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Legislative Authorities and

Regulatory Issues

Ernest B. Abbott and Douglas P. Brosnan

OVER V IEW OF THE PROBLEM

Catastrophic disasters disrupt the health and medical system. Medical infrastructure (e.g., hospitals, clinics, doctors’ offices, laboratories, pharmacies, and medical suppliers) may suffer physical damage, or lose electrical power or communications capabilities such as Internet and computer services. A disaster creates new requirements for medical care when large numbers of people suffer from serious injuries or infectious diseases or are exposed to chemical, radiological, or biological contamination. As demonstrated by the 2004 Indian Ocean tsunami and the 2005 Hurricane Katrina in the U.S., a disaster can generate evacuees in the hundreds of thousands that are separated from their regular medical care network (e.g., doctors, nurses, prescription medi- cations, and medical records), yet continue to require baseline health and medical needs.

Catastrophic disasters also challenge the legal basis of the medical system. Compliance with some legal requirements becomes impossible and practitioners must be aware of current standards and legal mandates that exist in the disaster environ- ment. For example, in the United States, federal rules require clin- icians to perform a medical screening examination and stabilize any patient who arrives on hospital grounds requesting medical care. How does this regulation apply when there is a physical plant disruption such as a hospital flood or fire, or chemical or radiological contamination of the building? Another example is that virtually all sovereign governments ensure the competence of medical professionals by issuing licenses to those authorized to practice medicine within its borders – yet in a disaster, medical volunteers will cross state or national boundaries to treat disas- ter victims. Under what circumstances do their medical or other professional licenses allow them to treat casualties? Should they be concerned about violating geographic restrictions contained in their malpractice insurance policies? In many countries, gov- ernment officials have broad emergency powers over healthcare and public health systems when there has been an official disas- ter or state of emergency declaration. Within the U.S., there is substantial variation among states on exactly what those powers are and who can exercise them.

This chapter will review disaster legal issues primarily from the perspective of a person or institution – including individual doctors or nurses, medical practices, laboratories, clinics, and hospitals, who collectively provide medical care to patients in the midst of catastrophic disaster or other public health emer- gency. This chapter summarizes the key changes in the legal environment under which disaster medicine is practiced. Med- ical providers are subject to requirements imposed by govern- ments – federal, state and, in some cases, local governments and agencies. Providers must be familiar with duties of care created by the tort/malpractice system, which is enforced by courts through money judgments. They must be cognizant of requirements existing with third-party payers and private cre- dentialing organizations and vendors. Despite what some may view as a minefield of legal risks – risks of criminal or civil penal- ties, revocation of critical licenses or credentials, and malpractice or breach of contract judgments – disaster medicine creates an extraordinary and rewarding opportunity to provide medical care to people when they need it most.

CURRENT STATE OF THE AR T

Medical Malpractice and Disaster Medicine

Just as they do during nondisaster times, medical care providers must manage the liability risk (for improper or inadequate treat- ment) during catastrophic events. In litigious countries like the U.S., the tort liability system may have as much or more effect on how medicine is practiced than do regulatory standards imposed by the government. Under the tort liability system, lia- bility attaches to any persons or institutions who participate in care provided to an individual patient who has suffered a sig- nificant injury or illness – if the injury or illness can be proven, in court after the fact, to be wholly or partially their “fault.” Damages can run into the millions of dollars for individual patients, including both “compensatory damages” (such as cur- rent and future medical expenses, lost wages, projected future losses in wages, a monetary reward for pain and suffering), and, in egregious situations, “punitive damages.” The liability system

151 Koenig and Schultz's Disaster Medicine : Comprehensive Principles and Practices, edited by Kristi L. Koenig, and Carl H. Schultz, Cambridge University Press, 2009. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/apus/detail.action?docID=564432. Created from apus on 2018-03-09 06:35:04.

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is intended to make “tortfeasors” (the label given to the per- sons whose improper actions or failure to act caused a patient’s injuries and illness) pay money damages to make that patient (or the patient’s estate) “whole,” to the extent possible. The liabil- ity system is also intended to create a strong incentive to persons and institutions to act with appropriate care, that is, prudent and reasonable care in accordance with accepted medical practice in the circumstances in which that care is provided.

Medical care providers are generally familiar with the liability system (in various degrees of fear and loathing) as it applies to the day-to-day practice of medicine. The same principals also apply to the practice of medicine under disaster conditions. In fact, one of the main issues discussed by public health officials and emergency planners is how to assure medical providers that they can assist in the response to a catastrophic event without incur- ring debilitating liability judgments.1 One can prepare medical providers to limit liability risk under disaster conditions if they have a basic understanding of key system characteristics. In the U.S. tort liability system, there are differences in legislation and case law in different jurisdictions. An individual or institution can be found “liable” for an injury to a person if the individual or institution owes a duty to provide treatment, fails to fulfill that duty, and thereby causes harm to that person. There is one major statutory exception for a sovereign government that supports many of the efforts to immunize medical providers from liability in disasters: the government cannot be liable if it does not give its consent.2 Indeed, a sovereign government can limit not only the extent of its own liability, it can completely immunize other persons from liability.

The “duty” whose breach leads to liability can arise from sev- eral sources. These include: 1) an agreement (in which a medical provider promises to perform certain services in a particular manner), 2) statutes (in which the legislature has declared that a person has a duty, or responsibility, to act in a particular way), or 3) “common law” resulting from judgments of courts in indi- vidual cases determining or denying liability in particular situa- tions and establishing legal precedents.

For medical malpractice liability, the most significant “duty” owed by a medical provider is a duty to diagnose and treat patients without negligence, in accordance with a standard of care. Normally this is the care which is reasonable for a qualified professional providing treatment in similar circumstances.3 In “normal,” nondisaster times, providers generally manage the risk that they might be found negligent by establishing and following standard procedures and protocols. Following these procedures minimizes the likelihood that their actions could, in hindsight, be characterized as “negligent.” Providers also protect themselves by purchasing medical malpractice insurance.4

During a disaster, however, medical providers’ ability to use nondisaster standard procedures and protocols is severely com- promised, because

■ Facilities are not fully functional due to infrastructure or operational damage

■ Facilities are crowded ■ Supplies and drugs are in short supply ■ Staff is short-handed and fatigued ■ Staff has been imported from other jurisdictions that use

different procedures and protocols ■ Medical records are missing or temporarily unavailable ■ Volunteer medical providers are working in unfamiliar facil-

ities and jurisdictions

The circumstances under which the conduct occurs deter- mine whether it can be classified as “negligent” medical care. A doctor operating in a tent field hospital established by gov- ernment officials or in an airport concourse may not have the equipment necessary for certain tests that in “normal times” would be standard medical procedure. It would not be “neg- ligence” for a doctor to treat a patient requiring care during this emergency without using unavailable equipment, even if the patient experienced life-threatening complications that would have been avoided had that equipment been used. Rather, the care provided would be reasonable given the environment.

There are nonetheless significant liability risks that providers face in providing care during an emergency. For example, a patient’s attorney may agree that a doctor did the best he or she could in the middle of a catastrophic event – but argue that the event became catastrophic because of negligence. For exam- ple, a medical facility could be found negligent in the develop- ment of its emergency plan which led to the loss of electrical power during a surgical procedure – and that this negligence, not the heroic efforts taken after disaster had struck – is what led to injury. Proper predisaster preparation might have ensured that necessary test equipment was available or training was pro- vided on substitute tests that did not require the equipment. Moreover, whether the particular care provided was “negligent” even under emergency conditions will likely be a question that a court would decide after the fact. Most medical providers are, accordingly, concerned that actions taken in a catastrophic envi- ronment could lead to large malpractice judgments based not on true negligence, but rather on their inability to provide the care that would be considered appropriate under normal con- ditions due to lack of resources. Even though practitioners are only held to a standard that care must be reasonable given the circumstances in which it was provided, practitioners are keenly aware that, given the delay inherent in litigation, the memory of emergency conditions will fade long before they will be judged for possible negligence.

Malpractice insurance may not provide protection to providers in the disaster environment. To limit an insurer’s mal- practice exposure, malpractice insurance is typically written to cover a particular type of practice in a particular geographic loca- tion. Yet in a disaster, medical providers may be needed in other jurisdictions, perhaps even in another state or country. They may be asked to practice in temporary or substandard facili- ties, and may perform procedures that are not normally within their scope of practice. Standard malpractice insurance may not provide protection for any of these circumstances.

