Zika Supplemental Funding: Status of HHS Agencies' Obligations, Disbursements, and the Activities Funded

Zika—a virus primarily transmitted through mosquito bites—can cause symptoms that include fever, rash, and joint and muscle pain. In pregnant women, the Zika virus can be passed to the fetus and cause severe brain defects. In response to an outbreak in the United States and its territories, Congress appropriated $932 million in September 2016 through the Zika Response and Preparedness Act to HHS and its agencies to prevent, prepare for, and respond to the Zika virus and its related health conditions, and conduct related research.

The act also included a provision that GAO study the activities supported with the appropriated funds. This report describes (1) the status of funds obligated and disbursed from the Zika supplemental funding appropriated to HHS and its agencies; and (2) how selected awardees used their Zika supplemental funding, and their experiences with applying for and managing the funding. To do this work, GAO reviewed agency documents on Zika supplemental funding and activities, and interviewed officials from the HHS agencies and selected awardees. To select awardees, GAO identified states based on the amount of initial Zika supplemental funding they received from CDC, the Centers for Medicare & Medicaid Services, and the Health Resources and Services Administration; and selected states with the highest and lowest funding. In total, GAO selected 12 awardees: 10 states, as well as one county and one city from 2 of the 10 states.

GAO provided a draft of this report to HHS. In response, HHS provided technical comments, which were incorporated as appropriate.

As of September 30, 2017, Department of Health and Human Services’ (HHS) agencies had obligated nearly all of the $932 million of Zika supplemental funding Congress appropriated in 2016 through the use of multiple funding mechanisms, including cooperative agreements, grants, and contracts. Four HHS agencies had small unobligated balances as of the September 30, 2017, obligation deadline; these balances cannot be used to incur new obligations, but may be used to adjust award amounts in future years. Disbursement of the obligated funds was ongoing, with about 21 percent of the Zika supplemental funding (approximately $195.5 million) disbursed as of December 31, 2017. The agencies have until September 30, 2022, to disburse the remainder.

The 12 awardees GAO interviewed—officials from 10 states and two local entities—funded multiple activities with their Zika supplemental funding, and had varying experiences applying for and managing the funds.

Awardees told GAO that they used their funding to support such activities as collection of information about individuals affected by the Zika virus (human surveillance), mosquito control activities, laboratory capacity building, public outreach, and health care services. For example, Florida used Zika supplemental funding in its state-run laboratories to purchase materials for testing Zika virus-related specimens.

A majority of the awardees GAO spoke with reported positive experiences applying for and managing the Zika supplemental funding, including good communication with agency officials and awardees’ familiarity with the mechanisms used to make the awards. However, some awardees noted challenges, such as time frames to use the funding that varied among multiple awards and identifying the activities that could be funded. These challenges added administrative burdens to applying for and managing the Zika supplemental funding while officials were responding to the outbreak, according to the awardees. In October 2017, the Centers for Disease Control and Prevention (CDC) issued a new notice of funding opportunity that agency officials said is intended to help minimize the administrative burden on states and certain localities during emergencies—such as preparing applications—by pre-approving public health departments in these jurisdictions to be eligible to rapidly receive future awards.

The Zika virus outbreak in 2015 affected individuals infected with the virus  in ways that had not been seen with other infectious disease outbreaks.  Zika—a virus primarily transmitted through mosquito bites—can cause  symptoms that include fever, rash, conjunctivitis (red eyes), and joint and  muscle pain, though many infected individuals do not have symptoms or  will only experience mild symptoms. However, in this outbreak, the Zika  infection in pregnant women has been linked to adverse pregnancy and  birth outcomes: the virus can be passed to the fetus and cause a birth  defect of the brain called microcephaly and other severe brain defects,  according to the Centers for Disease Control and Prevention (CDC).  CDC officials note that this is the first time in more than 50 years that an  infectious pathogen has been identified as the cause of birth defects. The  virus is also linked to other problems, such as miscarriage, stillbirth, and  other birth defects, as well as Guillain-Barré syndrome, an uncommon  sickness of the nervous system. In the western hemisphere, the first  cases of locally transmitted Zika virus disease were confirmed in Brazil in  May 2015; in the continental United States, the first locally transmitted  cases were confirmed in Florida during June to August 2016. The World  Health Organization declared the Zika virus a Public Health Emergency of  International Concern from February to November 2016, and maintains  that it is a significant, enduring public health challenge.

As of January 24, 2018, about 5,600 cases involving Zika virus disease  have been reported in the United States and about 37,000 cases have  been reported in the U.S. territories, primarily in Puerto Rico. In response  to the outbreak, Congress appropriated $932 million in September 2016  through the Zika Response and Preparedness Act to the Department of  Health and Human Services (HHS) and its agencies for activities such as  responding to the Zika virus, developing vaccines, and reimbursement for  health care costs related to the Zika virus. Specifically, the act  appropriated $394 million to CDC, $152 million to the National Institutes  of Health (NIH), and $387 million to HHS’s Public Health and Social  Services Emergency Fund (PHSSEF), of which $386 million was  allocated to additional HHS agencies—the Biomedical Advanced  Research and Development Authority (BARDA) within the Office of the  Assistant Secretary for Preparedness and Response, the Centers for  Medicare & Medicaid Services (CMS), and the Health Resources and  Services Administration (HRSA). The agencies had until September 30,  2017, to obligate the funding, for example, by awarding a contract or a  grant to an entity (awardee). Agencies have until September 30, 2022, to  disburse, or spend, the funding.

The Zika Response and Preparedness Act included a provision that we  study activities supported with funds appropriated by the act. In this  report, we describe  1.  the status of obligations and disbursements of Zika supplemental  funding by HHS agencies; and  2.  how selected awardees used their Zika supplemental funding, and  their experiences with applying for and managing the funding.

