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.
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What actions may the Secretary take under section 319 of the PHS Act when he declares a PHE?
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 use funds appropriated to the Public Health Emergency Fund (when funds are appropriated to this Fund) to immediately respond to the PHE or a potential PHE by facilitating coordination among Federal, State, local, Tribal and territorial entities and public and private health care entities; making awards; supporting advanced research and development and biosurveillance; supporting initial emergency operations related to preparation and deployment of NDMS teams, and other actions determined appropriate and applicable by the Secretary. 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.
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What other discretionary actions may the Secretary take to respond to a PHE that require a PHE declaration?
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:
- Waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP), and Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule requirements. Under section 1135 of the SSA, the Secretary may waive or modify certain requirements as necessary to ensure to the maximum extent feasible that, in an emergency area during an emergency period, sufficient healthcare items and services are available to meet the needs of individuals enrolled Medicare, Medicaid, and CHIP and that providers of such services in good faith who are unable to comply with certain statutory requirements are nonetheless reimbursed and exempted from sanctions for noncompliance, absent fraud or abuse. There must also be a Presidential declaration of an emergency or disaster in order to exercise this authority. See the response to items 3-6 below for details about this authority.
- Adjust Medicare reimbursement for certain Part B drugs. Most Medicare Part B drugs are paid on the basis of the manufacturer’s average sales price (ASP), which manufacturers are required to report quarterly. The ASP-based payment allowance is updated prospectively each quarter, using the data manufacturers report. The statutory scheme results in a two-quarter lag between the date of the reported sale and the date that sale’s price is factored into the Medicare payment rate. In the case of a PHE in which there is a documented inability to access drugs and biologicals and a concomitant increase in the price of a drug or biological that is not reflected in the manufacturer’s ASP for one or more quarters, the Secretary may use the wholesale acquisition cost or other reasonable measure of drug or biological price instead of the manufacturer’s ASP. The substituted price or measure may be used until the price of the drug or biological has stabilized and is substantially reflected in the manufacturer’s ASP.
- Enable the Centers for Disease Control and Prevention Director to access the Infectious Diseases Rapid Response Reserve Fund (when funds are so appropriated) to prevent, prepare for, or respond to an infectious disease emergency, either when the Secretary has declared a public health emergency or when the Secretary determines that the emergency has significant potential to imminently occur and potential on occurrence, to affect national security or the health and security of US citizens, domestically, or internationally.
- Waive certain Ryan White HIV/AIDS grant program requirements. Under section 2683 of the PHS Act, up to five percent of the funds available under each of the Parts A and B supplemental pools may be shifted to ensure access to care during the time period when the Secretary declares a PHE or when the President declares an emergency or major disaster under the Robert T. Stafford Disaster Relief and Emergency Assistance Act (“Stafford Act”) or the National Emergencies Act in the geographic area where the emergency, major disaster, or PHE exists. In addition, the Secretary may waive such requirements of title XXVI of the PHS Act, which addresses health care services related to HIV infection, to improve the health and safety of those receiving care under this title and the general public. This waiver authority is limited to the time period for which the emergency, major disaster, or PHE declaration exists.
- Make temporary (up to one year or the duration of the emergency) appointments of personnel to positions that directly respond to the PHE when the urgency of filling positions prohibits examining applicants through the competitive process. The Secretary may also waive dual compensation (salary offset) for temporarily re-employed annuitants during the time period when the Secretary declares a PHE or the President declares a national emergency involving a direct threat to life or property or other unusual circumstances.
- Use funds from the fiscal year 2019 appropriation to HHS that are available for salaries and expenses of HHS employees to pay travel and related expenses of an employee or family member when the employee is assigned to duty in the U.S. or in a U.S. territory during a period and in a location that are the subject of a public health emergency declaration, and travel is necessary to obtain medical care for an illness, injury, or medical condition that cannot be adequately addressed in that location at that time.