To address at least some of these concerns, in the U.S., most states and the federal government have enacted legislation that provides some immunity to medical professionals providing care during disasters. State Good Samaritan legislation and the Fed- eral Volunteer Protection Act of 19975 provide significant immu- nity protection. For example, in California’s Good Samaritan Law, there is “no liability where the licensee in good faith ren- ders emergency care at the scene of an emergency.”6 In many states, liability protection is also extended to medical profes- sionals who volunteer to help state or local public health or emergency management officials. California also has this type of provision: “health providers . . . who render services during any state of . . . emergency, at the express or implied request of any responsible state or local official or agency, shall have no liability for any injury sustained by reason of such services, regardless of how or under what circumstances or by what cause such injuries

Koenig and Schultz's Disaster Medicine : Comprehensive Principles and Practices, edited by Kristi L. Koenig, and Carl H. Schultz, Cambridge University Press, 2009. ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/apus/detail.action?docID=564432. Created from apus on 2018-03-09 06:35:04.

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LE G I S L AT I V E AU T H O R I T I E S A N D RE G U L ATO RY IS S U E S ■ 153

were sustained.”7 This immunity does not apply when the injury was intentional, or resulted from actions (or failures to act) that were clearly likely to cause harm, that is, where the injury results from a “willful” act or omission. Similarly, the Federal Volunteer Protection Act provides that “no volunteer of a nonprofit orga- nization or governmental entity shall be liable for harm caused by an act or omission of the volunteer if . . . the harm was not caused by willful or criminal misconduct, gross negligence, reck- less misconduct, or a conscious, flagrant indifference to the rights or safety of the individual harmed by the volunteer.”8 Note that protection under this law extends only to the actual volunteer – and not to any organization that dispatches or supports the work of volunteers (e.g., nongovernmental organizations such as the American Red Cross).

Furthermore, providers should be aware that the liability protection offered by Good Samaritan legislation and the Fed- eral Volunteer Protection Act typically does not extend to those who receive compensation for their efforts. Is a physician who is part of a group medical practice, and who receives a fixed share of the profits from that practice even though much of the profits were earned while the practitioner was “volunteer- ing” in a disaster, covered? Could the immunity provided by a Good Samaritan Act be challenged if a medical care provider receives an allowance for meals and living expenses while serving in a disaster field hospital? Is a pharmacist in the employ of a corporation a volunteer if the corporation allows the pharma- cist, during his paid vacation, to travel to a disaster and serve as a pharmacist at a shelter? The answers to these questions are unclear and leave a significant liability risk exposure in many U.S. states.

Immunity is provided under the laws of some U.S. states to contractors providing emergency response services in coordina- tion with or under contract to emergency response authorities.9

Other statutes may provide immunity to responders in partic- ular circumstances – such as in the administration of smallpox vaccine.10

There are often limitations on the scope of immunity. For example, no immunity extends to: 1) caregivers receiving com- pensation; 2) persons who are unlicensed; and 3) for-profit businesses (such as incorporated providers of medical care). Furthermore, the immunity from liability given to government contractors may also be limited. Although contractors are gener- ally not liable for performing under a government contract that spells out precisely the work they are required to perform, con- tractors can be liable if they are able to use judgment in perform- ing the contract.11 This exception can be very significant, because the provision of medical services requires the application of judgment.

Although liability concerns of true volunteers practicing dis- aster medicine are low, there is uncertainty about the definition of “volunteer” and the scope of liability protection provided by existing immunity statutes. At the time of this writing, the Dis- aster Response Committee of the Board of the American Red Cross had such strong concerns about the potential scope of lia- bility that it instructed the Red Cross’ Response and Recovery Division not to deploy volunteers during a Pandemic Influenza event without assuring adequate liability protections. There are a number of legislative efforts underway to clarify and extend the scope of immunity for medical providers.12 The accelerated pace of legislative changes and the variety of approaches adopted in states across the U.S. means solutions to many of these liability issues will be in a continuous state of flux.

Despite a lack of clarity under existing law, medical providers can take actions that will eliminate or significantly reduce their exposure to liability when providing volunteer medical services in an emergency. Within the U.S., virtually all of these solutions require that a medical provider be registered with an official governmental response organization and become a part of the government response. Government officials increasingly view the coordination of volunteer and private sector response efforts (public–private partnerships) to be a critical part of disaster preparedness and response efforts. In many U.S. states, statutes immunize actions taken at the direction of state emergency man- agement officials.13 In some state and federal government pro- grams, volunteer individual practitioners are “hired” as tem- porary employees for minimal or no salary and the government extends its immunity protection to them and becomes the defen- dant to pay judgments arising from any remaining liability.14 For example, if an individual is deployed to assist at a disaster site as part of a National Disaster Medical Assistance Team, the provider becomes “federalized” and is allowed to practice in any U.S. state or territory and has federal liability protections.

The liability protections available under current law and under a number of legislative proposals are primarily directed to individuals, and particularly to individual volunteers, rather than to the nonprofit organizations and private businesses that may participate in response efforts. Some of the organizations that will assist in medical care provision during disaster events are not traditionally part of the medical system. For example, during a pandemic influenza event, public health officials may request a major employer in a community to assist in the dis- tribution of pharmaceuticals and administration of vaccines to its employees and their families. Current law may provide only limited protection to these businesses and they may refuse to par- ticipate in planning and actual response unless they can obtain liability protection or indemnity.

Registration with an official government response organiza- tion provides other important benefits, particularly where medi- cal providers will be serving in facilities, communities, and states different from those in which their home practice is located. These benefits – discussed in greater detail later – include extend- ing the provider’s medical license in the new state, generation of identification documents and credentials that allow the provider entry into the disaster area, and logistical support.

LEGAL FRAMEWORK FOR DISASTER MEDICINE AND PUBLIC HEALTH EMERGENCIES: PUBLIC HEALTH POWERS

In the U.S., the foundation of both the “normal” and “disaster” legal system is the Constitution that created the federal system of government. In this system, it is state governments, and not the federal government, that have primary authority and responsi- bility to protect public welfare. In the Constitution, states enu- merate powers to the federal government, specifically authority over interstate and foreign commerce, national defense, and the right to tax and spend for the public welfare. Yet the states retain their basic police power – the power to place restrictions on people and property and business to protect the public.

The U.S. system of federalism devised by the Founders is reflected throughout the medical system. Acting under its police power authority, states have created licensing and certification requirements for hospitals, physicians, nurses, pharmacists, and

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other medical professionals. State statutes specify rules for reporting of communicable diseases and other public health con- cerns (such as unsafe conditions in restaurants), and empower public health officials to take action (impose quarantine, or close restaurants) to protect the public. State law is also generally responsible for determining the standards of care applicable to the medical system and these standards are enforced through state court judgments in the medical malpractice system.

The federal government nonetheless also exerts extraordi- nary power over the medical care system. Communicable diseases can spread across state and international boundaries – allowing the federal government to exercise its power over international and interstate commerce and impose federal rules to prevent transmission of disease. For example, federal legislation autho- rizes federal quarantine within a state upon findings that a state’s quarantine efforts are ineffective.15 Similarly, because pharma- ceuticals and medical supplies are sold in interstate commerce, the federal government has authority to regulate drug manu- facture and use. Federal taxes fund the Medicare and Medicaid programs that pay for 20%16 and 9%17 of the medical care pro- vided in the U.S., respectively. As a result, federal requirements placed on medical care providers who treat Medicare or Medicaid patients are enforced by federal civil and even criminal penal- ties. These requirements include protection of patient records and service obligations in addition to billing and reimbursement procedures.

In the U.S., officials at all levels of government have broadly worded authority to take action, in the face of “imminent threats,” to “save lives, defend property, and protect the pub- lic health and safety.” This authority can extend to actions that would normally be viewed as blatant violations of constitution- ally protected rights to “life, property and the pursuit of happi- ness.” These actions include seizure or destruction of property (including hospitals, medical supplies, or even animals); evac- uation of people from (or detention of people in) a facility or geographic area; or even mandatory treatment of persons.18 For some of these actions, the government may be required to pro- vide compensation. For others, the government may provide discretionary disaster assistance, and for still others, individuals and businesses are not provided any additional resources.

PROV IDER OBLIGATION TO PROTECT PATIENT RIGHTS

Privacy

Medical care involves one of the most personal of relationships between patient and doctor, and medical files contain a great deal of highly personal information. These files contain data not just about the state of a patient’s health, but about the patient’s habits, family, finances, sexual practices, and sexual orientation. Proper sharing of patient information (with multiple medical specialists and with third-party payers) is critical to medical care and to the successful operation of a healthcare system. In the U.S., however, disclosure without patient consent in accordance with specific provisions is prohibited, frequently by multiple statutory and regulatory provisions. Most medical providers use well-developed procedures to assure that any exchange of patient information complies with law.