To describe the status of obligations and disbursements of Zika  supplemental funding by HHS agencies, we analyzed BARDA, CDC,  CMS, HRSA, and NIH obligation data as of September 30, 2017—the  date funding had to be obligated—and disbursement data as of  December 31, 2017—the first full quarter of data available at the time of  our review. Each agency provided tabulated data that included  information such as the award title, awardee name and location, award  amount, award time frame, and the funding mechanism the agency used  to award the funding. We interviewed officials from each agency to  discuss the status of the agencies’ obligations and disbursements of the  Zika supplemental funding, the different mechanisms used to award the  funding, and the various factors that influenced the obligation and  disbursement of the funding to awardees. We also reviewed  documentation of the funding opportunity announcements to obtain  information such as the activities allowed under each type of award. To  determine the reliability of the data provided, we compared the tabulated  award amounts received from CDC and HRSA to the actual notices of  award provided by both agencies, and compared NIH award data to the  amounts reported in NIH’s online database. We also obtained information  from BARDA, CMS, and NIH officials regarding the underlying financial  data systems used to compile the data and the controls in place for  recording and maintaining the data. We reviewed the data from each  agency for data discrepancies and obtained the information necessary to  resolve the discrepancies from relevant agency officials. Furthermore, we  interviewed officials from HHS’s Office of the Assistant Secretary for  Financial Resources on the accuracy of the data and the steps the office  takes to verify agencies’ obligation and disbursement data. On this basis,  we determined that the data were sufficiently reliable for the purposes of  our reporting objectives.

Additionally, to describe the various factors that can affect the  disbursement of funding after obligation, we interviewed officials  representing selected awardees. To select awardees, we first identified  states that were awarded Zika supplemental funding from HHS agencies  (45 states) based on our review of the amount of initial Zika supplemental  funding they received from CDC, CMS, and HRSA. From those 45 states,  we judgmentally selected 10 states—5 states with the highest funding  and 5 states with the lowest funding—which included the 2 states that  experienced local Zika virus transmissions (Florida and Texas). Our  selected states with the highest funding were Arizona, California, Florida,  Louisiana, and Texas. Our selected states with the lowest funding were  Alaska, Colorado, Iowa, Kansas, and Oklahoma. To obtain perspectives  of awardees at the local level, we judgmentally selected two local  awardees within 2 of the selected states—Houston, Texas, and Los  Angeles County, California. For each selected state or jurisdiction, we  interviewed state, county, or city officials who could provide information  about their Zika supplemental funding. The perspectives of the 12  awardees we interviewed cannot be generalized to other awardees.

To describe how selected awardees used their Zika supplemental funding  and gain their perspectives on applying for and managing this funding, we  reviewed documentation from the 12 selected awardees to identify the  activities they funded. We also interviewed officials from the selected  awardees (state officials and officials from one county and one city) about  their experiences with using the Zika supplemental funding and to obtain  examples of awardees’ Zika activities. We conducted site visits to Florida  and Texas, because at the time of our work, they alone had reported local  Zika virus transmissions. Additionally, we reviewed CDC and CMS  documents to determine the amount of funding received and the purpose  of the funding for each of the selected awardees. We also interviewed  CDC officials regarding any changes the agency has made to its plans for  awarding funding in the future.

We conducted this performance audit from April 2017 to May 2018 in  accordance with generally accepted government auditing standards.  Those standards require that we plan and perform the audit to obtain  sufficient, appropriate evidence to provide a reasonable basis for our  findings and conclusions based on our audit objectives. We believe that  the evidence obtained provides a reasonable basis for our findings and  conclusions based on our audit objectives.

During a disease outbreak, including the Zika virus, HHS is the lead  federal agency for public health and medical response, and it leverages  national public health and medical resources to prepare for and respond  to the outbreak.

The Zika virus is primarily transmitted to humans by infected mosquitoes,  but can also be transmitted from mother to child during pregnancy or  around the time of birth, or from person-to-person through sexual contact  or blood transfusion. According to CDC, once an individual has been  infected with the Zika virus, they are likely to be protected from future  infections. The Aedes aegypti mosquitoes are reportedly the primary  mosquito spreading the Zika virus, while the Aedes albopictus  mosquitoes, which share many of the same traits as Aedes aegypti, also  have the ability to spread the virus. Local transmission of the virus has  occurred in American Samoa, Florida, Puerto Rico, Texas, and the U.S.

Virgin Islands. Travel-associated cases of Zika virus infection have been  reported in every state, with the largest numbers of cases reported in  California, Florida, New York, and Texas.

There is no vaccine to prevent the Zika virus, so CDC guidance  recommends preventing the spread of the virus by protecting against  mosquito bites by wearing protective clothing, using insect repellant, and  staying in places with air conditioning and window and door screens to  keep mosquitoes outside, among other actions. Mosquito control in the  United States is implemented and overseen at the state and local levels  by entities such as mosquito control districts and health agencies. Federal  agencies support such control entities with funding and subject matter  experts, and may regulate some control methods such as pesticides.

In April 2016, the Office of Management and Budget and the Secretary of  Health and Human Services announced that they had identified $589  million—$510 million of it from existing Ebola virus disease resources  within HHS, the Department of State, and the U.S. Agency for  International Development—that could quickly be redirected and spent on  immediate efforts to control and respond to the spread of the Zika virus.  According to HHS, out of the $589 million, $374 million was redirected to  domestic Zika virus control activities. HHS reports that almost all of this  funding ($354 million) was distributed to three HHS agencies, as follows:

CDC received $222 million for various activities including field staff,  state response teams, Zika virus testing, tracking of pregnant women  who were infected with the Zika virus, and grants for mosquito control  and other Zika prevention activities;

BARDA received $85 million for private sector development of Zika  vaccines, treatments, and technologies to protect the blood supply,  and other countermeasures; and

NIH received $47 million for Zika medical countermeasure  development, including clinical trials on the leading Zika vaccine  candidate.

