The President’s Emergency Plan for AIDS Relief (PEPFAR), U.S. Global HIV/AIDS, Tuberculosis, and Malaria Programs: A Description of Permanent and Expiring Authorities
Released: 2013-09-27T00:00:00

Background

In January 2003, President Bush announced the President's Emergency Plan for AIDS Relief (PEPFAR), a government-wide initiative to combat global HIV/AIDS. PEPFAR supports a wide range of HIV/AIDS prevention, treatment, and care activities and is the largest commitment by any nation to combat a single disease. Later that year, Congress enacted the United States Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003 (Leadership Act), P.L. 108-25 , which authorized $15 billion to be spent from FY2004 to FY2008 on bilateral and multilateral HIV/AIDS, tuberculosis (TB), and malaria programs. The Act included language that instructed how the funds should be spent, listed several goals and targets, and required the President to establish the Coordinator of the United States Government Activities to Combat HIV/AIDS Globally (known as the Global AIDS Coordinator) at the Department of State. The Office of the Global AIDS Coordinator (OGAC) distributes the majority of the funds it receives from Congress for global HIV/AIDS programs to U.S. federal agencies and departments and multilateral groups like the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund).

In 2008, Congress enacted the Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008 (Lantos-Hyde Act), P.L. 110-293 , which amended the Leadership Act to authorize the appropriation of $48 billion for global HIV/AIDS, TB, and malaria efforts from FY2009 to FY2013. Key amendments in the Act established the Coordinator of the United States Government Activities to Combat Malaria Globally (known as the Malaria Coordinator) at the U.S. Agency for International Development (USAID). The Malaria Coordinator oversees implementation of related efforts by USAID and the Centers for Disease Control and Prevention (CDC) and is advised by an Interagency Advisory Group that includes representatives from USAID, Department of Health and Human Services (HHS), Department of State (State), Department of Defense (DOD), the National Security Council (NSC), and the Office of Management and Budget (OMB).

Certain provisions within the Leadership Act, as amended, and the Lantos-Hyde Act are set to expire at the end of FY2013. The 113 th Congress is considering whether to reauthorize these authorities. On September 24 and 25, 2013, respectively, companion bills were introduced in the Senate and House ( S. 1545 and H.R. 3177 ) entitled the PEPFAR Stewardship and Oversight Act. The bills extend authorities related to key priority areas: authorizing appropriations for the Global Fund, expanding reporting requirements, and allocating a portion of global HIV/AIDS funds for orphans and vulnerable children (OVC) and for HIV/AIDS treatment and care.

Table A-1 in Appendix A offers a side-by-side comparison of the Leadership Act in its original form and the Lantos-Hyde Act, which amends the Leadership Act and other legislation. A third column explains which sections are set to expire and summarizes language in S. 1545 and H.R. 3177 that amend the Leadership Act, as amended. The Leadership Act, as amended, Lantos-Hyde Act, and legislation that these Acts amend include language to facilitate oversight of U.S. global HIV/AIDS, TB, and malaria programs, as well as to ensure key congressional priorities are met. The related reporting requirements are listed in Table A-2 of Appendix A . This report explains briefly which authorities in these two Acts are set to expire and which are permanent.

Congressional Issues

Congressional interest in combating HIV/AIDS, TB, and malaria has been unwavering. The Leadership and Lantos-Hyde Acts are important tools Congress has used to influence the design of projects aimed at fighting the three diseases and to oversee their implementation. The 108 th and 110 th Congresses were able to overcome ideological and political differences to enact the Leadership and Lantos-Hyde Acts. It does not appear some of the contentious issues that dominated debate when crafting the Leadership and Lantos-Hyde Acts (such as family planning) will be revisited at this time. S. 1545 , the PEPFAR Stewardship and Oversight Act and its House companion ( H.R. 3177 ) do not offer a comprehensive extension of the Leadership Act, as amended. Instead, it focuses on key priorities related to strengthening oversight, extending funding authorities for the Global Fund, orphans and vulnerable children, and HIV/AIDS treatments and care programs. A summary of the authorities that S. 1545 and H.R. 3177 seek to amend are listed in Table B-1 of Appendix B .