Disasters can overwhelm these procedures, force additional disclosures, and trigger exceptions to the “normal” disclosure

requirements. For example, in the aftermath of a catastrophic disaster, governments and families face the challenge of locating missing persons. Medical providers face the challenge of finding relatives of family members to authorize treatment, and deter- mining when to provide medical information to family mem- bers and the general public. Disaster conditions also require hospitals and medical personnel to operate in stressful, rapidly changing, and uncertain situations. Despite this environment, the need to share information and keep the public informed must be weighed against the privacy rights of patients and their families. Federal and state laws governing the release of patient information are generally unchanged in the setting of a disaster; however, there are provisions for information sharing in emer- gent settings. Typically, a provider should obtain patients’ verbal permission for a disclosure of health information, and patients should be “informed in advance of the use of the disclosure,” when possible.19

Federal Health Insurance Portability and Accountability Act Requirements and Protected Health Information in the United States

A principal objective of the Health Insurance Portability and Accountability Act (HIPAA) was to address difficulties experi- enced when employees with employer-provided health insur- ance changed jobs. There was a need to protect patient privacy when transferring health records to the new employer. Protect- ing privacy while addressing the portability of insurance led to a comprehensive federal regulation governing how partici- pants in the medical care system – care providers, laboratories, and third-party payers such as insurance companies – main- tain, protect, and disclose what is defined as protected health information (PHI) of patients only when authorized. To assure appropriate attention to the privacy interest of patients, HIPAA requires that medical care providers and payers have a docu- mented privacy policy and appoint a Privacy Official and contact person responsible for training the workforce in the PHI privacy policy.20

HIPAA allows healthcare providers to share a patient’s PHI as necessary to provide treatment, payment, or healthcare oper- ations; this sharing of information applies during disaster events just as it does in “normal” times.21 Treatment includes coordi- nating patient care with others such as emergency relief workers or personnel at potential referral receiving sites. Furthermore, where required or necessary to prevent or control disease, injury or disability, disclosure to a public health authority is expressly authorized by HIPAA.22

State legislation largely echoes the provisions of federal HIPAA regulations. Some states further delineate permissible activities for sharing PHI. For example, California legislation expressly permits the communication of PHI by radio transmis- sion or other means between emergency medical personnel.23

Location/ Health Status HIPAA generally permits providers to share very limited

information concerning a patient’s location and general con- dition or death as necessary to identify, locate, and notify family members or guardians.24 Therefore, if necessary, a hospital may notify the police, press, or the public at large to the extent nec- essary to help locate, identify, or otherwise notify family mem- bers as to the location and general condition of the patient. Federal regulations also permit the sharing of basic information

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including the patient’s identity, residence, age, sex, and condition to disaster relief organizations without patient consent if neces- sary to facilitate disaster response.25 Even when disclosures are permitted by HIPAA, however, providers must be aware of any state statutes that might restrict disclosure of patient informa- tion. California law expressly permits disclosure of basic patient information to state or federally recognized disaster relief orga- nizations,26 and Arkansas has adopted basic HIPAA disclosure provisions27 but other states have not done so and may have more stringent restrictions on disclosure. There is some confu- sion about whether HIPAA rules permitting disclosures preempt state laws.28 In any event, under normal circumstances, when a patient incapable of communication arrives at a hospital, the facility must attempt to make contact with a family member or surrogate within 24 hours – a requirement that is suspended during periods of disaster.29

Hurricane Katrina forced the rapid evacuation of well over one million residents, and in the process of evacuation, many families were separated. Isolated individuals included parents and other caregivers, children, and grandparents. This disas- ter questioned the ability of the federal government to effec- tively track evacuees and reunite family members. As a result, in the post-Katrina Emergency Management Reform Act of 2006,30

Congress enacted legislation requiring the Federal Emergency Management Agency Administrator to establish a: 1) National Emergency Child Locator Center (in cooperation with the U.S. Attorney General) within the National Center for Missing and Exploited Children, and 2) National Emergency Family Registry and Locator System. The former provides information about displaced children and serves as a resource for adults who have information about displaced children; the latter focuses on allow- ing displaced adults to register, furnish personal information to a database, and to make this personal information accessible to “those individuals named by displaced individuals.” Implemen- tation of this section will require negotiation of a memorandum of understanding with the Departments of Justice and Health and Human Services and with the American Red Cross and “other relevant private organizations.” This system should help medical providers in their efforts to locate a patient’s next of kin.

Public Health Officials In the U.S., HIPAA allows disclosure of PHI to a “public

health authority that is authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health inves- tigations, and public health interventions.” This authorization also permits disclosures to “a person or entity other than a pub- lic health authority” if it can demonstrate that it is acting “to comply with requirements of a public health authority.” PHI can also be disclosed to a person who may have been exposed to a communicable disease or is at risk of spreading a disease (for example, sexually transmitted disease), “and is authorized by (state) law to be notified as part of public health intervention or investigation.” These specific provisions governing disclosure to public health officials that facilitate public health interven- tions are even more important during a public health emergency than during “normal” times. The provision in the HIPAA rule authorizing disclosure of PHI to law enforcement officials “to help identify or locate a suspect, fugitive, missing person,” and

“to provide information related to victim of crime” is even more critical during public health emergencies, particularly those that are triggered by criminal or terrorist activity.31

Immediate Danger HIPAA further permits the disclosure of PHI without con-

sent or prior notification when “necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public; and is to a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.”32

This exception is particularly important when communicable disease is involved; it allows disclosure of a patient’s communi- cable disease status without the patient’s consent to other per- sons (such as a patient’s spouse or partner) to protect them from exposure.

Reporting and Recordkeeping Requirements Even where disclosures of PHI are fully authorized, and even

if those disclosures are in the midst of a public health emergency, HIPAA requires that the entity making the disclosure track when the disclosure was made, and to whom. Authorities must make this information available to the patient on request.33 As a result, when developing their emergency plans, medical providers in the U.S. must pay special attention to ensuring that they will have systems to document the disclosures that they make, whether required or permitted, of a patient’s PHI.

Media A public health emergency or disaster will generate signif-

icant media attention. Despite media inquiries, hospitals must maintain confidentiality of PHI. A hospital reporter must have a patient’s consent before releasing any personal information. A facility may, however, disclose general information about a disaster response such as the number of victims treated at the facility and the general types of injuries sustained so long as this information is not specifically identifiable to an individual. As mentioned previously, a hospital may disclose specific PHI to the media if this disclosure constitutes an effort to locate family members.

Data Storage and Security The requirements of HIPAA include a stipulation that “cov-

ered entities” institute a data recovery plan insuring continuity of operations in the aftermath of a disaster.34 A covered entity is a health plan, a healthcare clearinghouse, or a healthcare provider who transmits any health information in electronic form in con- nection with a HIPAA transaction.35 Covered entities include doctors, hospitals, laboratories, and pharmacists, and also the insurance companies and other third-party payers that have access to a patient’s PHI. This required system must include a data backup plan for the retrieval, and restoration of electronic PHI as well as an operations plan that enables the maintenance of privacy and security safeguards over PHI. State regulations may also require data protection and access in a disaster situa- tion. For example, in California, hospital licensing regulations require hospitals to safeguard their medical records against loss or corruption.36 California also details specific requirements for organizations maintaining only electronic records including off- site backup and retrieval systems.37

Although it is preferable to anticipate postdisaster challenges and proactively pass enabling legislation, in some situations the

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legal requirements can be modified postevent. For example, in the aftermath of Hurricane Katrina, the U.S. Secretary of the Department of Health and Human Services (DHHS) issued a waiver of penalties for violating certain HIPAA privacy provisions that proved impractical in the disaster setting including:

Sanctions and penalties arising from noncompliance with the following provisions of the HIPAA privacy regulations: (a) the requirements to obtain a patient’s agreement to speak with family members or friends or to honor a patient’s request to opt out of the facility directory (as set forth in 45 C.F.R. ‘164.510); (b) the requirement to distribute a notice of privacy practices (as set forth in 45 C.F.R. ‘164.520); or (c) the patient’s right to request privacy restrictions or confidential communications (as set forth in 45 C.F.R. ‘164.522).38

The U.S. DHHS provides a fact sheet confirming that HIPAA is not suspended and explaining what provisions may be waived during a national or public health emergency.39

Individual Liberty

Decisions on treatment of patients involving such issues as selec- tion of diagnostic tests, therapeutic agents, surgical procedures, drugs, and diets are generally made by physicians and other care providers only with consent after appropriate disclosure of the risks, costs, benefits, and alternatives. This system reflects the pri- vacy and liberty interests that patients have in their own bodies, and it is enforced not only by numerous regulatory requirements but also by judicial precedents. The provider may be liable after a patient suffers an adverse effect of treatment, if it was a known adverse effect of that treatment and it was not fully disclosed to the patient. The rules may change during a disaster. To protect the public health, the government is granted significant power to require testing or treatment of individuals, isolation of patients with a communicable disease, and quarantine of those with sus- pected or known exposure to communicable disease irrespective of the patients wishes. On a practical level, it is unclear whether the government would be able to exercise these authorities, par- ticularly in a democratic society. For example, if patients who are thought to be a “threat to the public health” refuse to remain in quarantine because they want to leave to check on the safety of a loved one, would the government use force (potentially lethal force) to prevent this? Balancing the threat to the public with the risks to the individual and those enforcing the laws could be very challenging, especially in borderline cases.

