Top Ten Federal AIDS Issues in 2005

The National Alliance of State and Territorial AIDS Directors (NASTAD) invited AFC to submit a guest column for its HIV Prevention Bulletin highlighting the Top Ten Federal Issues to Watch in 2005.

1. Federal Budgetary Priorities-Shortly after his electoral victory in November, President George W. Bush announced a series of second-term domestic priorities that, if adopted by Congress, would dramatically erode federal spending on health programs for decades to come. The president is planning a national tour to promote legislation to privatize portions of Social Security, a plan that could cost the Treasury $2 trillion and fundamentally restructure the way future generations plan for retirement. The White House is also seeking another round of tax cuts and has pledged to halve the budget deficit in five years, all at a time of record expenses for war and homeland security. In order to pay for its costly priorities, the White House is pursuing draconian cuts to public healthcare programs, including a plan to reduce Medicaid funding to the states. The White House will resurrect a 2003 proposal to convert Medicaid into a block grant, which would essentially end the program's guarantee of coverage for all eligible recipients. With 55% of people with AIDS relying on Medicaid for their healthcare, limits on federal Medicaid funding, if enacted, would have a detrimental effect on HIV/AIDS care for our country's poorest and most vulnerable citizens. In addition, the president's budget priorities will put additional pressure on Congress to reduce discretionary spending for such programs as the Ryan White CARE Act, the Housing Opportunities for People with AIDS (HOPWA) program, HIV prevention services, and HIV/AIDS research through the National Institutes of Health. Virtually all AIDS-related programs received funding cuts in the last two years, with deep reductions taken from HOPWA ($13 million less in FY05) and the CARE Act ($10 million less in FY05 for all titles except the AIDS Drug Assistance Program). As action on the budget unfolds, AIDS advocates will need tremendous grassroots support to tell lawmakers that funding cuts for AIDS and other healthcare programs are unacceptable.

2. FY06 Appropriations-The appropriations approval process for fiscal 2006 will begin in earnest in February when President Bush unveils his proposed budget. AIDS advocates expect it will include plans to block grant Medicaid, reduce discretionary spending—which may include a third consecutive year of AIDS program cuts—and provisions to implement the president's domestic priorities (see above). With more people living with HIV/AIDS than ever before and new infections continuing unabated, the need for expanded AIDS programs and services has never been greater. Unfortunately, AIDS advocates expect a political environment that will favor Social Security privatization and tax cuts over increased HIV/AIDS funding. In order to protect and expand critical HIV/AIDS prevention and care programs, AIDS advocates will need to redouble advocacy efforts. Dozens of regional and national AIDS organizations are planning a national MARCH TO END AIDS, May 1-4, 2005 in Washington, DC. The effort will encourage AIDS advocates and organizations to host press conferences and HIV/AIDS visibility events as they make their way towards Washington. The event is scheduled to coincide with AIDSWatch, an annual HIV/AIDS lobbying event on Capitol Hill. For more information visit www.aidsvote.org and www.napwa.org.

3. CARE Act Reauthorization-Members of Congress will determine the future of the Ryan White CARE Act in 2005 when they draft and deliberate CARE Act reauthorization legislation. Incoming Senator Tom Coburn (R-OK), who has been at odds with AIDS advocates on condom availability, abstinence-only-until-marriage funding, and other topics, is widely expected to play a prominent role in CARE Act legislation, much as he did in 1999 and 2000 as a member of the U.S. House of Representatives. Reauthorization legislation may likely include radical changes to the AIDS Drug Assistance Program (ADAP), which remains severely under-funded, limits on support services, and provisions narrowing the CARE Act's focus to medical activities. A host of negative amendments on issues ranging from mandatory testing to partner notification and name-based HIV reporting are also expected. Several local, regional, and national AIDS organizations are organizing advocacy efforts aimed at protecting and strengthening the CARE Act. For a list of these groups, visit www.aidsvote.org.

4. Medicare Drug Benefit-In November 2005, the federal government will begin enrolling tens of thousands of seniors and people with disabilities in Medicare's complicated, new prescription drug benefit, which was enacted and signed into law in 2003. For millions of beneficiaries who are dually enrolled in Medicaid and Medicare, including some 60,000 people with HIV/AIDS, the law stipulates that they cease receiving prescription benefits from Medicaid on December 31, 2005, thereafter relying solely on the less comprehensive benefits to be offered by Medicare. Individuals who quality for both Medicaid and Medicare, known as "dual eligibles," are among the sickest and poorest to be served by the new program. Unfortunately, they may have unacceptable and harmful gaps in coverage in the process of switching to the new program, and may find that Medicare will cover far fewer medications than were provided under Medicaid. In 2005, AIDS advocates will continue to urge the federal Centers for Medicare and Medicaid Services to ensure that people with HIV/AIDS have access to the comprehensive drug benefits they need to survive, and that dual eligibles receive assistance transferring to the new benefits program without an interruption in coverage.

5. The CDC's 2000-2005 Strategic Plan for HIV Prevention-Federal officials will need to answer for a failed five-year strategic plan for HIV prevention that aimed to reduce by half the annual number of new HIV infections from 40,000 to 20,000 by 2005. Through 2004, the CDC has reported a stable number of new annual HIV infections-approximately 40,000-and alarming evidence that new infections may actually be on the rise. How the CDC characterizes the strategic plan and efforts to implement it, as well as what it intends to put in its place for the period ahead, will likely be a central focus of the National HIV Prevention conference in Atlanta in June. CDC will also update participants on its Advancing HIV Prevention initiative, which was launched with virtually no community input in 2003. The new initiative expands HIV testing and risk-reduction services for HIV-positive individuals at the expense of prevention education efforts targeting at-risk populations, including youth.