Key authorities that are set to expire revolve around four themes:

establishing performance targets; evaluating and overseeing program implementation; advancing research on curative and preventive tools; and directing how funds are to be utilized.

There are far more permanent authorities than expiring ones. Enduring legislation authorized:

the establishment of HIV/AIDS and malaria coordinators; regular reporting on program evaluation and implementation; research for the identification and development of improved tools; mechanisms for advancing country ownership and cost sharing; the integration of nutritional support into HIV/AIDS programs; exemption from certain HIV/AIDS prevention activities due to moral objections (known as the conscience clause); and HIV-positive individuals to enter the United States.

Public statements by the Obama Administration and several Members of Congress suggest that support for maintaining global HIV/AIDS, TB, and malaria programs remains strong in both branches. Prospects remain high that the Administration will continue to request that Congress maintain funding levels for these programs in the coming years and Congress may comply, whether or not Congress enacts another five-year authorization for the diseases. The following sections describe which authorities in the Leadership Act, as amended, and the Lantos-Hyde Act are set to expire and which are enduring.

Expiring Authorities

Some of the provisions in the Leadership and Lantos-Hyde Acts that shape U.S. global HIV/AIDS, TB, and malaria programs are set to expire at the end of FY2013. These primarily entail the establishment of performance targets and interagency strategies for addressing the three diseases. Other expiring authorities enhance congressional oversight capacity, promote research, and direct how funds are to be spent. The discussion below summarizes authorizing language in the Leadership and Lantos-Hyde Acts that includes a precise end date. The subsections are discussed sequentially.

Performance Targets/Strategy

Throughout the Leadership and Lantos-Hyde Acts, Congress included language that shaped the scope and breadth of PEPFAR. Section 101 of the Leadership Act, for example, required the President to develop a five-year strategy for combatting HIV/AIDS worldwide from FY2004 through FY2008. The section also set several program targets for HIV/AIDS programs. Section 101 of the Lantos-Hyde Act amended the Leadership Act to require the President to develop another five year strategy for FY2009 through FY2013. The law mandates that the strategy describe how the Administration would reach new targets by the end of FY2013. These are:

prevent 12 million new HIV infections; care for 12 million people affected by HIV/AIDS, including 5 million orphans; treat at least 2 million more people; ensure at least 80% of target populations have access to counseling, testing, and treatment; and train at least 140,000 health care professionals and paraprofessionals.

Congress also used the Leadership and Lantos-Hyde Acts to set targets for combatting TB worldwide. Section 302 of the Leadership Act amended section 104B of the Foreign Assistance Act of 1961 (FAA) to authorize U.S. participation in several multilateral anti-TB efforts and specified treatment targets. Section 302 of the Lantos-Hyde Act amended section 104B(b) of the FAA to direct the President to establish a five-year strategy for expanding and improving U.S. TB programs and achieving the following targets by 2013:

treat 4.5 million new sputum smear TB patients under Directly Observed Treatment, Short Course (DOTS) programs; and diagnose and treat 90,000 new multiple drug resistant TB (MDR-TB) cases.

There is growing discussion about the utility of setting treatment and other numeric targets. On the one hand, such targets can be effective tools in demonstrating congressional intent and motivating an expansive and swift response. On the other hand, it could be argued that other indicators, such as changes in disease prevalence or survival rates, are better measures of program effectiveness. It can be difficult, however, to link these broader outcomes to particular project activities.

Efforts to attribute results to a particular activity have become complicated by the growing cadre of actors who often collaborate to address these diseases. The Global Fund and the United States, for example, frequently provide various elements of support to the same population. For instance, grantees of the Global Fund may purchase treatments for any of the three diseases but use U.S.-funded supply chain networks to distribute the medication.