Additionally, according to HHS officials, in August 2016, the Secretary of  Health and Human Services notified Congress of the department’s intent  to redirect an additional $81 million in unobligated HHS funds for Zika  vaccine development activities. Of this amount, $34 million was drawn  from accounts at NIH and $47 million was drawn from funds transferred  from other HHS agencies and reprogrammed from within PHSSEF.  From these redirected funds, $34 million (i.e., the amount drawn from  other NIH accounts) was to be used by NIH to continue clinical trials on  its lead Zika vaccine candidate. The remaining $47 million was to be used  by BARDA for continued private sector Zika vaccine development.

September 2016 Zika Supplemental Funding

In September 2016, Congress appropriated $932 million to HHS and its  agencies in the Zika Response and Preparedness Act. Of that amount,  $394 million was appropriated directly to CDC and $152 million was  appropriated directly to NIH. The remainder was appropriated to HHS’s  PHSSEF, from which HHS allocated $245 million to BARDA within the  Office of the Assistant Secretary for Preparedness and Response, $75  million to CMS, and $66 million to HRSA. (See fig. 1.)

The Zika supplemental funding remained available for obligation until  September 30, 2017, for the following purposes:

CDC: to prevent, prepare for, and respond to the Zika virus, health  conditions related to the virus, and other vector-borne diseases,  domestically and internationally.

NIH: for research on the virology, natural history, and pathogenesis of  the Zika virus infection, and preclinical and clinical development of  vaccines and other medical countermeasures for the Zika virus and  other vector-borne diseases, domestically and internationally.

PHSSEF: for various activities, including to prevent, prepare for, and  respond to the Zika virus, health conditions related to the virus and  other vector-borne diseases, domestically and internationally; and to  develop necessary countermeasures and vaccines, including the  development and purchase of vaccines, therapeutics, diagnostics,  necessary medical supplies, and administrative activities.

BARDA: HHS allocated funding to BARDA to support further  development of Zika vaccine candidates, diagnostics, and  pathogen reduction technologies initiated in fiscal year 2016 to  advance these projects toward licensure or approval by the Food  and Drug Administration.

CMS: HHS allocated funding to CMS for expenses to support  states, territories, tribes, or tribal organizations with active or local  transmission cases of the Zika virus, as confirmed by CDC. The  funding was allocated to reimburse the costs of health care for  health conditions related to the Zika virus, other than costs that  are covered by private health insurance, of which not less than  $60 million were for territories with the highest rates of Zika virus  transmission.

HRSA: HHS allocated $20 million for projects of regional and  national significance in Puerto Rico and other U.S. territories, $40  million to expand the delivery of primary health services in Puerto  Rico and the other territories, and $6 million to be used to assign  National Health Service Corps members to Puerto Rico and the  other territories to provide primary health services in areas  affected by the Zika virus or other vector-borne diseases through  the National Health Service Corps Loan Repayment Program.

Agencies have until September 30, 2022, to disburse the Zika  supplemental funding appropriated by the Zika Response and  Preparedness Act.

HHS Agencies Have Obligated Nearly All of the Zika Supplemental Funding; Disbursements Are Ongoing

Agencies Obligated Nearly All of Their Zika Supplemental Funding as of September 30, 2017, Primarily Through Cooperative Agreements, Grants, and Contracts

We found that as of September 30, 2017—the end of the Zika  supplemental appropriation’s period of availability—nearly all Zika  supplemental funding had been obligated, primarily through cooperative  agreements, grants, and contracts. BARDA obligated 100 percent of its  Zika supplemental funding, while CDC, CMS, HRSA, and NIH obligated  over 99 percent of their funding. (See table 1.)

Three of the five agencies had obligated over half of their Zika  supplemental funding by January 31, 2017, 4 months after enactment of  the appropriation. For example, according to CDC officials, using  cooperative agreements with application processes familiar to the  awardees helped enable the agency to obligate its funding soon after  receiving the appropriation. Some agencies began obligating later in the  one-year obligation time frame based on their approach to obligating the  Zika supplemental funding. For example, CMS withheld a portion of its  supplemental funds in the event additional awardees became eligible for  funding within the obligation time frame—eligibility included having active  or local transmission of the Zika virus.

Agency officials told us that they used cooperative agreements, grants,  and contracts to award Zika supplemental funding to existing and new  awardees. The agencies also used other mechanisms to obligate the Zika  supplemental funding, such as interagency agreements, intramural  research awards, and funding used within the agency for travel and other  expenses. According to officials, agencies used these mechanisms to  award Zika supplemental funding in the following ways.

BARDA executed new contracts and modified existing contracts  through the agency’s typical contracting process, officials said, for  research in the areas of Zika clinical diagnostics and vaccine  development. BARDA did not use any Zika supplemental funding to  support internal administrative or personnel costs. (See app. I for the  contracts BARDA awarded with its Zika supplemental funding.)

CDC generally obligated Zika supplemental funding to current  awardees through existing cooperative agreements, according to  agency officials. (See app. II through VII for the cooperative  agreements CDC used to award Zika supplemental funding to existing  awardees.) CDC also awarded funding through contracts and  interagency agreements, and obligated about $24 million for internal  CDC expenses, such as salaries and benefits, travel, supplies, and  equipment. (See app. VIII for the contracts and interagency  agreements CDC awarded with its Zika supplemental funding.)

CMS created a new program—the Zika Health Care Services  Program—to award its Zika supplemental funding through cooperative  agreements, according to agency officials. The purpose of the 3-year  program is to support prevention activities and treatment services for  women (including pregnant women), children, and men adversely or  potentially affected by the Zika virus. CMS awarded funding through  the Zika Health Care Services Program to those states, territories,  tribes, or tribal organizations with active or local transmission of the  Zika virus, as confirmed by CDC. CMS awarded funding to the health  departments in American Samoa, Florida, Puerto Rico, and the U.S.  Virgin Islands in January 2017. In June 2017, CMS awarded funding  to the health department in Texas, the only new state or territory with  local transmission of the Zika virus. In both CMS award rounds, only  states and territories received awards, because they were the only  areas with active or local transmission of the Zika virus. CMS retained  about $3.6 million of the Zika supplemental funding to use for  administrative support services, as well as for travel for monitoring  and oversight. (See app. IX for the awards CMS made with its Zika  supplemental funding.)