6. CDC Policy and Program Decisions-Federally funded HIV prevention organizations await a final determination from the CDC about regulations establishing review procedures they will need to follow before using any newly developed HIV educational materials. The CDC released in June 2004 a revised draft of the regulations, which require newly created materials to acknowledge the "effectiveness or lack of effectiveness" of condoms despite overwhelming evidence that, when used consistently and correctly, condoms are nearly 100% effective against HIV transmission. The draft rules also require jurisdictions to assemble independent panels representative of the community at-large (as opposed to previous requirements that membership on these panels be representative of the local HIV/AIDS epidemic) to ensure that newly created materials may not be considered obscene to the "average person." In addition, the jurisdiction's health department must independently determine that materials do not violate local obscenity standards (based on highly subjective and ambiguous criteria), thereby duplicating and potentially overriding the work of their review panels. In December 2004, the CDC announced that it is delaying a final determination of the rules as it has received some 5,000 public comments, ten-times more than it had expected. Final regulations may be announced in the spring or summer of 2005. AIDS organizations also remain concerned about the Program Evaluation and Monitoring System (PEMS), which will require extensive collection of client-level data, by encounter, and an increased amount of administrative support for data entry. The depth of information to be collected worries AIDS advocates who fear at-risk clients will be discouraged from continuing to seek important HIV prevention services. AIDS organizations also question the wisdom of such extensive data collection activities given the overwhelming and unmet community needs for HIV prevention services.

7. Drug Pricing Debate-Drug pricing will likely remain a potent political issue in 2005, with the 109th Congress expected to re-introduce legislation to allow the re-importation of drugs from Canada. For people with HIV/AIDS, the rising cost of HIV medications is one of the most significant barriers to care, and a contributing factor to the crisis facing AIDS Drug Assistance Programs (ADAP) across the country. With FDA approval of several new antiretroviral medications expected in 2005, states will need to weigh whether they can afford to add the new medications onto their ADAP formularies. In 2005, we also expect to learn whether the FDA is intent on providing expedited review of generic antiretroviral medications, including those manufactured abroad, for consideration under the President's Emergency Plan for AIDS Relief (PEPFAR). To date, the U.S. has only allowed PEPFAR to purchase brand name pharmaceuticals alleging that it cannot certify the safety of drastically cheaper foreign-made generics until the FDA has conducted a satisfactory review of each drug. By purchasing cheaper generic medications, the U.S. could vastly extend the reach of its global AIDS program and fulfill the promise made by President Bush during his 2003 State of the Union address to make generics available in the development world. In addition, Congress and the media will likely continue to discuss prescription drug safety following the high profile Vioxx scandal (Vioxx was found to elevate stroke risk) and emerging (and likely overblown) concerns about the safety of the antiretroviral nevirapine, which the U.S. has provided in the developing world as a low-cost method to prevent mother-to-child HIV transmission.

8. WHO's 3 x 5-Despite valiant efforts, it now remains clear that the World Health Organization (WHO) will be unlikely to meet its 3x5 campaign goal of providing antiretroviral therapy to 3 million people in the developing world by 2005. According to recent estimates, less that 1 million people in the developing world will actually obtain HIV therapies next year. While certainly disappointing, AIDS advocates will continue to press governments, including the U.S., and international organizations to accelerate efforts to create HIV treatment access in resource-poor settings worldwide.

9. Microbicide Funding-Annual federal funding for microbicide research and development is slated to exceed $100 million for the first time this year. While welcome news, research projects across various U.S. agencies and departments should be integrated into a singular federal plan to bring effective microbicide products to market in 7-10 years. In 2005, AIDS advocates will again call on House and Senate members to support the Microbicide Development Act, which would create a microbicide research and development branch at the National Institutes of Health (NIH) charged with setting scientific priorities and disbursing federal funds for microbicide research across various agencies and institutes. By centralizing funding, research, and planning activities, the NIH could more effectively lead efforts worldwide in the search for innovative, new HIV prevention tools that would be especially helpful for women.

10. Pre-Exposure Prophylaxis (PREP)-The CDC has begun clinical trials on three continents to investigate whether the antiretroviral drug tenofovir can be used as a new approach to HIV prevention. The studies are investigating the safety and efficacy of tenofovir as a daily oral HIV preventative among heterosexuals in Botswana, intravenous drug users in Thailand, and men who have sex with men in the U.S. The CDC will research the acceptability of the intervention, its affects on risk-taking behaviors, safety, and efficacy as an HIV prevention tool. Already ethical concerns about the research design have arisen in Thailand where AIDS advocates are calling on the U.S. to provide study participants access to sterile syringes-a polemic issue in the U.S., which prohibits by law federal funding for this proven HIV prevention intervention. The U.S. ban not withstanding, Thai law prohibits needle exchange as well. The CDC had also planned to conduct the trial with Cambodian sex workers but cancelled the project over objections by local AIDS advocates who demanded treatment guarantees for any trial participants who contracted HIV. Watch for more developments on PREP in the New Year.