PEPFAR has undergone tremendous expansion and transformation since its early years. Some question whether numerical targets are the appropriate measure of its impact at this current stage. During the first phase of PEPFAR, the United States and other stakeholders rushed to expand access to treatment and care for people affected by HIV/AIDS in low-resource countries. Numerical targets helped to leverage support for addressing HIV/AIDS both within the United States and in the global arena. As the program progressed, it became increasingly evident that the poor state of health systems in recipient countries encumbered efforts to rapidly implement treatment and care programs. Health system strengthening has become an increasingly important part of PEPFAR and has become a critical strategy for advancing country ownership. Some groups are calling for more qualitative studies that measure impact (declines in transmission rates, for example) rather than a count of beneficiaries.

Section 204 of the Leadership Act as amended made the strengthening of health policies and health systems a policy of the United States. The section requires the Global AIDS Coordinator, in collaboration with USAID, to develop and implement a plan to combat HIV/AIDS by strengthening health policies and health systems of partner countries. The section also authorizes the Secretary of the Treasury to provide assistance for the improvement of public finance management systems in recipient countries. The section authorizes such sums as necessary to carry out these activities for each of FY2009 through FY2013. It remains to be seen whether the Administration will continue to aim for achieving ambitious prevention, care, and treatment goals without congressional directives. The strategy for strengthening health systems and health policy worldwide, however, will likely remain a priority, evidenced in part by the creation of the Office of Health Systems at USAID in 2012.

Evaluation and Oversight

The $15 billion authorization included in the Leadership Act for global HIV/AIDS, TB, and malaria programs was the largest authorization for global health programs until that date. Congress included language in the Act to require the President to submit several reports detailing how the funds were spent. Congress amended these reporting requirements through the Lantos-Hyde Act and added some additional ones. A number of the reporting requirements were for a specific period of time, while others were included in permanent statute. This section summarizes the reporting requirements that were set for a particular time period.

Section 101 of the Leadership Act required the President to submit a report to Congress no later than 270 days after enactment of the Act that described the five-year global AIDS strategy and required the Institute of Medicine (IOM) to assess U.S. global HIV/AIDS, TB, and malaria programs. The Lantos-Hyde Act amended section 101 of the Leadership Act to require the President to develop another five-year global AIDS strategy plan and authorize IOM to conduct another evaluation study of U.S. efforts to combat the three diseases. The amended section includes additional oversight and evaluation requirements. These are:

an authorization of such sums as necessary for the Comptroller General to develop and submit a report evaluating PEPFAR; a requirement for OGAC to submit a best practices report; and an authorization of up to $15 million for the Inspectors General of USAID, the Department of State and Broadcasting Board of Governors, and Department of Health and Human Services (HHS) to jointly develop five coordinated annual plans for oversight activity through FY2013.

The IOM and Obama Administration have largely adhered to these reporting requirements (see Table A-2 ). It is unclear, however, whether parties will continue to submit such reports without a congressional mandate. Language in the PEPFAR Stewardship and Oversight Acts extended and expanded reporting requirements. The bills focus on extending authorities for:

the State Department, USAID, and HHS Inspectors General to develop annual, joint oversight/audit plans through FY2018; the President to submit annual reports through FY2019 that detail per-patient costs for PEPFAR-supported treatment and care programs, including a comparative study of per-patient costs by the Global Fund and recipient countries; and the President to submit comprehensive annual reports on PEPFAR implementation. The language in the PEPFAR Stewardship and Oversight Acts expand the reporting requirements.

Funding/Spending Requirements

Discussions about the Leadership and Lantos-Hyde Acts have tended to centralize on funding levels. The Leadership Act authorized $15 billion for the U.S. fight against HIV/AIDS, TB, and malaria from FY2004 through FY2008; and the Lantos-Hyde Act amended the Leadership Act to authorize $48 billion from FY2009 through FY2013 for the acceleration of U.S. efforts to combat the three diseases. Several sections in the Lantos-Hyde Act amended the FAA and Leadership Act to specify how much of the funds were to be spent on each disease. These sections are listed below.

