Public Health Emergency - Leading a Nation Prepared
Under section 319 of the Public Health Service (PHS) Act, the Secretary of the Department of Health and Human Services can declare a Public Health Emergency (PHE) if he determines, after consulting with such public health officials as may be necessary, that 1) a disease or disorder presents a PHE, or 2) a PHE, including significant outbreaks of infectious diseases or bioterrorist attacks, otherwise exists. A PHE declaration allows the Secretary to take certain actions in response to the PHE. In addition, a public health emergency can be a necessary step in authorizing the Secretary to take a variety of discretionary actions to respond to the PHE under the statutes HHS administers.
Questions have arisen from states, political subdivisions, and the healthcare community regarding PHE declarations. The following is not an exhaustive review of section 319 of the PHS Act or of PHE declarations in all contexts, nor a protocol for the Department of Health and Human Services’ (HHS) implementation of a PHE declaration.
Under section 319 of the PHS Act, when the Secretary has declared a PHE, consistent with his other statutory authorities, he can take such action as may be appropriate to respond to the PHE including making grants; entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder. The Secretary may also, upon request of the recipient of such award and subject to corresponding reductions in payments, provide supplies, equipment, and services, and detail employees of the Department to the recipient to aid the recipient in carrying out the award. In addition, the Secretary may access funds appropriated to the Public Health Emergency Fund (although currently there are no funds appropriated to this Fund). Finally, the Secretary may grant extensions or waive sanctions relating to submission of data or reports required under HHS laws, when the Secretary determines that as a result of the PHE, individuals or public or private entities are unable to comply with deadlines for such data or reports.
A PHE declaration can be a necessary step in enabling the Secretary to take a variety of discretionary actions to respond to the PHE. Certain authorities have been added to the PHS Act; the Social Security Act (SSA); and other laws administered by the Secretary that permit the Secretary to take certain actions when he has declared a PHE under section 319 of the PHS Act.
For example, the Secretary may:
The Secretary may exercise his authority under section 1135 of the SSA (“1135 waiver”) to temporarily waive or modify certain Medicare, Medicaid, CHIP, and HIPAA requirements in an emergency area during the emergency period. An emergency area and period is where and when there is: a) an emergency or disaster declared by the President pursuant to the National Emergencies Act or the Stafford Act, and b) a PHE declared by the Secretary.
Under section 1135 of the SSA, the following Medicare, Medicaid, CHIP, and HIPAA Privacy Rule requirements may be waived or modified:
No, in past practice when the Secretary has issued an 1135 waiver, the Medicare, Medicaid, and CHIP requirements that may be waived or modified under that 1135 waiver are not automatically waived or modified. Rather, CMS receives requests from affected hospitals, healthcare facilities, and healthcare providers for waivers or modifications of specific requirements and issues instructions or guidance as needed. CMS reviews such requests and generally approves the requested waivers or modifications on a case by case basis. Regardless of whether the Secretary has made a formal PHE 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 flexibilities that may be implemented as appropriate to address an emergency or disaster. CMS works closely with affected hospitals, healthcare facilities, and healthcare providers during such situations to address their concerns.
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’ current practice is to automatically waive such sanctions and penalties described in the 1135 waiver in the emergency area for 72 hours beginning on implementation of a hospital disaster protocol. The waiver of HIPAA Privacy Rule 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. Also, the waiver only applies if the hospital has implemented its hospital disaster protocol. The HIPAA sanctions and penalties that may be waived when an 1135 waiver is issued are specified in the 1135 waiver document. An 1135 waiver does not waive HIPAA in its entirety. Even without an 1135 waiver, there are various flexibilities and exceptions that may apply to permit covered entities to share protected health information during a PHE.
Please see Disclosure for Emergency Preparedness for more information about the application of HIPAA during public health emergencies (whether or not the Secretary makes a formal PHE declaration under section 319 of the PHS Act, or issues an 1135 waiver).
Waivers or modifications under section 1135 of the SSA may be retroactive to the beginning of the emergency period (or to any subsequent date). The waiver or modification terminates either upon termination of the emergency period or 60 days after the waiver or modification is first published (subject to 60-day renewal periods until termination of the emergency). However, waivers of EMTALA (except in the case of a pandemic disease) or HIPAA requirements are effective only for 72 hours beginning on implementation of a hospital disaster protocol. A waiver of EMTALA sanctions in connection with an emergency involving a pandemic disease (such as pandemic influenza) is effective until the termination of the pandemic-related public health emergency. However, a particular waiver or modification will terminate prior to the ultimate termination date described in this paragraph (e.g., prior to the 72 hour time period after a hospital begins to implement its disaster protocol) 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).
A PHE declaration lasts until the Secretary declares that the PHE no longer exists or upon the expiration of the 90-day period beginning on the date the Secretary declared a PHE exists, whichever occurs first. The Secretary may extend the PHE declaration for subsequent 90-day periods for as long as the PHE continues to exist, and may terminate the declaration whenever he determines that the PHE has ceased to exist.
Even without a PHE declaration, the Secretary has broad legal authority to provide assistance to states and to conduct research studies. For example, under section 301 of the PHS Act, the Secretary has broad authority to render assistance and promote research, investigations, demonstrations, and studies into the causes, diagnosis, treatment, control, and prevention of physical and mental diseases and impairments of man. Similarly, under section 311 of the PHS Act, the Secretary is authorized to assist states and their political subdivisions in the prevention and suppression of communicable diseases and to develop (and take necessary actions to implement) a plan under which personnel, equipment, medical supplies, and other resources of the Public Health Service and other agencies under the jurisdiction of the Secretary may be effectively used to control the epidemics of any disease or condition and to meet other health emergencies or problems. The Secretary may also activate the National Disaster Medical System under section 2812 of the PHS Act and deploy the Strategic National Stockpile under section 319F-2 of the PHS Act without a PHE declaration. For more information on actions the Secretary can take without a PHE declaration, see (insert link to page list the Secretary’s authority when he has not declared a PHE).