HRSA generally obligated Zika supplemental funding through grants  to existing awardees, according to agency officials. HRSA did not  retain any Zika supplemental funding for internal activities. (See app.  X for the grants HRSA awarded.)

NIH used grants and contracts to award its Zika supplemental funding  to new and existing awardees. NIH also used about $95 million of the  Zika supplemental funding for internal activities—studies conducted  by NIH researchers. According to NIH officials, the somewhat unique  aspects of the Zika virus as an arbovirus infectious disease led NIH to  focus on vaccines as a priority, along with development of  diagnostics, therapeutics, vector control, and surveillance. (See app.  XI for NIH’s Zika supplemental awards.)

For more information on the funding provided by CDC, CMS, and  HRSA—the only agencies that provided funding for states and  territories—and the number of reported Zika cases by state or territory,  see an interactive graphic at https://www.gao.gov/products/GAO-18-389.

Officials from all five agencies cited coordination initiatives through  regular interagency or organizational teleconferences and participation in  working groups. According to CMS officials, during the Zika virus  response, CDC, CMS, HRSA, and other federal partners held interagency  Zika coordination calls to discuss ongoing developments related to the  Zika virus. Additionally, because CMS and HRSA were both awarding  funding for perinatal health care services, officials said they collaborated  to ensure that activities available through the CMS grants complemented  the activities available through HRSA’s Special Projects of Regional and  National Significance. In addition, HRSA officials reported conducting joint  site visits with CDC and CMS, as well as streamlining reporting  requirements to reduce grantee reporting burden. Furthermore, BARDA  officials said that they awarded and administered a contract for CDC on  the development of a vector control product. CDC provided the funding  and topical subject matter expertise for the award, and BARDA provided  management services for the contract, because of BARDA’s experience  with these types of contracts. BARDA and NIH officials also reported  collaborating on vaccine development. BARDA officials explained that  while the vaccine development process requires that different agencies  support multiple vaccine development candidates, the two agencies  coordinated to avoid redundancy.

Agencies Had Disbursed About 21 Percent of the Zika Supplemental Funding as of December 31, 2017

We found that as of December 31, 2017, the HHS agencies had  disbursed about 21 percent (approximately $195.5 million of $932 million)  of the Zika supplemental funding. According to agency officials and  selected awardees we spoke with, various factors can affect the  disbursement of funding after obligation. These factors include time to  draw down funding from the federal agencies, allowing for program  implementation and a planning period, and awardees’ internal  administrative processes and unique characteristics, as described below.

Drawdown procedures. CDC officials said that awardees draw down  federal funding on their individual schedules based upon how they  manage their federal funding. Some awardees draw down on a daily  basis, as needed, while others draw down on a biweekly or monthly  basis. Additionally, drawdowns for personnel costs coincide with payroll  schedules, which could be biweekly or monthly. For example, in the case  of monthly payroll, two awardees told us that the federal funding for a  particular month’s expenses would be drawn down the following month.  Furthermore, selected awardees we spoke with said that they draw down  federal funding after they have incurred an expense, such as when they  receive an invoice. For example, Los Angeles County officials reported  that in order to draw down the funds for the organization that is  responsible for servicing their vector control activities, they have to first  receive an invoice from the organization, which the county pays with its  own funds. Only then can the county draw down the federal funding. This  process usually results in at least a 3-month period between receiving the  invoice and drawing down the federal funding, officials said.

Program implementation and planning period. According to CMS  officials, the agency awarded funding to health departments in American  Samoa, Florida, Puerto Rico, Texas, and the U.S. Virgin Islands from the  Zika Health Care Services Program, which was a new collaboration  between CMS and these specific awardees. The officials said that the  steps awardees needed to take to stand-up new programs—such as  budget review and approval processes, selection of key personnel to  administer the grant, grant activities related to contracting, and hiring and  procurement—can delay start-up and implementation of the grant  programs.

Additionally, CMS gave awardees in the Zika Health Care Services  Program a 3-month planning period after they received their notices of  award to amend their activities. For example, Texas officials reported  that they used the 3-month planning period to work on executing  contracts with the local health departments in three counties bordering  Mexico. Texas officials explained that collaborating with the local health  departments entailed determining the greatest potential benefit of the use  of the funds, because the award itself was not enough to cover all of the  costs of direct health care services associated with the Zika virus.

Awardees’ processes and characteristics. Local administrative  processes for spending federal supplemental funds can result in varied  disbursement time frames. For example, California received Zika  supplemental funding for an award that required an amendment to an  administrative contract, which state officials said takes about 7 to 8  months for internal state approval. Additionally, certain awardees’  characteristics affect disbursements. For example, Houston officials said  the city was eligible for and was directly awarded a CDC cooperative  agreement, but because it does not conduct vector control activities itself,  the city had to negotiate a contract with the surrounding county to conduct  these activities, adding additional time before it could begin  disbursements.

Officials also noted that awardees’ personnel hiring issues can affect  disbursement time frames. For example, CMS officials said that some  territories experienced delays in carrying out activities due to provider  shortages, particularly among specialists needed to care for children with  developmental delays and birth defects caused by the Zika virus. CMS  officials noted that island jurisdictions, such as the U.S. territories, can  find hiring more difficult due to a shortage of health care professionals  available within the territory, thus requiring individuals to be recruited from  outside the territory, which adds time to the process and raises costs. In  addition, Florida officials in Miami-Dade County reported that the  necessary staff surge during the Zika response was challenging to fill,  noting that it was particularly difficult to find phlebotomists and nurses,  because they were in high demand.

Standard vaccine development processes also influenced the rate of  disbursement. Due to the long duration of the vaccine development  process, BARDA officials said, disbursements to certain awardees have  occurred at varying intervals. For example, some contract invoices are  received on a monthly basis, or twice a month if the company is a small  business. The invoices are then reviewed and if deemed acceptable, they  are processed for payment.