Section 302 of the FAA, as amended, authorizes the United States to make contributions to the Aeras Global TB Vaccine Foundation and GAVI Fund from FY2009 through FY2013. Section 202 202(d) of the Leadership Act, as amended, authorizes $2 billion for the Global Fund in FY2009 and such sums as necessary through FY2013. Section 302(b) of the Leadership Act, as amended, authorizes $4 billion for global TB efforts from FY2009 through FY2013. Section 104C(b) of the FAA, as amended, authorizes $5 billion for global malaria efforts from FY2009 through FY2013. Section 401(a) of the Leadership Act, as amended, authorizes $48 billion from FY2009 through FY2013 to carry out the Leadership Act and the amendments made by the Act.

The Lantos-Hyde Act also amended the Leadership Act to apportion the funds among certain activities or to limit how the funds could be used. These sections of the Leadership Act, as amended are listed below.

Section 202(d) permits the Secretary of State to withhold portions of U.S. contributions for various purposes, including amounts that would have been provided to a country that "has repeatedly provided support for acts of international terrorism." Section 403 requires 10% of funds appropriated under the Act to be expended for children affected by or vulnerable to HIV/AIDS from FY2009 through FY2013. Section 403 requires more than half of funds appropriated for each of FY2009 through FY2013 to be expended for: HIV/AIDS treatments; clinical monitoring of HIV-positive people in need of treatment; care for associated opportunistic infections; nutrition and food support for people living with HIV/AIDS; and other essential HIV/AIDS-related medical care.

Irrespective of decisions to reauthorize expiring legislation for HIV/AIDS, TB, and malaria programs, the global efforts can continue to be funded through annual appropriations. The PEPFAR Stewardship and Oversight Acts do not authorize funding levels for any program, though they do authorize continued support for the Global Fund and maintain funding allocations for orphans and vulnerable children, as well as HIV/AIDS treatment and care efforts. Through FY2018, the bills:

maintain provisions limiting U.S. Global Fund contributions to 33% of contributions from all sources and continue withholding requirements related to Global Fund reforms and state sponsors of terrorism; require that at least 10% of all U.S.HIV/AIDS spending is allocated to orphans and vulnerable children; and require that at least 50% of all HIV/AIDS spending is allocated to care and treatment programs.

National Institutes of Health/Research

Until a cure or vaccine is identified, people will continue to die from HIV/AIDS if left untreated. Section 203 of the Lantos-Hyde Act amended subpart 1 of part D of title XXII of the Public Health Service Act to require the Director of the National Institutes of Health (NIH) Office of AIDS Research to develop a federal strategic plan for researching and developing tools to cure or prevent HIV/AIDS. The Public Health Service Act, as amended, also authorizes such sums as may be necessary from FY2009 through FY2013 for the Director of CDC to support research and development of microbicides for HIV prevention and for USAID to facilitate availability and accessibility of microbicides, provided they are authorized for use by the U.S. Food and Drug Administration (FDA) or some other quality assurance mechanism acceptable to the Secretary of HHS. Section 206 of the Lantos-Hyde Act requires the Secretary of the Treasury to negotiate the terms of U.S. participation in advanced market commitments for vaccine development and to submit a report to the appropriate congressional committees on the status of the negotiations no later than one year after the date of the enactment of the Lantos-Hyde Act.

Research and development can be an expensive endeavor. The quest to find improved tools for diagnosing, preventing, treating, and curing HIV/AIDS, TB, and malaria is still subsidized primarily by donor governments and philanthropic organizations. One study found, for example, that roughly 80% of all funding for TB research in 2010 was supported by public or philanthropic funding. Although language stipulating support for research and development, as described above, is set to expire, other language in other parts of the Leadership and Lantos-Hyde Acts that encourage research and development are enduring (for the permanent authorities, see " National Institutes of Health (NIH)/Research " in the " Permanent Authorities " section below). The PEPFAR Stewardship and Oversight Acts do not include language extending support for research and development efforts.