Legal Basis of Mandatory Public Health Measures Governments have a wide variety of legal tools that address

communicable disease. Some, such as quarantine, have a history extending back centuries if not millennia. These public health powers may significantly limit individual patient rights, but as illustrated later, U.S. courts have generally provided wide latitude to public health authorities in adopting them.

A seminal case on restricting individual rights to protect the public health is Jacobson v. Massachusetts, 197 U.S. 11 (1905). In 1902, the City of Cambridge, Massachusetts, passed an ordinance finding that “smallpox [was] prevalent in the city and continues to increase.” The city ordered vaccination of all its inhabitants, except children with a doctor’s note saying that they were unfit subjects for vaccination. Henning Jacobson, a charismatic min-

ister who had emigrated from Sweden, refused to be vaccinated. Reverend Jacobson viewed vaccination as unsafe and ungodly. Side effects of the cowpox vaccine used in vaccination were com- mon. He refused to pay the $5 fine specified for violators, and he appealed his fine all the way to the U.S. Supreme Court.40

The court responded with a decision supporting the right of communities to use their police powers to protect the public welfare. In the words of Justice Harlan:

Real liberty for all could not exist if each individual can use his own, whether in respect of his person or property, regardless of the injury that may be done to others. . . . Upon the principle of self defense, of paramount necessity, a community has the right to protect itself against an epidemic of disease which threatens the safety of its members.41

Justice Harlan also qualified the scope of the power to restrict liberty for public health:

Police power of state must be held to embrace, at least, such reasonable regulations established directly by leg- islative enactment as will protect the public health and safety . . . subject, of course, that . . . no rule . . . or regula- tion . . . shall contravene the Constitution of the United States, or with any right which that instrument gives or secures.42

In other words, within the U.S., public authorities have the right to protect their communities from an epidemic of disease, but the actions taken to do so must be “reasonable,” with some rational basis grounded in knowledge about treatment for the disease and its incubation period, virulence, and communicabil- ity. The requirement that public health measures – even those taken to protect the community from disease – cannot “con- travene the Constitution” or any “right which that instrument gives or secures” is also extremely significant. The 5th and 14th amendments to the U.S. Constitution preclude a federal or state government from taking a person’s liberty or property without “due process.” Mandatory treatment, inoculation, quarantine, and isolation measures clearly restrict the liberty of individu- als. Therefore, state and federal government use of these powers must be in accordance with due process, which includes both “procedural due process” (following appropriate procedures) and “substantive due process” (requiring that officials have a sub- stantive reason and a rational basis for restraining individual liberty).

Procedural Due Process means that the state must provide notice, counsel, and an opportunity for a hearing to any per- son subjected to these mandatory public health measures. This is similar to the procedural rights offered in connection with involuntary commitment of a patient due to a mental disor- der. “Substantive” Due Process requires that the state’s proposed restriction of individual liberty be rational and reasonable.

The case of Best v. Bellevue Hospital New York is illustrative of these “due process” principles.43 Mr. Best was diagnosed with tuberculosis but refused to complete his medication regimen and could have developed a drug-resistant strain. The Health Depart- ment issued an order detaining him and requiring completion of his treatment. Mr. Best filed suit against the health department and the hospital where he was confined. Mr. Best was granted a hearing and the courts assessed whether he was a danger to

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himself and the community. After a prolonged legal process that included four public hearings, significant attorneys’ fees, and at least seven administrative, state court and federal court orders, the court found that the Health Department and other defen- dants had indeed provided the due process required by the Con- stitution. On procedural due process, the federal appeals court described the factors considered in determining constitutionality of detention procedures:

First, the private interest that will be affected by the offi- cial action; second, the risk of an erroneous deprivation of such interest through the procedures used, and the probable value, if any, of additional or substitute pro- cedural safeguards; and finally, the Government’s inter- est, including the function involved and the fiscal and administrative burdens that the additional or substitute procedural requirement would entail.44

In general, quarantine and isolation procedures that provide notice, an opportunity for hearing (which can be held after an individual is detained) and access to counsel will satisfy procedu- ral due process requirements. The hearing requirement does not preclude health officers from taking action immediately when there is a risk that the public will be exposed to a communica- ble disease if a person is not immediately placed in isolation or quarantine.

Courts must also determine whether a public health order violates a person’s substantive due process rights; that is, it must review whether the government had a rational, reasonable basis for the order. This analysis involves a balancing of the collective right of self defense enunciated in Jacobson against individual rights to liberty and property. In these cases, courts have tradi- tionally given great deference to the judgment of public health officers. One historical example is provided in an opinion by Judge Hydrick of South Carolina’s Supreme Court in 1909:

In dealing with such matters, a wide range of discretion must be allowed the local authorities, and they should not be interfered with, unless it is clearly made to appear that they have abused that discretion to the probable injury to health or life.45

There are relatively few recent cases defining the Consti- tutional requirements for mass quarantine; at the time of this writing, the United States has not had occasion to impose a mass quarantine for more than 50 years. In the U.S. legal system, two basic principles that have support in the case law can assist public health officials in understanding the legal approaches to control of communicable disease. First, the greater the restraint on indi- vidual liberty, the greater is the responsibility that government has to provide for those restrained. For example, when the state confines individuals in prison, or involuntarily commits individ- uals in a mental health facility, these individuals are no longer able to access their own food or medicines; courts have declared confinement without food or medicine, or in crowded and dilap- idated prison conditions to be unconstitutional.46 When individ- uals and families are deprived of the ability to meet their basic needs for food, shelter, and medical care by quarantine or other movement restrictions, the state becomes obligated to provide those basic needs.

Second, despite the great deference given public health offi- cials, they cannot justify their orders simply by stating that the

actions will prevent the transmission of disease. They must also show that they could not have controlled the spread of disease with alternative public health measures that would have had less impact on individual liberty. The U.S. Constitution pro- vides that states cannot deprive persons of their “life, liberty, or property without due process.” As in the Best v. Bellevue case, this language has been interpreted to mean that the pub- lic health objective should be achieved with the least restrictive measures possible for all cases, including patients with a com- municable disease, suspected infections, and known or suspected exposures.47

By enforcing “restrictions of movement,” the goal of public health officials is to increase the ‘social distance’ between poten- tially infected persons and uninfected persons. Effectiveness of different movement restrictions in increasing social distance and reducing transmission of disease is highly dependent on dis- ease characteristics. These include incubation period, method of communicability, virulence, treatment options, and whether asymptomatic patients are contagious.

Some U.S. states have adopted statutes that include “the least restrictive means necessary test” (extrapolated from the Model State Emergency Health Powers Act).48 At the time of this writing, other states and the federal government have not yet defined the minimum constitutional requirements for quarantine. In many cases, strict quarantine procedures are not necessary to reduce disease transmission. Other restrictions of movement, which increase social distance, such as school closings, restrictions on public meetings, work quarantine, and wearing of masks or res- pirators may be just as effective.49 Because there are a number of less intrusive measures that may be equally or more effective than mandatory detention in a quarantine facility, a public health offi- cial may need to provide an affidavit with the quarantine order that explains why these less physically intrusive options were not selected.

Although there are a myriad of measures that reduce disease transmission, some are less intrusive on individual rights than others. For example, restricting public meetings or requiring use of face masks respects individual liberties much more than placing people in involuntary detention in a quarantine center. The decision about which measures to employ has important legal consequences.

Judge Hydrick’s observation in Kirk v. Wyman is unusual in that he reversed a decision, thereby overturning a Board of Health quarantine order. In Kirk v. Wyman, an elderly “lady of culture and refinement,” who had contracted leprosy while serving as a missionary in Brazil, was ordered released from a Board of Health operated quarantine facility because this “pest house” had previously been used to “detain Negroes with smallpox.” The majority simply found it unfathomable for an upper class and presumably white lady to be so treated. The facts of this case illustrate the difficulty in balancing the “collective right of self-defense” against individual rights, for both health officers and the judicial system.

Legal preparation for a large-scale quarantine from a pan- demic event extends beyond simply developing a notebook of standardized hearing notices and affidavits to be signed by pub- lic health officials. Attorneys must also enhance the procedural readiness of the judicial system, encouraging the courts to think through

■ The systems to be used for handling a large number of hearing requests

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■ The measures that will be employed to protect the safety of hearing officers and participants

■ Documentation/affidavits that will be required in a mass quarantine environment

■ How the court and other officials will communicate to the public

Consent Generally, rules for consent do not change in a disaster or

public health emergency. The medical care system is accustomed to situations in which it is impossible to obtain consent from patients. For children, or those who are unconscious, mentally disabled, or otherwise unable to make an informed choice, con- sent is generally obtained from parents, or a spouse, or a guardian. In an emergency, whether the emergency involves an individ- ual patient or a whole population during a catastrophic event, patient consent for management of an imminent medical cri- sis is implied. In this context, an “emergency” is a situation in which delay in immediate care would lead to serious disability or death, or immediate treatment is required to relieve severe pain. Frequently, within the U.S., state statutes provide specific requirements and definitions.