No, a PHE declaration does not waive or preempt state licensing requirements. States determine whether and under what circumstances a non-federal healthcare provider is authorized to provide services in the state without state licensure.
As discussed in response #4 above, when the Secretary issues an 1135 waiver, the Secretary may waive Medicare, Medicaid, or CHIP requirements that physicians and other health care professionals hold licenses in the State in which they provide services. This would be for Medicare, Medicaid, or CHIP reimbursement purposes only, and would apply only if the physicians or other health care providers have an equivalent license from another state (and are not affirmatively barred from practice in any state in the emergency area).
No, a PHE declaration is not needed for the Secretary to authorize emergency use of medical countermeasures. The Secretary must issue a different declaration to authorize the Federal Food and Drug Administration to issue an Emergency Use Authorization (EUA) for an unapproved drug, biological product, or device or unapproved use of a drug, biological product, or device. The Secretary must declare that the emergency circumstances justify such authorization based on one of the following:
No, under the PREP Act, codified at sections 319F-3 and 319F-4 of the PHS Act,, the Secretary may issue a declaration that provides liability immunity (except for willful misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration and use of countermeasures to diseases, threats, and conditions determined by the Secretary to constitute a present or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.
A PREP Act declaration is different from a PHE. The declarations are made on different public health determinations and have different legal effects. A PREP Act Declaration may be made in advance of a public health emergency and may provide liability immunity for activities both before and after a declared public health emergency. A separate declaration under section 319 or other statutes is not needed for immunity under the PREP Act to take effect unless the PREP Act declaration states that a public health or other emergency declaration is needed to trigger immunity. For more information about the PREP Act, please see Public Readiness and Emergency Preparedness Q&As.
No, there is no requirement under section 319 of the PHS Act, nor under section 1135 of the SSA that a state or other entity make a formal request for a PHE declaration or an 1135 waiver. When state or local officials believe that a PHE declaration and 1135 waivers are needed to assist the response to a particular event, HHS encourages them to work with the HHS Regional Emergency Coordinator at the HHS regional office in their area who can help facilitate the request. Hospitals, healthcare entities, and healthcare providers who have concerns about Medicare, Medicaid, and CHIP requirements should contact the CMS regional office in their area who can help address such concerns.
No, the statutory language in section 319 of the PHS Act does not address a “potential” or threat of a PHE. However, the Secretary has the discretion to determine that a disease or condition “presents” a PHE or a PHE otherwise exists, based on conditions that exist prior to the actual outbreak of disease or natural catastrophe. For example, the Secretary may declare a PHE based on emergency needs that exist preceding the outbreak of disease or in anticipation of a storm before a hurricane makes landfall.
The Secretary may also determine that a disease or disorder, including a novel and emerging public health threat, is significantly likely to become a public health emergency for purposes of waiving the PRA, as discussed under question #2 above.
A PHE declaration under section 319 of the PHS Act and a Presidential declaration of an emergency or disaster under the Stafford Act are distinct and separate declarations. When an incident overwhelms or is anticipated to overwhelm state or tribal resources, the Governor of an affected state or a Chief Executive of an affected Indian tribe, may request federal assistance, including assistance under the Stafford Act. The Stafford Act authorizes the President to provide financial and other assistance to state, local, and tribal governments, certain private nonprofit organizations, and individuals to support response, recovery, and mitigation efforts following Presidential emergency or disaster declarations.
The Stafford Act is triggered by a Presidential declaration of a major disaster or emergency, when an event causes damages of sufficient severity and magnitude to warrant federal disaster assistance to supplement the efforts and available resources of states, local, and tribal governments, and the disaster relief organizations in alleviating the damage, loss, hardship, or suffering. Most incidents are not of sufficient magnitude to warrant a Presidential declaration. However, if state and local resources are insufficient, a Governor or Chief Executive of an affected Indian tribe may ask the President to make such a declaration. Ordinarily only a Governor or a Chief Executive of an affected Indian tribe can initiate a request for a Presidential emergency or major disaster declaration. In extraordinary circumstances, the President may unilaterally declare an emergency.
Unlike a Presidential declaration of a major disaster or emergency under the Stafford Act which ordinarily requires a formal request by a state Governor or a Chief Executive of an affected Indian tribe, there is no requirement that a Governor, Chief Executive of an affected Indian tribe, or other entity make a formal request in order for the Secretary to declare a PHE under section 319 of the PHS Act. The President may declare a major disaster or emergency under the Stafford Act in the absence of a Secretarial declaration of a PHE under section 319 of the PHS Act. Likewise, the Secretary of HHS may declare a PHE under section 319 of the PHS Act in the absence of a Presidential declaration under the Stafford Act.
While a Presidential declaration under the Stafford Act and a Secretarial declaration of a PHE are separate declarations, sometimes a Stafford Act declaration is required in order for the Secretary to exercise certain authorities. For example, as discussed in the response to item #3 above, in order for the Secretary to exercise his waiver authority under section 1135 of the SSA to temporarily waive or modify certain Medicare, Medicaid, CHIP, and HIPAA Privacy Rule requirements, there must be a PHE declaration in place, as well as a Presidential declaration of a major disaster or emergency pursuant to the Stafford Act (or the National Emergencies Act).
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