Permanent Authorities

Congress has played a key role not only in ensuring that global HIV/AIDS, TB, and malaria programs are adequately funded, but also in shaping how the programs are to be implemented. The section below highlights the sections in these Acts that are enduring.

Program Coordination

Section 102 of the Lantos-Hyde Act amended section 1(f)(2) of the State Department Basic Authorities Act of 1956 to establish an interagency working group on HIV/AIDS headed by OGAC and comprised of representatives from USAID and HHS to coordinate overall U.S. global HIV/AIDS policy and programs, among other things.

Reporting/Best Practices

In an effort to oversee PEPFAR implementation and assess its impact, several sections in the Leadership Act, as amended, direct several groups to evaluate the initiative. These sections are listed below. (A complete list of reporting requirements and the status of compliance is outlined in Table A-2 ).

Section 101 requires OGAC to publish annually a best practices report that highlights the programs receiving financial assistance from the United States that have the potential for replication or adaption, particularly at a low cost, across global AIDS programs. Section 101 requires OGAC to publish annually a report on per-patient HIV/AIDS treatment costs. Section 403 requires the President to submit annual reports on the U.S. global HIV sexual transmission prevention strategy.

National Institutes of Health (NIH)/Research

The Lantos-Hyde Act (primarily through amendments to permanent statutes) includes authorities that expanded U.S. engagement in research and development for the identification of improved tools for controlling and curing the three diseases. The relevant sections are summarized below.

Subpart 1 of part D of title XXII of the Public Health Service Act, as amended, requires NIH to carry out research on identifying safe and effective methods of preventing HIV transmission, including microbicides, among women. Section 307 of the Public Health Service Act, as amended, authorizes HHS to enter into cooperative agreements with other countries for the advancement of biomedical research, health care technology, health services research, and statistical analysis, and permitted HHS to provide financial assistance for the construction of facilities in foreign countries as part of related research efforts. Section 206 of the Lantos-Hyde Act requires USAID to coordinate with other development agencies to collect evidence for informed decision-making and introduction of new vaccines, including potential HIV/AIDS, TB, and malaria vaccines; and to review protocols for clinical trials. The section also requires the United States to participate in negotiations for advance market commitments for the development of future vaccines, including potential vaccines for HIV/AIDS, TB, and malaria. Language in the section requires the President to produce a comprehensive report that sets forth a coordinated strategy to accelerate development of vaccines for infectious diseases.

Country Ownership/Cost Sharing

As discussed earlier, the sustainability of PEPFAR programs and country ownership of related activities became an increasingly important part of debates about PEPFAR implementation. Section 301(c)(6) of the Lantos-Hyde Act amended section 104A(d) of the FAA to require the development of compacts or framework agreements at the country level that promote host government commitment; contribute to deeper integration of HIV/AID services into health systems; strengthen health systems; and enhance sustainability. Among other things, the country compacts outline the role of the United States and recipient countries in achieving national HIV/AIDS plans and specify cost sharing over a five-year period.

Nutrition

During the first phase of PEPFAR, a large body of research demonstrated how insufficient nutritional intake reduced the efficacy of HIV/AIDS treatment. Support for including nutritional support in PEPFAR programs grew and Congress amended section 301(c) of the FAA to require OGAC and USAID to adhere to World Health Organization (WHO) standards for HIV/AIDS food and nutrition services, integrate nutrition programs with HIV/AIDS activities, and provide food and nutritional support as a component of HIV/AIDS care and treatment programs.

Conscience Clause/ HIV Prevention

Debate about appropriate methods of preventing sexual transmission of HIV/AIDS has been intense, particularly in the early years of PEPFAR. Congress amended section 301(c) of the FAA and added language, known as the "conscience clause," to exempt faith-based groups and other organizations from engaging in activities that they deem morally objectionable. Specifically the FAA, as amended, specifies that organizations, including faith-based organization (FBOs), shall not be required to

endorse or utilize a multisectoral or comprehensive approach to combating HIV/AIDS; endorse, utilize, make a referral to, become integrated with, or otherwise participate in any program or activity to which the organization has a religious or moral objection; and shall not be discriminated against in the solicitation or issuance of such grants.