For example, in California, B&P § 2397 protects a medical care provider from liability when treatment is provided without consent, if the patient was unconscious, there was insufficient time to inform the patient, or the patient was without the legal capacity to provide consent and there was no time to find and obtain consent from the patient’s legal representative. The term “capacity” is defined by statute as, “a person’s ability to under- stand the nature and consequences of a decision and to make and communicate a decision.” Minor patients lack capacity as a mat- ter of law except when the minor has been given “emancipation” status (e.g., by court order, by military service, by marriage, or because the minor has been determined self-sufficient). In some jurisdictions, there are additional exceptions to the rule that minor patients lack decision-making capacity. For example, in California, a patient 12 years of age or older has the legal capacity to make informed consent decisions with respect to communi- cable reportable diseases, outpatient mental health, substance abuse, and pregnancy-related treatments.

The specific rules of consent can vary substantially in differ- ent states. For example, rules regarding pregnancy-related treat- ment are frequently controversial and there is no national con- sensus on the age at which a minor does not require parental consent. As a result, if volunteers in the U.S. from one state pro- vide disaster medical services in another state, they should be aware of the specific consent laws that apply in that state.

AUTHORIZATION TO PROV IDE MEDICAL CARE

Licensing and Credentialing

Licensing In the U.S., states regulate the practice of medicine. Thus,

providers must be licensed in the state in which they are provid- ing medical care. State licensing requirements generally extend not only to clinical care providers (e.g., physicians, nurses, pharmacists, veterinarians), but also to institutions (e.g., clin- ics, hospitals, and nursing homes). To obtain a state license, a provider or institution must demonstrate that they meet partic- ular educational, training, and experience requirements. Medical

practice is restricted to those skills and procedures commensu- rate to the training received and authorized under a professional license, a so-called “scope of practice.”50 Requirements are estab- lished by state laws and agencies; they vary by state, and licenses authorize professional activities only in the state in which the license is granted. States experiencing a disaster, however, fre- quently find that their existing resources of medical (and other) professionals are insufficient and that they must rapidly obtain assistance of professionals from other states. Medical profession- als from other areas must be qualified to provide disaster relief services.

Upon declaration of a disaster or state of emergency, the governor of a state generally has the power to adjust the state’s licensing requirements to allow practice by professionals from out of state. In some states the governor has the power to com- pletely suspend the state’s licensing scheme,51 although in prac- tice this power is not invoked except through procedures that assure professional qualifications. More commonly, a governor will exercise an emergency power that temporarily recognizes professional licenses issued in another state. For example, after declaring an emergency in California, the California Emergency Services Act bestows on the Governor broad emergency powers that include the ability to grant “any person holding a license issued by any state for professional skill permission to render aid involving such skill to meet the emergency as fully as if the license had been issued in California.”52 In the U.S., the Emer- gency Management Assistance Compact automatically provides for “cross licensing” to professionals who are deployed to a state as “state personnel” under this agreement. During Hurricane Katrina, existing laws allowing cross licensing of professionals did not work as quickly or as broadly as needed, and several efforts to broaden these rules were initiated. The Commission on Uniform State Laws adopted the Uniform Volunteer Emer- gency Health Practitioners Act in 2006 and 2007. This Uniform Law, which is only effective in a state after it is introduced to and enacted by the state, will provide automatic cross licens- ing of health professionals volunteering through a recognized credentialing system during emergencies.

Hospital Credentialing The Joint Commission (formerly known as Joint Commis-

sion on the Accreditation of Healthcare Organizations) is an independent, not for profit U.S.-based organization nationally recognized for setting certain hospital performance standards and granting accreditation and certification to those hospitals meeting these standards. Joint Commission International, estab- lished in 1997, “extends The Joint Commission’s mission world- wide by assisting international health care organizations, public health agencies, health ministries and others to improve the qual- ity and safety of patient care in more than 80 countries” (http:// www.jointcommission.org/AboutUs/Fact Sheets/jci facts.htm). The Joint Commission 2006 Hospital Accreditation Manual includes standards for administrators to grant disaster privileges, i.e. authorization for practitioners to work in their hospitals. When the healthcare facility emergency management plan has been activated and the hospital capacity is exceeded by the immediate surge in patients, “the CEO {Chief Executive Officer} or medical staff president or their designee(s) has the option to grant disaster privileges.”53 The official authorized to grant dis- aster privileges has broad discretion. To receive these privileges, however, the provider must present 1) a current picture hospital

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identification card, 2) a current license to practice issued by any state, federal, or regulatory agency, 3) identification indicating that the individual is a member of a federal Disaster Medical Assistance Team, or 4) a current hospital or medical staff member with personal knowledge regarding the practitioner’s identity.54 This standard requires that individuals authorized to grant hospital privileges be specifically identified and that there is a mechanism for managing personnel operating under temporary disaster privileges. The requirement further specifies that there must be a means for allowing staff to readily identify these personnel and that verification of credentials and privileges begins as soon as the immediate patient surge has resolved. This process is identical to the process established under Joint Commission standard M.S.4.100 for granting privileges to meet an important patient care need.55 As an alternative to the Joint Commission process, the Executive Branch of state government may also have authority to grant hospital privileges in the setting of a declared emergency.

Financial and Reimbursement Issues

Regional disaster plans may include memoranda of understand- ing between healthcare facilities for staff sharing during emergen- cies. In some models, the facility requesting assistance provides reimbursement directly to temporary employees; in other sys- tems the regular employer continues to pay salaries and receives reimbursement from the hospital that benefited from the shared services. For example, the District of Columbia Hospital Asso- ciation in Washington, D.C. maintains an agreement among its members to assist hospitals in emergency management. This agreement addresses the logistics of personnel and equipment sharing and the transfer of patients. It also assigns credentialing responsibilities and legal liability to hospitals receiving assistance from others.56

Federal rules for reimbursement in the U.S. under Medicare, Medicaid, and state children’s health insurance programs were relaxed in the aftermath of Hurricane Katrina. This was primarily because compliance with prior provider enrollment in these pro- grams, recordkeeping, and licensure in the same state in which services were provided was both impractical and counter to pub- lic policy. Six days after the storm made landfall in the U.S., the DHHS issued a waiver of various requirements for participation in federally funded healthcare programs.

1) Certain conditions of participation, certification require- ments, program participation or similar requirements, or pre-event approval requirements for individual healthcare providers or types of healthcare providers, including as appli- cable, a hospital or other provider of services, a physician or other healthcare practitioner or professional, a healthcare facility, or a supplier of healthcare items or services.

2) The requirement that physicians and other healthcare pro- fessionals hold licenses in the state in which they provide services, if they have a license from another state (and are not affirmatively barred from practice in that state or any state in the emergency area).57

Although a post hoc administrative response may not repre- sent the most prudent of reactions, the government recognized the importance of encouraging flexibility in staffing to provide adequate healthcare delivery in the midst of a mass casualty inci-

dent. To accommodate an increasing patient surge, this waiver also extended to hospital bed classification requirements allow- ing “nonmedical beds” to be used for patients requiring medical services. The government reimbursed these services according to relaxed billing requirements. During the time of disaster relief, paper billing and substitute data were acceptable for those records that were destroyed or unrecoverable.

HEALTHCARE FACILITIES

The Joint Commission standards require hospitals, acute care facilities and acute care psychiatric facilities to maintain and regularly update disaster plans and to train and test staff pre- paredness.58 Medicare in the U.S. also promulgates federal hos- pital emergency management plan accreditation requirements. Although Medicare conditions of participation for critical care facilities do not contain specific requirements for disaster man- agement plans, the Interpretative Guidelines issued by Medicare to its state survey teams require the adoption of “emergency pre- paredness plans and capabilities.”59 The Medicare Interpretative Guidelines for hospitals and “critical access hospitals” (a safety network of hospitals identified by Medicare to ensure access to healthcare services in rural areas) require that the hospital for- mulate and implement a disaster plan to “ensure that the safety and well-being of patients are assured” during a disaster and that such plans include coordination among all levels of government emergency preparedness authorities with specific identification and response to likely risks in their general areas such as earth- quakes, floods, and so forth.60 The Interpretative Guidelines are detailed in their list of issues to be addressed in the disaster plan and include consideration for security of walk-in patients; secu- rity of supplies (including pharmaceuticals, water, and equip- ment); communications systems; provisions in the event of gas, power, and water disruptions; and mechanisms for the transfer of patients.