- Modify practice of telemedicine. The Ryan Haight Online Pharmacy Consumer Protection Act and implementing regulations allow the Secretary, with concurrence of the DEA Administrator, to designate patients, location of patients, and use of controlled substances during a public health emergency declared by the Secretary.
- Enable the Secretary of Defense, in consultation with the Secretary, to deploy military trauma care providers providing care at high-acuity trauma centers pursuant to grants awarded under section 1291 of the PHS Act.
- Grant an extension or waive application deadlines or compliance with any other requirement of certain SAMHSA grants, on a State by State basis, as the circumstances of the emergency reasonably require and for the period of the emergency. Such grants include those authorized under sections 521, 1911, or 1921 of the PHS Act. This authority also applies to allotments authorized under Public Law 99-319.
- Allow State and local governments to access the General Services Administration (GSA) Federal supply schedule when using federal grant funds. GSA policy allows state, local, and tribal government grantees to use federal supply schedules to respond to public health emergencies declared by the Secretary. Pursuant to 48 U.S.C. § 1469e as amended, Puerto Rico, Guam, American Samoa, the Commonwealth of the Northern Mariana Islands, and the U.S. Virgin Islands may always buy off of the GSA schedules regardless of whether there is a declared PHE.
- Temporary reassignment of state and local personnel. The Secretary may authorize a requesting Governor of a state or tribal organization to temporarily reassign state and local public health department or agency personnel funded in whole or in part through programs authorized under the PHS Act to immediately address a public health emergency in the state or Indian tribe during the period of the emergency.
- Limit liability of health care professionals who are members of the Medical Reserve Corps or professionals included in the Emergency System for Advance Registration of Volunteer Health Professionals responding to a PHE in the initial 90 days so that such professionals shall be subject only to the State liability laws in which the professional has been deployed to respond to the PHE and only to the extent permitted under the laws of the State in which care is provided.
- Determine a waiver of Paperwork Reduction Act (PRA) requirements is necessary. Section 319(f), recently added by the 21st Century Cures Act, allows the Secretary to determine that the circumstances of a PHE or a disease or disorder, including a novel and emerging public health threat that is significantly likely to become a PHE, necessitate a waiver from PRA requirements. If the Secretary makes such a determination, then PRA requirements for voluntary collection of information do not apply during the immediate investigation of, and response to the PHE during the period of the PHE or the time period necessary to determine if a disease or disorder, including a novel and emerging public health threat, will become a PHE.
- Waive certain requirements of the Drug Supply Chain Security Act (DSCSA). A public health emergency is considered an “emergency medical reason” under the DSCSA, 21 U.S.C. 360eee. Thus, upon the Secretary’s declaration of a public health emergency, certain activities are automatically excluded through the time period of the declaration. Notably, product distribution for such emergency medical reasons is excluded from the DSCSA definitions of “transaction” and “wholesale distribution.” Therefore, the DSCSA requirements related to product tracing and wholesale distribution do not apply to trading partner activities that address the public health emergency declaration.
- Allow the Department of Labor (DOL) to issue dislocated worker program grants for disaster relief employment pursuant to 29 U.S.C. § 3225. A federal agency emergency or disaster declaration or a Stafford Act declaration triggers an opportunity for eligible entities to apply for disaster relief employment National Dislocated Worker Grants. In order for a federal agency declaration to trigger this authority, the chief official of a federal agency with authority for or jurisdiction over the federal response must declare or otherwise recognize an emergency or disaster situation of national significance that could result in a potentially large loss of employment.
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In addition to a PHE declaration, what other conditions are necessary for the Secretary to waive or modify certain Medicare, Medicaid, CHIP, and HIPAA Privacy Rule requirements under section 1135 of the SSA?
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.
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When the Secretary issues an 1135 waiver, what Medicare, Medicaid, CHIP, and HIPAA Privacy Rule requirements may be temporarily waived or modified?
Under section 1135 of the SSA, the following Medicare, Medicaid, CHIP, and HIPAA Privacy Rule requirements may be waived or modified:
- Certain conditions of participation, certification requirements, program participation, or similar requirements for individual healthcare providers or types of health care providers, and pre-approval requirements.