Meanwhile, Congress amended section 403(a) of the Leadership Act to ensure that the promotion of abstinence and monogamy would remain a central focus in any U.S. HIV/AIDS sexual prevention strategy. Specifically, the Leadership Act, as amended requires OGAC to establish an HIV sexual transmission prevention strategy governing the expenditure of funds. If any country does not allocate at least 50% of sexual transmission prevention funds to activities promoting abstinence, delay of sexual debut, monogamy, fidelity, and partner reduction, the Act directs OGAC to submit a report to Congress no later than 30 days after issuance of the strategy justifying the decision. Programs and activities that implement or purchase new prevention technologies or modalities, such as medical male circumcision and microbicides, are not to be included in determining compliance.

Tuberculosis and Malaria

Although discussions about reauthorizing the Lantos-Hyde Act and Leadership Act, as amended, tend to focus on global HIV/AIDS programs, the Acts also featured language that authorizes support for global TB and malaria programs. In addition to expiring authorities cited above, language in the Leadership Act, as amended and Lantos-Hyde Act (and the legislation that they amended) set program targets for TB programs, prioritized U.S. efforts to fight TB and malaria worldwide, and established a coordinator of all U.S. global malaria programs. Specific language included:

Section 104B(b) of the FAA, as amended, makes TB a major objective of U.S. foreign assistance, supports the objectives of the multilateral Global Plan to Stop TB , and establishes related goals for U.S. programs, which are to: halve the TB death and disease burden from 1990 levels and sustain or exceed the detection of at least 70% sputum smear-positive cases of TB and successfully treating at least 85% of the cases detected in countries with USAID programs. Section 302(d) of the Lantos-Hyde Act requires the President to submit an annual report to Congress that describes the impact of U.S. foreign assistance on efforts to control TB. Section 303 of the Leadership Act, as amended, makes the prevention, control, treatment, and ultimate eradication of malaria a major U.S. objective. Section 304 of the Leadership Act, as amended, establishes a Malaria Coordinator at USAID to oversee and coordinate all U.S. resources for combating malaria worldwide. Section 304 of the Leadership Act, as amended required the President to submit an annual report to Congress on U.S. assistance for preventing, treating, controlling, and eliminating malaria.

Immigration

HIV/AIDS advocates have long fought U.S. laws prohibiting HIV-positive people without special waivers from entering the United States. Section 305 of the Lantos-Hyde Act ended this practice by amending section 212(a)(1)(A)(i) of the Immigration and National Act. The amendment removed HIV/AIDS as a health-related ground for making an individual ineligible to receive a visa or be admitted into the United States. Due to the amendment, the United States was able to host the International AIDS Conference for the first time in July 2012. People living with HIV/AIDS are critical participants in the biannual conference.

Appendix A. Legislative Tables

The Leadership Act, as amended, Lantos-Hyde Act, and Foreign Assistance Act as amended, include several reporting requirements. The tables below list each requirement by section. The status column provides an interpretation of the extent to which the requirements have been addressed in formal reporting documents. "/" means some elements of the reporting requirement were included in the report, but not all. " " means all elements of the reporting requirement were included in the report. "x" means no elements of the reporting requirement were included in the report. The Administration may have submitted reports to Congress that adhered to reporting requirements but not made them publically available. "?" indicates that the report was not available on an executive agency website, but may have been made available elsewhere. This review of compliance is described chronologically and is limited to the reports indicated within the table notes.

Appendix B. Summary of the PEPFAR Stewardship and Oversight Act

The PEPFAR Stewardship and Oversight Act ( H.R. 3177 and S. 1545 ) extend certain funding authorities and strengthen program oversight. The bills do not authorize multi-year funding levels for bilateral HIV/AIDS, tuberculosis (TB), and malaria assistance overall, though they do authorize support for the Global Fund. The table below distinguishes authorities the bills seek to amend from those that are set to expire. Permanent authorities are not detailed here.