (for Mississippi, retroactive to August 28, 2008)

� August 31, 2008 (for Alabama, retroactive to August 29, 2008)

Severe flooding � Severe storms, tornadoes, and flooding in Iowa � June 14, 2008 (for Iowa, retroactive to May 25, 2008)

� Severe storms and flooding in Indiana � June 14, 2008 (for Indiana, retroactive to June 6, 2008)

Hurricane Dean � Hurricane Dean in Texas � August 19, 2007 (retroactive to August 18, 2007), terminated on August 23, 2007 because Hurricane Dean did not striking Texas and the risk of the storm having a substantial impact on the state was reduced

Hurricane Rita � Hurricane Rita and its impact on Louisiana and Texas

� September 23, 2005 (retroactive to September 20, 2005)

Hurricane Katrina � Hurricane Katrina and its impact on Florida, Alabama, Louisiana, and Mississippi

� August 31, 2005 (for Florida, retroactive to August 24, 2005)

� August 31, 2005 (for Alabama, Louisiana, and Mississippi, retroactive to August 29, 2005)

� Hurricane Katrina and the evacuation of residents of certain affected areas to Texas

� September 4, 2005 (for Texas, retroactive to September 2, 2005)

� Hurricane Katrina and the evacuation of residents of certain affected areas to Arkansas, Colorado, Georgia, North Carolina, Oklahoma, Tennessee, West Virginia, and Utah

� September 7, 2005 (for Arkansas, Colorado, Georgia, North Carolina, Oklahoma, Ten- nessee, West Virginia, and Utah, retroactive to August 29, 2005)

� All Katrina declarations were renewed through January 31, 2006.

September 11, 200135

aUnless otherwise noted, the Public Health Emergency declarations expired after 90 days.

256 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science

FEDERAL DECLARATION OF A PUBLIC HEALTH EMERGENCY

ability for CMS to waive EMTALA sanctions for a 72-hour period upon implementation of a hospital disaster protocol or for the duration of the PHE for emergencies involving pandemic infectious disease may be an important tool if healthcare facilities are damaged by a hurricane or other event or are overwhelmed with surges of patients or indi- viduals who are ill or concerned that they may be ill.27 For example, the ability for CMS to waive EMTALA sanctions and certain Medicare requirements may be important during a pandemic or other event if a hospital must divert individuals to an off-campus alternative care site to receive a medical screening exam if the emergency room is over- whelmed.38 Also, waivers of sanctions related to Stark self-referral prohibitions on a case-by-case basis may be important to retain physicians when an area is severely af- fected by a PHE and to permit hospitals to provide free office space or low- or no-interest loans, or to offer certain arrangements to physicians displaced by the PHE.

Conclusion

The Secretary of HHS has broad authorities to render as- sistance during a public health emergency. Many public health emergencies will not require a formal declaration of a PHE even when the event overwhelms state and local re- sources and requires federal assistance. However, a PHE declaration may be an important tool during a public health emergency because it can be a necessary step to au- thorize the secretary to take a variety of discretionary ac- tions under other authorities as HHS responds to the PHE. Most notably, PHE declarations have been necessary for the secretary to issue 1135 waivers, which facilitate the ability of healthcare systems to address surges in patient volume, among other concerns. Also, a PHE declaration was nec- essary at the outset of the 2009 H1N1 influenza outbreak so that the FDA Commissioner could issue multiple EUAs to make available to public health and medical personnel and the public important diagnostic, therapeutic, and re- spiratory protection tools to identify and respond to the 2009 H1N1 flu virus under certain circumstances.

A Public Health Emergency declaration does have lim- itations: currently, a PHE declaration does not trigger specific funding to HHS for response activities since the PHEF is not funded. Likewise, a PHE declaration does not provide HHS with funding to distribute to states or other entities outside of HHS. The exercise of a PHE and other authorities that may flow from a PHE are discretionary and do not create entitlements for those who may benefit from any of these actions.

Acknowledgments

I would like to thank David Benor, Jennifer Garver, and Susan Sherman for their thoughtful review and input. The

content of the article represents the personal views of the author and does not express the opinion or policy of HHS or its components. The information contained in this ar- ticle does not constitute legal advice. Healthcare entities and providers affected by the issues discussed in this col- umn should contact legal counsel for specific legal advice on these matters.

