The Secretary of the Department of Health and Human Services (HHS) may, under section 319 of the Public Health Service (PHS) Act determine that: a) a disease or disorder presents a public health emergency; or b) that a public health emergency, including significant outbreaks of infectious disease or bioterrorist attacks, otherwise exists. Duration and Notification:
The declaration lasts for the duration emergency or 90 days, but may be extended by the Secretary. Congress must be notified of the declaration within 48 hours, and relevant agencies, including the Department of Homeland Security, Department of Justice, and Federal Bureau of Investigation, must be kept informed.
Prior to issuing the declaration, the Secretary should consult with public health officials as necessary.
Following a section 319 declaration, the Secretary can:
- Take appropriate actions in response to the emergency, including: making grants; entering into contracts; and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder.
- Access “no-year” funds appropriated to the Public Health Emergency Fund (when funds are so appropriated). The Secretary must report to Congress 90 days after the end of the fiscal year about any funds spent from the Public Health Emergency Fund, the emergency for which funds were spent, and activities undertaken with respect to the emergency. Public Health Emergency Funds supplement, and do not supplant, other Federal, State, and local funds provided for public health grants, awards, contracts, and investigations.
- Grant extensions or waive sanctions relating to submission of data or reports required under laws administered by the Secretary, when the Secretary determines that, wholly or partially as a result of a public health emergency, individuals or public or private entities are unable to comply with deadlines for such data or reports. The Secretary must notify Congress and publish a Federal Register notice before or promptly after granting an extension or waiver.
- Waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP) and Health Insurance Portability and Accountability Act (HIPAA) requirements. Under section 1135 of the Social Security Act (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 health care items and services are available to meet the needs of individuals enrolled in SSA programs (including Medicare, Medicaid, and CHIP) and that providers of such services in good faith who are unable to comply with certain statutory requirements are reimbursed and 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.
- 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 reimbursement rate. In the case of a public health emergency 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. As of April 2013, CMS has not formally interpreted, nor exercised, this authority. However, in the event of a public health emergency in which this authority were triggered, the price change could be implemented without rulemaking. (See Section 1847A(c)(5)(C) of the Social Security Act, which states that notwithstanding any other provision of law, the Secretary may implement any of the provisions of Section 1847A by program instruction or otherwise.)
- Make temporary (up to one year or the duration of the emergency) appointments of personnel to positions that directly respond to the public health emergency when the urgency of filling positions prohibits examining applicants through the competitive process.
- Waive certain Ryan White HIV/AIDS program requirements (section 2683 of the PHS Act). Under this authority, up to five percent of the funds available under each of the Parts A and B base supplemental pools may be shifted to ensure access to care during a public health emergency declared by the Secretary under section 319 of the PHS Act or an emergency or disaster declared by the President under the Stafford Act or the National Emergencies Act in the geographic area where the emergency, major disaster, or public health emergency exists. In addition, the Secretary may waive such requirements of title XXVI of the PHS Act 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 public health emergency declaration exists.
- Waive dual compensation (salary offset) for temporarily re-employed annuitants during a public health emergency declared by the Secretary or national emergency declared by the President (see above) involving a direct threat to life or property or other unusual circumstances.
- 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 and use of controlled substances during a public health emergency declared by the Secretary.
- 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.
- 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.