- Requirements that physicians and other health care professionals 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 (note however, that this waiver is for the purposes of Medicare, Medicaid, and CHIP reimbursement only – states determine whether a non-federal provider is authorized to provide services in the state without state licensure).
- Sanctions under the Emergency Medical Treatment and Labor Act (EMTALA) for direction or relocation of an individual to another location to receive medical screening pursuant to an appropriate state emergency preparedness plan or a state pandemic preparedness plan or for the transfer of an individual who has not been stabilized if the transfer is necessitated by the circumstances of the declared federal public health emergency. A waiver of EMTALA sanctions 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. EMTALA waivers are subject to special time limits. See question 6 for more information.
- Sanctions under section 1877(g) (Stark) relating to limitations on physician referral under such conditions and in such circumstances as the Centers for Medicare & Medicaid Services (CMS) determines appropriate.
- Deadlines and time tables for performance of required activities to allow timing of such deadlines to be modified.
- Limitations on payments for health care items and services to permit Medicare Advantage plan enrollees to use out-of-network providers in an emergency situation. To the extent possible, the Secretary must reconcile payments so that enrollees do not pay additional charges and so that the plan pays for services included in the capitation payment.
- Sanctions and penalties arising from noncompliance with HIPAA privacy regulations relating to: a) obtaining a patient’s agreement to speak with family members or friends or honoring a patient’s request to opt out of the facility directory; b) distributing a notice of privacy practices; or c) the patient’s right to request privacy restrictions or confidential communications. The waiver of HIPAA requirements is effective only if actions under the waiver do not discriminate on the basis of a patient’s source of payment or ability to pay. These HIPAA waivers under are subject to special time limits. See question 6 for more information.
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If the Secretary issues an 1135 waiver, are the Medicare, Medicaid, CHIP, and HIPAA Privacy Rule requirements listed above automatically waived or modified upon issuance of the 1135 waiver document?
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).
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When the Secretary waives or modifies certain Medicare, Medicaid, CHIP, and/or HIPAA Privacy Rule requirements under section 1135 of the SSA, how long are such waivers or modifications applicable?
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).
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How long does a PHE declaration last?
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.
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Is a PHE declaration required in order for HHS to provide assistance to states and political subdivisions during a PHE or other incident?
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).
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Does a PHE declaration waive or preempt state licensing requirements for healthcare providers?
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).
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Is a PHE required for the Secretary to authorize emergency use of medical countermeasures against pandemic, epidemic, or biological, chemical, radiological, nuclear, or chemical threats?
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:
- A determination by the Secretary of Homeland Security that there is an actual or significant potential for a domestic emergency involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent(s);
- A determination by the Secretary of Homeland Security of a material threat of a chemical, biological, radiological, or nuclear agent sufficient to affect national security or the health and security of United States citizens living abroad.
- A determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, of attack with (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces.
- His own determination that there is a public health emergency, or a significant potential for a public health emergency that affects, or has significant potential to affect, national security or the health and security of U.S. citizens living abroad and involves a biological, chemical, radiological, or nuclear agent(s) or a disease or condition that may be attributable to such agent(s).
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Is a PHE required for the Secretary to provide liability immunity under the Public Readiness and Emergency Preparedness (PREP) Act?
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.
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Does a state governor or other entity have to make a formal request for a PHE or for an 1135 waiver?
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.
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May the Secretary declare a “potential” PHE?
No, the statutory language in section 319(a) 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 determine that there is a significant potential for a PHE to access the Public Health Emergency Fund (when funds are so appropriated), and may enable the Centers for Disease Control and Prevention Director to access the Infectious Diseases Rapid Response Reserve Fund (when funds are so appropriated) as discussed under questions #1 and #2 above.
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.
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How does a PHE declaration relate to a Presidential declaration of an emergency or major disaster under the Stafford Act?
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).