The U.S. Occupational Safety and Health Administration asserts authority to regulate “any reasonably anticipated disaster that could create a hazard for employees” at the workplace.61

Such hazards include workplace injuries, fires, blood-borne pathogen exposure, and radiation and other hazardous materials exposures.

States within the U.S. also impose hospital disaster plan requirements. For example, California hospital licensing regu- lations require a “disaster and mass casualty program,” which must be approved by the medical staff and administration, prac- ticed by conducting at least two drills per year, and available for review by representatives of the California Department of Health Services.62 California regulations require the plan to con- tain a hazards vulnerability analysis, community linkages with an “all-hazards” command structure, specific procedures during a disaster, a mechanism for plan activation, a process for report- ing emergencies to external authorities, a command structure, and a means to notify and activate personnel.63 Even though hospitals may fulfill these disaster regulations, they could be out of compliance with a multitude of requirements placed on them during non-disaster operational periods. For example, patient– nurse ratio requirements in the State of California (designed to provide individual patients with optimum nursing care) are unlikely to be practical in the setting of mass casualties and may actually be harmful to the affected population. Staffing

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ratios should not determine hospital capacity, as is often the case in nondisaster settings when nursing shortages frequently dictate the maximum number of patients that may be cared for at a facility. During a disaster, however, it would be difficult to obtain timely waivers of legislated nurse–patient ratios. Hospitals should be encouraged to prepare agreements with its nursing staffs and unions prior to and in anticipation of a patient surge during a disaster. Discussions between hospital administration and nursing should also explore means to increase staffing during emergencies.

EMERGENCY MEDICAL TREATMENT AND LABOR ACT

The U.S. Emergency Medical Treatment and Labor Act (EMTALA) was passed in 1986 in response to reports that hospitals were refusing to treat individuals with emergency conditions if they did not have insurance.64 The EMTALA requires Medicare- participating hospitals to provide any individual presenting for care on hospital grounds with medical screening, stabilizing ser- vices, and appropriate transfer to a higher level of care if indi- cated. In addition, EMTALA sets forth civil monetary penalties on hospitals and physicians for:

1) Failing to properly screen an individual seeking medical care 2) Negligently failing to provide stabilizing treatment to an indi-

vidual with an emergency medical condition 3) Negligently transferring or releasing from care an individ-

ual with an emergency medical condition (including active labor)65

Waivers to EMTALA mandates, even in the setting of a mass casualty event, have not been well developed. Project Bioshield legislation (enacted in the U.S. in 2004) provides some relief from EMTALA when the federal government declares an emergency.66

This legislation allows the DHHS and the Centers for Medicare and Medicaid Services to waive temporarily EMTALA standards relating to

1) Transfer of unstabilized emergency patients if required by the circumstances of a declared emergency by a hospital in the emergency area during the period of the emergency; and

2) Directing or relocating patients for medical screening to alternate locations in accordance with the state emergency preparedness plan

The U.S. federal government issued an EMTALA waiver during Hurricane Katrina that suspended the requirement for hospitals in the designated disaster area to screen and stabilize patients if the disaster situation prevented it, provided that these patients were redirected to another facility for the medical screening examination and stabilization.67 As the Agency for Healthcare Research and Quality notes, EMTALA requirements are not entirely clear, particularly with respect to transfer or “surge” facilities. The Agency for Healthcare Research and Quality rec- ommends that elements of EMTALA “be reduced/waived for a temporary/limited service surge facility.” For example, the ben- efits of transfer to a surge facility would be to make room for other patients needing tertiary hospital services, not necessarily for the benefit of the transferred patient; the patients would not necessarily be asked to consent to transfer to the surge facility.68

EMERGENCY MANAGEMENT AND PUBLIC HEALTH SYSTEMS

Through the end of the 20th century, there was relatively little effort to incorporate the public health and medical care systems with the emergency management system. Public health officials worked independently, operating under public health laws and authorities to protect public health and transmission of com- municable diseases. Similarly, emergency management officials worked in isolation and were not prepared to assist in response to a major public health emergency such as an epidemic that had the potential to overwhelm the healthcare system. There was rarely coordination of disaster programs development between public health, medical, and emergency management officials.

In the U.S., there was a major philosophical shift after the terrorist attacks of September 11, 2001. The federal government mobilized massive resources to focus attention on preparing the nation for catastrophic events. Within a year of the attacks, Congress had enacted legislation creating a new federal depart- ment, the Department of Homeland Security (DHS), with the mission of protecting the nation from terrorist attacks and other threats. By Executive Order, President Bush directed the new DHS to establish a National Response Plan that would coordi- nate emergency response efforts of the entire federal government, in collaboration with states.69 The President also required DHS to establish a National Incident Management System (NIMS) and directed that every federal agency (not just DHS) require state and local governments to be “NIMS compliant” as a con- dition for receipt of federal preparedness grants.70 Meanwhile, Congress passed legislation adding new emergency healthcare authorities, with particular emphasis on preparation for a bioter- rorism event.71 Federal funding for state and local governments, first responders, and, to some extent, hospitals expanded dra- matically to address the healthcare impact of potential terrorist attacks. Applicants for these billions of dollars in preparedness funding72 had to demonstrate that they were “NIMS compliant.”

THE U.S. NATIONAL INCIDENT MANAGEMENT SYSTEM

The goal of the National Incident Management System is to enable emergency responders from many different agencies, lev- els of government, and organizations to effectively coordinate disaster response activities. A key element of NIMS is its require- ment that all entities involved in emergency response adopt the “Incident Command System (ICS)” to manage events. Under this system, “incident command” is established by the local or state government. Response resources arriving from outside the affected area establish contact within the incident command sys- tem. Although the emergency management system tradition- ally focused only on government actions, legislation passed after September 11, 2001, required that all first responders, including the private owners of critical infrastructure like hospitals and other medical facilities, be included in any emergency manage- ment plans and responses.73

People staffing an ICS in a major disaster may be from many different states and regions. Therefore, common terminology may be lacking. A request for a “nurse” does not communicate whether the need is for someone trained in triage or in adminis- tering immunizations or in caring for nonambulatory patients. Each medical organization involved in incident response should

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designate a staff member as liaison to local public health offi- cials to determine how NIMS procedures and guidance apply to their group. The staff member should also review the developing guidance on NIMS applications to the healthcare sector.74

First responders (and first receivers) should negotiate mutual aid agreements with neighboring providers so that assistance can be delivered faster, and with fewer legal complications, when disaster strikes. Many of the issues addressed elsewhere in this chapter, for example, licensing, credentialing, reimbursement, and liability can be managed through mutual aid agreements. This can include the use of existing mutual aid agreements such as the Emergency Management Assistance Compact (an agree- ment approved by Congress and adopted by all 50 states and the principal territories of the U.S.).

U.S. FEDERAL DISASTER ASSISTANCE PROGRAMS

If a catastrophic event creates emergency or disaster conditions that exceed the response capacity of state and local governments, the governor of a state may request the President of the United States to declare a “major disaster” or emergency under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act).75 This declaration, once issued, triggers eligibility for a number of different federal assistance programs, including both grant assistance and direct federal assistance. Several of these programs are important for medical providers.

First, under the Stafford Act’s Public Assistance Program, the federal government will provide a grant to “eligible applicants” of “not less than 75%” of the “eligible cost” of 1) performing certain emergency work to save lives, property, and the pub- lic health and safety; and 2) “repairing, restoring, replacing, or reconstructing” any damaged state or local government facilities, and eligible facilities of nonprofit organizations. The Stafford Act’s public assistance program, administered by the Federal Emergency Management Agency (FEMA) within the DHS, can be critical to the financial survival of eligible entities affected by a declared disaster event. These include government and non- profit healthcare providers, such as hospitals, clinics, ambulance services, and nursing homes.

Entities must meet certain requirements to be eligible for FEMA grant assistance. For example, the provision of emer- gency medical care is considered part of the normal business of a medical facility and the associated costs are not generally eligible for FEMA reimbursement, except in the most catastrophic of events.76 The cost of creating additional facilities for emergency treatment may, however, be eligible during a catastrophic disas- ter.77 Disaster assistance grants provided by FEMA are considered federal grants, subject to all of the boilerplate requirements of federal regulations,78 including a requirement that all contracts for work be competitively bid.79 Federal support will only be provided to supplement (not replace) assistance available from insurance, including employer-provided and individual policies, and Medicare/Medicaid.