The 2017 hurricane season may have affected certain awardees’ use of  their Zika supplemental funding, which prompted agencies to respond by  approving various types of short-term relief for administrative, financial  management, and audit requirements for awardees affected by the  hurricanes. Three agencies—CDC, CMS, and HRSA—awarded Zika  supplemental funding to areas affected by hurricanes Harvey, Irma, and  Maria in 2017: Florida, Puerto Rico, Texas, and the U.S. Virgin Islands.  CDC officials told us, for example, that because of the hurricanes they  granted extensions at the request of the awardees for submitting financial  and progress reports, and continuation of activities. Similarly, CMS  offered hurricane-affected awardees of the Zika Health Care Services  Program the option to extend the deadline for deliverables, if necessary.  CMS officials told us that grant activities had been affected by the  hurricanes, and all grantees had communicated the intent to fully resume  activities as soon as they are able to do so. Due to the 3-year project  period for grantees, CMS officials said that the affected entities can still  accomplish programmatic responsibilities, even if there is a temporary  halt in project activities. Furthermore, HRSA officials said that they  provided Puerto Rico and the U.S. Virgin Islands with extensions on  required program, financial, and audit reports.

Selected Awardees Undertook Multiple Activities with Zika Supplemental Funding, and Had Varying Experiences Applying for and Managing Funds

Selected Awardees Used Zika Supplemental Funding for Activities Including Surveillance, Vector Control, Laboratory Capacity, and Health Care Services

Selected awardees we spoke with used Zika supplemental funding for a  variety of activities. Collectively, the activities included four primary types:  medical surveillance, vector control, laboratory capacity building, and  providing health care services, as described below.

Medical surveillance activities include identifying and reporting Zika  virus disease cases to CDC, as well as reporting Zika virus infections  in pregnant women and infants to the U.S. Zika Pregnancy Registry.

Vector control activities include detecting and monitoring Aedes  aegypti and Aedes albopictus mosquito distribution and mosquito  control, and monitoring of insecticide resistance and management.

Laboratory capacity building activities include developing laboratory  capacity to perform Zika virus testing.

Health care service activities for those selected awardees that  received funding from CMS (Florida and Texas) included increasing  access to contraceptive services for men and women; increasing  access to and reducing barriers to diagnostic testing, screening, and  counseling for pregnant women and newborns; and increasing access  to appropriate specialized health care services for pregnant women,  children born to mothers with maternal Zika virus infection, and their  families.

Table 2 provides examples of the types of activities funded by the  selected awardees we interviewed. This table does not include a  comprehensive list of all of the awardees’ Zika activities—see appendixes  II through VI, and appendix IX for more information on the Zika  supplemental funding CDC and CMS awarded to states, territories, and  local jurisdictions.

Of the awardees we spoke with, Florida and Texas were the only states  that had experienced local mosquito-borne transmission of the Zika virus.  Other selected awardees—which included Arizona, Los Angeles County,  and Louisiana—were primarily responding to travel-related cases of Zika  virus disease. The following are additional examples of activities funded  using Zika supplemental funding. For more information on the types of  activities authorized under each award, see appendixes II-VI and IX.

Florida. Florida, which has a centralized health department with county- based offices, used Zika supplemental funding for laboratory capacity and  vector control activities, among other activities. According to state  officials, funding for state-run laboratories was used for purchasing  materials, such as those used for testing urine for the Zika virus, and  funding staff located in counties to assist with handling Zika samples and  testing, data entry, and result reporting to surveillance networks.  Additionally, Florida used Zika supplemental funding for local vector  control activities. For example, Miami-Dade County officials said that they  purchased mosquito traps and removed mosquito breeding grounds,  including plants, tires, and other objects that can hold standing water.  (See fig. 2 for examples of the mosquito control activities in Miami-Dade  County.)

Through CMS’s Zika Health Care Services Program, Florida received  funding for, among other things, two part-time advanced registered nurse  practitioners to provide consultation and technical assistance in family  planning clinics, and assist in the prescribing and management of various  birth control methods. Florida also funded a health educator for Zika  prevention and response duties, which included assisting local health  care organizations in the development of educational programming to  ensure that health care services are provided in accordance with CDC  guidelines. The health educator’s duties also included ensuring that  pregnant women with the Zika virus and infants with congenital Zika  infection are referred to proper care and other available programs and  resources.

Texas. Texas officials said that the state used a CDC award to rapidly  identify cases and conduct data analysis of Zika-related birth defects, to  enhance surveillance of Zika virus-related birth defects by improving the  Texas Birth Defects Registry database, and to facilitate remote access to  electronic records. Texas also disseminated prevention materials and  interviewed mothers of children with Zika-related birth defects about their  experience in dealing with the health system in order to help identify  developmental outcomes of the children.

Texas intends to use its CMS Zika Health Care Services Program  funding—awarded on June 30, 2017—to increase clients’ access to  contraceptives; for care management, including counseling on Zika virus  testing for pregnant women and their families; and for counseling to refer  clients for services and support. State officials provided the following  information on some of the activities intended for the program.  1.  Increasing clients’ access to contraceptives: Community health  workers and case management staff will assist clinic providers with  informing women and their partners about contraceptive availability  and about the potential Zika virus risks during pregnancy. They will  also work with the women to determine what messages work best  with their partners regarding contraceptives.  2.  Care management that includes pre- and post-test counseling on Zika  virus testing for pregnant women and their families: Officials said that  this activity is important because the CDC testing algorithm is  complex, the results from various tests can be confusing, and there  can be false positives from the tests. Generally, doctors do not have  the time to go through the complexities of these issues with clients,  such as how to understand the laboratory tests and results.  3.  Counseling to refer clients for services and supports: This can include  counseling about various types of resources to support clients pre- delivery, after delivery, and during the infant’s first year of life.