References

1. Section 2801(a) of the PHS Act (42 U.S.C. § 300hh(a) (2009)).

2. National Response Framework. January 2008. http:==www. fema.gov=emergency=nrf=. Accessed July 31, 2009. HHS is also a support agency for other ESF Annexes, including ESF 3, 5, 7, 9, 10, 11, 14, and 15.

3. Section 2811(b)(1) of the PHS Act (42 U.S.C. § 300hh- 10(b)(1) (2009)).

4. Hoffman S, Goodman R, Stier D. Law, liability, and public health emergencies. Disaster Medicine and Public Health Preparedness 2008;3(1):2.

5. Section 319 of the PHS Act (42 U.S.C. § 247d (2009)). The secretary is required to consult with such public health of- ficials as may be necessary before making a determination.

6. H.R. Rep. 98-143, U.S.C.A.A.N. (1983). 7. Section 319 of the PHS Act was modified in 2000 by the

Public Health Improvement Act, Pub. L. No. 106-505, which repealed the former section 319 and inserted a new section 319. However, the new language was substantially similar to the 1983 version. The new version clarified that a PHE in- cludes ‘‘significant outbreaks of infectious disease or bio- terrorist attacks’’ and that the PHEF could be used only if the secretary declares a PHE under section 319. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107-188, modified section 319 by inserting several new provisions. Pub. L. No. 107-188 added ‘‘providing awards for expenses’’ as an action the HHS Se- cretary may take to respond to a PHE, added a termination provision clarifying when the public health emergency ends and establishing a renewal option, and added subsection (d), which allows the secretary to extend deadlines and waive sanctions relating to data or reports that individuals are re- quired to submit under laws administered by HHS.

8. Section 319(b) of the PHS Act (42 U.S.C. § 247d(b) (2009)).

9. Beginning in 2001, Congress has appropriated either sup- plemental or annual appropriations to a ‘‘Public Health and Social Services Emergency Fund’’ to, among other things, support activities related to countering potential biological, disease, and chemical threats to civilian populations and for pandemic flu preparedness activities. See, eg, Pub. L. No. 107-38 (Sept. 18, 2001), Pub. L. No. 107-117 ( January 10, 2002), Pub. L. No. 108-199 ( January 23, 2004), etc.

10. See discussions of Federal-to-Federal Support and definition of a mission assignment in Department of Homeland Secur- ity. National Response Framework. January 2008. http:==www. fema.gov=emergency=nrf=. Accessed July 31, 2009.

11. Section 319(a) of the PHS Act (42 U.S.C. § 247d(a) (2009)).

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12. Section 319(d) of the PHS Act (42 U.S.C. § 247d(d) (2009)).

13. Eg, see sections 301, 311, and 2812 of the PHS Act (42 U.S.C. §§ 241, 243, and 300hh-11 (2009)).

14. 42 U.S.C. § 243 (2009). 15. 42 U.S.C. §§ 241, 247d-6b, 264, 300hh-11, and 300hh-15. 16. 42 U.S.C. § 1320b-5 (2009). 17. 21 U.S.C. § 360bbb-3 (2009). 18. Section 351A(g)(3) of the PHS Act (42 USC § 262a)

(2009). 19. 21 U.S.C. § 355-1(f )(7) (2009). 20. Section 1847A of the SSA (42 U.S.C. § 1395w-3a (2009)). 21. 42 U.S.C. § 300ff-83 (2009). 22. 5 C.F.R. 213.3102(i)(1), 5 U.S.C. §§ 8344, 8468 (2009). 23. Section 1135(a) of the SSA (42 U.S.C. § 1320b-5(a)

(2009)). 24. Section 1135(g) of the SSA (42 U.S.C. § 1320b-5(g)

(2009)). 25. Section 1135(b) of the SSA (42 U.S.C. § 1320b-5(b)

(2009)). 26. This is for purposes of Medicare, Medicaid, or CHIP re-

imbursement only. 27. For more discussion of EMTALA waivers, see Courtney B.

Waiving EMTALA sanctions in response to public health emergencies. Biosecur Bioterror 2008;6(3):213-217.