U.S. GOVERNMENT EMERGENCY POWERS OVER HEALTHCARE FACILITIES

State emergency statutes are drafted extremely broadly and pro- vide enormous power to governors and other designated state officials for emergency response. As previously discussed, the

scope of these powers allows substantial restrictions on individ- ual liberties by evoking quarantine, isolation, and mandatory treatment or inoculations. The governors’ powers over private property are similarly expansive. For example, in Georgia (and in many other states) the governor may “Commandeer or utilize any private property if he finds this necessary to cope with the emergency or disaster.”80

Although the power to commandeer property is clear, any exercise of this power is subject to two critical requirements identified in the Fifth Amendment to the U.S. Constitution: “a person shall not be deprived of life, liberty, or property, without due process of law . . . nor shall private property be taken for public use, without just compensation.” Thus, an owner can object to seizure of the property, and is entitled to due process to deter- mine whether the seizure is justified. Similarly, the owner will be entitled to government compensation, measured by the value (as determined in court) of the property taken. In emergency circumstances, the due process and compensation hearings will occur after the government has taken possession of the property.

Although it may be authorized in law, commandeering of property in emergencies is highly disfavored. Effective catas- trophic response by governments requires development of response plans, training of those who will implement them, and exercising those plans to ensure that they work. Govern- ments recognize that the voluntary involvement of the private sector is fundamental to effective disaster response. In fact, the U.S. Congress has added a number of amendments to federal emergency management laws since Hurricane Katrina, direct- ing FEMA and other agencies to include the private sector in emergency response plans and exercises. These statutory direc- tives are repeated in several of the President’s Homeland Security Presidential Directives.81 Moreover, the emphasis in emergency planning is to identify emergency response needs in advance of the disaster and, if private sector response resources are required, to invite bids and proposals for contracts under which resources will be provided in an emergency. The cooperation from the private sector that is necessary for effective emergency planning and response is incompatible with any plan that relies upon com- mandeering of property except in the most unusual of events – where a need could not have been anticipated, and circumstances precluded negotiation of contractual arrangements.

EMERGENCY WAIVER OF U.S. STATE LAWS

In addition to commandeering property, many U.S. states also give their governors the power to temporarily suspend state laws and regulations that may interfere with the response or that become impossible to implement due to emergency conditions. California law states that “the Governor may suspend any regu- latory statute . . . or the orders, rules, or regulations of any state agency . . . where he declares that compliance would . . . in any way prevent, hinder, or delay the mitigation of the effects of the emergency.”82 This provision can be applied to procedural and paperwork requirements of agencies, to medical staffing or other state regulatory requirements governing medical care, to sub- stantive licensing provisions, or virtually any regulatory statute. For example, during the 2004 hurricane season (after Florida was struck by Hurricanes Charlie, Francis, Ivan, and Jean), Florida’s State Coordinating Officer (with authority delegated from the governor) issued 61 Supplemental Orders that overrode statu- tory and regulatory requirements encompassing such varied

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subjects as property valuations for ad valorem taxes (taxes based on the value of real estate or personal property), the cancella- tion of homeowners’ insurance policies, staffing requirements for home care services, and the reconstruction of facilities for cattle auctions.83 Medical providers should be aware of this pro- vision so that they can request waiver or suspension of require- ments if necessary during a catastrophic event.

RECOMMENDATIONS FOR FUR THER RESEARCH

Legal issues encountered in catastrophic events are extremely dependent on who is the client and how that client may be affected by the event – either as a person or entity suffering loss, as a government seeking to protect the welfare of residents and businesses, or as a medical worker providing services on a contract or volunteer basis to assist those in need.

The kinds of legal issues encountered include “zero sum gain” situations where different individuals or entities seek to redistribute the cost or pain of the catastrophe by imposing liability so that negligent providers must pay the injured patient for the loss caused by their acts. This can include nonmonetary or regulatory issues, where those subject to regulatory requirements are simply trying to ensure that they do not run afoul of the law when their world has been disrupted by a catastrophic event.

To reduce ambiguity in the aftermath of a disaster, it is useful to clarify the rules prior to an event. It is harder to act confidently if liability is a concern. The knowledge that authorities will grant a waiver of a compliance rule when a disaster has rendered com- pliance much more difficult would improve a responder’s ability to care for patients. A directive by the Uniform Law Commission to develop and then encourage legislative adoption of a Uni- form Emergency Healthcare Practitioners Act is one example of a project that addresses these issues. Changing legislation may not be the most important challenge. The U.S. Centers for Disease Control and Prevention’s Public Health Law Program convened a group of experts to develop a National Action Agenda for Pub- lic Health Legal Preparedness.84 Although summit participants identified some areas in which new laws would be useful; they did not believe that developing new law was the first priority. Instead, they maintained that those who make, use, and are affected by law should become more familiar with the scope, substance, and application of existing laws.

Thus, in the United States and other nations, there may be adequate legal authority to grapple with public health emergen- cies. However, public health and medical personnel may have inadequate understanding of existing laws and how they can be applied in the unusual environment of a public health emergency. Furthermore, even in cases when providers do comprehend the statute, existing laws have not necessarily been enacted with the consideration for scenarios in which patient care needs mas- sively exceed available medical and health resources, creating a scarce resource environment. Further work is needed to define an effective approach to these circumstances.85,86

Emergency managers strongly encourage the use of exercises, whether they are tabletop or full-scale drills. These simulations serve to test emergency plans, train emergency responders, and familiarize all organizations that will be involved in emergency response with the other organizations, governments, and busi- nesses with whom they will work during a catastrophic event. In most of these exercises, relatively little attention is paid to the kind of legal issues that are important to the government

response – let alone that by private and nonprofit organiza- tions. Future research in the area of legal issues in disasters will be significantly advanced through the careful development of a Legal Issues Tabletop exercise.87 Here, a potential public health emergency scenario is presented, and participants drawn from organizations that must respond determine what regulations and laws might interfere with providing medical care effectively. The result of the tabletop exercise would be the identification of legal obstacles that are as yet unresolved – and require further research.

REFERENCES

1. “Legal Issues” Report identified in a study for the Department of Health and Human Services’ Emergency System for the Advance Registration of Volunteer Health Professionals, September 2006 Draft. Available at http://www.hrsa.gov/esarvhp/legregissues/ default.htm.

2. This doctrine of sovereign immunity, which originates from English common law during the feudal period, premised on the maxim that the “King could do no wrong” persists as a basic principle of sovereignty. See 74 Fordham L. Rev. 2927, April 2006. The Federal Tort Claims Act, 28 USC § 1346(b), provides limited exception to the doctrine of sovereign immunity only under certain circumstances.

3. Koenig KL, Cone DC, Burstein JL, Camargo CA. Surging to the Right Standard of Care. Acad Emerg Med 2006 Feb;13(2):195–8.

4. Malpractice insurers in turn manage their risk by requiring that insured practitioners and institutions establish systems and pro- cedures that will reduce the likelihood of malpractice judgments.

5. 42 U.S.C. § 14503. 6. Cal. B&P § 2395. 7. Cal. GC § 8659. 8. 42 U.S.C. § 14503. 9. Fla. Stat. § 252.51.

10. 42 U.S.C. § 239(2). 11. N.Y.Unconsol.Law § 9101. 12. The Commission on Uniform State Laws has approved the Uni-

form Volunteer Emergency Health Practitioners Act. This “Uni- form Act” – which becomes “law” in a state only when adopted by state legislatures – includes alternate provisions on liability with varying protection. Pre-final as of 10/17/2007 Available at: http://www2a.cdc.gov/phlp/docs/UEVHPA.pdf.

13. In Florida, a person is not liable for civil damages arising out of care or treatment, in emergency situations, including declared emergencies. Fla. Stat. § 252.51.

14. Under 42 U.S.C. §§ 300hh–15, the federal government extends immunity to “Intermittent Disaster-Response Person- nel” appointed by the Secretary, to assist the Corps in carrying out duties during a public health emergency. Applicable protec- tions of section 2812 shall apply to such individuals. Pandemic and All-Hazards Preparedness Act PL109–417, December 19, 2006, 120 Stat. 2831.

15. 42 USC § 264 is the principal federal quarantine statute. The Department of Health and Human Services has proposed revised quarantine regulations, but these have not been finalized at the time of this writing. 70 Fed.Reg. 71892 November 30, 2005.

16. Medicare Spending and Financing, The Henry J Kaiser Founda- tion Fact Sheet, June 2007.

17. Total expenditure for Medicaid in 2007 was $181.7 billion, repre- senting approximately 9% of the $2 trillion spent on healthcare annually in the United States. Ku L., “Medicaid costs are growing

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more slowly than costs for Medicare or private insurance,” Cen- ter on Budget and Policy Priorities, Nov. 13, 2006.

18. Gene Matthews, Ernest Abbott, Legal Authorities for Interven- tions in Public Health Emergencies, Law in Public Health Practice, 2nd Ed., Oxford Press, 2006.; Lawrence Gostin, Restrictions of the Person: Autonomy, Liberty, and Bodily Integrity, in Public Health Law, University of California Press, 2000.