Arizona. According to state officials, Zika supplemental funding was used  to create an action plan with counties, and increase the state’s ability to  raise public awareness about the threat of the Zika virus, its transmission  routes, and prevention measures. Officials stated that Arizona’s border  with Mexico makes communicating about Zika more complex, because  individuals frequently cross the border for a variety of reasons including  work, school, and to visit family, and do not necessarily consider  themselves to be travelers. Additionally, the state used funding to  increase the amount of personal protective equipment for the vector  surveillance staff, and set up vector control contracts that could be  accessed if the Zika virus spread locally, and in the event that vector  control could not be handled at the local level. However, this contracting  mechanism was not used, because there was no local transmission of the  Zika virus in Arizona. According to state officials, Arizona plans to ask for  an extension to use the funding in the next mosquito season. The state  health department also sponsored training on mosquito identification.

Los Angeles County. County officials said that some funding was used  to support personnel involved with Zika surveillance, testing, and case  management. This included the detection of cases—individuals  diagnosed with Zika infection—and also the dissemination of information  to Los Angeles County’s Maternal and Child Health group, which follows  pregnant women through delivery and then transfers the cases to the  county’s Children’s Medical Services group. For example, according to  officials, once a case is identified, information is shared with the relevant  vector control district about the location of the case, and the vector control  district can then conduct inspection and abatement activities to reduce  the risk of a local outbreak. Los Angeles County officials found that this  process takes about one week from finding out about a case to  completion of inspection and abatement. This included 1 day to get  information to the vector control district and 1 to 5 days for completing  inspection and abatement. The funding was also used to provide funds to  the vector control districts to augment Aedes mosquito detection efforts  and support outreach activities, according to county officials.

Louisiana. Louisiana officials said they used a CDC award, in part, to  provide equipment and mileage reimbursement for nurses, who served as  clinical liaisons between the birth defects surveillance program and  hospitals and physicians statewide, to help enable rapid surveillance  activities.

Awardees also funded other activities, such as outreach campaigns. See  figure 3 for examples of outreach funded with Zika supplemental funding.

Selected Awardees Had Mixed Experiences Applying for and Managing the Zika Supplemental Funding

While a majority of the 12 selected awardees we spoke with reported  positive experiences with the process of applying for and managing the  Zika supplemental funding, some awardees cited aspects of the process  that were challenging. The awardees we spoke with received much of  their supplemental funding from CDC and noted that the process went  well: there was good communication with CDC officials; CDC’s  Epidemiology and Laboratory Capacity for Infectious Diseases  cooperative agreement process to apply for Zika supplemental funds was  more streamlined than the regular application process; and awardees  said they were familiar with the mechanisms, which helped them navigate  the process.

Awardees we spoke to also cited some challenges to applying for and  managing the Zika supplemental funding. These awardees noted that  various time frames among multiple awards and restrictions on authorized  activities under the awards added administrative burdens that officials  had to deal with while responding to the outbreak. Florida officials said  that the state received funding from different federal agencies, from  different cooperative agreement awards, with different deadlines, and  different rules on what the funding could be used for. For example, CDC  distributed Zika supplemental funds to states and certain localities and  territories through five cooperative agreements—some of which had  multiple application rounds. Florida officials said that they had to track  funding separately and identify the activities that could be funded under  each award—administrative requirements that were burdensome during  an emergency response. Figure 4 presents the period of time Florida had  to use the Zika supplemental funding from multiple awards received from  CDC.

In addition, awardees we spoke with cited challenges with adjusting their  plans when federal funding was more or less than anticipated. For  example, CDC officials said that they provided average award amount  ranges as guidance for awardees as part of the application process for  one of CDC’s cooperative agreements. Los Angeles County officials  said that they applied for an amount that was near the limit, and county  officials said that they had to adjust the activities they planned to fund  when they received less than what they applied for. Iowa officials said  that without knowing exactly how much funding would be available it was  difficult to know what to apply for and made staffing changes difficult.  Iowa officials had to adjust their initial plan when they later received  additional unexpected funding.

In October 2017, CDC issued a new notice of funding opportunity that,  according to agency officials, was intended to help minimize the  administrative burden on these awardees (e.g., preparing applications  and other paperwork) during significant public health emergencies by pre- approving public health departments in these jurisdictions to rapidly  receive future awards. This new notice of funding opportunity will be  used to establish a list of awardees, with existing emergency  preparedness and response capacity, that would be pre-approved for  funding by CDC when a public health threat occurs, including infectious  disease threats. It requires that awardees have structures and plans in  place to receive funding, as well as plans to respond to a public health  threat. According to CDC officials, awards could potentially be provided  within 2 weeks to pre-approved awardees after supplemental  appropriations are enacted. According to CDC officials, as of February  2018, the agency had approved all 64 applicants for the notice of funding  opportunity. This means that CDC will consider these approved  applicants for future funding if an emergency occurs and funding  becomes available.

We provided a draft of this report to HHS for review and comment. HHS  provided technical comments, which we incorporated as appropriate.

We also provided relevant draft portions of this report to the Zika  supplemental funding awardees we interviewed. Specifically, we provided  the excerpts to officials in Alaska; Arizona; California; Colorado; Florida;  Houston, Texas; Iowa; Kansas; Los Angeles County, California;  Louisiana; Oklahoma; and Texas. All but one awardee responded.  Awardees provided technical comments, which we incorporated as  appropriate.

We are sending copies of this report to the appropriate congressional  committees, the Secretary of Health and Human Services, and to other  interested parties. In addition, the report is available at no charge on the  GAO website at http://www.gao.gov.

If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or crossem@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix XII.

Appendix I: Biomedical Advanced Research and Development Authority’s Zika Supplemental Awards

The Biomedical Advanced Research and Development Authority  (BARDA), within the Department of Health and Human Services’ Office of  the Assistant Secretary for Preparedness and Response, executed  contracts to obligate its Zika supplemental funding for research in the  areas of (1) vaccine development, (2) diagnostic development, and (3)  pathogen reduction systems.

Table 3 presents information for each award as it was provided to us by  BARDA.