28. For additional information about the application of HIPAA during public health emergencies (whether or not the sec- retary makes a formal PHE declaration under section 319 of the PHS Act, or issues an 1135 waiver), see U.S. Department of Health and Human Services. Health Information Privacy: Emergency Preparedness Planning and Response. http:==www.hhs. gov=ocr=privacy=hipaa=understanding=special=emergency= index.html. Accessed July 31, 2009.

29. Section 1135(c) of the SSA (42 U.S.C. § 1320b-5(c) (2009)).

30. Section 1135(e) of the SSA (42 U.S.C. § 1320b-5(e) (2009)). This section provides that a waiver may also last until the presidential declaration expires. However, since Stafford Act declarations generally last for up to a year or more after the event until all funding programs provided under that Act for a particular event are terminated, HHS usually terminates an 1135 waiver on the same date that the PHE is terminated.

31. The HHS Secretary may have declared a PHE under section 319 in the 1980s in response to the AIDS epidemic, al- though the author could not confirm whether this action was taken.

32. Besides September 11, 2001, HHS has issued PHE decla- rations in response to Hurricanes Katrina and Rita in 2005, Hurricane Dean in 2007, severe flooding in Indiana and Iowa in 2008, Hurricanes Gustav and Ike in 2008, the 2009 Presidential Inauguration, severe flooding in North Dakota and Minnesota in 2009, and the 2009 H1N1 influenza outbreak. For declarations and 1135 waivers related to

hurricanes, see http:==www.cms.hhs.gov=Emergency=02_ Hurricanes.asp#TopOfPage. Accessed July 31, 2009. For declarations and 1135 waivers related to severe flooding, see http:==www.cms.hhs.gov=Emergency=12_StormFlood.asp# TopOfPage. Accessed July 31, 2009. For the H1N1 influenza outbreak declaration, see http:==www.hhs.gov=secretary= phe_swh1n1.html. Accessed July 31, 2009.

33. U.S. Department of Health and Human Services. FDA au- thorizes emergency use of influenza medicines, diagnostic test in response to swine flu outbreak in humans [press re- lease]. April 27, 2009. http:==www.fda.gov=NewsEvents= Newsroom=PressAnnouncements=ucm149571.htm. Accessed July 31, 2009.

34. The secretary did not ultimately need to issue an 1135 waiver for the 2009 Presidential Inauguration. For 1135 waivers related to hurricanes, see http:==www.cms.hhs.gov= Emergency=02_Hurricanes.asp#TopOfPage. Accessed July 31, 2009. For 1135 waivers related to severe flooding, see http:==www.cms.hhs.gov=Emergency=12_StormFlood.asp# TopOfPage. Accessed July 31, 2009.

35. The author could not locate specific information pertaining to the PHE declaration for September 11, 2001.

36. U.S. Department of Health and Human Services. Centers for Medicare & Medicaid Services. CMS Response to the Hurricane Emergency—Gustav=Ike Medicare Fee-For-Service. October 3, 2008 (relating to Medicare requirements and Hurricanes Gustav and Ike, including in part flexibilities relating to 1135 waiver authority). http:==www.cms.hhs. gov=Emergency=Downloads=GustavMasterQsAs_100308. pdf. Accessed July 31, 2009.

37. U.S. Department of Health and Human Services. Centers for Medicare & Medicaid Services. Provider Survey and Certification Frequently Asked Questions, Declared Public Health Emergencies—All Hazards. August 31, 2008. http:==www.cms.hhs.gov=SurveyCertEmergPrep=Downloads= AllHazardsFAQs.pdf. Accessed July 31, 2009.

38. For more information about EMTALA and alternative care facilities during a pandemic, see U.S. Department of Health and Human Services. Centers for Medicare & Medicaid Services. Fact Sheet—Emergency Medical Treatment and Labor Act (EMTALA) & Surges in Demand for Emergency Department (ED) Services During a Pandemic. August 14, 2009. http:==www.cms.hhs.gov=SurveyCertificationGenInfo= downloads=SCLetter09_52.pdf. Accessed August 25, 2009.

Address correspondence to: Jennifer Ray

U.S. Dept of Health and Human Services Office of the General Counsel, Public Health Division

200 Independence Ave., SW Suite 638-G, #49

Washington, DC 20201

E-mail: [email protected]

FEDERAL DECLARATION OF A PUBLIC HEALTH EMERGENCY

258 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science