Status of Public Health Emergency Authorities
GAO-18-685R: Published: Sep 26, 2018. Publicly Released: Oct 23, 2018.
Over 42,000 people died from opioid overdoses in 2016, according to the Department of Health and Human Services (HHS). Partly due to this, HHS declared the opioid crisis a public health emergency on October 26, 2017. This declaration allows HHS some leeway to conduct certain activities in response to the opioid crisis.
For example, we found that HHS waived the public notice period for approval of two state Medicaid demonstration projects related to treatments for substance use disorders to speed up implementation of these projects. These demonstrations allow states to test and evaluate new approaches for delivering services within Medicaid.
Prescription and Illicit Opioids
Photo showing pills spilling out of a prescription bottle next to a syringe and lines of white powder.
What GAO Found
The Acting Secretary of Health and Human Services declared a public health emergency for opioids on October 26, 2017, and the declaration was renewed on January 19, 2018. According to Department of Health and Human Services (HHS) officials, the primary factors for the declaration and renewal were increasing rates of opioid-related deaths and opioid use disorder. Officials cited still-increasing rates of opioid-related deaths in 2017 for the declaration's renewal on April 20, 2018, as well as the consideration that a nationwide public health emergency underscores the urgency of ongoing federal, state, and local efforts to combat the opioid crisis. Further, HHS officials stated that renewing the public health emergency declaration provides HHS additional time to consider how the authorities that became available during the public health emergency might be used to supplement ongoing federal efforts. On July 19, 2018, the Secretary of HHS again renewed the declaration due to the continued consequences of the opioid crisis.
A public health emergency triggers the availability of certain authorities under federal law that allow the federal government to take actions such as waiving certain administrative requirements that may enhance or supplement other federal efforts. The federal government has launched a number of other initiatives to address the opioid crisis, and HHS issued an Opioid Strategy in April 2017 to guide the department's efforts.
The federal government has used 3 available authorities since declaring the public health emergency for the opioid crisis. First, HHS used a Paperwork Reduction Act waiver authority that, according to HHS officials, allowed the agency to quickly field a survey of more than 13,000 providers to assess prescribing trends for a medication used to treat opioid use disorder and any barriers to prescribing it. As of April 2018, officials reported receiving over 5,000 responses and told GAO the results of the survey will inform policy and programmatic decisions related to increasing access to treatment. Second, HHS used an authority to waive the public notice period for approval of two state Medicaid demonstration projects related to substance use disorder treatment, which was intended to speed up implementation of the projects. These demonstrations allow states to test and evaluate new approaches for delivering services in the Medicaid program, which finances health care coverage for low-income and medically needy populations. Third, HHS took steps to expedite support for research on opioid use disorder treatments and to disseminate information on opioid misuse and addiction, as required by another authority.
In addition to these 3 authorities, GAO identified 14 other authorities that become available when there is a public health emergency, and which have not been used. According to HHS officials, these additional authorities have not been used for a variety of reasons. For example, HHS officials determined that many are not relevant to the circumstances presented by the opioid crisis. Some of these authorities have been used during previous public health emergency declarations for infectious disease outbreaks, such as the Zika virus, and for public health emergencies resulting from hurricanes, such as Hurricane Maria in Puerto Rico. Officials told GAO they will continue to review the authorities as the opioid crisis evolves and in the context of HHS's other efforts to address the opioid crisis.
GAO provided a draft of this report to HHS, the Department of Justice (Justice), and the Department of Labor (Labor) for comment. HHS and Labor provided technical comments, which we incorporated as appropriate. Justice told us that they did not have any comments.
Why GAO Did This Study
Opioid misuse and related deaths are a serious, growing public health problem in the United States. According to HHS's Centers for Disease Control and Prevention (CDC), over 42,000 people died from opioid-involved overdoses in 2016. On October 26, 2017, the Acting Secretary of HHS declared the opioid crisis a public health emergency under section 319 of the Public Health Service Act--the first time such a declaration has been made for opioids.
GAO was asked to review the decision to declare a public health emergency for the opioid crisis and what actions have been taken under the declaration. This report describes: (1) the factors HHS indicated as affecting its decision to declare and renew the public health emergency for the opioid crisis, and (2) the public health emergency authorities the federal government has used to address the opioid crisis.
GAO reviewed HHS statements and decision documents and interviewed federal officials about the basis for declaring a public health emergency for the opioid crisis. GAO reviewed statutory and regulatory provisions to identify the authorities that become available during a public health emergency. GAO also reviewed HHS, Justice, and Labor documents and interviewed agency officials to determine which authorities were used to address the crisis and reasons some authorities were not used. This report focuses on public health emergency authorities and does not examine other federal efforts to combat the opioid crisis.
For more information, contact Mary Denigan-Macauley at (202) 512-7114 or DeniganMacauleyM@gao.gov.