Appendix II: Centers for Disease Control and Prevention—Epidemiology and Laboratory Capacity for Infectious Diseases Awardees

This appendix presents information on Zika supplemental funding awards  made by the Centers for Disease Control and Prevention (CDC) through  the Epidemiology and Laboratory Capacity for Infectious Diseases (ELC)  cooperative agreement. CDC awarded Zika supplemental funding for the  ELC cooperative agreement for the following activities:

Zika epidemiology and laboratory surveillance, and

The Zika supplemental funding awarded through the ELC cooperative  agreement was to further support and strengthen activities to protect the  public’s health, especially pregnant women, through epidemiologic  surveillance and investigation, improving mosquito control and  monitoring, and strengthening laboratory capacity. The funding will also  support participation in the U.S. Zika Pregnancy Registry to monitor  pregnant women with the Zika virus disease and their infants.

For each award, we present information as it was provided to us by CDC,  as well as the activities funded. Table 4 provides information on ELC Zika  supplemental funding awarded to states and territories, and table 5  presents information on awards to local health departments.

In addition to states and territories, six large city and county local health  departments—Chicago, the District of Columbia, Houston, Los Angeles  County, New York City, and Philadelphia—received ELC Zika  supplemental awards.

Appendix III: Centers for Disease Control and Prevention—Birth Defects Awardees

This appendix presents information on Zika supplemental funding awards  made by the Centers for Disease Control and Prevention (CDC) through  the Surveillance, Intervention, and Referral to Services Activities for  Infants with Microcephaly or other Adverse Outcomes Linked with the  Zika Virus (birth defects) cooperative agreement.

The Zika supplemental funding awarded through the birth defects  cooperative agreement was to provide additional resources to better  establish, enhance, and maintain rapid population-based surveillance of  microcephaly and other adverse outcomes (especially central nervous  system defects) possibly linked to Zika virus infection during pregnancy  using an active case-finding methodology; participation in centralized  pooled clinical and surveillance data projects; ensuring affected infants  and families are referred to services; and assessing health and  developmental outcomes of these children.

Table 6 presents information for each award as it was provided to us by  CDC.

Appendix IV: Centers for Disease Control and Prevention—Behavioral Risk Factor Surveillance System Awardees

This appendix presents information on Zika supplemental funding awards  made by the Centers for Disease Control and Prevention (CDC) through  the Behavioral Risk Factor Surveillance System (BRFSS) cooperative  agreement.

The Zika supplemental funding awarded through the BRFSS cooperative  agreement was to conduct a rapid population-based assessment of  women and couples using or in need of contraceptives in order to provide  comprehensive contraceptive services related to Zika virus exposure.

Table 7 presents information for each award as it was provided to us by  CDC.

Appendix V: Centers for Disease Control and Prevention—Pregnancy Risk Assessment Monitoring System Awardees

This appendix presents information on Zika supplemental funding awards  made by the Centers for Disease Control and Prevention (CDC) through  the Pregnancy Risk Assessment Monitoring System (PRAMS)  cooperative agreement.

The Zika supplemental funding awarded through the PRAMS cooperative  agreement was to assess maternal behaviors and experiences related to  Zika virus exposure among recently pregnant women who deliver a live- born infant in the United States.

Table 8 presents information for each award as it was provided to us by  CDC.

Appendix VI: Centers for Disease Control and Prevention—Public Health Preparedness and Response Awardees

This appendix presents information on Zika supplemental funding awards  made by the Centers for Disease Control and Prevention (CDC) through  the Public Health Preparedness and Response (PHPR) Cooperative  Agreement for All-Hazards Public Health Emergencies.

According to CDC officials, the Zika supplemental funding awarded  through the PHPR cooperative agreement was to enable identified state,  territorial, and local jurisdictions to address Zika virus disease planning  and operational response gaps.

Table 9 presents information for each award as it was provided to us by  CDC.

Appendix VII: Centers for Disease Control and Prevention—Other Cooperative Agreements’ Awardees

This appendix presents information on Zika supplemental funding awards  made by the Centers for Disease Control and Prevention (CDC) through  additional cooperative agreements.

Tables 10-17 present information for each award as it was provided to us  by CDC.

Administrative Support for the Zika Supplemental for Sentinel Enhanced Dengue Surveillance System Project

The Zika supplemental funding awarded through the Sentinel Enhanced  Dengue Surveillance System Project cooperative agreement was to  support sites working to provide new information on dengue and other  acute febrile illnesses in Puerto Rico, which is located in the subtropics  and where dengue epidemiology is similar to dengue endemic areas  worldwide. The Zika supplemental funding was for two studies: (1)  pregnant women with Zika infection, and (2) postnatal Zika infection by  following 0-5 year old children.

Vector-Borne Disease Regional Centers of Excellence

The Zika supplemental funding awarded through the Vector-Borne  Disease Regional Centers of Excellence cooperative agreement is to  establish regional centers of excellence aimed at building the capacity to  address the problem of emerging and exotic vector-borne diseases in the  United States, including Zika virus infection.

Enhancing Capacity for Vector Surveillance and Control to Prevent Zika, Dengue and Chikungunya Infection in Puerto Rico

The Zika supplemental funding awarded through the Enhancing Capacity  for Vector Surveillance and Control to Prevent Zika, Dengue and  Chikungunya Infection in Puerto Rico cooperative agreement is to fund  activities to increase the surveillance and control of vectors, specifically  Aedes aegypti mosquitoes (the vector of dengue, chikungunya, and Zika).  The purpose of the program is to establish a vector control unit to oversee  and implement comprehensive vector control activities in Puerto Rico.

Immunization Grants-CDC Partnership: Strengthening Public Health Laboratories

The Zika supplemental funding awarded through the Immunization  Grants-CDC Partnership: Strengthening Public Health Laboratories  cooperative agreement is to promote quality and safe public health  laboratory practice, improve public health laboratory infrastructure,  strengthen the public health laboratory system, and develop a well-trained  public health laboratory workforce.