19. 45 C.F.R. § 164.510. 20. 45 C.F.R. § 164 et seq. 21. Id. 22. 45 C.F.R. § 164.512(b). 23. CA Civil Code § 56.10. 24. 45 C.F.R. § 164.510(b)(3). 25. 45 C.F.R. § 164.510(b)(4). 26. CA Civil Code § 56.10(c)(15). 27. Arkansas C.A § 20–27–1706: “Pursuant to the Health Insurance

Portability and Accountability Act of 1996, disclosure of pro- tected health information is allowed for public health, safety, and law enforcement purposes.”

28. Beverly Cohen, RECONCILING THE HIPAA PRIVACY RULE WITH STATE LAWS REGULATING EX PARTE INTERVIEWS OF PLAINTIFFS’ TREATING PHYSICIANS: A GUIDE TO PERFORMING HIPAA PREEMPTION ANALYSIS, 43 Hous. L. Rev. 1091 (2006).

29. California Probate Code § 4717. 30. 6 U.S.C. § 774. 31. 45 C.F.R. § 164.512(f)(2). Disclosure to law enforcement officials

is also authorized where it is pursuant to a court subpoena or order. 45 CFR § 164.512(f)(l)(ii).

32. 45 C.F.R. § 164.512. 33. 45 C.F.R. §164.515 Accounting for disclosures of protected

health information. 34. 45 C.F.R. § 164.512. 35. 45 CFR § 160.103. 36. 22 Cal. Code Regs. § 70751 et seq. 37. Health and Safety Code § 123149. 38. Leavitt Mike, Secretary of the Department of Health and Human

Services, “Waiver Under Section 1135 of the Social Security Act,” September 4, 2005. Available at: http://www.hhs.gov/katrina/ ssawaiver.html.

39. http://www.hhs.gov/hipaafaq/providers/hipaa-1068.html. Accessed November 25, 2008.

40. Parmet, Wendy. Individual Rights versus the Public’s Health – 100 Years After Jacobson v. Massachusetts. N Engl J Med 352; 7. (2005).

41. Jacobson v. Massachusetts, 197 U.S. 11, 25 S.Ct. 358 (1905). 42. Id. 43. Best v. Bellevue Hospital New York. 115 Fed.Appx. 459. C.A.2

(N.Y.), 2004. After this two year saga, the federal court declared that in order to detain a patient under the health code, New York had to comply with both procedural due process (“the right to a particularized assessment of an individual’s danger to self or others”) and substantive due process (“the right to less restrictive alternatives”).

44. Id. 45. Kirk v. Wyman, 83 S.C. 372 at 394 (1909)(dissenting). 46. Wellman v. Faulkner, 715 F.2d 269, In this case, the judge held

that inadequate medical care and overcrowding in prison was unconstitutional.

47. Best v. Bellevue Hospital New York. 48. The Georgia provision was adopted after review of the Model

State Emergency Health Powers Act. 49. In, Moore v. Morgan, C.A.11 (Ala.) 1991, 922 F.2d 1553, County

failed to satisfy constitutional responsibility in maintaining county jail by delay in rectifying overcrowded conditions and

was held liable for damages, as provided under 42 U.S.C. § 1983 and U.S.Const.amend.VIII.

50. Joint Commission MS 4.110. 51. In disasters other than minor ones, the declaration also con-

stitutes authority for medical practitioners licensed in other jurisdictions to practice in Florida, subject to such conditions as the declaration may prescribe. FLA. Stat. 252.36(3)(c)(1) (2004).

52. California Emergency Services Act § 8850 et seq. 53. JCAHO Standard M.S.4.110 (amended January 2004). 54. Id. 55. Id. 56. D.C. HOSPITAL ASSOCIATION, MUTUAL AID MEMORAN-

DUM OF UNDERSTANDING 6–10 (Sept 27, 2001), available at http://www.dcha.org/EP/dchamou.pdf. 22 J. Contemp. Health L. & Policy 5.

57. Leavitt Mike, Secretary of the Department of Health and Human Services, “Waiver Under Section 1135 of the Social Security Act,” September 4, 2005. Available at: http://www.hhs. gov/katrina/ssawaiver.html.

58. The National Fire Protection Association (NFPA) § 1600 pro- vides disaster and emergency management and business con- tinuity programs the criteria to assess current programs or to develop, implement, and maintain aspects for prevention, mit- igation, preparation, response, and recovery from emergencies. Voluntary private sector compliance with NFPA § 1600 recom- mendations was strongly encouraged by the U.S. Congress in passing in the 9/11 bill, P.L. 110–53, 6 U.S.C 321k. However, Joint Commission standards supersede any NFPA recommen- dations.

59. SOM, Appendix A, Interpretive Guidelines for Hospitals (guid- ance for § 482.41) and Appendix W. Interpretive Guidelines for Critical Access Hospitals (§ 485.623).

60. Id. 61. 29 U.S.C § 651 62. Title 22, Cal. Code Regs. §§ 7(a), 71539(a), and 72551. 63. Id. 64. Centers for Medicare & Medicaid Services, Department of

Health and Human Services. Medicare Program: Clarifying Poli- cies Related to the Responsibilities of Medicare-Participating hospitals in Treating Individuals with Emergency Medical Con- ditions, Federal Register. September 9, 2003, Vol. 68, No. 174.

65. 42 C.F.R. § 489.24. 66. 42 U.S.C. § 1320b-5 67. Leavitt M, Secretary of the Department of Health and Human

Services, “Waiver Under Section 1135 of the Social Secu- rity Act,” September 4, 2005. Available at: http://www.hhs. gov/katrina/ssawaiver.html.

68. Hassol A., Zane R., Reopening Shuttered Hospitals to Expand Surge Capacity; Bioterrorism and Other Public Health Emergen- cies –Tools and Models for Planning and Preparedness, February 2006.

69. HSPD 5. Available at: http://www.whitehouse.gov/news/ releases/2003/02/20030228–9.html.

70. HSPD 8. Available at: http://www.whitehouse.gov/news/ releases/2003/12/20031217–6.html.

71. Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Pub. L. No. 107–88, 116 Stat. 594; see also Pandemic Flu and All-Hazards Preparedness Act, Pub.L. No. 109–417.

72. FY 2007 budget allocates $3.393 billion state and local govern- ments for disaster preparedness.

73. 42 USCA § 5122. 74. For example in FEMA Document 508–5, “Typed Resource Def-

initions, Health and Medical Resources (May 2005 – available

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as of April 2007 at http://www.fema.gov/pdf/emergency/nims/ 508–5 health medical resources.pdf .)

75. P.L. 93–288, as amended, 42 USC §§ 5121–5206 and related authorities.

76. FEMA Recovery Policy 9524, available at http://www.fema.gov/ government/grant/pa/9525 4.shtm.

77. Id. 78. 44 CFR Part 13, “Uniform Administrative Requirements

for Grants and Cooperative Agreements to State and Local Governments.”

79. 44 CFR § 13.36. 80. Ga. Code Ann., § 38–3–51. In California the statute is even

broader: it provides that the Governor may “commandeer or utilize any private property or personnel deemed by him neces- sary in carrying out his responsibilities and the state shall pay the reasonable value thereof.” California Emergency Services Act, GC § 8572. The power granted to commandeer personnel is unusual in emergency management statutes, and the limita- tions on exercise of this authority are unclear.

81. E.g., HSPD 5, HSPD 8. 82. California Emergency Services Act, GC § 8571. 83. A. Bragg, “Experiencing the 2004 Florida Hurricanes: A Lawyers

Perspective,” in E. Abbott and O. Hetzel, A Legal Guide

to Homeland Security and Emergency Management for state and Local Governments, (ABA Press 2005).

84. Journal of Law, Medicine, and Ethics, Supplement to Volume 36, available at http://www.aslme.org/cdc/.

85. Emile F. Chang MSC, Howard Backer MD, Tareg A. Bey MD, and Kristi L. Koenig MD (2008) “Maximizing Medical and Health Outcomes after a Catastrophic Disaster: Defining a New “Crisis Standard of Care,” Western Journal of Emer- gency Medicine: Vol. 9: No. 3, Article 18. Available at: http:// repositories.cdlib.org/uciem/westjem/vol9/iss3/art18. Accessed November 25, 2008.

86. “American Lawyers” Public Information Series; Community panflu preparedness: A checklist of key legal issues for health- care providers; 2008 American Health Lawyers Association, pg. 20, footnote 45. Available at: www.healthlawyers.org/ panfluchecklist. Accessed November 25, 2008.

87. A “Table Top” is so named because it does not try to recreate an emergency event by simulating the event and actually deploying response resources (ambulances, helicopters, doctors, nurses, and so forth), rather a scenario is presented to participants rep- resenting their organizations. These participants – perhaps while sitting around a table – think through and describe how they would respond to an event and interact with other organizations.

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