Building Capacity of the Public Health System to Improve Population Health through National, Nonprofit Organizations

According to CDC officials, the Zika supplemental funding awarded  through the Building Capacity of the Public Health System to Improve  Population Health through National, Nonprofit Organizations cooperative  agreement is to ensure national capacity for responding to the Zika  outbreak and meeting the needs of those affected, such as by reaching  out to specialized constituents to ensure they were informed on  epidemiology and practice guidelines.

Strengthening the Public Health System in the U.S.- Affiliated Pacific Islands

The Zika supplemental funding awarded through the Strengthening the  Public Health System in the U.S.-Affiliated Pacific Islands cooperative  agreement is to provide capacity building assistance through a regional,  nonprofit organization to strengthen the U.S.-Affiliated Pacific Islands’  public health leadership, workforce, and public health systems and  infrastructure in response to Zika virus within the U.S. Pacific territories.

Pan American Health Organization: Building Capacity and Networks to Address Emerging Infectious Diseases in the Americas

The Zika supplemental funding awarded through the Pan American  Health Organization: Building Capacity and Networks to Address  Emerging Infectious Diseases in the Americas cooperative agreement is  for various activities including technical assistance, such as to develop  standard operating procedures for diagnostic and integrated surveillance  activities, as well as to support the development, implementation, and  evaluation of diagnostic and surveillance guidelines.

Global Health Security Partner Engagement: Expanding Efforts and Strategies to Protect and Improve Public Health Globally

According to CDC officials, the Zika supplemental funding awarded  through the Global Health Security Partner Engagement: Expanding  Efforts and Strategies to Protect and Improve Public Health Globally  cooperative agreement is for enhanced surveillance for pregnant women  in Colombia, including laboratory testing and case investigations.

Appendix VIII: Centers for Disease Control and Prevention—Contracts and Interagency Agreements

This appendix presents information on Zika supplemental funding awards  made by the Centers for Disease Control and Prevention (CDC) through  additional contracts and interagency agreements.

Tables 18 and 19 present information for each award as it was provided  to us by CDC, as well as the activity funded.

Appendix IX: Centers for Medicare & Medicaid Services—Zika Health Care Services Program Awards

This appendix presents information on Zika supplemental funding awards  made by the Centers for Medicare & Medicaid Services (CMS) through  the Zika Health Care Services Program. The Zika Health Care Services  Program is aimed at supporting prevention activities and treatment  services for women (including pregnant women), children, and men  adversely or potentially affected by the Zika virus. According to CMS  documentation, the Zika Health Care Service Program is intended to  address four critical components of a comprehensive response to Zika:  1.  Increase access to contraceptive services for women and men.  2.  Increase access to and reduce barriers to diagnostic testing,  screening, and counseling for pregnant women and newborns.  3.  Increase access to appropriate specialized health care services for  pregnant women, children born to mothers with maternal Zika virus  infection, and their families.  4.  Improve provider capacity and capability.

CMS awarded funding through the Zika Health Care Services Program, in  two award rounds, to states, territories, tribes, or tribal organizations with  active or local transmission of the Zika virus, as confirmed by the Centers  for Disease Control and Prevention. In January 2017, CMS awarded  funding to American Samoa, Florida, Puerto Rico, and the U.S. Virgin  Islands. In June 2017, CMS awarded funding to Texas, the only new area  with local transmission of the Zika virus. Table 20 presents the awards  CMS made through its Zika Health Care Services Program.

Appendix X: Health Resources and Services Administration’s Zika Supplemental Awards

This appendix presents information on Zika supplemental funding awards  made by the Health Resources and Services Administration (HRSA) to  health centers and for Special Projects of Regional and National  Significance.

Health centers: HRSA provided awards to health centers through  supplemental grant awards to support existing health centers in  Puerto Rico and other territories in their efforts to expand the delivery  of health care services, including the prevention of Zika and  prevention and treatment of Zika-related illness. HRSA also provided  supplemental grant awards to existing Health Center Program  cooperative agreement awardees for efforts to provide training and  technical assistance for Zika-related health center expansion  activities.

Special Projects of Regional and National Significance: HRSA  provided awards for Special Projects of Regional and National  Significance to support public health departments and other entities in  Puerto Rico and other territories in efforts to ensure access to  recommended services for pregnant women, infants, and children  infected by the Zika virus in the prenatal, perinatal, and neonatal  period. Activities include early identification through developmental  screening, regular assessments and monitoring, telemedicine, care  coordination, enabling services, family engagement and family-to- family support; purchasing of diagnostic equipment and health  information technology; and the training of health care providers, care  coordinators, and other health care and public health professionals to  ensure delivery of comprehensive, interdisciplinary health and social  services for this population.

Tables 21 and 22 present information for each award as it was provided  to us by HRSA.

Appendix XI: National Institutes of Health Zika Supplemental Awards

The National Institutes of Health (NIH) awarded Zika supplemental  funding to support research to better understand Zika and its  complications, and inform the development of new interventions. The  three primary activities of funding include (1) vaccine development; (2)  Zika in Infants and Pregnancy study; and (3) diagnostics, therapeutics,  vector control, and other interventions. NIH used contracts, grants,  intramural research awards, and other awards to provide funding for  research on the Zika virus and its complications.

Tables 23-26 present information for each award as it was provided to us  by NIH.

Appendix XII: GAO Contact and Staff Acknowledgments

In addition to the contact named above, Karen Doran (Assistant Director),  Sarah Resavy (Analyst-in-Charge), and Hannah Grow made key  contributions to this report. Also contributing were Muriel Brown, Christine  Davis, and Drew Long.

The Zika virus outbreak that began in 2015 sickened adults, but also had another particularly tragic result—brain defects and other problems in infected fetuses. It represented the first time in more than 50 years that an infectious pathogen had been found to cause birth defects. As the virus spread into the United States, Congress appropriated $932 million to address the growing threat.

We reviewed how agencies have used this money. We found that they attacked the problem on a variety of fronts, including researching the virus, controlling mosquito populations, and raising public awareness about Zika and its prevention.